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Liu Y, Liu HG, Zhao C. Intraperitoneal perfusion of endostatin improves the effectiveness and prolongs the prognosis of patients with gastric cancer. World J Gastrointest Oncol 2025; 17:103131. [DOI: 10.4251/wjgo.v17.i4.103131] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2024] [Revised: 01/02/2025] [Accepted: 02/18/2025] [Indexed: 03/25/2025] Open
Abstract
BACKGROUND Studies on the application of recombinant human endostatin (RH-endostatin) intraperitoneal perfusion in gastric cancer (GC) with malignant ascites are limited.
AIM To explore the effectiveness, prognosis, and safety of intraperitoneal RH-endostatin perfusion in treating patients with GC and malignant ascites.
METHODS Patients with GC and malignant ascites were divided into the cisplatin intraperitoneal perfusion (control group) group and the cisplatin combined with RH-endostatin intraperitoneal perfusion group (RH-endostatin group). Efficient ascites control, overall survival (OS), quality of life, and adverse events were observed, and possible influencing factors on prognosis outcomes analyzed.
RESULTS We identified no significant differences in baseline characteristics between the control and RH-endostatin groups. The latter group had higher ascites control rates than the control group. Treatment methods were identified as an independent OS factor. Clinically, RH-endostatin-treated patients had significantly improved OS rates when compared with control patients, particularly in those with small and moderate ascites volumes. Quality of life improvements in control patients were significantly lower when compared with RH-endostatin patients. Adverse events were balanced between the groups.
CONCLUSION Overall, intraperitoneal RH-endostatin improved treatment efficacy and prolonged prognosis in patients with GC and malignant ascites. This approach may benefit further clinical applications for treating GC.
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Affiliation(s)
- Yong Liu
- Department of Gastric Surgery, Tianjin Medical University Cancer Institute & Hospital, Tianjin 300000, China
- Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin 300000, China
- Tianjin Key Laboratory of Digestive Cancer, Tianjin Clinical Research Center for Cancer, Tianjin 300000, China
| | - Hong-Gen Liu
- Department of Oncology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300000, China
- National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin Cancer Institute of Traditional Chinese Medicine, Tianjin 300380, China
| | - Cheng Zhao
- Department of Oncology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300000, China
- National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin Cancer Institute of Traditional Chinese Medicine, Tianjin 300380, China
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Wang C, Hu X, Yang L, Xu Y, Zheng B, Yang J, Liao Z, Sun Z, Zhang S, Yu L, Yan Y, Chen Y, Fujiwara T, Zhang J, Buhtoiarov IN, Sun Y, Yan W. Anlotinib versus Placebo as Adjuvant Therapy for Localized High-Grade Soft-Tissue Sarcomas: A Phase II, Double-Blinded, Randomized Controlled Trial. Clin Cancer Res 2025; 31:1194-1203. [PMID: 39918552 DOI: 10.1158/1078-0432.ccr-24-2531] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2024] [Revised: 12/11/2024] [Accepted: 02/05/2025] [Indexed: 04/02/2025]
Abstract
PURPOSE We aimed to investigate the efficacy and safety of anlotinib as adjuvant targeted therapy for completely resected localized high-grade soft-tissue sarcomas (STS). PATIENTS AND METHODS Patients with localized high-grade STS after complete resection were randomly assigned in a 1:1 ratio to receive either oral 12 mg anlotinib or placebo once daily on days 1 to 14 every 21 days as a cycle, with up to six cycles until disease relapse, unmanageable toxicity, or death. The efficacy and safety were analyzed. This trial was the first trial exploring adjuvant targeted therapy for STS (NCT03951571). RESULTS Between June 2019 and November 2023, 88 patients were randomly assigned to receive anlotinib (n = 44) or placebo (n = 44). With a median follow-up of 30.95 months, the 1- and 2-year disease-free survival rates were 88% and 77% in the anlotinib group compared with 64% and 58% in the placebo group, respectively. Compared with patients treated with surgery alone, patients receiving adjuvant anlotinib combined with surgery had a reduced risk of disease recurrence [HR, 0.47; 95% confidence interval (CI), 0.22-1.00; P = 0.0445]. Based on the tumor histology, the reduced risk of disease recurrence with anlotinib versus placebo was observed in patients with myxofibrosarcoma (HR, 0.54; 95% CI, 0.17-1.65; P = 0.2698) and undifferentiated pleomorphic sarcoma (HR, 0.58; 95% CI, 0.12-2.87; P = 0.4971). Four patients discontinued anlotinib: two for proteinuria/hematuria (2/44, 5%) and two for poor healing of surgical wound (2/44, 5%). CONCLUSIONS Compared with surgery alone, adjuvant anlotinib following surgery reduces the incidence of disease relapse in localized high-grade STS, with acceptable toxicity.
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Affiliation(s)
- Chunmeng Wang
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Xianglin Hu
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Lingge Yang
- Department of Oncology, Yueyang People's Hospital of Hunan Normal University, Yueyang, China
| | - Yu Xu
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Biqiang Zheng
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Jilong Yang
- Department of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
- Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
| | - Zhichao Liao
- Department of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
- Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
| | - Zhengwang Sun
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Shengjian Zhang
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
- Department of Radiology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China
| | - Lin Yu
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
- Department of Pathology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China
| | - Yan Yan
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Yong Chen
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Tomohiro Fujiwara
- Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Jianrong Zhang
- Centre for Cancer Research & Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia
- Victorian Comprehensive Cancer Centre, Melbourne, Australia
| | - Ilia N Buhtoiarov
- Pediatric Hematology/Oncology and Bone Marrow Transplantation, Cleveland Clinic Children's Hospital, Cleveland, Ohio
| | - Yangbai Sun
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
| | - Wangjun Yan
- Department of Musculoskeletal Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
- Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
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Aoki T, Kudo M, Nishida N, Ueshima K, Tsuchiya K, Tada T, Morita M, Chishina H, Takita M, Hagiwara S, Ida H, Minami Y, Kuroda H, Nakamura N, Hiraoka A, Tomonari T, Tani J, Naganuma A, Kakizaki S, Ogawa C, Hatanaka T, Ishikawa T, Kawata K, Takebe A, Matsumoto I, Hidaka M, Kurosaki M, Kumada T, Izumi N. Proposal of discontinuation criteria of atezolizumab plus bevacizumab after curative conversion therapy for unresectable early-to-intermediate-stage hepatocellular carcinoma: a multicenter proof-of-concept study. J Gastroenterol 2025:10.1007/s00535-025-02233-z. [PMID: 40055288 DOI: 10.1007/s00535-025-02233-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/29/2024] [Accepted: 02/18/2025] [Indexed: 04/02/2025]
Abstract
BACKGROUND Achieving complete response (CR) is a desirable goal in early-to-intermediate-stage hepatocellular carcinoma (HCC). While systemic and locoregional therapies show promise, optimal drug discontinuation criteria remain unclear. This study aims to investigate drug-off criteria for atezolizumab plus bevacizumab as a proof-of-concept study. METHODS This retrospective multicenter study included child-pugh class A patients with unresectable HCC without extrahepatic spread or macrovascular invasion who received atezolizumab plus bevacizumab as first-line therapy. Modified clinical CR (mCCR) was defined as CR per mRECIST with sustained normal alpha-fetoprotein (AFP) levels (< 10.0 ng/dl). Recurrence-free survival (RFS) and overall survival (OS) were analyzed based on the "drug-off" criteria defined by following: (1) mRECIST CR with locoregional therapies, (2) sustained normalization of AFP/AFP-L3/ des-gamma-carboxy prothrombin (DCP) for 12-24 weeks, and (3) complete tumor vascularity disappearance by contrast-enhanced ultrasonography (CEUS) or pathological curative resection. RESULTS The median follow-up was 16.5 months (95% CI 15.2-17.8). Among 51 patients achieving mCCR, 11 underwent surgery, with pathological CR in three cases. In contrast, viable lesions were observed in 7 of 40 cases assessed using CEUS. All patients meeting the drug-off criteria (n = 9) showed no recurrence and none of them experienced mortality, while 45.2% (19/42) of those not meeting the criteria experienced recurrence (median RFS: 12.8 months, p = 0.007). The median OS was not reached in dug-off criteria met patients (n = 9), 37.7 months (95% CI: NA) in non-criteria met patients (n = 42), and 27.1 months (95% CI 16.7-37.6) in non-mCCR patients (n = 184) (p < 0.001). CONCLUSION In patients with unresectable and TACE-unsuitable early-to-intermediate-stage HCC who met the drug-off criteria, significantly improved RFS and OS were observed compared those who did not meet the criteria. However, further validation studies are required to confirm the utility of the criteria.
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Affiliation(s)
- Tomoko Aoki
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan.
| | - Naoshi Nishida
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Kazuomi Ueshima
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Kaoru Tsuchiya
- Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
| | - Toshifumi Tada
- Department of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan
| | - Masahiro Morita
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Hirokazu Chishina
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Masahiro Takita
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Satoru Hagiwara
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Hiroshi Ida
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Yasunori Minami
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, 589-8511, Japan
| | - Hidekatsu Kuroda
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan
| | - Noriaki Nakamura
- Department of General Surgery, Shuuwa General Hospital, Saitama, Japan
| | - Atsushi Hiraoka
- Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan
| | - Tetsu Tomonari
- Department of Gastroenterology and Oncology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan
| | - Joji Tani
- Department of Gastroenterology and Neurology, Kagawa University, Kagawa, Japan
| | - Atsushi Naganuma
- Department of Gastroenterology, NHO Takasaki General Medical Center, Takasaki, Japan
| | - Satoru Kakizaki
- Department of Clinical Research, NHO Takasaki General Medical Center, Takasaki, Japan
| | - Chikara Ogawa
- Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan
| | - Takeshi Hatanaka
- Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan
| | - Toru Ishikawa
- Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan
| | - Kazuhito Kawata
- Hepatology Division, Department of Internal Medicine II, Hamamatsu University School of Medicine, Hamamatsu, Japan
| | - Atsushi Takebe
- Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan
| | - Ippei Matsumoto
- Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan
| | - Masaaki Hidaka
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
| | - Masayuki Kurosaki
- Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
| | - Takashi Kumada
- Department of Nursing, Gifu Kyoritsu University, Ogaki, Japan
| | - Namiki Izumi
- Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
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Culakova E, Mohamed M, Flannery M, Jensen‐Battaglia M, Zhang Z, Ramsdale E, Tylock R, Stauffer F, Wells M, Magnuson A, Loh KP, Gada U, Janelsins M, Mohile S. Relationships between patient-reported and clinician-rated toxicities and daily functioning in older adults with advanced cancer undergoing systemic therapy. Cancer 2025; 131:e35766. [PMID: 39945245 PMCID: PMC11822747 DOI: 10.1002/cncr.35766] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/21/2024] [Revised: 01/10/2025] [Accepted: 01/14/2025] [Indexed: 02/16/2025]
Abstract
BACKGROUND Older adults with advanced cancer are at higher risk of treatment-related toxicities, which can impair function. Relationships between clinician-rated and patient-reported toxicities with functional decline remain unclear. METHODS This secondary analysis of the GAP70+ trial aimed to evaluate the associations between clinician-rated (Clinician-rated common Terminology Criteria for Adverse Events [CTCAE]) and patient-reported toxicities (PRO-CTCAE) with changes in physical performance and functional outcomes in older adults receiving systemic therapy. Physical performance was measured using the Short Physical Performance Battery (SPPB; impairment: score ≤9). Functional capacity was assessed using activities of daily living (ADL) and instrumental ADL (IADL); impairment: any task difficulty. Toxicities were captured by CTCAE and PRO-CTCAE, which assess symptom severity and activity interferences. Generalized estimating equations evaluated the association of toxicity grades (0-1, 2, ≥3) within 3 months of treatment initiation with new functional impairments within 6 months. RESULTS Patients were age 70 to 96 years. At baseline, 82.9% had impaired SPPB, 51.5% had impaired IADL, and 27.4% had impaired ADL. Among patients without baseline impairments, 57.7%, 47.4%, and 31.0% developed new SPPB, IADL, and ADL impairments, respectively. No association was found between CTCAE toxicity and new SPPB impairment (p = .70), but higher PRO-CTCAE toxicity severity (p = .02) and interference (p = .02) were associated with new SPPB impairments. New IADL impairments were more common with higher grades of CTCAE (p = .02) severe PRO-CTCAE toxicities (p = .02). CONCLUSION These findings emphasize the need to assess both clinician-rated and patient-reported toxicities to understand and mitigate functional decline in older adults with advanced cancer.
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Affiliation(s)
- Eva Culakova
- Department of SurgerySupportive Care in CancerUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Mostafa Mohamed
- Department of Public Health SciencesUniversity of RochesterRochesterNew YorkUSA
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Marie Flannery
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | | | - Zhihong Zhang
- School of NursingUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Erika Ramsdale
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Rachael Tylock
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Fiona Stauffer
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Megan Wells
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Allison Magnuson
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Kah Poh Loh
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Umang Gada
- Department of SurgerySupportive Care in CancerUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Michelle Janelsins
- Department of SurgerySupportive Care in CancerUniversity of Rochester Medical CenterRochesterNew YorkUSA
| | - Supriya Mohile
- Division of Hematology/OncologyDepartment of MedicineJames P Wilmot Cancer InstituteUniversity of Rochester Medical CenterRochesterNew YorkUSA
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Mohamed MR, Juba K, Awad H, Flannery M, Culakova E, Wells M, Cacciatore J, Jensen-Battaglia M, Mohile S, Ramsdale E. Effect of polypharmacy and potentially inappropriate medications on physical functional decline among older adults with advanced cancer receiving systemic treatment. Support Care Cancer 2024; 32:674. [PMID: 39294452 DOI: 10.1007/s00520-024-08877-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2024] [Accepted: 09/12/2024] [Indexed: 09/20/2024]
Abstract
BACKGROUND Polypharmacy and potentially inappropriate medications (PIM) are common among older adults with advanced cancer, but their association with physical functional outcomes is understudied. This study aimed to estimate the risk of physical functional decline associated with medication measures in older adults with advanced cancer starting a new line of systemic treatment. METHODS This secondary analysis of GAP 70+ Trial (PI: Mohile) enrolled patients aged 70+ with advanced cancer, had ≥ 1 geriatric assessment domain impairment and planned to start a new antineoplastic regimen with a high risk of toxicity. Polypharmacy (concurrent use of ≥ 8 medications (meds)) was assessed before initiation of treatment. PIM were categorized using Screening Tool of Older Person's Prescriptions (STOPP) criteria and 2019 Beers criteria. Physical functional outcomes were assessed within 3 months of treatment initiation: (1) Activity of Daily Living (ADL) decline: 1-point decrease in ADL score between baseline and 3 months; (2) Instrumental ADL (IADL) decline: 1-point decrease in IADL score between baseline and 3 months; (3) Short physical performance battery (SPPB) decline, defined as 1-point decrease on SPPB; (4) ≥ 1 falls within 3 months of treatment. Separate multivariable, cluster-weighted Generalized Estimating Equations models adjusted for relevant covariates (e.g., age, baseline function/comorbidities). RESULTS Among 616 participants, mean number of meds was 6 (range 0-24); 28% received ≥ 8 meds. Polypharmacy was associated with increased risk of ADL decline (adjusted risk ratio [aRR], 1.31; 95% CI, 1.00-1.71). Taking ≥ 1 PIM per STOPP was associated with increased risk of IADL decline (aRR, 1.21; 95% CI, 1.04-1.40) and falls (aRR, 1.93; 95% CI, 1.49-2.51). CONCLUSIONS In a large cohort of vulnerable older adults with advanced cancer receiving systemic treatment, polypharmacy and PIM were independently associated with an increased risk of physical functional decline. This emphasizes the need to develop interventions to optimize medication use, intending to improve outcomes in these patients. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02054741. Registered 01-31-2014.
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Affiliation(s)
- Mostafa R Mohamed
- Department of Public Health, University of Rochester, Rochester, NY, USA.
- Wilmot Cancer Institute, University of Rochester, 601 Elmwood Avenue, Box 704, Rochester, NY, 14642, USA.
| | - Katherine Juba
- Department of Pharmacy Practice, Wegmans School of Pharmacy, Rochester, NY, USA
| | - Hala Awad
- Wilmot Cancer Institute, University of Rochester, 601 Elmwood Avenue, Box 704, Rochester, NY, 14642, USA
| | - Marie Flannery
- University of Rochester School of Nursing, Rochester, NY, USA
| | - Eva Culakova
- Department of Surgery, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA
| | - Megan Wells
- Wilmot Cancer Institute, University of Rochester, 601 Elmwood Avenue, Box 704, Rochester, NY, 14642, USA
| | - Jenna Cacciatore
- Wilmot Cancer Institute, University of Rochester, 601 Elmwood Avenue, Box 704, Rochester, NY, 14642, USA
| | - Marielle Jensen-Battaglia
- Department of Public Health, University of Rochester, Rochester, NY, USA
- Wilmot Cancer Institute, University of Rochester, 601 Elmwood Avenue, Box 704, Rochester, NY, 14642, USA
| | - Supriya Mohile
- Wilmot Cancer Institute, University of Rochester, 601 Elmwood Avenue, Box 704, Rochester, NY, 14642, USA
| | - Erika Ramsdale
- Wilmot Cancer Institute, University of Rochester, 601 Elmwood Avenue, Box 704, Rochester, NY, 14642, USA
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Liu Y, Ji Y, Zhu J, Zhu L, Zhu Y, Bao Z, Zhao H. Repeated high‑intensity focused ultrasound combined with iodine‑125 seed interstitial brachytherapy offers improved quality of life and pain control for patients with advanced pancreatic cancer: A 52‑patient retrospective study. Oncol Lett 2024; 27:157. [PMID: 38426153 PMCID: PMC10902751 DOI: 10.3892/ol.2024.14290] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/18/2023] [Accepted: 01/29/2024] [Indexed: 03/02/2024] Open
Abstract
Patients diagnosed with pancreatic cancer who have 5-year survival rates of ~5% are typically in the advanced stage. Pancreatic cancer has become the third leading cause of cancer-related death in the United States and there is still a lack of effective treatments to improve patient survival rate. Hence, the purpose of the present retrospective study was to assess the potential clinical impact of repeated high-intensity focused ultrasound (HIFU) combined with iodine-125 (125I) interstitial brachytherapy for the treatment of patients with advanced pancreatic cancer who were ineligible for or declined surgery and chemotherapy. A total of 52 patients diagnosed with advanced pancreatic cancer were included in the study. At least one course of HIFU therapy combined with percutaneous ultrasound-guided 125I seed implantation was administered to each patient. The clinical assessment included an evaluation of Karnofsky Performance Scale (KPS) score at baseline, and at 1 and 2 months after combined therapy. Pain intensity was additionally evaluated with the numerical rating score (NRS). Overall survival (OS) times and survival rates at 3, 6, 9 and 12 months after combined treatment were evaluated. Adverse events commonly associated with HIFU and 125I seed implantation were recorded, and the severity of adverse events was graded according to the Common Terminology Criteria for Adverse Events, version 4. All 52 patients received successful repeated HIFU treatment combined with 125I seed implantation and were included in the analysis of efficacy and safety. The median OS time of patients was estimated to be 13.1 months (95% CI, 11.3-14.8). The survival rates at 3, 6, 9 and 12 months were 100.0, 86.5, 61.5 and 53.8%, respectively. The mean KPS score was 62.7±6.3 at baseline, 73.7±7.9 at 1 month and 68.8±6.5 at 2 months after combined treatment. KPS score increased significantly after combined therapy. The mean NRS score was 6.7±1.6 at baseline, and 4.7±1.7 and 5.4±1.5 at 1 and 2 months after combined treatment, respectively. The number of patients with severe pain and the NRS score were both significantly lower at 1 and 2 months after 125I seed implantation compared with those at baseline. No serious complications were detected during the follow-up period. In conclusion, the present study demonstrated the survival benefit and improvement in quality of life of patients with advanced pancreatic cancer receiving repeated HIFU treatment combined with 125I interstitial brachytherapy, which may provide new ideas and methods for the treatment of pancreatic cancer.
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Affiliation(s)
- Yumei Liu
- High-Intensity Focused Ultrasound Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, P.R. China
| | - Yongshuo Ji
- High-Intensity Focused Ultrasound Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, P.R. China
| | - Junqiu Zhu
- High-Intensity Focused Ultrasound Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, P.R. China
| | - Linglin Zhu
- High-Intensity Focused Ultrasound Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, P.R. China
| | - Yanfei Zhu
- High-Intensity Focused Ultrasound Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, P.R. China
| | - Zhijun Bao
- Department of Gerontology, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, P.R. China
- Shanghai Key Laboratory of Clinical Geriatric Medicine, Fudan University, Shanghai 200040, P.R. China
- Research Center on Aging and Medicine, Fudan University, Shanghai 200040, P.R. China
| | - Hong Zhao
- High-Intensity Focused Ultrasound Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, P.R. China
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Chen C, Duan X, Shen Y, Li G. The clinical efficacy and safety of TACE combined with apatinib for advanced hepatocellular carcinoma: A propensity score matching analysis. Indian J Cancer 2024; 61:390-395. [PMID: 36861715 DOI: 10.4103/ijc.ijc_967_20] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2020] [Accepted: 03/12/2021] [Indexed: 12/02/2022]
Abstract
BACKGROUND The combined treatment of transcatheter arterial chemoembolization (TACE) and apatinib had beneficial effects on the survival of patients with advanced hepatocellular carcinoma (HCC), but the efficacy of this regimen is still controversial and needs further investigation. MATERIALS AND METHODS The clinical records of advanced HCC patients between May 2015 and December 2016 were collected from our hospital. They were categorized into the TACE monotherapy group and the combination of TACE and apatinib group. After propensity score matching (PSM) analysis, the disease control rate (DCR), objective response rate (ORR), progression-free survival (PFS), and occurrence of adverse events were compared between the two treatments. RESULTS There were 115 HCC patients included in the study. Among them, 53 received TACE monotherapy and 62 were treated with TACE plus apatinib. After PSM analysis, 50 pairs of patients were compared. The DCR of the TACE group was significantly lower than that of the combination of TACE and apatinib group (35 [70%] versus 45 [90%], P < 0.05). The ORR of the TACE group was also significantly lower than that of the combination of TACE and apatinib group (22 [44%] versus 34 [68%], P < 0.05). Patients who received the combined treatment of TACE and apatinib had longer PFS compared with those in the TACE monotherapy group ( P < 0.001). Moreover, hypertension, hand-foot syndrome, and albuminuria were more common in the combination of TACE and apatinib group ( P < 0.05), although all adverse events were well tolerated. CONCLUSIONS The combined treatment of TACE and apatinib showed beneficial effects on tumor response, survival outcomes, and tolerance to treatment, which may be used as a routine regimen for advanced HCC patients.
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Affiliation(s)
- Cheng Chen
- Department of Oncology, Affiliated Hospital of Hebei University of Engineering, Handan, Hebei, People's Republic of China
| | - Xiaoting Duan
- Department of Nephrology, Affiliated Hospital of Hebei University of Engineering, Handan, Hebei, People's Republic of China
| | - Yanfeng Shen
- Department of Oncology, Affiliated Hospital of Hebei University of Engineering, Handan, Hebei, People's Republic of China
| | - Guiying Li
- Department of Nephrology, Affiliated Hospital of Hebei University of Engineering, Handan, Hebei, People's Republic of China
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8
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de Freitas Neiva Lessa A, Meirelles DP, Do Couto AM, Duarte Da Silva K, De Aguiar MCF. Scales to graduate oral mucositis: What are the limitations? Oral Oncol 2023; 144:106489. [PMID: 37421673 DOI: 10.1016/j.oraloncology.2023.106489] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/04/2023] [Revised: 04/17/2023] [Accepted: 06/29/2023] [Indexed: 07/10/2023]
Abstract
Oral mucositis is a common acute complication of a head and neck squamous cell carcinoma treatment. Multiple scales can be used to diagnose and grade this lesion, but they all have some limitation regarding this group of patients. Most of these issues are associated with the hardness to differentiate signs and symptoms from oral mucositis vs. the inherent neoplasm. This study highlights the importance of a specifically developed scale for patients with head and neck squamous cell carcinoma.
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Affiliation(s)
- Adriele de Freitas Neiva Lessa
- Department of Oral Pathology and Surgery, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil; Research Department - Hospital do Câncer de Muriaé. Fundação Cristiano Varella, Muriaé, MG, Brazil.
| | - Daniela Pereira Meirelles
- Department of Oral Pathology and Surgery, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil
| | - Aline Maria Do Couto
- Department of Oral Pathology and Surgery, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil
| | - Karine Duarte Da Silva
- Department of Oral Pathology and Surgery, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil
| | - Maria Cássia Ferreira De Aguiar
- Department of Oral Pathology and Surgery, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil
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9
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Ning J, Wang S, Guo Y, Diao J, Bai X, Wang H, Hu K, Zhao Q. High Intensity Focused Ultrasound Ablation for Patients With Locally Advanced Pancreatic Adenocarcinoma: A Propensity Score-Matching Analysis. JOURNAL OF ULTRASOUND IN MEDICINE : OFFICIAL JOURNAL OF THE AMERICAN INSTITUTE OF ULTRASOUND IN MEDICINE 2023; 42:1595-1607. [PMID: 36691925 DOI: 10.1002/jum.16181] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/22/2022] [Revised: 11/30/2022] [Accepted: 12/17/2022] [Indexed: 06/17/2023]
Abstract
OBJECTIVES This retrospective study was conducted to assess the efficacy and safety of high intensity focused ultrasound (HIFU) in combination with chemotherapy compared with chemotherapy alone in treating patients with unresectable locally advanced pancreatic cancer (LAPC). METHODS The data of unresectable LAPC patients who received chemotherapy with or without HIFU ablation were retrieved retrospectively. The overall survival (OS), objective response rate (ORR), cancer antigen 19-9 response rate, and safety were compared between these two groups before and after propensity score matching (PSM). RESULTS Overall, 254 patients with LAPC were included, of whom 92 underwent HIFU ablation. After PSM to control for potential biases, HIFU was associated with improved OS (12.8 versus 12.2 months, log-rank P = .046), as compared to patients without HIFU ablation. Patients with numeric rating scale (NRS) less than 4, and receiving HIFU ablation were significantly associated with improved OS (adjusted hazard ratio [aHR] = 0.365 [95% confidence interval (CI) = 0.148-0.655], P = .002; aHR = 0.490 [95% CI = 0.250-0.961], P = .038; respectively) by multivariate analyses with the adjustment of age, NRS, and tumor size. ORR was also observed to be higher in HIFU group of 30.0% than in the chemotherapy group of 13.3% (P = .039). No severe adverse events of special interest or HIFU-caused deaths were observed. CONCLUSIONS Patients with unresectable LAPC who received gemcitabine-based chemotherapy might benefit from additional HIFU ablation.
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Affiliation(s)
- Jiwei Ning
- Clinical Lab, The Third People's Hospital of Datong, Datong, People's Republic of China
| | - Shifeng Wang
- Department of Gastroenterology, The Second People's Hospital of Datong Cancer Hospital, Datong, People's Republic of China
| | - Yuehao Guo
- Department of Health Science, University of York, York, England
| | - Jianfeng Diao
- Department of Gastroenterology, The Second People's Hospital of Datong Cancer Hospital, Datong, People's Republic of China
| | - Xuehong Bai
- Department of Gastroenterology, The Second People's Hospital of Datong Cancer Hospital, Datong, People's Republic of China
| | - Hongjin Wang
- Department of Gastroenterology, The Second People's Hospital of Datong Cancer Hospital, Datong, People's Republic of China
| | - Kaimeng Hu
- Marketing Department, Shanghai A&S Science Technology Development Co., Ltd, Shanghai, People's Republic of China
| | - Qingwen Zhao
- Department of Gastroenterology, The Second People's Hospital of Datong Cancer Hospital, Datong, People's Republic of China
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10
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Riegel AC, Nosrati JD, Sidiqi BU, Cooney A, Wuu YR, Lee L, Potters L. Determining Combined Modality Dosimetric Constraints by Integration of IMRT and LDR Prostate Brachytherapy Dosimetry and Correlation with Toxicity. Adv Radiat Oncol 2023; 8:101156. [PMID: 36896208 PMCID: PMC9991539 DOI: 10.1016/j.adro.2022.101156] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2022] [Accepted: 12/14/2022] [Indexed: 12/30/2022] Open
Abstract
Purpose Intermediate- and high-risk prostate cancer patients undergoing combination external beam radiation therapy (EBRT) and low dose rate (LDR) brachytherapy have demonstrated increased genitourinary (GU) toxicity. We have previously demonstrated a method to combine EBRT and LDR dosimetry. In this work, we use this technique for a sample of patients with intermediate- and high-risk prostate cancer, correlate with clinical toxicity, and suggest preliminary summed organ-at-risk constraints for future investigation. Methods and Materials Intensity modulated EBRT and 103Pd-based LDR treatment plans were combined for 138 patients using biological effective dose (BED) and deformable image registration. GU and gastrointestinal (GI) toxicity were compared with combined dosimetry for the urethra, bladder, and rectum. Differences between doses in each toxicity grade were assessed by analysis of variance (α = 0.05). Combined dosimetric constraints are proposed using the mean organ-at-risk dose, subtracting 1 standard deviation for a conservative recommendation. Results The majority of our 138-patient cohort experienced grade 0 to 2 GU or GI toxicity. Six grade 3 toxicities were noted. Mean prostate BED D90 (± 1 standard deviation) was 165.5±11.1 Gy. Mean urethra BED D10 was 230.3±33.9 Gy. Mean bladder BED was 35.2±11.0 Gy. Mean rectum BED D2cc was 85.6±24.3 Gy. Significant dosimetric differences between toxicity grades were found for mean bladder BED, bladder D15, and rectum D50, but differences between individual means were not statistically significant. Given the low incidence of grade 3 GU and GI toxicity, we propose urethra D10 <200 Gy, rectum D2cc <60 Gy, and bladder D15 <45 Gy as preliminary dose constraints for combined modality therapy. Conclusions We successfully applied our dose integration technique to a sample of patients with intermediate- and high-risk prostate cancer. Incidence of grade 3 toxicity was low, suggesting that combined doses observed in this study were safe. We suggest preliminary dose constraints as a conservative starting point to investigate and escalate prospectively in a future study.
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Affiliation(s)
- Adam C Riegel
- Department of Radiation Medicine, Northwell Health, Lake Success, New York.,Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York
| | - Jason D Nosrati
- Department of Radiation Medicine, Northwell Health, Lake Success, New York
| | - Baho U Sidiqi
- Department of Radiation Medicine, Northwell Health, Lake Success, New York
| | - Ann Cooney
- Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Yen-Ruh Wuu
- Department of Radiation Medicine, Northwell Health, Lake Success, New York
| | - Lucille Lee
- Department of Radiation Medicine, Northwell Health, Lake Success, New York.,Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York
| | - Louis Potters
- Department of Radiation Medicine, Northwell Health, Lake Success, New York.,Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York
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11
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Lee GJ, Kim H, Cho SS, Park HS, An HJ, Woo IS, Byun JH, Hong JH, Ko YH, Sun DS, Won HS, Jin JY, Park JC, Kim IH, Roh SY, Shim BY. A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation. J Gastric Cancer 2023; 23:315-327. [PMID: 37129155 PMCID: PMC10154142 DOI: 10.5230/jgc.2023.23.e16] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2022] [Revised: 02/05/2023] [Accepted: 02/09/2023] [Indexed: 05/03/2023] Open
Abstract
PURPOSE Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. MATERIALS AND METHODS Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. RESULTS Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). CONCLUSIONS After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02289547.
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Affiliation(s)
- Guk Jin Lee
- Division of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hyunho Kim
- Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Sung Shim Cho
- Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hyung Soon Park
- Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Ho Jung An
- Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - In Sook Woo
- Division of Medical Oncology, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Jae Ho Byun
- Division of Medical Oncology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Ji Hyung Hong
- Division of Medical Oncology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Yoon Ho Ko
- Division of Medical Oncology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Der Sheng Sun
- Division of Medical Oncology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hye Sung Won
- Division of Medical Oncology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Jong Youl Jin
- Division of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Ji Chan Park
- Division of Medical Oncology, Department of Internal Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - In-Ho Kim
- Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Sang Young Roh
- Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Byoung Yong Shim
- Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
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12
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Matsuda Y, Jayasinghe RD, Zhong H, Arakawa S, Kanno T. Oral Health Management and Rehabilitation for Patients with Oral Cancer: A Narrative Review. Healthcare (Basel) 2022; 10:healthcare10050960. [PMID: 35628095 PMCID: PMC9140416 DOI: 10.3390/healthcare10050960] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2022] [Revised: 04/29/2022] [Accepted: 05/20/2022] [Indexed: 12/10/2022] Open
Abstract
Surgery is the current first choice for oral cancer treatment. Intensity-modulated radiation therapy, molecular targeted drugs, and immune checkpoint inhibitors are still used as adjuvant therapy for advanced cancer. In addition, postoperative rehabilitation and multidisciplinary treatment have also been developed in recent years. Multidisciplinary team approaches and supportive care in oral cancer treatment reportedly shorten the time to treatment and improve outcomes. Although there is enough evidence confirming the role of oral and maxillofacial surgeons, dentists, and dental hygienists in supportive care in oral cancer treatment, there are very few systematic studies. In particular, oral health management is a concept that encompasses oral function management, oral hygiene management, and oral care during oral cancer treatment. We provide a narrative review focusing on oral health management from a multidisciplinary and supportive care perspective, applicable in oral cancer treatment.
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Affiliation(s)
- Yuhei Matsuda
- Department of Lifetime Oral Health Care Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo 113-8501, Japan; (H.Z.); (S.A.)
- Department of Oral and Maxillofacial Surgery, Shimane University Faculty of Medicine, Izumo 693-8501, Japan;
- Correspondence: ; Tel.: +81-3-5803-4649
| | - Ruwan D. Jayasinghe
- Center for Research in Oral Cancer, Department of Oral Medicine and Periodontology, Faculty of Dental Sciences, University of Peradeniya, Getambe 20400, Sri Lanka;
| | - Hui Zhong
- Department of Lifetime Oral Health Care Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo 113-8501, Japan; (H.Z.); (S.A.)
| | - Shinichi Arakawa
- Department of Lifetime Oral Health Care Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo 113-8501, Japan; (H.Z.); (S.A.)
| | - Takahiro Kanno
- Department of Oral and Maxillofacial Surgery, Shimane University Faculty of Medicine, Izumo 693-8501, Japan;
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13
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Hyperthermic Intraperitoneal Chemotherapy plus Intravenous Chemotherapy of Paclitaxel with or without Sintilimab in Gastric Cancer: A Comparative Study. JOURNAL OF ONCOLOGY 2022; 2022:3054485. [PMID: 35242186 PMCID: PMC8888085 DOI: 10.1155/2022/3054485] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/03/2021] [Revised: 12/22/2021] [Accepted: 12/28/2021] [Indexed: 11/24/2022]
Abstract
Objective To compare the clinical efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) plus intravenous chemotherapy of paclitaxel with or without sintilimab in peritoneal metastasis of gastric cancer. Methods A total of 120 patients assessed for eligibility with peritoneal metastasis of gastric cancer treated in the oncology department of our hospital from January 2019 to June 2020 were recruited. They were concurrently randomly assigned in a 1 : 1 ratio to receive HIPEC plus sintilimab-paclitaxel intravenous chemotherapy (study group) or plus paclitaxel intravenous chemotherapy only (control group). Results The objective remission rate (ORR) of ascites in the study group was significantly higher than that in the control group. Subgroup analysis showed that an age ≤60 years or well-differentiated tumors were associated with better objective remission. After treatment, significantly higher Karnofsky Performance Status (KPS) scores were observed in the study group versus those of the control group. Adverse events reported were comparable between groups. The study group obtained longer 12-month progression-free survival (PFS) and overall survival (OS) than those of the control group. Conclusion On top of HIPEC, intravenous chemotherapy with sintilimab and paclitaxel constitute an effective alternative for patients with peritoneal metastasis of gastric cancer to enhance ascites remission, ameliorate the quality of life, and prolong survival, versus with paclitaxel alone.
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14
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Aoki T, Nishida N, Ueshima K, Morita M, Chishina H, Takita M, Hagiwara S, Ida H, Minami Y, Yamada A, Sofue K, Tsurusaki M, Kudo M. Higher Enhancement Intrahepatic Nodules on the Hepatobiliary Phase of Gd-EOB-DTPA-Enhanced MRI as a Poor Responsive Marker of Anti-PD-1/PD-L1 Monotherapy for Unresectable Hepatocellular Carcinoma. Liver Cancer 2021. [PMID: 34950184 DOI: 10.1159/000518048.] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/19/2022] Open
Abstract
Introduction Immune checkpoint inhibitors (ICIs) are promising agents for the treatment of hepatocellular carcinoma (HCC). However, the establishment of noninvasive measure that could predict the response to ICIs is challenging. This study aimed to evaluate tumor responses to ICIs using the hepatobiliary phase of gadolinium-ethoxybenzyl-diethylenetriamine (Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI), which was shown to reflect Wnt/β-catenin activating mutation. Methods A total of 68 intrahepatic HCC nodules from 18 patients with unresectable HCC and Child-Pugh class A liver function who received anti-programmed cell death 1 (PD-1)/programmed death-ligand 1 (PD-L1) monotherapy were enrolled in this study. All patients had viable intrahepatic lesions evaluable using the hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI within the 6 months prior to the treatment. The relative enhancement ratio was calculated, and the time to nodular progression (TTnP) defined as 20% or more increase in each nodule was compared between higher or hypo-enhancement HCC nodules. Then, the progression-free survival (PFS) and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) were compared between patients with and without HCC nodules with higher enhancement on hepatobiliary phase images. Results The median PFS was 2.7 (95% confidence interval [CI]: 1.4-4.0) months in patients with HCC nodules with higher enhancement (n = 8) and 5.8 (95% CI: 0.0-18.9) months in patients with hypointense HCC nodules (n = 10) (p = 0.007). The median TTnP of HCC nodules with higher enhancement (n = 23) was 1.97 (95% CI: 1.86-2.07) months and that of hypointense HCC nodules (n = 45) was not reached (p = 0.003). The ORR was 12.5% (1/8) versus 30.0% (3/10); the disease control rate was 37.5% (3/8) versus 70.0% (7/10), respectively, in patients with or without higher enhancement intrahepatic HCC nodules. Conclusion The TTnP on HCC nodules with higher enhancement and the median PFS in patients who carried higher enhancement intrahepatic HCC nodules were significantly shorter than those in hypointense HCC nodules with anti-PD-1/PD-L1 monotherapy. The intensity of the nodule on the hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI is a promising imaging biomarker for predicting unfavorable response with anti-PD-1/PD-L1 monotherapy in patients with HCC.
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Affiliation(s)
- Tomoko Aoki
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Naoshi Nishida
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Kazuomi Ueshima
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masahiro Morita
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Hirokazu Chishina
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masahiro Takita
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Satoru Hagiwara
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Hiroshi Ida
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Yasunori Minami
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Akira Yamada
- Department of Radiology, Shinshu University School of Medicine, Nagano, Japan
| | - Keitaro Sofue
- Department of Radiology, Kobe University Graduate School of Medicine, Kobe, Japan
| | - Masakatsu Tsurusaki
- Department of Radiology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
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Darvishpour S, Avan R, Azadbakht M, Maham M, Akbari J, Janbabaei G, Zaboli E, Amirabadizadeh AR, Salehifar E. Malus domestica reduces chemotherapy-induced nausea and vomiting: A randomized double-blind placebo-controlled clinical trial. JOURNAL OF RESEARCH IN MEDICAL SCIENCES 2021; 26:72. [PMID: 34759989 PMCID: PMC8548888 DOI: 10.4103/jrms.jrms_833_20] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/29/2020] [Revised: 10/03/2020] [Accepted: 04/22/2021] [Indexed: 11/04/2022]
Abstract
Background Chemotherapy-induced nausea and vomiting (CINV) is considered as the most common complications of chemotherapy which has a detrimental influence on the quality of life of patients with cancer. We assessed the efficacy of Apple (Malus domestica) syrup for reducing CINV. Materials and Methods This study was a randomized, double-blind, placebo-controlled trial carried out in a Hematooncology Clinic affiliated to Mazandaran University of Medical Sciences, Sari, Iran (from October 2017 to August 2018). Subjects were randomly allocated to receive apple syrup or placebo along with their previous antiemetic treatment and chemotherapy regimen, three times a day. Thirty-four patients received apple syrup (n = 16) or placebo (n = 18). Statistical analysis was conducted using SPSS software Version 21® (SPSS Inc., Chicago, IL, USA). A P < 0.05 indicated statistical significance. Results Both acute and delayed nausea grades were significantly lower in M. domestica syrup in comparison to placebo syrup (P = 0.001 and 0.001, respectively). The duration of nausea (P = 0.04) was lower in intervention group compared to placebo group. Conclusion These findings demonstrated that M. domestica syrup can reduce the severity and duration of nausea in cancer patients who received chemotherapy.
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Affiliation(s)
- Sharareh Darvishpour
- Department of Clinical Pharmacy, Gastrointestinal Cancer Research Center, Student Research Committee, Mazandaran University of Medical Sciences, Sari, Iran
| | - Razieh Avan
- Department of Clinical Pharmacy, Medical Toxicology and Drug Abuse Research Center (MTDRC), School of Pharmacy, Birjand University of Medical Sciences, Birjand, Iran
| | - Mohammad Azadbakht
- Department of Pharmacognosy, Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
| | - Monireh Maham
- Department of Clinical Pharmacy, Student Research Committee, Resident of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
| | - Jafar Akbari
- Department of Pharmaceutics, Pharmaceutical Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
| | - Ghasem Janbabaei
- Department of Hematology and Oncology, Gastrointestinal Cancer Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
| | - Ehsan Zaboli
- Department of Hematology and Oncology, Gastrointestinal Cancer Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
| | - Ali Reza Amirabadizadeh
- Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran
| | - Ebrahim Salehifar
- Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
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Lin YT, Chen Y, Liu TX, Kuang F, Huang P. Cost-Effectiveness Analysis of Camrelizumab Immunotherapy versus Docetaxel or Irinotecan Chemotherapy as Second-Line Therapy for Advanced or Metastatic Esophageal Squamous Cell Carcinoma. Cancer Manag Res 2021; 13:8219-8230. [PMID: 34754242 PMCID: PMC8572144 DOI: 10.2147/cmar.s335515] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2021] [Accepted: 10/24/2021] [Indexed: 01/18/2023] Open
Abstract
Purpose The aim of this study was to assess the cost-effectiveness of camrelizumab immunotherapy versus docetaxel or irinotecan chemotherapy as second-line therapy for advanced esophageal squamous cell carcinoma (ESCC), which was evaluated in the ESCORT trial. Materials and Methods A partitioned survival model was developed to reflect the costs and effectiveness of the ESCORT trial. The clinical efficacy data, safety data, and health-related costs and utilities were derived from published data from clinical trials or health administration departments in China. Adverse event-related costs, drug administration, and other expenses were derived from a single center of Fujian Medical University Cancer Hospital in 2021. All survival analyses were performed with SPSS software. Overall survival was estimated with the Kaplan-Meier method, and progression-free survival was estimated with the life table method. Sensitivity analyses were conducted to assess the uncertainty of the model. Incremental cost, quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (ICER) were calculated. Results Camrelizumab therapy had 0.232 QALYs at an incremental cost of USD$9959.44 compared with the chemotherapy group with 0.158 QALYs at an incremental cost of USD$8601.67. The ICER was USD$18393.12/QALY. Probabilistic sensitivity analyses showed that when the willingness-to-pay threshold reached USD$31200/QALY, which is nearly three times the Chinese gross domestic product per capita, camrelizumab had an 80% possibility of being cost-effective versus docetaxel or irinotecan chemotherapy. Conclusion Camrelizumab is a cost-effective option compared with docetaxel or irinotecan chemotherapy in patients with advanced ESCC as second-line therapy in China.
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Affiliation(s)
- Ying-Tao Lin
- Administration Office of Drug Clinical Trial, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, People's Republic of China
| | - Ying Chen
- Management Office of Science and Technology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, 350014, People's Republic of China
| | - Tian-Xiu Liu
- Department of Thoracic Radiotherapy, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, 350014, People's Republic of China
| | - Fang Kuang
- Administration Office of Drug Clinical Trial, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, People's Republic of China
| | - Ping Huang
- Administration Office of Drug Clinical Trial, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, People's Republic of China
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Xiong Y, Shi L, Zhu L, Peng G. Comparison of TPF and TP Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma Based on TNM Stage and Pretreatment Systemic Immune-Inflammation Index. Front Oncol 2021; 11:731543. [PMID: 34616680 PMCID: PMC8488348 DOI: 10.3389/fonc.2021.731543] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/27/2021] [Accepted: 08/31/2021] [Indexed: 12/24/2022] Open
Abstract
Purpose To evaluate the efficacy and toxicity of the two IC (induction chemotherapy) regimens, TPF (taxanes, cisplatin, and 5-fluorouracil) and TP (taxanes and cisplatin) combined with concurrent chemoradiotherapy (CCRT) in locally advanced nasopharyngeal carcinoma (LA-NPC) patients. Methods Ultimately, we enrolled 213 patients at stage III-IVA in this retrospective study. The prognosis of TPF and TP was compared by Kaplan-Meier and Cox proportional hazard regression. The toxicities were evaluated according to CTCAE v4.0 and RTOG criteria. Results TPF was found to have a higher 5-year DMFS in stage IVA and N2-3 patients. The optimal value of pretreatment SII was 432.48. A further subgroup analysis revealed that patients in stage IVA combined with SII ≥432.48 showed superior OS (P=0.038) and DMFS (P=0.028) from TPF. Also, SII was proved to be a prognostic element for PFS (HR 2.801, P=0.018) and DMFS (HR 3.735, P=0.032) in multivariate analysis, and IC regimen (HR 2.182, P=0.049) for predicting DMFS. The rate of grade 3–4 leukopenia (P=0.038), neutropenia (P=0.021), radiation oral mucositis (P=0.048), diarrhea (P=0.036), and ear damage (P=0.046) were more common in TPF group. Conclusion Our study revealed that TPF regimen showed a higher 5-year DMFS for stage IVA and N2-3 patients, while for stage III and N0-1, TP might be ample. In high-risk LA-NPC patients (stage IVA combined with pretreatment SII ≥432.48), TPF had a higher 5-year OS and DMFS, with more grade 3–4 toxicities, but most of them were endurable.
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Affiliation(s)
- Ying Xiong
- Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Liangliang Shi
- Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Lisheng Zhu
- Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Gang Peng
- Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
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Aoki T, Nishida N, Ueshima K, Morita M, Chishina H, Takita M, Hagiwara S, Ida H, Minami Y, Yamada A, Sofue K, Tsurusaki M, Kudo M. Higher Enhancement Intrahepatic Nodules on the Hepatobiliary Phase of Gd-EOB-DTPA-Enhanced MRI as a Poor Responsive Marker of Anti-PD-1/PD-L1 Monotherapy for Unresectable Hepatocellular Carcinoma. Liver Cancer 2021; 10:615-628. [PMID: 34950184 PMCID: PMC8647075 DOI: 10.1159/000518048] [Citation(s) in RCA: 30] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2021] [Accepted: 06/23/2021] [Indexed: 02/04/2023] Open
Abstract
INTRODUCTION Immune checkpoint inhibitors (ICIs) are promising agents for the treatment of hepatocellular carcinoma (HCC). However, the establishment of noninvasive measure that could predict the response to ICIs is challenging. This study aimed to evaluate tumor responses to ICIs using the hepatobiliary phase of gadolinium-ethoxybenzyl-diethylenetriamine (Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI), which was shown to reflect Wnt/β-catenin activating mutation. METHODS A total of 68 intrahepatic HCC nodules from 18 patients with unresectable HCC and Child-Pugh class A liver function who received anti-programmed cell death 1 (PD-1)/programmed death-ligand 1 (PD-L1) monotherapy were enrolled in this study. All patients had viable intrahepatic lesions evaluable using the hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI within the 6 months prior to the treatment. The relative enhancement ratio was calculated, and the time to nodular progression (TTnP) defined as 20% or more increase in each nodule was compared between higher or hypo-enhancement HCC nodules. Then, the progression-free survival (PFS) and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) were compared between patients with and without HCC nodules with higher enhancement on hepatobiliary phase images. RESULTS The median PFS was 2.7 (95% confidence interval [CI]: 1.4-4.0) months in patients with HCC nodules with higher enhancement (n = 8) and 5.8 (95% CI: 0.0-18.9) months in patients with hypointense HCC nodules (n = 10) (p = 0.007). The median TTnP of HCC nodules with higher enhancement (n = 23) was 1.97 (95% CI: 1.86-2.07) months and that of hypointense HCC nodules (n = 45) was not reached (p = 0.003). The ORR was 12.5% (1/8) versus 30.0% (3/10); the disease control rate was 37.5% (3/8) versus 70.0% (7/10), respectively, in patients with or without higher enhancement intrahepatic HCC nodules. CONCLUSION The TTnP on HCC nodules with higher enhancement and the median PFS in patients who carried higher enhancement intrahepatic HCC nodules were significantly shorter than those in hypointense HCC nodules with anti-PD-1/PD-L1 monotherapy. The intensity of the nodule on the hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI is a promising imaging biomarker for predicting unfavorable response with anti-PD-1/PD-L1 monotherapy in patients with HCC.
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Affiliation(s)
- Tomoko Aoki
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan,*Masatoshi Kudo,
| | - Naoshi Nishida
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Kazuomi Ueshima
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masahiro Morita
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Hirokazu Chishina
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masahiro Takita
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Satoru Hagiwara
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Hiroshi Ida
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Yasunori Minami
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Akira Yamada
- Department of Radiology, Shinshu University School of Medicine, Nagano, Japan
| | - Keitaro Sofue
- Department of Radiology, Kobe University Graduate School of Medicine, Kobe, Japan
| | - Masakatsu Tsurusaki
- Department of Radiology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
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Al-Rudayni AHM, Gopinath D, Maharajan MK, Veettil SK, Menon RK. Efficacy of Photobiomodulation in the Treatment of Cancer Chemotherapy-Induced Oral Mucositis: A Meta-Analysis with Trial Sequential Analysis. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2021; 18:7418. [PMID: 34299869 PMCID: PMC8307997 DOI: 10.3390/ijerph18147418] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/22/2021] [Revised: 06/24/2021] [Accepted: 07/06/2021] [Indexed: 01/14/2023]
Abstract
Oral mucositis is a debilitating complication of chemotherapy, characterized by erythema, ulcers and oedema of the oral mucosa. This review aimed to evaluate the efficacy of Photobiomodulation in the treatment of oral mucositis using meta-analysis and trial sequential analysis, and also to assess the quality of the results by Grading of Recommendations, Assessment, Development and Evaluation (GRADE). A comprehensive search of three databases, including Embase, Medline and Central, was performed to identify randomized controlled trials studying the efficacy of Photobiomodulation in the treatment of cancer chemotherapy-induced oral mucositis. The primary outcome was reduction in the severity of oral mucositis. Secondary outcomes were pain relief, duration of oral mucositis and adverse effects. The meta-analysis was performed using the random-effects model, and random errors of the meta-analyses were detected by trial sequential analysis. A total of 6 randomized controlled trials with 398 participants were included in our analysis. Photobiomodulation significantly reduced the severity of oral mucositis when compared to sham radiation (RR 0.43, 95% CI 0.20 to 0.93; p < 0.05). Sensitivity analysis by excluding trials with high risk of bias reiterated the robustness of our results (RR 0.28, 95% CI 0.16 to 0.48). Trial sequential analysis illustrated that the evidence from the meta-analysis was conclusive. The result of the meta-analyses with trial sequential analysis illustrated that Photobiomodulation is an effective therapeutic intervention for the treatment of oral mucositis, and the evidence gathered can be considered conclusive with a moderate level of certainty according to GRADE. Further trials are recommended to standardize the laser parameters required for the optimal effect.
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Affiliation(s)
| | - Divya Gopinath
- Department of Oral Diagnostics & Surgical Sciences, International Medical University, Kuala Lumpur 57000, Malaysia
| | - Mari Kannan Maharajan
- Department of Pharmacy Practice, School of Pharmacy, International Medical University, Kuala Lumpur 57000, Malaysia;
| | - Sajesh K. Veettil
- Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA;
| | - Rohit Kunnath Menon
- Division of Restorative Dentistry, International Medical University, Kuala Lumpur 57000, Malaysia
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Kamachi N, Nakano M, Okamura S, Niizeki T, Iwamoto H, Shimose S, Shirono T, Noda Y, Kuromatsu R, Koga H, Torimura T. Evaluating the therapeutic effect of lenvatinib against advanced hepatocellular carcinoma by measuring blood flow changes using contrast-enhanced ultrasound. Cancer Rep (Hoboken) 2021; 5:e1471. [PMID: 34105904 PMCID: PMC8842703 DOI: 10.1002/cnr2.1471] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2020] [Revised: 04/21/2021] [Accepted: 05/26/2021] [Indexed: 01/22/2023] Open
Abstract
Background The antitumor effect of a drug is considered to be associated with a decrease in tumor blood flow. Aims We investigated whether the efficacy of lenvatinib (LEN) could be accurately assessed by measuring blood flow in hepatocellular carcinoma (HCC) during early treatment stages. Methods and results Blood flow changes and treatment results of 19 patients who underwent contrast‐enhanced ultrasound (CEUS), before and after LEN administration, in Kurume University Hospital from July 2018 to June 2020 were examined. Blood flow was evaluated after the intravenous administration of perflubutane (0.015 ml/kg). The vascular phase was photographed and used as RAW data, and time‐intensity curve analysis was used to obtain the region of interest (ROI) on the entire tumor nodule and quantify tumor blood flow. The evaluation was performed before and 1 and 4 weeks after LEN administration. Mean ± standard deviation (SD) values of the brightness of blood flow in the background liver before and 1 and 4 weeks after LEN administration were 2.84 × 10−4 ± 2.94 × 10−4, 3.07 × 10−4 ± 3.79 × 10−4, and 10.0 × 10−4 ± 20.8 × 10−4 dB, respectively. Blood flow in the background liver did not significantly decrease at 1 and 4 weeks compared with that before treatment. Mean ± SD values of the brightness of blood flow in HCC before and 1 and 4 weeks after administration were 3.49 × 10−3 ± 4.58 × 10−3, 1.16 × 10−3 ± 1.57 × 10−3, and 6.39 × 10−3 ± 22.8 × 10−3 dB, respectively. Blood flow in HCC after 1 week was significantly lower than that before administration (p = .0192). The therapeutic effects were significantly higher in the group with ≥50% blood flow reduction in HCC at 1 week after administration (p = .0038) and the group with reduced blood flow in HCC at 4 weeks after administration (p = .0051) than those before administration. Conclusion Early blood flow evaluation by CEUS may be useful in predicting the therapeutic effect of LEN for unresectable advanced HCC.
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Affiliation(s)
- Naoki Kamachi
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Masahito Nakano
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Shusuke Okamura
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Takashi Niizeki
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Hideki Iwamoto
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Shigeo Shimose
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Tomotake Shirono
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Yu Noda
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Ryoko Kuromatsu
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Hironori Koga
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Takuji Torimura
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
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21
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Sharabiani M, Clementel E, Andratschke N, Collette L, Fortpied C, Grégoire V, Overgaard J, Willmann J, Hurkmans C. Independent external validation using the EORTC HNCG-ROG 1219 DAHANCA trial data of NTCP models for acute oral mucositis. Radiother Oncol 2021; 161:35-39. [PMID: 33872641 DOI: 10.1016/j.radonc.2021.04.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2020] [Revised: 04/07/2021] [Accepted: 04/07/2021] [Indexed: 11/15/2022]
Abstract
PURPOSE To externally validate previously published Normal Tissue Complication Probability (NTCP) models developed by separate teams for grade 3 oral mucositis (g3OM). MATERIALS AND METHODS Two models were validated: a logistic model, based on 144 head and neck cancer (HNC) patients receiving induction chemotherapy followed by chemo-IMRT; a multivariable logistic model for prediction of g3OM for 253 patients receiving radical treatment for the head and neck squamous cell carcinoma (HNSCC). The EORTC HNCG-ROG 1219 DAHANCA trial dataset, consisting of 169 patients was used as the validation cohort. This cohort was treated with accelerated fractionated chemo-IMRT, with/without the hypoxic radiosensitizer Nimorazole for HNSCC. External validity was assessed using the scaled Brier score. Calibration was assessed in terms of calibration curves as well as measures of mean and weak calibration. Hosmer-Lemeshow was used for goodness-of-fit test. Discrimination was calculated using the area under the receiver operating curve (AUC-ROC). RESULTS The prevalence of g3OM in the validation cohort (35.5%) was similar to that of two development cohorts, i.e. 38.7% and 31.9% for Bhide logistic and Otter multivariable logistic models respectively. The scaled Brier scores showed good overall model performance. Perfect calibration was observed in the prevalence range of 20% to 40%. AUC-ROC was acceptable in external validation (0.67). The Hosmer-Lemeshow test showed good agreement between predicted and observed outcomes for two models. CONCLUSION The NTCP models were validated and lead to valid predictions in a wide range of diverse treatment techniques and patient characteristics, also when Nimorazole is added as hypoxic radiosensitizer.
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Affiliation(s)
| | | | - N Andratschke
- Department of Radiation Oncology, University Hospital Zürich, University of Zurich, Switzerland
| | - L Collette
- Department of Biostatistics, International Drug Development Institute, Louvain-la-Neuve, Belgium
| | | | - V Grégoire
- Radiation Oncology Department, Léon Bérard Cancer Center, Lyon, France
| | - J Overgaard
- Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark
| | - J Willmann
- Department of Radiation Oncology, University Hospital Zürich, University of Zurich, Switzerland
| | - C Hurkmans
- Department of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands
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22
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Nakano M, Kuromatsu R, Niizeki T, Okamura S, Iwamoto H, Shimose S, Shirono T, Noda Y, Kamachi N, Koga H, Torimura T. Immunological inflammatory biomarkers as prognostic predictors for advanced hepatocellular carcinoma. ESMO Open 2021; 6:100020. [PMID: 33399083 PMCID: PMC7807940 DOI: 10.1016/j.esmoop.2020.100020] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2020] [Revised: 10/29/2020] [Accepted: 10/31/2020] [Indexed: 12/24/2022] Open
Abstract
Background The immunological inflammatory biomarkers for advanced hepatocellular carcinoma are unclear. We aimed to investigate the association of immunity and inflammatory status with treatment outcomes in patients with advanced hepatocellular carcinoma who received molecular-targeted agents as primary treatment. Patients and methods We enrolled 728 consecutive patients with advanced hepatocellular carcinoma who received sorafenib (n = 554) or lenvatinib (n = 174) as primary treatment in Japan between May 2009 and June 2020. Changes in the neutrophil-to-lymphocyte ratio before and 1 month after treatment and their impact on survival were evaluated. The cut-off values of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio for predicting overall and progression-free survival were calculated using receiver operating characteristic curves. Results The neutrophil-to-lymphocyte ratio, but not the platelet-to-lymphocyte ratio, was an independent prognostic factor. Patients with decreased neutrophil-to-lymphocyte ratio survived significantly longer than patients with increased neutrophil-to-lymphocyte ratio (median overall survival: 14.7 versus 10.4 months, P = 0.0110). Among patients with a low pre-treatment neutrophil-to-lymphocyte ratio, the overall survival did not differ significantly between those with decreased and those with increased neutrophil-to-lymphocyte ratio after 1 month (median: 19.0 versus 14.8 months, P = 0.1498). However, among patients with high pre-treatment neutrophil-to-lymphocyte ratio, those whose neutrophil-to-lymphocyte ratio decreased after 1 month showed significantly longer survival than those whose neutrophil-to-lymphocyte ratio increased (median: 12.7 versus 5.5 months, P < 0.0001). The therapeutic effect was not correlated with pre-treatment neutrophil-to-lymphocyte ratio or platelet-to-lymphocyte ratio. Conclusions The neutrophil-to-lymphocyte ratio is a prognostic factor, along with liver function and tumor markers, in patients with advanced hepatocellular carcinoma who received molecular-targeted agents as primary treatment. Thus, the neutrophil-to-lymphocyte ratio could be a prognostic biomarker for advanced hepatocellular carcinoma primarily treated with immunotherapy.
NLR was an independent prognostic factor with advanced HCC, along with liver function and tumor markers. Patients with decreased NLR 1 month after treatment survived significantly longer than patients with increased NLR. The therapeutic effect was not correlated with pre-treatment NLR or PLR. NLR is a prognostic factor in patients with advanced HCC who received molecular-targeted agents as primary treatment. Thus, NLR could be a prognostic biomarker for advanced HCC treated with immunotherapy.
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Affiliation(s)
- M Nakano
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
| | - R Kuromatsu
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - T Niizeki
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - S Okamura
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - H Iwamoto
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - S Shimose
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - T Shirono
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - Y Noda
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - N Kamachi
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - H Koga
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
| | - T Torimura
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
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- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan
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Kawashita Y, Soutome S, Umeda M, Saito T. Oral management strategies for radiotherapy of head and neck cancer. JAPANESE DENTAL SCIENCE REVIEW 2020; 56:62-67. [PMID: 32123547 PMCID: PMC7037635 DOI: 10.1016/j.jdsr.2020.02.001] [Citation(s) in RCA: 46] [Impact Index Per Article: 9.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/24/2019] [Revised: 01/13/2020] [Accepted: 02/02/2020] [Indexed: 12/11/2022] Open
Abstract
Radiotherapy, often with concomitant chemotherapy, has a significant role in the management of head and neck cancer, however, radiotherapy induces adverse events include oral mucositis, hyposalivation, loss of taste, dental caries, osteoradionecrosis, and trismus, all of which have an impact on patients' quality of life. Therefore, it is necessary to implement oral management strategies prior to the initiation of radiotherapy in patients with head and neck cancer. Since 2014, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) have enumerated the "Principles of Dental Evaluation and Management (DENT-A)" in the section on head and neck cancers, however, oral management was not explained in detail. Oral management has not been achieved a consensus protocol. The aim of this literature is to show that oral management strategy include removal infected teeth before the start of radiotherapy to prevent osteoradionecrosis, oral care for preventing severe oral mucositis to support patient complete radiotherapy during radiotherapy, and prevent of dental caries followed by osteoradionecrosis after radiotherapy.
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Affiliation(s)
- Yumiko Kawashita
- Department of Oral Management Center, Nagasaki University Hospital, Japan
| | - Sakiko Soutome
- Department of Oral Management Center, Nagasaki University Hospital, Japan
| | - Masahiro Umeda
- Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Japan
| | - Toshiyuki Saito
- Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Japan
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Ji Y, Zhu J, Zhu L, Zhu Y, Zhao H. High-Intensity Focused Ultrasound Ablation for Unresectable Primary and Metastatic Liver Cancer: Real-World Research in a Chinese Tertiary Center With 275 Cases. Front Oncol 2020; 10:519164. [PMID: 33194582 PMCID: PMC7658544 DOI: 10.3389/fonc.2020.519164] [Citation(s) in RCA: 30] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2019] [Accepted: 09/29/2020] [Indexed: 12/12/2022] Open
Abstract
This retrospective analysis was conducted to evaluate the feasibility and safety of high-intensity focused ultrasound ablation for primary liver cancer and metastatic liver cancer. Patients with liver cancer who received high-intensity focused ultrasound were included in this analysis, including a primary liver cancer cohort (n=80) and a metastatic liver cancer cohort (n=195). The primary endpoint of our research was tumor response. The secondary endpoints included survival outcomes, visual analog scale pain scores, alpha-fetoprotein relief, and complications. Objective response rate and disease control rate were observed to be 71.8% and 81.2%, respectively, in patients with primary liver cancer and were 63.7% and 83.2% in cases with metastatic liver cancer. Alpha-fetoprotein levels and visual analogue scale levels significantly decreased after treatment compared with the baseline levels in patients with primary liver cancer (p<0.05). Median overall survival was estimated to be 13.0 and 12.0 months in the primary liver cancer and metastatic liver cancer cohorts. The 1-year survival rate was 70.69% and 48.00%, respectively. Multivariate regression analysis showed that visual analogue scale ≥ 5, longest diameter ≥ 5 cm, and portal vein invasion were the independent risk factors for poor survival in primary liver cancer. For patients with metastatic liver cancer, independent risk factors were identified as visual analogue scale ≥ 5, longest diameter ≥ 5 cm, existence of extrahepatic metastases, existence of portal vein invasion, and time to high-intensity focused ultrasound treatment from diagnosis < 3 months. Severe adverse events were rarely reported. In conclusion, high-intensity focused ultrasound might be an effective and safe option for patients with liver cancer regardless of primary and metastatic lesions.
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Affiliation(s)
| | | | | | | | - Hong Zhao
- HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai, China
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25
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Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study. Chin J Integr Med 2020; 27:674-679. [PMID: 32820453 DOI: 10.1007/s11655-020-3420-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/11/2020] [Indexed: 12/24/2022]
Abstract
BACKGROUND Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC. OBJECTIVE To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy. METHODS The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score. DISCUSSION This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov).
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Panariello L, Donnarumma M, Iaffaioli RV, Chiodini P, Annunziata MC, Peduto T, Fabbrocini G. Skin Toxicities During Colorectal Cancer Chemotherapy: Incidence and Pearls of Treatment in Our Experience. Clin Colorectal Cancer 2020; 19:e235-e242. [PMID: 32665093 DOI: 10.1016/j.clcc.2020.05.006] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2019] [Revised: 05/19/2020] [Accepted: 05/22/2020] [Indexed: 12/27/2022]
Abstract
INTRODUCTION Medical treatment of advanced colorectal cancer is effective in prolonging the survival of patients. The aim of this study was to describe the most common skin toxicities that occur in those patients, analyzing the association between the type of reaction and the different chemotherapeutic drugs; and to evaluate the importance of an outpatient dermatologic service to improve quality of life. PATIENTS AND METHODS Seventy-two patients with skin reactions from advanced colorectal cancer chemotherapy were included. Each patient underwent physical examination and digital photographic imaging, and completed a quality-of-life questionnaire (Dermatology Life Quality Index [DLQI]). RESULTS Papulopustular rash was the most common side effect observed. It was statistically associated with EGFRi + irinotecan, EGFRi + FOLFOX, and EGFRi. Xerosis occurred in 50% of patients during EGFRi therapy. Periungual pyogenic granuloma-like lesions occurred in 30% of patients during EGFRi therapy. Our data underline a statistically significant association between capecitabine, FOLFOX + EGFRi, FOLFIFI + EGFRi, and hand-foot syndrome (P < .001). Because none of patients treated with EGFRi alone developed this kind of reaction, we suppose that it is associated with the use of 5-fluorouracil. Fifty percent of patients receiving anti-epidermal growth factor receptor (EGFR) therapy developed trichomegaly. These data underline a statistically significant association between these reactions and this specific drug. CONCLUSION A dermatologic visit is useful, both for the correct diagnosis of and for the adequate therapy of chemotherapy side effects. The prevention and treatment of these toxicities are important, not only to improve quality of life but also to avoid unnecessary dose reduction or interruption, which can have a negative effect on treatment outcome.
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Affiliation(s)
- Luigia Panariello
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
| | - Marianna Donnarumma
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
| | - Rosario Vincenzo Iaffaioli
- Gastro-intestinal Medical Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale," IRCCS, Naples, Italy
| | - Paolo Chiodini
- Medical Statistics Unit, Second University of Naples, Naples, Italy
| | - Maria Carmela Annunziata
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
| | - Tiziana Peduto
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
| | - Gabriella Fabbrocini
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
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Nakano M, Kuromatsu R, Niizeki T, Okamura S, Iwamoto H, Shimose S, Shirono T, Noda Y, Kamachi N, Koga H, Torimura T. Primary Treatment with Molecular-Targeted Agents for Hepatocellular Carcinoma: A Propensity Score-matching Analysis. Hepatol Commun 2020; 4:1218-1228. [PMID: 32766480 PMCID: PMC7395064 DOI: 10.1002/hep4.1535] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/02/2020] [Revised: 04/13/2020] [Accepted: 04/28/2020] [Indexed: 12/22/2022] Open
Abstract
Sorafenib and lenvatinib, as molecular-targeted agents, constitute effective primary treatment options for advanced hepatocellular carcinoma (HCC). However, the choice of optimal primary treatment agent remains controversial. Here, we aimed to assess the respective outcomes between these agents as primary treatment in patients with advanced HCC through use of propensity score-matching analysis (PSMA). We enrolled 670 consecutive patients who were diagnosed with advanced HCC and received sorafenib (n = 524) or lenvatinib (n = 146) as the primary treatment among 18 participating institutions between May 2009 and October 2019. To reduce confounding, we used PSMA regarding seven variables related to advanced HCC prognosis, resulting in the selection of 292 patients (n = 146 for each agent). Following PSMA, no significant difference was observed in the outcome of overall survival time between patients treated with sorafenib or lenvatinib (median survival time 15.3 or 14.9 months, respectively; P = 0.2358). Patients treated with lenvatinib exhibited significantly greater therapeutic effects (response rate: 5% and 31%; disease control rate: 46% and 69% for sorafenib and lenvatinib, respectively; P < 0.0001), but showed significantly lower probability of transition to secondary treatment (sorafenib, 60%; lenvatinib, 45%; P < 0.0269) and higher any adverse events rate (sorafenib, 86%; lenvatinib, 95%; P = 0.0207). Conclusion: As a primary molecular-targeted agent-based treatment for advanced HCC, our findings suggested that sorafenib is generally appropriate as it offers significantly lower frequency of adverse events and higher probability of transition to secondary treatment, in consideration of the enhanced postprogression survival mediated by sequential treatment. Alternatively, lenvatinib affords a significantly higher therapeutic effect and should be used when immediate tumor reduction is required.
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Affiliation(s)
- Masahito Nakano
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Ryoko Kuromatsu
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Takashi Niizeki
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Shusuke Okamura
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Hideki Iwamoto
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Shigeo Shimose
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Tomotake Shirono
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Yu Noda
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Naoki Kamachi
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Hironori Koga
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
| | - Takuji Torimura
- Division of Gastroenterology Department of Medicine Kurume University School of Medicine Kurume Japan
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Li Z, Si G, Jiao DC, Han X, Zhang W, Li Y, Zhou X, Liu J, Chen J. Portal Vein Stenting Combined with 125I Particle Chain Implantation Followed by As 2O 3 in the Treatment of Hepatocellular Carcinoma with Portal Vein Tumour Thrombus. BIOMED RESEARCH INTERNATIONAL 2020; 2020:4109216. [PMID: 32090088 PMCID: PMC7013352 DOI: 10.1155/2020/4109216] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/12/2019] [Revised: 12/01/2019] [Accepted: 12/27/2019] [Indexed: 02/08/2023]
Abstract
OBJECTIVE To evaluate the feasibility and safety of portal vein stenting (PVS) combined with 125I particle chain implantation and sequential arsenic trioxide (As2O3) for the treatment of hepatocellular carcinoma (HCC) with portal vein tumour thrombus (PVTT) by transcatheter arterial chemoembolization (TACE). METHODS From January 2015 to January 2018, the clinical data of 30 patients with HCC complicated by PVTT were retrospectively analysed (26 men and 4 women). The laboratory examinations, incidence of adverse events, cumulative survival rate, and stent patency were analysed for all enrolled patients. RESULTS The success rate of interventional treatment in all patients was 100%. The results of the laboratory tests before and 1 week after surgery showed that the mean concentrations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) decreased from 50.9 U/L ± 25.8 to 41.8 U/L ± 21.6 (P < 0.001) and 57.6 U/L ± 19.9 to 44.2 U/L ± 26.1 (P < 0.001) and 57.6 U/L ± 19.9 to 44.2 U/L ± 26.1 (. CONCLUSION PVS combined with 125I particle chain implantation followed by TACE with As2O3 is safe and feasible for patients with PVTT. The long-term efficacy of this treatment needs to be further studied.
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Affiliation(s)
- Zhaonan Li
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Guangyan Si
- 2Department of Interventional Radiology, The Affiliated Hospital of Traditional Chinese Medicine, Southwest Medical University, Luzhou 646000, China
| | - De-Chao Jiao
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Xinwei Han
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Wenguang Zhang
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Yahua Li
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Xueliang Zhou
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Juanfang Liu
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Jianjian Chen
- 1Department of Interventional Radiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
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Shi D, Qian JJ, Fan GH, Shen JK, Tian Y, Xu L. Salivary gland function in nasopharyngeal carcinoma before and late after intensity-modulated radiotherapy evaluated by dynamic diffusion-weighted MR imaging with gustatory stimulation. BMC Oral Health 2019; 19:288. [PMID: 31864328 PMCID: PMC6925496 DOI: 10.1186/s12903-019-0951-x] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2019] [Accepted: 11/07/2019] [Indexed: 11/15/2022] Open
Abstract
Background Xerostomia caused by radiation-induced salivary glands injury has a considerable impact on patients’ quality of life. Nowadays, the existed different methods of evaluating xerostomia in clinical practice there are still some disadvantages and limitations. This study used diffusion-weighted magnetic resonance imaging (DW-MRI) with gustatory stimulation to assess salivary glands function after intensity-modulated radiotherapy (IMRT) in patients with nasopharyngeal carcinoma (NPC). Methods DW-MRI was performed in 30 NPC patients and swab method was used to calculate rest and stimulated salivary flow rates (SFR). DW sequence at rest and then repeated ten times during stimulation were obtained. Apparent diffusion coefficients (ADCs) maps of three glands were calculated. Patients before and after RT were recorded as xerostomia and non-xerostomia groups separately. Rest and stimulated ADCs, ADCs increase rates (IRs), time to maximum ADCs (Tmax), ADCs change rates (CRs), rest and stimulated SFR, SFR increase rates (IRs) and SFR change rates (CRs) before and after RT were assessed. Results The rest and stimulated ADCs of three glands after RT were higher than those before RT (p < 0.001). The rest and stimulated SFR of all salivary glands after RT were lower than those before RT (p < 0.001). A correlation existed between rest ADCs of submandibular glands and rest SFR of submandibular mixed with sublingual glands and full three glands before RT (p = 0.019, p = 0.009), stimulated ADCs and stimulated SFR in parotid glands before RT (p = 0.047). The rest ADCs of parotid glands after RT correlated to XQ scores (p = 0.037). Conclusions The salivary glands’ ADCs increased after RT both in rest and stimulated state due to the radiation injury and the ADCs correlated with SFR and XQ scores of evaluating the xerostomia in clinical practice.
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Affiliation(s)
- Dai Shi
- Department of Radiology, The Second Affiliated Hospital of Soochow University, Suzhou, 215004, People's Republic of China
| | - Jian-Jun Qian
- Department of Radiotherapy and Oncolog, The Second Affiliated Hospital of Soochow University, Suzhou, 215004, People's Republic of China
| | - Guo-Hua Fan
- Department of Radiology, The Second Affiliated Hospital of Soochow University, Suzhou, 215004, People's Republic of China
| | - Jun-Kang Shen
- Department of Radiology, The Second Affiliated Hospital of Soochow University, Suzhou, 215004, People's Republic of China
| | - Ye Tian
- Department of Radiotherapy and Oncolog, The Second Affiliated Hospital of Soochow University, Suzhou, 215004, People's Republic of China
| | - Liang Xu
- Department of Radiology, The Second Affiliated Hospital of Soochow University, Suzhou, 215004, People's Republic of China.
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Tao SF, Gu WH, Gu JC, Zhu ML, Wang Q, Zheng LZ. A Retrospective Case Series Of High-Intensity Focused Ultrasound (HIFU) In Combination With Gemcitabine And Oxaliplatin (Gemox) On Treating Elderly Middle And Advanced Pancreatic Cancer. Onco Targets Ther 2019; 12:9735-9745. [PMID: 31814733 PMCID: PMC6863124 DOI: 10.2147/ott.s220299] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2019] [Accepted: 10/18/2019] [Indexed: 12/24/2022] Open
Abstract
Purpose This retrospective study was conducted to evaluate the safety and efficacy of high-intensity focused ultrasound (HIFU) ablation combined with Gemcitabine and Oxaliplatin (Gemox) for the treatment of middle and advanced pancreatic cancer in elderly patients. Methods Forty-seven patients with pancreatic cancer treated with HIFU and Gemox were evaluated for inclusion, and 38 cases were finally included. The primary endpoint was safety. Secondary endpoints included the response rate, the clinical benefit response (CBR), overall survival (OS), progression-free survival (PFS). Results After combination therapy of HIFU and Gemox, severe complications were rarely reported, and no treatment-related death occurred. The rate of three or four-degree myelosuppression was low, and no obvious impairment of hepatorenal function was observed. Pancreatitis and gastrointestinal injury did not occurred. The disease control rate (DCR) was estimated to be 76.3%, including complete remission (CR), partial remission (PR), stable disease (SD) in 1, 6, 22 cases, respectively. And the objective response rate (ORR) was 18.4%. The clinical benefit rate (CBR) was 68.4%, with the pain significantly relieved (P<0.01). The serum level of CA19-9 showed significant changes after HIFU treatment. The median overall survival (OS) was 12.5 months, with a 6-month and 12-month OS rate of 82.13% and 59.34%, respectively. Stratified analyses did not reveal any significant difference between patients in different stages. Conclusion Elderly patients (≥ 60 years old) with pancreatic cancer would experience tolerable toxicity and obtain good clinical benefits from the combination therapy of HIFU ablation and Gemox.
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Affiliation(s)
- Shuang-Fen Tao
- Oncology Department, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, People's Republic of China
| | - Wen-Hua Gu
- Oncology Department, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, People's Republic of China
| | - Jian-Chun Gu
- Oncology Department, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, People's Republic of China
| | - Mei-Ling Zhu
- Oncology Department, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, People's Republic of China
| | - Qing Wang
- Oncology Department, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, People's Republic of China
| | - Lei-Zhen Zheng
- Oncology Department, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, People's Republic of China
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Wu J, Li S, Wang Y, Hu L. Pretreatment Aspartate Aminotransferase-to-Alanine Aminotransferase (De Ritis) Ratio Predicts the Prognosis of Nonmetastatic Nasopharyngeal Carcinoma. Onco Targets Ther 2019; 12:10077-10087. [PMID: 31819502 PMCID: PMC6878916 DOI: 10.2147/ott.s232563] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2019] [Accepted: 11/15/2019] [Indexed: 12/24/2022] Open
Abstract
Background The pretreatment aspartate aminotransferase-to-alanine aminotransferase (De Ritis) ratio is reportedly valuable in prognosis prediction of various malignancies. However, its value in the prognosis of nasopharyngeal carcinoma (NPC) has not yet been reported. This study aimed to evaluate the effect of the De Ritis ratio on the survival outcomes of patients with nonmetastatic NPC. Methods We retrospectively reviewed the medical data of 1023 patients with nonmetastatic NPC admitted between 2009 and 2013 at a single center. The Fine and Gray competing risk regression model was used to analyze the associations between the De Ritis ratio and the survival outcomes of cancer-specific survival (CSS) and progression-free survival (PFS) by using the subdistribution hazard ratio (SHR) and 95% confidence interval (CI) as size effects. The Cox proportional hazard model was used to evaluate the correlation between the De Ritis ratio and overall survival (OS) by using hazard ratio (HR) and 95% CI as size effects. Results Patients were divided into two groups in accordance with the pretreatment De Ritis ratio by using an optimal cutoff value of 1.65. Compared with the patients with low De Ritis ratio (< 1.65), those with elevated De Ritis ratio (≥ 1.65) had poorer prognosis with regard to CSS, PFS, and OS. Notably, multivariate analyses showed that high De Ritis ratio was independently associated with poor CSS (SHR = 1.64, 95% CI: 1.25–2.16), PFS (SHR = 1.69, 95% CI: 1.30–2.19), and OS (HR = 1.81, 95% CI: 1.39–2.40). Conclusion Pretreatment De Ritis ratio can be an independent prognostic predictor for patients with nonmetastatic NPC.
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Affiliation(s)
- Jiayuan Wu
- Department of Clinical Research, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China
| | - Shasha Li
- Department of Epidemiology and Health Statistics, School of Public Health, Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China
| | - Yufeng Wang
- Department of Epidemiology and Health Statistics, School of Public Health, Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China
| | - Liren Hu
- Department of Epidemiology and Health Statistics, School of Public Health, Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China
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Xie L, Xu J, Dong S, Gao J, Tang X, Yan T, Yang R, Guo W. Gain and loss from transcatheter intra-arterial limb infusion of cisplatin for extremity osteosarcoma: a retrospective study of 99 cases in the past six years. Cancer Manag Res 2019; 11:7183-7195. [PMID: 31447583 PMCID: PMC6684488 DOI: 10.2147/cmar.s214604] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2019] [Accepted: 07/10/2019] [Indexed: 01/23/2023] Open
Abstract
Purpose We intend to analyze the gain and loss from transcatheter intra-arterial (IA) limb infusion of cisplatin for extremity osteosarcoma in the past six years. Patients and methods Between December 2009 and August 2014, a total of 99 patients were analyzed for efficiency and followed up for long-term survival. Based on the different administration methods of cisplatin, we divided them into the following two cohorts: IA infusion of cisplatin (n=48) and intravenous (IV) infusion of cisplatin (n=51). Except for cisplatin, all the other drugs were given intravenously. Cisplatin was given intra-arterially with an infusion time of 3 hrs or 6 hrs using a pump, whereas historical controls received IV infusion of cisplatin within 60 mins. Tumor neovascularity (TNV) was analyzed before infusion, and subsequent arteriograms were compared with the baseline to determine percent changes. Definitive surgery with intended wide resection and postoperative pathological evaluation were performed in all these patients. Results No local or overall survival benefit was found in the patients preoperatively treated with IA infusion of cisplatin compared with IV infusion (P=0.336 and 0.173, respectively). Furthermore, serial arteriography was used to predict a good histologic response with an accuracy of 73.1% and a sensitivity of 100%. There were sporadic cases with the telangiectatic subtype, which did not respond very well to IV chemotherapy, but later, the tumor obviously shrank after IA infusion of cisplatin. Our study also showed that the rates of the complication of skin and muscle necrosis were not so low as reported. Conclusion We did not observe any survival advantage of chemotherapy using IA infusion in osteosarcoma of the extremities. Arteriography for TNV can be used to predict the tumor histologic response. Malposition of the catheter might severely increase the complication of skin or muscle necrosis.
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Affiliation(s)
- Lu Xie
- Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Jie Xu
- Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Sen Dong
- Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Jian Gao
- Catheterization Room & Radiology Department, Peking University People's Hospital, Beijing, People's Republic of China
| | - Xiaodong Tang
- Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Taiqiang Yan
- Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Rongli Yang
- Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Wei Guo
- Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, People's Republic of China
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Miller TP, Fisher BT, Getz KD, Sack L, Razzaghi H, Seif AE, Bagatell R, Adamson PC, Aplenc R. Unintended consequences of evolution of the Common Terminology Criteria for Adverse Events. Pediatr Blood Cancer 2019; 66:e27747. [PMID: 30968531 PMCID: PMC6681806 DOI: 10.1002/pbc.27747] [Citation(s) in RCA: 41] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/08/2018] [Revised: 02/19/2019] [Accepted: 03/18/2019] [Indexed: 11/07/2022]
Abstract
BACKGROUND Adverse events (AEs) on Children's Oncology Group (COG) trials are reported manually by clinical research assistants (CRAs). The Common Terminology Criteria for Adverse Events (CTCAE) was developed to provide standardized definitions for identifying and grading AEs. The CTCAE has expanded significantly over its five versions, but the impact of CTCAE definitional changes has not been examined. PROCEDURE This study compared AE number and ascertainment among the first four CTCAE versions using a case vignette. Each CTCAE version was used to create a list of AEs and grades by two separate CRAs. RESULTS The CTCAE expanded from 9 categories and 49 AEs in v1.0 to 26 categories and 790 AEs in v4.0. CRAs independently selected different approaches to AE ascertainment-comprehensive and parsimonious. The number of AEs identified in the parsimonious approach was stable with 10-14 in each CTC version. The comprehensive approach identified 9, 20, 29, and 37 AEs in CTC versions 1.0, 2.0, 3.0, and 4.0, respectively. Only approximately 65% of AEs were conclusively graded in versions 2.0 to 4.0 using the comprehensive approach. CONCLUSIONS CTCAE has increased in complexity. Although this increased complexity allows for more granular AE reporting, these data demonstrate potential unintended negative consequences of increasing CTC AE complexity, including the risk of varying approaches to AE capture. A comprehensive evaluation of CTC AE definitions and CRA reporting practices across COG institutions and AEs are needed to improve the accuracy and efficiency of AE reporting.
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Affiliation(s)
- Tamara P. Miller
- Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Atlanta, Georgia
- Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia
| | - Brian T. Fisher
- Division of Infectious Diseases, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- Center for Pediatric Clinical Effectiveness, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
- Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
| | - Kelly D. Getz
- Center for Pediatric Clinical Effectiveness, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
- Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Leah Sack
- Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Hanieh Razzaghi
- Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- Department of Biomedical and Health Informatics, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Alix E. Seif
- Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
- Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Rochelle Bagatell
- Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
- Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Peter C. Adamson
- Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
- Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
| | - Richard Aplenc
- Center for Pediatric Clinical Effectiveness, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
- Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
- Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- Department of Biomedical and Health Informatics, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
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Okamoto K, Ninomiya I, Yamaguchi T, Terai S, Nakanuma S, Kinoshita J, Makino I, Nakamura K, Miyashita T, Tajima H, Takamura H, Fushida S, Ohta T. Oral cryotherapy for prophylaxis of oral mucositis caused by docetaxel, cisplatin, and fluorouracil chemotherapy for esophageal cancer. Esophagus 2019; 16:207-213. [PMID: 30600487 DOI: 10.1007/s10388-018-00655-8] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/13/2018] [Accepted: 12/21/2018] [Indexed: 02/08/2023]
Abstract
BACKGROUND Chemotherapy, including preoperative chemotherapy, plays an important role in the treatment of esophageal cancer. However, although docetaxel, cisplatin, and fluorouracil (DCF) therapy has a powerful antitumor effect, the associated adverse events make it difficult to maintain the patient's general condition. Oral mucositis is an important adverse effect of chemotherapy, and its severity, frequency, and impact on patient quality of life should not be underestimated. This study evaluated the role of oral cryotherapy for prophylaxis of oral mucositis caused by DCF therapy. METHODS We retrospectively examined the incidence and severity of adverse events, including mucositis, in 72 patients with esophageal cancer treated with DCF. Fifty-eight patients received cryotherapy during docetaxel administration and 14 received no cryotherapy. RESULTS The incidence of mucositis of all grades and grade 3 was significantly lower in the cryotherapy group compared with the no-cryotherapy group (24.1% vs. 71.4%, P < 0.001 and 0% vs. 28.6%, P = 0.001, respectively). The incidence of anorexia of all grades and grade 3 was also significantly lower in the cryotherapy group (22.4% vs. 57.1%, P = 0.037 and 0% vs. 28.6%, P = 0.010, respectively). CONCLUSION Adjunctive oral cryotherapy is effective for the prophylaxis and relief of oral mucositis and anorexia caused by chemotherapy.
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Affiliation(s)
- Koichi Okamoto
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Itasu Ninomiya
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan.
| | - Takahisa Yamaguchi
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Shiro Terai
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Shinichi Nakanuma
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Jun Kinoshita
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Isamu Makino
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Keishi Nakamura
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Tomoharu Miyashita
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Hidehiro Tajima
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Hiroyuki Takamura
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Sachio Fushida
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
| | - Tetsuo Ohta
- Department of Gastroenterological Surgery, Kanazawa University, 13-1 Takara-Machi, Kanazawa, Ishikawa, 920-8641, Japan
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Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol 2019; 12:633-639. [PMID: 30797141 PMCID: PMC6383173 DOI: 10.1016/j.tranon.2019.01.002] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2018] [Revised: 12/30/2018] [Accepted: 01/02/2019] [Indexed: 11/30/2022] Open
Abstract
In this study, we aim to compare the progression-free survival (PFS) rates and side effects of induction chemotherapy based on docetaxel, cisplatin and fluorouracil (TPF) versus cisplatin and fluorouracil (PF) in patients with locoregionally-advanced nasopharyngeal carcinoma who received subsequent chemoradiotherapy. We randomly assigned 278 patients with stage III or IV NPC (without distant metastases) to receive either TPF or PF induction chemotherapy, followed by cisplatin-based chemoradiotherapy every 3 weeks and intensity-modulated radiation therapy for 5 days per week. After a minimum of 2 years follow-up, a PFS benefit was observed for TPF compared to PF, though this difference was not statistically significant (84.5% vs. 77.9%, P = .380). Due to increased frequencies of grade 3 or 4 neutropenia and diarrhea, significantly more patients in the TPF group required treatment delays and dose modifications. Our findings suggest that PF induction chemotherapy has substantially better tolerance and compliance rates than TPF induction chemotherapy. However, the treatment efficacy of PF is not superior to TPF induction chemotherapy in patients with locoregionally-advanced NPC (ClinicalTrials.gov number, NCT01536223).
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Affiliation(s)
- Ting Jin
- Key Laboratory of Head & Neck Cancer Translational Research of Zhejiang Province, Hangzhou, Zhejiang 310022, People's Republic of China; Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, People's Republic of China
| | - Wei-Feng Qin
- Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, People's Republic of China; Key Laboratory of Radiation Oncology in Zhejiang Province, Hangzhou, Zhejiang 310022,People's Republic of China
| | - Feng Jiang
- Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, People's Republic of China; Key Laboratory of Radiation Oncology in Zhejiang Province, Hangzhou, Zhejiang 310022,People's Republic of China
| | - Qi-Feng Jin
- Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, People's Republic of China; Key Laboratory of Radiation Oncology in Zhejiang Province, Hangzhou, Zhejiang 310022,People's Republic of China
| | - Qi-Chun Wei
- Department of Radiation Oncology, Key Laboratory of Cancer Prevention and Intervention, China National Ministry of Education, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310009, People's Republic of China
| | - Yong-Shi Jia
- Department of Radiation Oncology, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang 310014, People's Republic of China
| | - Xiao-Nan Sun
- Department of Radiation Oncology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang 310000, People's Republic of China
| | - Wen-Feng Li
- Department of Chemoradiation Oncology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, People's Republic of China
| | - Xiao-Zhong Chen
- Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, People's Republic of China; Key Laboratory of Radiation Oncology in Zhejiang Province, Hangzhou, Zhejiang 310022,People's Republic of China.
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Ji Y, Zhang Y, Zhu J, Zhu L, Zhu Y, Hu K, Zhao H. Response of patients with locally advanced pancreatic adenocarcinoma to high-intensity focused ultrasound treatment: a single-center, prospective, case series in China. Cancer Manag Res 2018; 10:4439-4446. [PMID: 30349376 PMCID: PMC6188211 DOI: 10.2147/cmar.s173740] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/24/2023] Open
Abstract
Purpose Patients with unresectable locally advanced pancreatic cancer (LAPC) are still in dire need of effective therapies. We performed this cohort study in order to assess the efficacy and safety of high-intensity focused ultrasound (HIFU) ablation in treating patients with unresectable LAPC. Patients and methods Eighty-seven cases with unresectable LAPC from January 2014 to December 2016 were finally recruited according to the inclusion criteria. The primary end point of our study was OS of all the cases, and the secondary end points included 6-month and 12-month survival rate, tumor response rate, carbohydrate antigen (CA) 19-9 response rate, VAS, quality of life, and safety. Results All the 87 patients received HIFU ablation successfully, and were included in the efficacy and safety analysis. With a median follow-up of 16 months, median OS was estimated to be 12.2 months, with 95 % CI of 11.1–12.7 months. The 6-month and 12-month survival rates were 94.25% (95% CI =86.74–97.57) and 50.85% (95% CI =38.17–62.21), respectively. Multivariate analysis revealed that patients with VAS <4, Karnofsky performance status ≥80, and tumor size <3 cm have a significant improvement in their OS (adjusted HR [aHR] =0.26 [95% CI =0.12–0.57], P=0.001; aHR =0.34 [95% CI =0.17–0.68], P=0.02; and aHR =0.39 [95% CI =0.20–0.78], P=0.007; respectively). Tumor responses were observed in 32 (36.8%) of 87 patients and CA 19-9 response rate was 56.2%. Global health status, physical function, emotional function, and cognitive function of patients were significantly improved after HIFU treatment, and symptoms of fatigue and pain were significantly reduced. A total of 28.7% (25/87) of patients reported adverse events (AEs), mainly including fatigue (14/87), abdominal pain (7/87), fever (7/87), nausea (5/87), and rash (4/87). No severe AEs and HIFU-related deaths were reported. Conclusion HIFU ablation might be a potentially effective and safe therapeutic option for the patients with unresectable LAPC.
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Affiliation(s)
- Yongshuo Ji
- HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, China,
| | - Yu Zhang
- HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, China,
| | - Junqiu Zhu
- HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, China,
| | - Linglin Zhu
- HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, China,
| | - Yanfei Zhu
- HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, China,
| | - Kaimeng Hu
- Marketing Department, Shanghai A&S Science Technology Development Co., Ltd, Shanghai 200000, China
| | - Hong Zhao
- HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, China,
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Radiotherapy for cutaneous head and neck cancer and parotid tumours: a prospective investigation of treatment-related acute swallowing and toxicity patterns. Support Care Cancer 2018; 27:573-581. [PMID: 30019149 DOI: 10.1007/s00520-018-4352-5] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2017] [Accepted: 07/11/2018] [Indexed: 10/28/2022]
Abstract
PURPOSE Reports of acute treatment-related dysphagia and toxicities for patients with parotid tumours or cutaneous head and neck cancer (HNC) are limited. This study aimed to describe the severity and timing of dysphagia and related toxicities experienced during radiotherapy for cutaneous HNC and parotid tumours, to inform the nature of future speech pathology (SP) service models required during treatment. METHODS Prospective study of 32 patients with parotid tumours and 36 with cutaneous HNC undergoing curative non-surgical management. Dysphagia and acute toxicity data was collected weekly during treatment and at 2, 4 and 12 weeks post-treatment using the Functional Oral Intake Scale, diet descriptors and CTCAE v4.0. RESULTS In both groups, minimal treatment toxicities (grades 0-1) were observed. Xerostomia and dysgeusia were the most frequently reported grade 2 toxicities. Only 3% of parotid patients and 6% with cutaneous HNC experienced grade 3 dysphagia. Full or soft texture diets were maintained by > 70% of patients in both groups. Symptoms peaked in the final week of treatment and rapidly improved thereafter. Apart from xerostomia < 10% of patients had any grade 2 toxicity at 12 weeks post-treatment. CONCLUSION Patients in these subgroups of HNC experienced minimal treatment-related toxicity during radiotherapy. As such, the need for supportive symptom management by SP is low. Models that involve interdisciplinary surveillance of symptoms with referral to SP only when required may be best suited for these individuals to ensure issues are identified whilst minimising patient burden created by unnecessary routine SP appointments.
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Peuvrel L, Cassecuel J, Bernier C, Quéreux G, Saint-Jean M, Le Moigne M, Frénard C, Khammari A, Dréno B. TOXICAN: a guide for grading dermatological adverse events of cancer treatments. Support Care Cancer 2018. [PMID: 29532244 DOI: 10.1007/s00520-018-4153-x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Abstract
PURPOSE The dermatological toxicity of cancer treatments is frequent and sometimes debilitating. Its reference classification, the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), is sometimes difficult to use and does not include yet the newest toxicities. Our objective was to create a guide, TOXICAN, based on the CTCAE, which is easy to use in everyday practice and which facilitates the recognition and grading of these dermatological toxicities. METHODS This guide was developed by a working group ("GESTIM") comprising oncodermatologists, allergists, pathologists, and researchers from Nantes University Hospital. It was based on the dermatological toxicities found in the CTCAE and adapted to daily practice. These toxicities were grouped into categories and associated with photographs of typical cases to aid recognition. A simplified grading scale derived from the CTCAE was also created. This booklet was validated by means of user evaluation, and then the Delphi consensus method. RESULTS We selected 32 dermatological toxicities, including 12 created by our group, sorted into 7 categories: skin rash, dry skin/pruritus, hyperkeratotic papules, palmoplantar changes, hair and nail changes, mucosal changes, and others. Our simplified grading scale only differed from the CTCAE for one item, urticaria. Three items were modified after evaluation by the user group and 11 after application of the Delphi method. CONCLUSION The objective of our practical guide is to facilitate the use of the CTCAE for recognizing and grading dermatological toxicity of cancer treatments in order to provide optimal guidance for therapeutic adaptations. Its impact on clinical practice remains to be evaluated.
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Affiliation(s)
- L Peuvrel
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - J Cassecuel
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - C Bernier
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - G Quéreux
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - M Saint-Jean
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - M Le Moigne
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - C Frénard
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - A Khammari
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France
| | - B Dréno
- Department of Dermatology, CHU Nantes, CIC 1413, CRCINA INSERM 1232, Nantes, France.
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Rogers SN, Barber B. Using PROMs to guide patients and practitioners through the head and neck cancer journey. PATIENT-RELATED OUTCOME MEASURES 2017; 8:133-142. [PMID: 29184455 PMCID: PMC5687779 DOI: 10.2147/prom.s129012] [Citation(s) in RCA: 33] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Abstract
The measurement of patient-reported outcome measures (PROMs) following head and neck cancer (HNC) has the capacity to substantially enhance the care of patients and their care-givers following the diagnosis and treatment of HNC. Literature concerning PROMs has increased exponentially in the past 2 decades, producing a vast array of data upon which the multidisciplinary team can reflect. For this review, “Handle On QOL” has been used as a source of references to illustrate the points raised. PROMs are contextualized by considering the clinically-distinct key stages that cancer patients endure: diagnosis, treatment, acute toxicity, early recovery, late effects, recurrence, and palliation. The PROMs are considered in six main categories: 1) those addressing cornucopia of issues not specific to cancer; 2) those addressing issues common to all cancers; 3) questionnaires with items specific to HNC; 4) questionnaires that focus on a particular aspect of head and neck function; 5) those measuring psychological concerns, such as depression, anxiety, or self-esteem; and 6) item prompt lists. Potential benefits of PROMs in clinical practice are discussed, as are barriers to use. The way forward in integrating PROMs into routine HNC care is discussed with an emphasis on information technology.
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Affiliation(s)
- Simon N Rogers
- Evidence-Based Practice Research Centre (EPRC), Faculty of Health and Social Care, Edge Hill University, Ormskirk, UK.,Regional Maxillofacial Unit, University Hospital Aintree, Liverpool, UK
| | - Brittany Barber
- Head and Neck Department, Icahn School of Medicine at Mount Sinai (MSSM), New York, NY, USA
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Wang J, Zheng R, Wang Z, Yang Y, Wang M, Zou W. Efficacy and Safety of Vinorelbine Plus Cisplatin vs. Gemcitabine Plus Cisplatin for Treatment of Metastatic Triple-Negative Breast Cancer After Failure with Anthracyclines and Taxanes. Med Sci Monit 2017; 23:4657-4664. [PMID: 28957036 PMCID: PMC5629993 DOI: 10.12659/msm.905300] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023] Open
Abstract
BACKGROUND This study aimed to compare the efficacy and safety of vinorelbine plus cisplatin (NP regimen) vs. gemcitabine plus cisplatin (GP regimen) for treatment of metastatic TNBC after failure with anthracyclines and taxanes. MATERIAL AND METHODS A total of 48 patients with metastatic TNBC that failed in anthracyclines and taxanes treatment were enrolled and randomly grouped. Patients in the NP group (n=22) were given 25 mg/m² vinorelbine on days 1 and 8 and 25 mg/m² cisplatin on days 2-4 of each 21-day cycle, while subjects in the GP group (n=26) were administered 1000 mg/m² gemcitabine on days 1 and 8 and 25 mg/m² cisplatin on days 2-4 of each 21-day cycle. The treatment response and adverse events were compared between the 2 groups every 2 cycles. RESULTS The ORR, DCR, and median TTP were 45.5%, 77.3%, and 5 months in the NP group, and 46.2%, 80.8%, and 5.2 months in the GP group, and no significant differences were observed in ORR, DCR, and median TTP between the 2 groups (P>0.05). The major adverse events included grade I-II bone marrow inhibition, gastrointestinal reactions, and phlebitis, and a lower incidence of thrombocytopenia and rash and a higher incidence of phlebitis was found in the NP group than in the GP group (P<0.05). CONCLUSIONS Either NP or GP regimen is active and tolerated in treatment of metastatic TNBC with anthracyclines and/or taxanes resistance, which may be used as a salvage treatment for metastatic TNBC.
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Affiliation(s)
- Junbin Wang
- Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China (mainland)
| | - Rongsheng Zheng
- Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China (mainland)
| | - Zishu Wang
- Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China (mainland)
| | - Yan Yang
- Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China (mainland)
| | - Mingxi Wang
- Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China (mainland)
| | - Weiyan Zou
- Department of Histology and Embryology, Bengbu Medical College, Bengbu, Anhui, China (mainland)
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Hickman M, Meade S, Fong C, Sanghera P, Good J, Hartley A. A prospective comparison of common toxicity criteria adverse events Version 3 and 4 in assessing oral mucositis for oral and oropharyngeal carcinoma. Tech Innov Patient Support Radiat Oncol 2017; 1:18-21. [PMID: 32095539 PMCID: PMC7033787 DOI: 10.1016/j.tipsro.2017.02.001] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2016] [Revised: 01/17/2017] [Accepted: 02/06/2017] [Indexed: 12/02/2022] Open
Abstract
BACKGROUND AND PURPOSE Oral mucositis is an expected complication of radiotherapy in the management of carcinoma of the head and neck. The Common Terminology Criteria for Adverse Events (CTCAE) Version 3 (V3) and related systems based on mucosal appearance have been used in clinical trials historically. More recently, Version 4 (V4) which is based on patient symptoms has been employed. This study compares the use of V3 and V4 in the grading of mucositis in patients undergoing radiotherapy with or without concurrent systemic therapy for carcinoma of the oral cavity and oropharynx. METHODS Oral mucositis was graded prospectively in patients receiving radiotherapy with or without concurrent systemic therapy using both V3 and V4. Grading was recorded during and after completion of therapy. RESULTS Between November 2014 and November 2015, 555 measurements were taken from 73 patients. Mucositis scores were equal in both versions in 327 (59%) measurements. Significant differences between V3 and V4 were seen in patients receiving cetuximab-based concurrent therapy (p < 0.001) and beyond 8 weeks from the start of radiotherapy (p = 0.004). CONCLUSION Differences in grading of mucositis scored by V3 and V4 are frequent. Relationships between biologically effective dose and rates of grade 3 mucositis have historically been based on mucosal appearances. It is not known whether the same relationships apply when mucositis is graded based on symptomatic grading systems. Both V3 and V4 should be used in clinical trials to improve understanding of mucositis and its relationship to quality of life and late mucosal toxicity.
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Affiliation(s)
| | | | | | | | | | - A. Hartley
- Hall-Edwards Radiotherapy Research Group, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK
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Chun SG, Hughes R, Sumer BD, Myers LL, Truelson JM, Khan SA, Ma TW, Xie Y, Yordy JS, Cooley S, Wu J, Choy H, Nedzi LA. A Phase I/II Study of Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Squamous Cell Cancer of the Head and Neck. Cancer Invest 2017; 35:23-31. [PMID: 27892728 DOI: 10.1080/07357907.2016.1213275] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
Nab-paclitaxel might impact efficacy of radiation for head and neck (H&N) cancer. Nab-paclitaxel, cisplatin, cetuximab, and radiation were evaluated in patients with locally advanced head and neck cancer in this phase I/II trial. Median follow-up was 24 months for 34 patients. The maximum tolerated dose of nab-paclitaxel was 20 mg/m2 with 20 mg/m2 cisplatin and 250 mg/m2 cetuximab. The 2-year progression-free survival (PFS) was 60% (95% confidence interval (CI) 0.42, 0.78), local control 71% (95% CI 0.55, 0.87), and overall survival 68% (95% CI 0.50, 0.86). This is the first study evaluating these agents with radiation in humans, with similar 2-year PFS as historic control.
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Affiliation(s)
- Stephen G Chun
- a Division of Radiation Oncology, M.D. Anderson Comprehensive Cancer Center , Houston , TX , USA
| | - Randall Hughes
- b Division of Hematology and Oncology, Department of Internal Medicine, Harold C. Simmons Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Baran D Sumer
- c Department of Otolaryngology , University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Larry L Myers
- c Department of Otolaryngology , University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - John M Truelson
- c Department of Otolaryngology , University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Saad A Khan
- b Division of Hematology and Oncology, Department of Internal Medicine, Harold C. Simmons Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Tsung-Wei Ma
- d Department of Clinical Sciences , University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Yang Xie
- d Department of Clinical Sciences , University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - John S Yordy
- e Valley Radiation Therapy Center , Anchorage , AK , USA
| | - Susan Cooley
- f Department of Radiation Oncology , Harold C. Simmons Comprehensive Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Jean Wu
- f Department of Radiation Oncology , Harold C. Simmons Comprehensive Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Hak Choy
- f Department of Radiation Oncology , Harold C. Simmons Comprehensive Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA
| | - Lucien A Nedzi
- f Department of Radiation Oncology , Harold C. Simmons Comprehensive Cancer Center, University of Texas at Southwestern Medical Center , Dallas , TX , USA
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Krasuska-Sławińska E, Brożyna A, Dembowska-Bagińska B, Olczak-Kowalczyk D. Antineoplastic chemotherapy and congenital tooth abnormalities in children and adolescents. Contemp Oncol (Pozn) 2016; 20:394-401. [PMID: 28373822 PMCID: PMC5371707 DOI: 10.5114/wo.2016.64602] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2015] [Accepted: 11/30/2015] [Indexed: 11/26/2022] Open
Abstract
AIM OF THE STUDY Chemotherapeutic treatment in children and adolescents carries a risk of congenital tooth disorders and dentinoma. Study objective is to assess the correlation between tooth abnormalities, early complications of multidrug chemotherapy, and chemotherapeutics used in different antineoplastic therapies in children and adolescents. MATERIAL AND METHODS Enamel defects (developmental defects of enamel index - DDE index) and defects in tooth number, size, and structure were assessed clinically and radiologically in 60 patients who underwent chemotherapy on average 4.9 ±3.4 years earlier (PCH), and 60 generally healthy subjects (control group - CG), aged 6-18 years. Höltta's defect index (DeI) was calculated. Medical files provided information on neoplasm type, age at treatment start and chemotherapy duration, chemotherapeutic type and dose, vomiting, and mucositis (CTCAE v4.0). Statistical significance of differences between groups was assessed with the Mann-Whitney U test and the correlation between dental defects and chemotherapy with Spearman's rank correlation coefficient (significance p ≤ 0.05). RESULTS Enamel defects, tooth agenesis, microdontia, root resorption, taurodontism, and dentinoma occurred statistically significantly more often in the PCH group. A correlation was established between vincristine use and dose and all types of dental defects; cyclophosphamide, doxorubicin, and isophosphamide and hypodontia; microdontia, root resorption, and enamel defects; etoposide and cisplatin and microdontia, root resorption, and enamel defects; methotrexate root resorption and enamel defects; carboplatin and dentinoma and enamel defects. Mucositis and vomiting promoted root resorption, microdontia, and enamel defects. CONCLUSIONS Dental defects are related to both the use of respective chemotherapeutics, especially vincristine, cyclophosphamide, doxorubicin, and isophosphamide, and to early complications in multidrug chemotherapy - mucositis and vomiting. Vincristine and carboplatin use may promote dentinoma.
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Affiliation(s)
| | - Agnieszka Brożyna
- Department of Paediatric Oncology, Children Memorial Hospital, Warsaw, Poland
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Milazzo-Kiedaisch CA, Itano J, Dutta PR. Role of Gabapentin in Managing Mucositis Pain in Patients Undergoing Radiation Therapy to the Head and Neck. Clin J Oncol Nurs 2016; 20:623-628. [PMID: 27857262 PMCID: PMC5621478 DOI: 10.1188/16.cjon.623-628] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
Abstract
BACKGROUND Oral mucositis (OM) is a painful and debilitating side effect that affects 80%-100% of patients undergoing radiation therapy for head and neck cancer. This dose-limiting side effect may potentially lead to pain, dehydration, malnutrition, infection, and treatment breaks. Treatment breaks can lead to decreased disease control and suboptimal patient outcomes. No primary prevention exists for OM, and management is focused on pain control. Compelling evidence exists that OM pain has somatic and neuropathic components. OBJECTIVES This article reviews the existing literature on the use of gabapentin (Neurontin®) as a co-analgesic in treating the neuropathic pain in OM. METHODS A literature search was performed using CINAHL® and PubMed with the search terms gabapentin and oral mucositis. The selected articles were briefly screened for relevance, and three were included in this review. FINDINGS No systematic reviews exist on the role of gabapentin for neuropathic pain in radiation-induced OM. Two retrospective studies concluded that gabapentin reduced escalation of opioid doses and unplanned treatment breaks. One retrospective study demonstrated favorable swallowing outcomes. Pain and OM are nursing-sensitive outcomes that can be significantly affected by evidence-based nursing interventions.
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Instruments to measure the quality of life in patients with oral mucositis undergoing oncological treatment: a systematic review of the literature. BOLETIN MEDICO DEL HOSPITAL INFANTIL DE MEXICO 2016; 73:457-466. [PMID: 29421290 DOI: 10.1016/j.bmhimx.2016.10.007] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2016] [Accepted: 10/20/2016] [Indexed: 11/20/2022] Open
Abstract
BACKGROUND Oral mucositis (OM) is an inflammatory reaction of the oropharyngeal mucosa to cumulative chemotherapy (CT) and radiation therapy (RT), affecting one or more parts of the digestive tract along with the quality of life (QoL) of the patient. The goal of this study was to identify valid and reliable tools to evaluate QoL related to OM. METHODS A systematic review of the literature was conducted up to May 2016. Articles were selected by peers using the PubMed database through a search following the inclusion and exclusion criteria and STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklist with a cut-off point ≥ 70%. RESULTS We identified four relevant articles that described instruments to assess the QoL related to OM in patients undergoing cancer treatment. CONCLUSIONS The evaluation of the QoL in patients with OM is a difficult scenario because of its multiple variables. The knowledge of this relationship is limited because general instruments of oral health or cancer therapy are commonly used for evaluation. However, valid instruments are already available for estimating the impact of OM on the QoL from the patient's perspective.
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Denda T, Kanda M, Morita Y, Kim HM, Kashiwada T, Matsuda C, Fujieda S, Nakata K, Murotani K, Oba K, Sakamoto J, Mishima H. Pharmacokinetic dose adjustment of 5-FU in modified FOLFOX7 plus bevacizumab for metastatic colorectal cancer in Japanese patients: a-JUST phase II clinical trial. Cancer Chemother Pharmacol 2016; 78:1253-1261. [PMID: 27807652 DOI: 10.1007/s00280-016-3184-6] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2016] [Accepted: 10/25/2016] [Indexed: 01/27/2023]
Abstract
PURPOSE Dose adjustment of 5-fluorouracil (FU) based on pharmacokinetic monitoring has been shown to reduce toxicities and increase efficacy compared with dosing based on body surface area in patients with metastatic colorectal cancer (mCRC). We evaluated the efficacy and safety of pharmacokinetic dose adjustment of FU in a modified FOLFOX7 (mFOLFOX7) plus bevacizumab regimen in Japanese patients with previously untreated mCRC. METHODS This single-arm, multicenter phase II trial enrolled 48 patients with mCRC. Treatment consisted of 5 mg/kg intravenous bevacizumab followed by mFOLFOX7 (oxaliplatin 85 mg/m2 on day 1, infused leucovorin 200 mg/m2, followed by a 2400 mg/m2 infusion of FU for 46 h starting on day 1), repeated every 2 weeks. FU concentrations were measured by immunoassay between 18 and 36 h after the start of continuous FU infusion, and the FU dose was then adjusted if required in subsequent cycles. The primary endpoint was response rate. RESULTS The median initial area under the concentration-time curve for FU was 23 mg h/L. Twenty-nine patients (60%) achieved the target concentration at the first cycle, and all 48 achieved it within the fourth cycle. The overall frequency of grade 3/4 adverse effects was 38%, with no significant difference between patients who did and not require dose adjustments. The overall response rate was 48% (95% confidence intervals = 34-62%). The median progression-free and overall survival rates were 11.3 and 24.1 months, respectively. CONCLUSIONS Pharmacokinetic dose adjustment of FU in mFOLFOX7 plus bevacizumab can optimize FU concentrations promptly and is safe in Japanese patients with mCRC.
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Affiliation(s)
- Tadamichi Denda
- Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan
| | - Mitsuro Kanda
- Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
| | | | - Ho Min Kim
- Department of Surgery, Rinku General Medical Center, Izumisano, Japan
| | - Tomomi Kashiwada
- Division of Cancer Center, Saga University Hospital, Saga, Japan
| | - Chu Matsuda
- Department of Surgery, Osaka General Medical Center, Osaka, Japan
| | - Shinji Fujieda
- Division of Gastroenterology, Ibaraki Prefectural Hospital, Kasama, Japan
| | - Ken Nakata
- Department of Surgery, Sakai City Hospital, Sakai, Japan
| | - Kenta Murotani
- Clinical Research Center, Aichi Medical University Hospital, Nagakute, Japan
| | - Koji Oba
- Department of Biostatistics, School of Public Health, Tokyo University Graduate School of Medicine, Tokyo, Japan.,Interfaculty Initiative in Information Studies, Tokyo University, Tokyo, Japan
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Yeh PH, Hung SK, Lee MS, Chiou WY, Lai CL, Tsai WT, Hsieh HL, Shih YT, Chen LC, Huang LW, Lin YA, Lin PH, Lin YH, Liu DW, Hsu FC, Tsai SJ, Liu JC, Chung ES, Lin HY. Implementing web-based ping-pong-type e-communication to enhance staff satisfaction, multidisciplinary cooperation, and clinical effectiveness: A SQUIRE-compliant quality-improving study. Medicine (Baltimore) 2016; 95:e5236. [PMID: 27858876 PMCID: PMC5591124 DOI: 10.1097/md.0000000000005236] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/15/2016] [Revised: 09/28/2016] [Accepted: 10/07/2016] [Indexed: 11/25/2022] Open
Abstract
BACKGROUND Frequent multidisciplinary communication is essential in conducting daily radiotherapy (RT) practice. However, traditional oral or paper-based communication has limitations. E-communication has been suggested, but its effects are still not well demarcated in the field of radiation oncology. OBJECTS In our web-based integrated information platform, we constructed a ping-pong-type e-communication function to transfer specific notations among multidisciplinary RT staffs. The purpose was to test whether applying this e-communication can increase effectiveness of multidisciplinary cooperation when compared with oral or paper-based practice. Staff satisfaction and clinical benefits were also demonstrated. DESIGN AND SETTING A real-world quality-improving study was conducted in a large center of radiation oncology. PARTICIPANTS AND DATASET USED Before and after applying multidisciplinary e-communication (from 2014 to 2015), clinical RT staffs were surveyed for their user experience and satisfaction (n = 23). For measuring clinical effectiveness, a secondary database of irradiated head and neck cancer patients was re-analyzed for comparing RT toxicities (n = 402). INTERVENTIONS Applying ping-pong-type multidisciplinary reflective e-communication was the main intervention. OUTCOME MEASURES For measuring staff satisfaction, eight domains were surveyed, such as timeliness, convenience, and completeness. For measuring clinical effectiveness of multidisciplinary cooperation, event rates of severe (i.e., grade 3-4) RT mucositis and dermatitis were recorded. RESULTS Overall, when compared with oral communication only, e-communication demonstrated multiple benefits, particularly on notation-review convenience (2.00 ± 1.76 vs 9.19 ± 0.81; P < 0.0001).When compared with paper-based practice, e-communication showed statistically significant benefits on all eight domains, especially on notation-review convenience (5.05 ± 2.11 vs 9.19 ± 0.81; P < 0.0001) and convenience of feedback notation (4.81 ± 1.72 vs 8.76 ± 1.09; P < 0.0001).Moreover, staff satisfaction was gradually increased from oral (3.57 ± 1.94), paper-based (5.57 ± 2.06), to e-communication (8.76 ± 0.70; P < 0.0001). Secondary measurement confirmed these observations.Before and after facilitating multidisciplinary cooperation by using e-communication, severe (i.e., grade 3-4) mucositis and dermatitis were decreased from 21.7% to 10% then to 5.1%. CONCLUSIONS Replacing oral or paper-based practice with e-communication is useful in facilitating RT multidisciplinary teamwork. Staff satisfaction and clinical effectiveness can be increased.
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Affiliation(s)
| | - Shih-Kai Hung
- Department of Radiation Oncology
- School of Medicine, Tzu Chi University, Hualien
| | - Moon-Sing Lee
- Department of Radiation Oncology
- School of Medicine, Tzu Chi University, Hualien
| | - Wen-Yen Chiou
- Department of Radiation Oncology
- School of Medicine, Tzu Chi University, Hualien
| | - Chun-Liang Lai
- Section of Chest Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- School of Medicine, Tzu Chi University, Hualien
| | - Wei-Ta Tsai
- Department of Radiation Oncology
- Department of Biomedical Imaging and Radiological Sciences, National Yang Ming University, Taipei
| | | | | | - Liang-Cheng Chen
- Department of Radiation Oncology
- School of Medicine, Tzu Chi University, Hualien
| | - Li-Wen Huang
- Department of Radiation Oncology
- School of Medicine, Tzu Chi University, Hualien
| | | | | | | | - Dai-Wei Liu
- Department of Radiation Oncology, Buddhist Tzu Chi General Hospital
- School of Medicine, Tzu Chi University, Hualien
| | | | | | | | | | - Hon-Yi Lin
- Department of Radiation Oncology
- School of Medicine, Tzu Chi University, Hualien
- Institute of Molecular Biology, National Chung Cheng University, Min-Hsiung, Chia-Yi, Taiwan, ROC
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Park JW, Roh JL, Lee SW, Kim SB, Choi SH, Nam SY, Kim SY. Effect of polypharmacy and potentially inappropriate medications on treatment and posttreatment courses in elderly patients with head and neck cancer. J Cancer Res Clin Oncol 2016; 142:1031-40. [PMID: 26744323 DOI: 10.1007/s00432-015-2108-x] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2015] [Accepted: 12/28/2015] [Indexed: 10/22/2022]
Abstract
PURPOSE The use of excessive and inappropriate medications is a common problem in elderly populations. The use of polypharmacy (PP) and potentially inappropriate medication (PIM) may affect treatment-related morbidities in elderly cancer patients, which has rarely been studied in patients with head and neck cancer (HNC). Here, we evaluate the effects of PP and PIM on treatment and posttreatment courses in elderly HNC patients. METHODS This study included 229 elderly HNC patients who underwent definitive treatment. Medications were carefully recorded, and the prevalences of PP and PIM are reported. We evaluated the associations between PP, PIM, treatment, and posttreatment course in terms of comorbidities, treatment-related toxicity, prolonged hospitalization, and posttreatment noncancer health events. RESULTS The prevalences of PP and PIM in our elderly HNC patients were 29.3 and 24.0 %, respectively, and frequently described PIMs include aspirin (12.2 %), calcium channel blockers (4.8 %), benzodiazepines (4.3 %), and nonsteroidal anti-inflammatory drugs (3.9 %). PP and PIM were not significantly associated with treatment-related toxicity, but were associated with modestly increased prolonged hospitalization [odds ratio [OR] 2.30 (95 % confidence interval 0.89-5.95); P = 0.080] and noncancer health events [OR 1.81 (0.99-3.31); P = 0.052], respectively. Among high-risk medications, benzodiazepine [OR 5.09 (1.21-21.5); P = 0.015] and calcium channel blockers [OR 5.69 (1.07-33.25); P = 0.031) were significantly associated with prolonged hospitalization. CONCLUSIONS Neither PP nor PIM are significantly associated with treatment-related toxicity in elderly HNC patients, but these are associated with modest increases in prolonged hospitalization and noncancer health events.
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Affiliation(s)
- Jun Woo Park
- Department of Otolaryngology, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea
| | - Jong-Lyel Roh
- Department of Otolaryngology, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.
| | - Sang-Wook Lee
- Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
| | - Sung-Bae Kim
- Department of Internal Medicine (Oncology), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
| | - Seung-Ho Choi
- Department of Otolaryngology, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea
| | - Soon Yuhl Nam
- Department of Otolaryngology, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea
| | - Sang Yoon Kim
- Department of Otolaryngology, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea
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De Sanctis V, Bossi P, Sanguineti G, Trippa F, Ferrari D, Bacigalupo A, Ripamonti CI, Buglione M, Pergolizzi S, Langendjik JA, Murphy B, Raber-Durlacher J, Russi EG, Lalla RV. Mucositis in head and neck cancer patients treated with radiotherapy and systemic therapies: Literature review and consensus statements. Crit Rev Oncol Hematol 2016; 100:147-66. [DOI: 10.1016/j.critrevonc.2016.01.010] [Citation(s) in RCA: 90] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2015] [Revised: 11/30/2015] [Accepted: 01/14/2016] [Indexed: 12/27/2022] Open
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Krasuska-Sławińska E, Brożyna A, Dembowska-Bagińska B, Olczak-Kowalczyk D. Factors influencing caries incidence in permanent teeth in children/adolescents under and after anti-neoplastic treatment. Contemp Oncol (Pozn) 2016; 20:45-51. [PMID: 27095939 PMCID: PMC4829740 DOI: 10.5114/wo.2015.55319] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2014] [Accepted: 11/19/2014] [Indexed: 11/23/2022] Open
Abstract
AIM OF THE STUDY To determine reasons for the increase in caries among children/adolescents treated for neoplasms. MATERIAL AND METHODS Health promoting behaviour, oral hygiene (PLI), gingiva (GI), dentition (DMFt/DMFs), number of teeth with white spot lesions (WSL), and enamel defects (ED) were assessed in three groups of 60 patients each. The three groups were as follows: under chemotherapy (CH), after chemotherapy (PCH), and generally healthy (CG). Medical files supplied information on neoplasm type, chemotherapeutic type and dose, age at treatment start, chemotherapy duration, and complications. Statistical analysis was performed with Mann-Whitney U test and Spearman's rho test. RESULTS The age at which chemotherapy was started/its duration was 5.9 ±4.0/1.3 ±0.5 years in PCH and 9.12 ±4.44/0.8 ±0.3 years in CH; PCH completed treatment 4.9 ±3.4 years ago. Chemotherapy most often included vincristine (VCR), etoposide (VP-16), adriamycin (ADM), cyclophosphamide (CTX), cisplatin (CDDP), and ifosphamide (IF). Mucositis occurrence was 28.33% in PCH and 45.00% in CH; vomiting occurrence was 43.33% and 50.00%, respectively. Nutrition and prophylaxis mistakes occurred more often in CH/PCH than in CG; PLI, GI, caries incidence and severity, and the number of teeth with WSL were higher. Correlation between caries incidence and chemotherapeutic type and dose, age at treatment start and treatment duration, mucositis, emesis, PLI, GI, ED, no fluoride prophylaxis, and nutritional mistakes was established. Ifosphamide and mucositis treatment played a major role in chemotherapy; after chemotherapy - ED and CTX, ADM, IF, and VP-16. CONCLUSIONS Caries in permanent teeth in children/adolescents undergoing chemotherapy result from nutritional mistakes, poor prophylaxis, and indirectly from chemotherapy complications (first mucositis and emesis, and later developmental ED).
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