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Kamat S, Brown BR, Cohen SA, Vyas A. Prophylactic Neurokinin-1 Receptor Antagonist Use Pre- and Post-Choosing Wisely Initiative Among Women With Invasive Breast Cancer. Health Serv Res 2025:e14626. [PMID: 40227057 DOI: 10.1111/1475-6773.14626] [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: 07/30/2024] [Revised: 02/20/2025] [Accepted: 03/08/2025] [Indexed: 04/15/2025] Open
Abstract
OBJECTIVE To examine the impact of Choosing Wisely (CW) on prophylactic NK1-RA use among women with breast cancer. STUDY SETTING AND DESIGN This was a retrospective cohort study conducted using administrative claims data. The exposure variable was the start of chemotherapy relative to the implementation date for the CW antiemetic measure. The outcome was prophylactic NK1-RA use. Interrupted time series using segmented regression was used to assess the effect of CW on prophylactic NK1-RA use. DATA SOURCES AND ANALYTIC SAMPLE Optum's de-identified Clinformatics Data Mart Database (2010-2018) was used. This study included women aged ≥ 18 years with breast cancer with at least one newly initiated claim for low/minimal/moderate emetic risk chemotherapy (n = 25,549). PRINCIPAL FINDINGS The prophylactic use of NK1-RAs among patients with breast cancer receiving low/minimal/moderate emetic risk chemotherapy decreased from 11.1% pre-CW to 7.7% post-CW. Segmented regression analysis showed a significant increase of 0.11 per 100 patients per quarter in the use of prophylactic NK1-RAs prior to CW recommendation (95% CI = 0.10-0.12; p < 0.0001). However, immediately after the CW (occurred in Q4 2013), there was a significant decline in the prophylactic NK1-RA use by 1.03 per 100 patients in Q2 2014 (-0.93 to -1.13; p < 0.0001). For the time after intervention, there was a significant decline in NK1-RA use by 0.37 per 100 patients per quarter in the post-CW period compared to the pre-CW period (95% CI = -0.36 to -0.38; p < 0.0001). CONCLUSION This study highlights a significant but modest decline in the use of prophylactic NK1-RAs. Educational efforts for the dissemination of CW recommendations are needed to facilitate appropriate prophylactic NK1-RAs use.
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Affiliation(s)
- Shweta Kamat
- Department of Pharmacy Practice and Clinical Research, College of Pharmacy, University of Rhode Island, Kingston, Rhode Island, USA
| | - Britny R Brown
- Department of Pharmacy Practice and Clinical Research, College of Pharmacy, University of Rhode Island, Kingston, Rhode Island, USA
| | - Steven A Cohen
- Department of Health Studies, College of Health Sciences, University of Rhode Island, Kingston, Rhode Island, USA
| | - Ami Vyas
- Department of Pharmacy Practice and Clinical Research, College of Pharmacy, University of Rhode Island, Kingston, Rhode Island, USA
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McShane E, Furness K, Hanna L, Connell K, Haines T, Huggins CE, Zalcberg J, Carey S, Pilgrim CHC, Lundy J, Metz A, Kissane D, Franco M, Coutsouvelis J, De Boo DW, Bell JS, Iddawela M, Dodson T, Pereira I, Imad N, Kirkpatrick J, Dear C, Croagh D. Assessing the impact of an intensive dietitian-led telehealth intervention focusing on nutritional adequacy, symptom control and optional supplemental jejunal feeding, on quality of life in patients with pancreatic cancer: a randomised controlled trial protocol. Nutr J 2025; 24:54. [PMID: 40197383 PMCID: PMC11974167 DOI: 10.1186/s12937-025-01113-9] [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: 12/23/2024] [Accepted: 03/14/2025] [Indexed: 04/10/2025] Open
Abstract
BACKGROUND Pancreatic cancer is the third leading cause of cancer-related death in Australia, with a persistently poor 5-year survival rate of around 13%. Symptoms arising from the disease and chemotherapy such as epigastric pain, anorexia, bloating and fat-malabsorptive diarrhoea cause poor oral intake and weight loss, and reduce an individual's quality of life and ability to tolerate anti-cancer treatment. The primary aim of this study is to determine if an early, intensive telehealth nutrition intervention can improve quality of life compared to usual care for people undergoing treatment for pancreatic cancer. METHODS This multicentre randomised controlled trial will recruit adults newly diagnosed with borderline resectable, locally advanced or metastatic pancreatic cancer from multiple health services across Victoria (metropolitan and regional). The control group will receive usual nutrition care, which is site-dependent. The intervention group will receive weekly telehealth dietetic consultations for six months, targeting nutritional adequacy through dietary education and counselling, oral nutrition supplement drinks and dietetics-led symptom management advocacy, including appropriate dosing of pancreatic enzymes. Escalation to supplemental jejunal tube feeding may occur if clinically required in the intervention arm. The primary outcome is quality of life (EORTC-QLQ C30 summary score); secondary outcomes include survival, chemotherapy dosing changes, and nutrition status markers including body composition. Outcomes will be measured at baseline, and three- and six-months. DISCUSSION The findings of this study will provide evidence of the impact that intensive nutrition therapy, including counselling, provision of oral nutrition supplement drinks and the option for jejunal feeding, has on quality of life and health outcomes in pancreatic cancer. The consistent dietetic approach with the use of telehealth consultations to reduce malnutrition and aid symptom management challenges the current model of care. TRIAL REGISTRATION 31st January 2024, Australian and New Zealand Clinical Trial Registry (Trial ID/No. ACTRN12624000084583).
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Affiliation(s)
- Emma McShane
- Nutrition & Dietetics Department, Alfred Health, Melbourne, VIC, Australia
- Department of Sport, Exercise and Nutrition Sciences, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, VIC, Australia
| | - Kate Furness
- Department of Sport, Exercise and Nutrition Sciences, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, VIC, Australia
| | - Lauren Hanna
- Department of Nutrition, Dietetics and Food, Faculty of Medicine Nursing and Health Sciences, Monash University, Notting Hill, VIC, Australia.
| | - Kate Connell
- Department of Sport, Exercise and Nutrition Sciences, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, VIC, Australia
| | - Terrence Haines
- School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Frankston, VIC, Australia
| | - Catherine E Huggins
- Department of Nutrition, Dietetics and Food, Faculty of Medicine Nursing and Health Sciences, Monash University, Notting Hill, VIC, Australia
- Institute for Health Transformation, Global Centre for Preventive Health and Nutrition, School of Health and Social Development, Deakin University, Geelong, VIC, Australia
| | - John Zalcberg
- Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia
- School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
| | - Sharon Carey
- Nutrition and Dietetics Department, Royal Prince Alfred Hospital, Camperdown, NSW, Australia
| | - Charles H C Pilgrim
- School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
- Hepaticopancreaticobiliary Surgery Unit, Alfred Health, Melbourne, VIC, Australia
- School of Translational Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
| | - Joanne Lundy
- Department of Medical Oncology, Peninsula Health, Frankston, VIC, Australia
- Department of Medicine, Peninsula Clinical School, Monash University, Frankston, VIC, Australia
| | - Andrew Metz
- Department of Gastroenterology, Royal Melbourne Hospital, Parkville, VIC, Australia
- The University of Melbourne, Parkville, VIC, Australia
- Jreissati Pancreatic Centre, Epworth HealthCare, Richmond, VIC, Australia
| | - David Kissane
- School of Medicine, University of Notre Dame Australia, Sydney, NSW, Australia
- Department of Psychiatry, Monash University, Clayton, VIC, Australia
| | - Michael Franco
- St Vincent's Health, Fitzroy, VIC, Australia
- Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
- Faculty of Information Technology, Monash University, Clayton, VIC, Australia
| | - John Coutsouvelis
- Centre for Medication Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia
- Pharmacy Department, Alfred Health, Melbourne, VIC, Australia
| | - Diederick W De Boo
- Department of Radiology, Monash Medical Centre, Monash Health, Clayton, VIC, Australia
- Department of Medical Imaging and Radiation Sciences, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
| | - J Simon Bell
- Centre for Medication Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia
| | - Mahesh Iddawela
- School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
- Latrobe Regional Health, Traralgon, VIC, Australia
| | - Theresa Dodson
- Upper Gastrointestinal and Hepatobiliary Surgery, Monash Medical Centre, Monash Health, Clayton, VIC, Australia
| | - Ignatius Pereira
- Department of Medical Imaging and Radiation Sciences, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
| | - Nina Imad
- Department of Nursing and Allied Health, School of Health Sciences, Swinburne University of Technology, Hawthorn, VIC, Australia
| | | | - Cherie Dear
- Consumer Representatives, Melbourne, VIC, Australia
| | - Daniel Croagh
- Upper Gastrointestinal and Hepatobiliary Surgery, Monash Medical Centre, Monash Health, Clayton, VIC, Australia
- Department of Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
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Tatsuta R, Tanaka R, Tashibu A, Suzuki Y, Suzuki K, Shibata T, Ando T, Shin T, Sato Y, Itoh H. Association of chemotherapy-induced nausea and vomiting or anorexia with plasma levels of five gastrointestinal peptides in patients receiving chemotherapy. J Pharm Health Care Sci 2025; 11:17. [PMID: 40045433 PMCID: PMC11881272 DOI: 10.1186/s40780-025-00424-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2025] [Accepted: 02/25/2025] [Indexed: 03/09/2025] Open
Abstract
BACKGROUND Imbalance between gastrointestinal peptides has been implicated as a cause of chemotherapy-induced nausea and vomiting (CINV) and anorexia in cancer patients. This study comprehensively evaluated the changes in blood levels of five gastrointestinal peptide: substance P, neuropeptide (NPY), motilin, ghrelin and leptin, following chemotherapy, and the relationship between these peptides and CINV or anorexia. METHODS This single-center, prospective, observational study recruited 20 patients with esophageal cancer, urothelial cancer, or testiculoma undergoing cisplatin-based chemotherapy. Plasma levels of five gastrointestinal peptides were measured on days 1 (baseline; before administering chemotherapy), 3, 5 and 8 of the chemotherapy session. Anorexia and CINV were defined as visual analog scale scores 25 mm or higher at least once during the observation period. RESULTS Plasma NPY and leptin were significantly elevated in the early phase (day 3) of the chemotherapy session, while plasma motilin and substance P were significantly elevated in the late phase (days 5 and 8). Plasma motilin showed significant elevation on days 5 and 8 compared to baseline in CINV group but no significant increase in non-CINV group, and the levels were significantly higher in CINV than in non-CINV group. Plasma leptin peaked significantly on day 3 in both anorexia and non-anorexia groups, and remained significantly higher on day 5 compared to baseline in anorexia group but not in non-anorexia group. CONCLUSION CINV is associated with excessive secretion of motilin and anorexia is related to sustained elevation of leptin, suggesting the potential of these peptides as quantitative indicators of CINV and anorexia.
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Affiliation(s)
- Ryosuke Tatsuta
- Department of Clinical Pharmacy, Oita University Hospital, Yufu, Oita, Japan.
| | - Ryota Tanaka
- Department of Clinical Pharmacy, Oita University Hospital, Yufu, Oita, Japan
| | - Asami Tashibu
- Department of Clinical Pharmacy, Oita University Hospital, Yufu, Oita, Japan
| | - Yosuke Suzuki
- Department of Clinical Pharmacy, Oita University Hospital, Yufu, Oita, Japan
| | - Kosuke Suzuki
- Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Yufu, Oita, Japan
| | - Tomotaka Shibata
- Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Yufu, Oita, Japan
| | - Tadasuke Ando
- Department of Urology, Oita University Faculty of Medicine, Yufu, Oita, Japan
| | - Toshitaka Shin
- Department of Urology, Oita University Faculty of Medicine, Yufu, Oita, Japan
| | - Yuhki Sato
- Department of Clinical Pharmacy, Oita University Hospital, Yufu, Oita, Japan
| | - Hiroki Itoh
- Department of Clinical Pharmacy, Oita University Hospital, Yufu, Oita, Japan
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Wang Y, Wang F, Hu F, Long F. Effect of non-pharmacological interventions on chemotherapy induced delayed nausea and vomiting for tumors: A systematic review and Bayesian network meta-analysis. Complement Ther Med 2025; 88:103124. [PMID: 39798818 DOI: 10.1016/j.ctim.2024.103124] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2024] [Revised: 12/15/2024] [Accepted: 12/31/2024] [Indexed: 01/15/2025] Open
Abstract
OBJECTIVE To evaluate the efficacy of non-pharmacological interventions in improving chemotherapy induced delayed nausea and vomiting symptoms using a network meta-analysis. METHODS Four Chinese databases (CNKI, Wanfang Data Knowledge Service Platform, VIP, Sinomed) and five English databases (PubMed, Cochrane Library, Embase, Web of Science, CINAHL) were searched from the establishment of the database to April 2024. A Bayesian network meta-analysis was performed on the response rate to the improvement of chemotherapy induced delayed nausea and vomiting, as well as improvement in KPS score, under different non-pharmacological interventions by using R 4.4.0 software and the GeMTC package. RESULTS A total of 58 RCTs 4081 patients were selected, involving 14 non-pharmacological interventions. The results of Meta-analysis showed that acupoint patch was identified as the most probable superior intervention in the improvement of chemotherapy induced delayed nausea and vomiting, and acupuncture was identified as the most probable superior intervention on the improvement of KPS scores. CONCLUSION Non-pharmacological interventions can serve as an effective complementary approach to managing delayed chemotherapy-induced nausea and vomiting. In particular, acupoint application may be the optimal complementary therapy to mitigate the incidence of delayed nausea and vomiting, though more high-quality, large-scale evidence is required to conclusively demonstrate the efficacy of acupuncture in enhancing the quality of life for cancer patients.
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Affiliation(s)
- Yongni Wang
- School of Nursing, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China.
| | - Fang Wang
- Director's Office, Guang' an Hospital, Affiliated Hospital of Chengdu University of Chinese Medicine/Guang' an Hospital of Traditional Chinese Medicine, Guang' an 638001, China.
| | - Feifei Hu
- School of Nursing, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China.
| | - Fang Long
- School of Nursing, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China.
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Borner T, Pataro AM, De Jonghe BC. Central mechanisms of emesis: A role for GDF15. Neurogastroenterol Motil 2025; 37:e14886. [PMID: 39108013 PMCID: PMC11866100 DOI: 10.1111/nmo.14886] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/15/2024] [Revised: 07/08/2024] [Accepted: 07/24/2024] [Indexed: 02/06/2025]
Abstract
BACKGROUND Nausea and emesis are ubiquitously reported medical conditions and often present as treatment side effects along with polymorbidities contributing to detrimental life-threatening outcomes, such as poor nutrition, lower quality of life, and unfavorable patient prognosis. Growth differentiation factor 15 (GDF15) is a stress response cytokine secreted by a wide variety of cell types in response to a broad range of stressors. Circulating GDF15 levels are elevated in a range of medical conditions characterized by cachexia and malaise. In recent years, GDF15 has gained scientific and translational prominence with the discovery that its receptor, GDNF family receptor α-like (GFRAL), is expressed exclusively in the hindbrain. GFRAL activation may results in profound anorexia and body weight loss, effects which have attracted interest for the pharmacological treatment of obesity. PURPOSE This review highlights compelling emerging evidence indicating that GDF15 causes anorexia through the induction of nausea, emesis, and food aversions, which encourage a perspective on GDF15 system function in physiology and behavior beyond homeostatic energy regulation contexts. This highlights the potential role of GDF15 in the central mediation of nausea and emesis following a variety of physiological, and pathophysiological conditions such as chemotherapy-induced emesis, hyperemesis gravidarum, and cyclic vomiting syndrome.
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Affiliation(s)
- Tito Borner
- Department of Biobehavioral Health Sciences, School of NursingUniversity of PennsylvaniaPhiladelphiaPennsylvaniaUSA
- Department of PsychiatryUniversity of Pennsylvania, Perelman School of MedicinePhiladelphiaPennsylvaniaUSA
- Department of Biological Sciences, Human and Evolutionary Biology SectionUniversity of Southern CaliforniaLos AngelesCaliforniaUSA
| | - Allison M. Pataro
- Department of Biobehavioral Health Sciences, School of NursingUniversity of PennsylvaniaPhiladelphiaPennsylvaniaUSA
| | - Bart C. De Jonghe
- Department of Biobehavioral Health Sciences, School of NursingUniversity of PennsylvaniaPhiladelphiaPennsylvaniaUSA
- Department of PsychiatryUniversity of Pennsylvania, Perelman School of MedicinePhiladelphiaPennsylvaniaUSA
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Tao V, Tennant G, Clayden C, Reynolds LM. Shifting perspectives: an investigation of a virtual reality awe experience in people going through cancer treatment. Support Care Cancer 2025; 33:136. [PMID: 39891780 PMCID: PMC11787277 DOI: 10.1007/s00520-025-09192-4] [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: 10/03/2024] [Accepted: 01/21/2025] [Indexed: 02/03/2025]
Abstract
PURPOSE Evoking awe using virtual reality appears to be a promising intervention that has potential to positively impact physical and psychological well-being. The purpose of this exploratory study was to investigate the acceptability and potential benefits of a VR experience of awe for patients undergoing cancer treatment. METHODS Twenty cancer patients viewed a 5-min VR nature experience designed to induce awe and completed questionnaires assessing anxiety, symptom distress, spirituality, and connectedness to nature. Qualitative interviews assessed acceptability and ways to improve the intervention. RESULTS The VR experience effectively induced awe. Following the experience, participants reported decreased anxiety and symptom distress and increased feelings of spirituality and connectedness to nature. Participants enjoyed the experience and said they would use it again and would recommend it to others. CONCLUSION VR nature interventions that induce awe are worthy of future investigation as a psychological approach to support cancer patients undergoing treatment.
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Affiliation(s)
- V Tao
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand
| | - G Tennant
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand
- Harbour Cancer & Wellness, Southern Cross North Harbour Hospital, 212 Wairau Road, Wairau Valley, Auckland, 0627, New Zealand
| | - C Clayden
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand
| | - Lisa M Reynolds
- Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand.
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Belluomini L, Avancini A, Sposito M, Pontolillo L, Tregnago D, Trestini I, Insolda J, Carbognin L, Milella M, Bria E, Pilotto S. Integrating nutrition, physical exercise, psychosocial support and antiemetic drugs into CINV management: The road to success. Crit Rev Oncol Hematol 2024; 201:104444. [PMID: 39002789 DOI: 10.1016/j.critrevonc.2024.104444] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2024] [Revised: 06/26/2024] [Accepted: 07/06/2024] [Indexed: 07/15/2024] Open
Abstract
Over the years, advancements in antiemetic drugs have improved chemotherapy-induced nausea and vomiting (CINV) control. However, despite the antiemetics therapies, in a relevant number of adult patients (∼30 %), CINV is still persistent, leading to several complications, such as electrolyte imbalances, anorexia, and treatment discontinuation. Supportive care interventions have gained credibility in cancer care, helping to improve patients' psycho-physical condition, quality of life, and managing symptoms, including CINV. Physical exercise and tailored nutritional counseling have demonstrated benefits in reducing the severity of nausea and vomiting. Psychological intervention has been postulated as a key approach in controlling anticipatory nausea/vomiting, as well as acupuncture/acupressure has been shown to decrease nausea and vomiting after chemotherapy treatments. In the current review, we aim to provide a clinical update on current prophylactic and delayed antiemetic guidelines for CINV and an overview of the non-pharmacological interventions tested for alleviating CINV in patients with cancer.
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Affiliation(s)
- Lorenzo Belluomini
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Alice Avancini
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Marco Sposito
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Letizia Pontolillo
- UOC Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Medical Oncology, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Roma, Italy.
| | - Daniela Tregnago
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Ilaria Trestini
- Dietetic Service, Hospital Medical Direction, University and Hospital Trust (AOUI) of Verona, Italy.
| | - Jessica Insolda
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Luisa Carbognin
- UOC Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Medical Oncology, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Roma, Italy.
| | - Michele Milella
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
| | - Emilio Bria
- UOC Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Medical Oncology, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Roma, Italy.
| | - Sara Pilotto
- Section of Innovation Biomedicine, Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona, Italy.
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Furness K, Huggins CE, Hanna L, Croagh D, Sarkies M, Haines TP. Effect of Communication Mode on Disclosure of Nutrition Impact Symptoms During Nutrition Intervention Delivered to People With Upper Gastrointestinal Cancer. Eval Health Prof 2024:1632787241267051. [PMID: 39045879 DOI: 10.1177/01632787241267051] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/25/2024]
Abstract
Individuals diagnosed with upper gastrointestinal cancers experience a myriad of nutrition impact symptoms (NIS) compromise a person's ability to adequately meet their nutritional requirements leading to malnutrition, reduced quality of life and poorer survival. Electronic health (eHealth) is a potential strategy for improving the delivery of nutrition interventions by improving early and sustained access to dietitians to address both NIS and malnutrition. This study aimed to explore whether the mode of delivery affected participant disclosure of NIS during a nutrition intervention. Participants in the intervention groups received a nutrition intervention for 18 weeks from a dietitian via telephone or mobile application (app) using behaviour change techniques to assist in goal achievement. Poisson regression determined the proportion of individuals who reported NIS compared between groups. Univariate and multiple regression analyses of demographic variables explored the relationship between demographics and reporting of NIS. The incidence of reporting of NIS was more than 1.8 times higher in the telephone group (n = 38) compared to the mobile group (n = 36). Telephone predicted a higher likelihood of disclosure of self-reported symptoms of fatigue, nausea, and anorexia throughout the intervention period. A trusting therapeutic relationship built on human connection is fundamental and may not be achieved with current models of mobile health technologies.
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Affiliation(s)
- Kate Furness
- Department of Nutrition and Dietetics, Monash Health, Monash Medical Centre, Clayton, VIC, Australia
- Dietetics, Department of Nursing and Allied Health, Swinburne University of Technology, Hawthorn, VIC, Australia
- Department Sport, Exercise and Nutrition Sciences, School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, VIC, Australia
- School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia
| | - Catherine E Huggins
- Department of Nutrition, Dietetics and Food, School of Clinical Sciences, Faculty of Medicine Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
- Global Centre for Preventative Health and Nutrition, Institute for Health Transformation, School of Health and Social Development, Faculty of Health, Deakin University, Burwood, VIC, Australia
| | - Lauren Hanna
- Department of Nutrition and Dietetics, Monash Health, Monash Medical Centre, Clayton, VIC, Australia
- Department of Nutrition, Dietetics and Food, School of Clinical Sciences, Faculty of Medicine Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
| | - Daniel Croagh
- Upper Gastrointestinal and Hepatobiliary Surgery, Monash Medical Centre, Clayton, VIC, Australia
- Department of Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia
| | - Mitchell Sarkies
- School of Health Sciences, Faculty of Medicine and Health, University of Sydney, NSW, Australia
| | - Terry P Haines
- School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia
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9
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Tian SC, Yang J, Li X, Huang RX, Chen J. Bibliometric and visual analysis of chemotherapy-induced nausea and vomiting (2004-2023). Front Oncol 2024; 14:1377486. [PMID: 38720800 PMCID: PMC11076682 DOI: 10.3389/fonc.2024.1377486] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2024] [Accepted: 04/04/2024] [Indexed: 05/12/2024] Open
Abstract
Background Patients undergoing chemotherapy often encounter troubling and common side effects, notably Chemotherapy-induced nausea and vomiting (CINV). This side effect not only impairs the patient's quality of life but could also result in the interruption or discontinuation of the chemotherapy treatment. Consequently, research into CINV has consistently remained a focal point in the realm of clinical medicine. In this research domain, bibliometric analysis has not been conducted. The purpose of this study is to deliver a thorough summary of the knowledge framework and key areas of interest in the field of Chemotherapy-induced nausea and vomiting, using bibliometric methods. This approach aims to furnish novel concepts and pathways for investigators working in this area. Methods Publications focusing on Chemotherapy-induced nausea and vomiting, spanning from 2004 to 2023, were identified using the Web of Science Core Collection (WoSCC) database. Tools such as VOSviewer, CiteSpace, and the R package "bibliometrix" were employed for this bibliometric analysis. Results This research covers 734 publications from 61 countries, with the United States and China being the primary contributors. There has been a significant rise in the volume of papers published in the most recent decade compared to the one before it, spanning over the past twenty years. However, the annual publication rate in the last ten years has not shown a significant upward trend. The University of Toronto, Merck & Co., Sun Yat-sen University, and Helsinn Healthcare SA emerged as the principal research institutions in this field. Supportive Care in Cancer stands out as the most frequently published and cited journal in this domain. These works are contributed by 3,917 authors, with Rudolph M Navari, Matti Aapro, Shimokawa Mototsugu, and Lee Schwartzberg being among those who have published the most. Paul J. Hesketh is notably the most co-cited author. The primary focus of this research field lies in exploring the mechanisms of CINV and the therapeutic strategies for managing it. Key emerging research hotspots are represented by terms such as "Chemotherapy-induced nausea and vomiting," "nausea," "vomiting," "chemotherapy," and "antiemetics." Conclusion This represents the inaugural bibliometric study to thoroughly outline the research trends and advancements in the field of CINV. It highlights the latest research frontiers and trending directions, offering valuable insights for scholars engaged in studying CINV.
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Affiliation(s)
- Shao-Chuang Tian
- Department of Oncology, The First People’s Hospital of Kunming, Kunming, China
| | - Jing Yang
- Department of Oncology, The First People’s Hospital of Kunming, Kunming, China
| | - Xin Li
- Department of Gynecology, Kunming Maternal and Child Health Hospital, Kunming, China
| | - Rong-Xia Huang
- Department of Gynecology, Kunming Maternal and Child Health Hospital, Kunming, China
| | - Jian Chen
- Department of Gynecology, Kunming Maternal and Child Health Hospital, Kunming, China
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Perkovich B, Atayee RS, Kim JS, Rubenzik T. Use of Fosaprepitant for Management of Suspected Antimicrobial-Associated Nausea: A Case Report. J Pain Palliat Care Pharmacother 2024; 38:28-32. [PMID: 37983131 DOI: 10.1080/15360288.2023.2282465] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2023] [Accepted: 11/05/2023] [Indexed: 11/22/2023]
Abstract
Intractable nausea can occur in numerous settings. We report on a 49-year-old woman with a past medical history of cystic fibrosis (CF) with chronic hypoxia, chronic nausea, complex infection history and frequent hospitalizations who was admitted to an academic medical center with a CF exacerbation. Her chronic nausea worsened with the use of antimicrobials, and she was unable to tolerate dopamine or serotonin antagonist antiemetics. Nausea persisted despite the use of benzodiazepines and antihistamines. She was given a one-time dose of fosaprepitant 150 mg intravenously (IV) with marked improvement of her nausea. During subsequent exacerbations, she again developed severe nausea which continued to respond well to a one-time dose of fosaprepitant 150 mg IV. Fosaprepitant is a substance P/neurokinin-1 (NK1) receptor antagonist that is FDA-approved for the prevention of chemotherapy-induced nausea and vomiting and has been used to prevent post-operative nausea and vomiting. Its use in other contexts has not been well established. This case suggests a role for fosaprepitant in the management of nausea outside the context of chemotherapy or general anesthesia.
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Affiliation(s)
- Brandon Perkovich
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
| | - Rabia S Atayee
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
- Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA
- San Diego Health, Department of Pharmacy, University of California, San Diego, La Jolla, California, USA
| | - Jennifer S Kim
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
| | - Tamara Rubenzik
- Division of Geriatrics, Gerontology and Palliative Care, University of California San Diego, La Jolla, California, USA
- Division of Nephrology and Hypertension, University of California San Diego, La Jolla, California, USA
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11
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Baéz-Gutierrez N, Suárez-Casillas P, Pérez-Moreno MA, Blázquez-Goñi C, Abdelkader-Martín L. Antiemetic prophylaxis in hematologic malignancies patients receiving conditioning protocols for hematopoietic stem cell transplantation: A study protocol for a systematic review. FARMACIA HOSPITALARIA 2023; 47:T289-T293. [PMID: 37858519 DOI: 10.1016/j.farma.2023.09.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/29/2023] [Revised: 07/12/2023] [Accepted: 07/13/2023] [Indexed: 10/21/2023] Open
Abstract
OBJECTIVE Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. METHODS A systematic review will be conducted using MEDLINE via PubMed, EMBASE, ClinicalTrials.gov., and Cochrane databases. Studies written in English, French, Italian or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, two independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. DISCUSSION Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them includes specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life.
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12
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Baéz-Gutierrez N, Suárez-Casillas P, Pérez-Moreno MA, Blázquez-Goñi C, Abdelkader-Martín L. Antiemetic prophylaxis in hematologic malignancies patients receiving conditioning protocols for hematopoietic stem cell transplantation: A study protocol for a systematic review. FARMACIA HOSPITALARIA 2023; 47:289-293. [PMID: 37541914 DOI: 10.1016/j.farma.2023.07.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/29/2023] [Revised: 07/12/2023] [Accepted: 07/13/2023] [Indexed: 08/06/2023] Open
Abstract
OBJECTIVE Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. METHODS A systematic review will be conducted using MEDLINE via PubMed, EMBASE, Clinical-Trials.gov., and Cochrane databases. Studies written in English, French, Italian, or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, 2 independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. DISCUSSION Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them include specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life.
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13
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Borner T, Tinsley IC, Milliken BT, Doebley SA, Najjar NR, Kerwood DJ, De Jonghe BC, Hayes MR, Doyle RP. Creation of a Peptide Antagonist of the GFRAL-RET Receptor Complex for the Treatment of GDF15-Induced Malaise. J Med Chem 2023; 66:11237-11249. [PMID: 37506293 PMCID: PMC10461225 DOI: 10.1021/acs.jmedchem.3c00667] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/12/2023] [Indexed: 07/30/2023]
Abstract
Growth differentiation factor 15 (GDF15) is a contributor to nausea, emesis, and anorexia following chemotherapy via binding to the GFRAL-RET receptor complex expressed in hindbrain neurons. Therefore, GDF15-mediated GFRAL-RET signaling is a promising target for improving treatment outcomes for chemotherapy patients. We developed peptide-based antagonists of GFRAL that block GDF15-mediated RET recruitment. Our initial library screen led to five novel peptides. Surface plasmon resonance and flow cytometric analyses of the most efficacious of this group, termed GRASP, revealed its capacity to bind to GFRAL. In vivo studies in rats revealed that GRASP could attenuate GDF15-induced nausea and anorexia resulting from cisplatin. Combined with Ondansetron, GRASP led to an even greater attenuation of the anorectic effects of cisplatin compared to either agent alone. Our results highlight the beneficial effects of GRASP as an agent to combat chemotherapy-induced malaise. GRASP may also be effective in other conditions associated with elevated levels of GDF15.
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Affiliation(s)
- Tito Borner
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
- Department
of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Ian C. Tinsley
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Brandon T. Milliken
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Sarah A. Doebley
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Nicholas R. Najjar
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Deborah J. Kerwood
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
| | - Bart C. De Jonghe
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
- Department
of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Matthew R. Hayes
- Department
of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
- Department
of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
| | - Robert P. Doyle
- Department
of Chemistry, Syracuse University, 111 College Place, Syracuse, New York 13244, United States
- Departments
of Medicine and Pharmacology, State University
of New York, Upstate Medical University, Syracuse, New York 13245, United States
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14
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Borner T, Doebley SA, Furst CD, Pataro AM, Halas JG, Gao X, Choi GK, Ramadan SA, Chow A, De Jonghe BC. Screening study of anti-emetics to improve GDF15-induced malaise and anorexia: Implications for emesis control. Physiol Behav 2023; 267:114229. [PMID: 37164246 PMCID: PMC10883415 DOI: 10.1016/j.physbeh.2023.114229] [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: 03/17/2023] [Revised: 05/05/2023] [Accepted: 05/06/2023] [Indexed: 05/12/2023]
Abstract
Considerable preclinical and clinical attention has focused on the food intake and body weight suppressive effects of growth differentiation factor 15 (GDF15) and its elevated blood levels as a consequence of disease states and disease treatment therapeutics. We have previously reported that exogenous administration of GDF15 induces anorexia through nausea and emesis in multiple species. Importantly, GDF15 signaling as a meditator of chemotherapy-induced anorexia and emesis has recently been demonstrated in both murine and nonhuman primate models. The mechanism, however, by which GDF15 induces malaise and the utility of existing therapeutic targets to counteract its effects remain largely unknown. Using a dose of GDF15 that mimics stimulated levels following chemotherapy administration and reliably induces malaise, we sought to screen anti-emetics that represent distinct pharmacotherapeutic classes hypothesized to reduce GDF15-induced effects in rats. Strikingly, our results showed that none of the tested compounds were effective at preventing GDF15-induced malaise. These results illustrate the complexity of GDF15 signaling mechanism and may have important implications for medical conditions characterized by elevated GDF15 levels and incomplete symptom control, such as chemotherapy-induced nausea and vomiting.
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Affiliation(s)
- Tito Borner
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States; Department of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA 19104, United States.
| | - Sarah A Doebley
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - C Daniel Furst
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - Allison M Pataro
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - Julia G Halas
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - Xing Gao
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - Grace K Choi
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - Sarah A Ramadan
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - Angela Chow
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States
| | - Bart C De Jonghe
- Department of Biobehavioral Health Sciences, University of Pennsylvania, School of Nursing, Philadelphia, PA 19104, United States; Department of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA 19104, United States
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Yang Q, Zou X, Xie YL, Lin C, Ouyang YF, Liu YL, Duan CY, You R, Liu YP, Liu RZ, Huang PY, Guo L, Hua YJ, Chen MY. Fosaprepitant Weekly vs Every 3 Weeks for the Prevention of Concurrent Chemoradiotherapy-Induced Nausea and Vomiting: A Pilot Randomized Clinical Trial. JAMA Netw Open 2023; 6:e2326127. [PMID: 37498596 PMCID: PMC10375310 DOI: 10.1001/jamanetworkopen.2023.26127] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 07/28/2023] Open
Abstract
Importance Unlike substantial evidence in the prevention of chemotherapy-induced nausea and vomiting (CINV), research in the prevention of nausea and vomiting caused by concurrent chemoradiotherapy (CCRT) is currently lacking. Objective To compare the efficacy and safety of fosaprepitant weekly vs every 3 weeks for the prevention of nausea and emesis caused by CCRT among patients with nasopharyngeal carcinoma. Design, Setting, and Participants This pilot randomized clinical trial was conducted at a single cancer center from November 24, 2020, to July 26, 2021, among patients with nasopharyngeal carcinoma who had achieved CINV control after 2 to 3 cycles of induction chemotherapy. Efficacy analyses were performed in the intention-to-treat population. Data were analyzed on November 4, 2022. Interventions Eligible patients were randomly assigned (1:1) to receive fosaprepitant either weekly or every 3 weeks. Main Outcomes and Measures The primary end point was the proportion of patients with sustained complete response (defined as no emesis and no rescue therapy) during CCRT. Secondary end points were sustained no emesis, no nausea, no significant nausea, mean time to first emetic episode, quality of life, and 1-year progression-free survival (PFS). Results A total of 100 patients (mean [SD] age, 46.6 [10.9] years; 83 [83.0%] male) who had achieved CINV control after induction chemotherapy were randomly assigned to receive fosaprepitant weekly (50 patients) or every 3 weeks (50 patients). There was no significantly significant difference in cumulative risk of emesis or rescue therapy in the group that received weekly fosaprepitant compared with those who received fosaprepitant every 3 weeks (subhazard ratio, 0.66 [95% CI, 0.43-1.02]; P = .06). The proportion of patients with sustained no emesis (38% vs 14%; P = .003) or no significant nausea (92% vs 72%; P = .002) was significantly higher in the group that received fosaprepitant weekly vs those who received fosaprepitant every 3 weeks. Treatments were well tolerated. Patients in the weekly group had improved scores for multiple quality-of-life measures. There was no significant difference in survival outcomes between groups (91.8% vs 93.7%; P = .99). In the mean brainstem dose subgroups, a possible treatment interaction effect was observed in sustained complete response (mean brainstem dose ≥36 Gy: hazard ratio [HR], 0.32 [95% CI, 0.15-0.69]; mean brainstem dose <36 Gy: HR, 0.95 [95% CI, 0.55-1.63]) and sustained no emesis (mean brainstem dose ≥36 Gy: HR, 0.21 [95% CI, 0.08-0.53]; mean brainstem dose <36 Gy: HR, 0.73 [95% CI, 0.41-1.28]). Conclusions and Relevance In this pilot randomized clinical trial, there was no statistically significant difference in the complete response primary end point, but patients receiving weekly fosaprepitant were less likely to experience emesis compared with those who received fosaprepitant every 3 weeks, especially in the subgroup with a mean brainstem dose of 36 Gy or more. Weekly fosaprepitant was well tolerated and improved quality of life of patients without compromising survival. Trial Registration ClinicalTrials.gov Identifier: NCT04636632.
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Affiliation(s)
- Qi Yang
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Xiong Zou
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Yu-Long Xie
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Chao Lin
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Yan-Feng Ouyang
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Yong-Long Liu
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Chong-Yang Duan
- Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China
| | - Rui You
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - You-Ping Liu
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Rong-Zeng Liu
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Pei-Yu Huang
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Ling Guo
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Yi-Jun Hua
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
| | - Ming-Yuan Chen
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China
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16
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Borner T, Reiner BC, Crist RC, Furst CD, Doebley SA, Halas JG, Ai M, Samms RJ, De Jonghe BC, Hayes MR. GIP receptor agonism blocks chemotherapy-induced nausea and vomiting. Mol Metab 2023; 73:101743. [PMID: 37245848 PMCID: PMC10326744 DOI: 10.1016/j.molmet.2023.101743] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/10/2023] [Revised: 05/17/2023] [Accepted: 05/24/2023] [Indexed: 05/30/2023] Open
Abstract
OBJECTIVE Nausea and vomiting remain life-threatening obstacles to successful treatment of chronic diseases, despite a cadre of available antiemetic medications. Our inability to effectively control chemotherapy-induced nausea and vomiting (CINV) highlights the need to anatomically, molecularly, and functionally characterize novel neural substrates that block CINV. METHODS Behavioral pharmacology assays of nausea and emesis in 3 different mammalian species were combined with histological and unbiased transcriptomic analyses to investigate the beneficial effects of glucose-dependent insulinotropic polypeptide receptor (GIPR) agonism on CINV. RESULTS Single-nuclei transcriptomics and histological approaches in rats revealed a topographical, molecularly distinct, GABA-ergic neuronal population in the dorsal vagal complex (DVC) that is modulated by chemotherapy but rescued by GIPR agonism. Activation of DVCGIPR neurons substantially decreased behaviors indicative of malaise in cisplatin-treated rats. Strikingly, GIPR agonism blocks cisplatin-induced emesis in both ferrets and shrews. CONCLUSION Our multispecies study defines a peptidergic system that represents a novel therapeutic target for the management of CINV, and potentially other drivers of nausea/emesis.
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Affiliation(s)
- Tito Borner
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - Benjamin C Reiner
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - Richard C Crist
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - C Daniel Furst
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - Sarah A Doebley
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - Julia G Halas
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - Minrong Ai
- Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, 46285, USA
| | - Ricardo J Samms
- Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, 46285, USA
| | - Bart C De Jonghe
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - Matthew R Hayes
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA, 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.
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Kiernan JM, Vallerand AH. Mitigation of Chemotherapy-Induced Nausea Using Adjunct Music Listening: A Pilot Study. Clin Nurs Res 2023; 32:469-477. [PMID: 36744581 DOI: 10.1177/10547738221149895] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
The persistence of chemotherapy-induced nausea (CIN) underscores the need to consider nonpharmacologic treatments such as music listening as adjunct interventions. This pilot study investigated the feasibility and overall effects of a 30-minute adjunct music listening intervention in 12 patients experiencing CIN. Music listening was started at the time participants took their as-needed antiemetic medication, and it was repeated as needed during the 5 days after chemotherapy. Data for 66 music listening engagements were collected. A significant reduction of nausea severity (t = 10.97, p < .001) and distress (t = 9.86, p < .001) was noted overall, as well as significant reductions when examining the acute and delayed phases of nausea individually. Qualitative data on study feasibility demonstrated the intervention was well received by participants and held minimal operational difficulty. Investigator feasibility data suggested good understanding of data collection tools. Improvements to the study design have been collected and will form the basis of the future randomized controlled trial.
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18
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Chen W, Zhao Y, Dai Y, Nie K. Gastrointestinal inflammation plays a critical role in chemotherapy-induced nausea and vomiting. Eur J Pharmacol 2022; 936:175379. [PMID: 36356927 DOI: 10.1016/j.ejphar.2022.175379] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2022] [Revised: 10/28/2022] [Accepted: 11/03/2022] [Indexed: 11/09/2022]
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Md Yusof M, Abdullah MM, Yap BK, Ng SC, Low JSH, Lam KS, Ahmad Badruddin RBA, Lai CNB, Lau KL, Chong KJ, Nonis JG, Ahmad Annuar MA, Abdul Rahman MHFB. Real-world multicenter study of the safety and efficacy of netupitant plus palonosetron fixed-dose combination to prevent chemotherapy-induced nausea and vomiting among Malaysian patients receiving moderately or highly emetogenic chemotherapy. Asia Pac J Clin Oncol 2021; 18:419-427. [PMID: 34811924 DOI: 10.1111/ajco.13667] [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: 07/16/2021] [Accepted: 08/17/2021] [Indexed: 11/30/2022]
Abstract
AIM A large proportion of cancer patients are at high risk for chemotherapy-induced nausea and vomiting (CINV), but the choice of anti-emetics for CINV in Malaysia is limited. METHODS This was a real-world study of a fixed-dose combination of netupitant and palonosetron (NEPA) to inhibit CINV in adult patients receiving moderately (MEC) or highly emetogenic chemotherapy (HEC) for solid/hematological malignancies at eight Malaysian centers. Each HEC/MEC cycle received one dose of NEPA + dexamethasone for CINV prevention. Complete response (no emesis, no rescue medication) (CR), no more than mild nausea (severity score ≤ 2.5), and complete control (CR) (no more than mild nausea) during the acute (0-24 h), delayed (25-120 h), and overall (0-120 h) phases post-chemotherapy were measured. Treatment-related adverse events (AEs) were recorded. RESULTS During March 2016-April 2018 (NMRR-17-3286-38282), NEPA + dexamethasone was administered to 54 patients (77.8% solid, 22.2% hematological malignancies). Note that 59.3% received HEC, while 40.7% received MEC regimen. During the overall phase of the first cycle, the majority had CR (77.8%), no more than mild nausea (74.1%), and complete control (61.1%). Seventeen patients received two consecutive cycles at any point of chemotherapy cycles. During the overall phases across two consecutive cycles, all patients achieved CR, and the majority reported no more than mild nausea and complete control. No grades 3-4 AEs were reported. CONCLUSIONS NEPA had sustained efficacy and tolerability at first administration and across two cycles of MEC/HEC for CINV prevention.
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Affiliation(s)
| | | | | | - Soo Chin Ng
- Subang Jaya Medical Centre, Subang Jaya, Selangor, Malaysia
| | | | - Kai Seng Lam
- Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
| | | | | | - Kah Liew Lau
- Borneo Medical Centre, Kuching, Sarawak, Malaysia
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Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer 2021; 7:e25648. [PMID: 34738909 PMCID: PMC8663669 DOI: 10.2196/25648] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/10/2020] [Revised: 06/14/2021] [Accepted: 09/25/2021] [Indexed: 11/30/2022] Open
Abstract
Background Cancer is a chronic disease with an incidence of 24.5 million and 9.6 million deaths worldwide in 2017. Lung and colorectal cancer are the most common cancers for both sexes and, according to national and international recommendations, platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) may persist. Moreover, cancer patients are increasingly interested in alternative and complementary medicines and have expressed the desire that nonpharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology significantly decreases the severity of CINV in patients with breast cancer. Objective The primary aim of this study was to assess the benefits of foot reflexology as a complement therapy to conventional treatments regarding the severity of acute CINV in patients with digestive or lung cancer. The secondary objectives assessed were the frequency and severity of delayed CINV, quality of life, anxiety, and self-esteem. Methods This study was conducted between April 2018 and April 2020 in the Hospices Civils de Lyon, France. This was an open-label randomized controlled trial. Participants were randomized into two groups: the intervention group (ie, conventional care with foot reflexology; n=40) and the control group (ie, conventional care without foot reflexology; n=40). Foot reflexology sessions (30 minutes each) were performed on outpatients or inpatients. Eligible participants were patients with lung or digestive cancer with an indication for platinum-based chemotherapy. Results The severity of acute nausea and vomiting was assessed with a visual analog scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for the control group (7/34, 21%; P=.001). Across all cycles, the foot reflexology group showed a trend toward less frequent delayed nausea (P=.28), a significantly less frequent consumption of antiemetic drugs (P=.04), and no significant difference for vomiting (P=.99); there was a trend toward a perception of stronger severity for delayed nausea in the control group (P=.39). Regarding quality of life and anxiety, there was no significant difference between the intervention group and the control group (P=.32 and P=.53, respectively). Conclusions This study’s results indicate that foot reflexology provides significantly better management of acute nausea severity and decreased consumption of antiemetic drugs in patients with lung or digestive cancer. In order to fulfill patients’ desires to use nonpharmacological treatments and complementary and alternative medicines in hospitals, foot reflexology could be provided as a complementary intervention to conventional antiemetic drugs. Foot reflexology did not result in adverse effects. To assess the benefits of foot reflexology in routine practice, a larger study with several health care centers would be needed with a cluster randomized controlled trial. Trial Registration ClinicalTrials.gov NCT03508180; https://clinicaltrials.gov/ct2/show/NCT03508180 International Registered Report Identifier (IRRID) RR2-10.2196/17232
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Affiliation(s)
- Audrey Murat-Ringot
- Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.,INSERM U1290, Research on Healthcare Performance, Claude Bernard University I, Lyon, France.,Groupe de Recherche en Psychologie Sociale EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France
| | | | - Fabien Subtil
- Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France.,Biometrics and Evolutionary Biology UMR 5558, Claude Bernard University I, Centre national de la recherche scientifique, Villeurbanne, France
| | - Florent Boutitie
- Pôle Santé Publique - Service de Biostatistiques, Hospices Civils de Lyon, Lyon, France
| | - Marie Preau
- Groupe de Recherche en Psychologie Sociale EA 4163, Institut de Psychologie, Université Lyon 2, Bron, France
| | - Vincent Piriou
- Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.,INSERM U1290, Research on Healthcare Performance, Claude Bernard University I, Lyon, France
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21
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Quinn CS, Bergsbaken JJ, Blessinger EJ, Piccolo JK. Implementation of a clinical pharmacist-led service to optimize management of refractory chemotherapy-induced nausea and vomiting in adult hematology/oncology clinic. J Oncol Pharm Pract 2021; 28:1499-1507. [PMID: 34225524 DOI: 10.1177/10781552211029702] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
OBJECTIVE Chemotherapy-induced nausea and vomiting (CINV) is a common and potentially debilitating adverse effect of chemotherapy. Refractory CINV can be particularly difficult to control. This report provides details on the implementation and evaluation of a pharmacist-led program for the management of refractory CINV in hematology and oncology clinics. METHODS A pharmacist-led program open to adult outpatients with refractory CINV was implemented at University of Wisconsin. Pharmacists conducted baseline and follow-up assessments, provided patient education, and started, discontinued, and/or adjusted antiemetics as clinically necessary for all enrolled patients. Retrospective chart review was used to describe the proportion of patients whose CINV improved through pharmacist intervention, effect of the program on antiemetic adherence, categorization of pharmacist interventions, and duration of patient enrollment. RESULTS Forty-six patients were enrolled between February 2019 and January 2020. Forty-one patients (89.1%) had an overall reduction in their nausea and vomiting from baseline. Eleven patients (23.9%) met criteria for nonadherence to prescribed antiemetics at baseline; all patients were adherent at unenrollment. A total of 111 pharmacist interventions were made. The most common intervention was addition of new breakthrough antiemetic. The least common intervention was dose escalation of a previously prescribed antiemetic. The average number of interventions made per patient was 2.5. On average, patients were enrolled in the program for 16.6 days and met with a pharmacist three times. CONCLUSION Implementation of this program standardized and streamlined pharmacist involvement with refractory CINV. Enrollment resulted in a measurable reduction in nausea and/or vomiting for patients with refractory CINV.
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Affiliation(s)
- Caroline S Quinn
- Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
| | | | | | - Jennifer K Piccolo
- Pharmacy Service, William S Middleton Memorial Veterans Hospital, Madison, WI, USA
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22
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Wang DS, Hu MT, Wang ZQ, Ren C, Qiu MZ, Luo HY, Jin Y, Fong WP, Wang SB, Peng JW, Zou QF, Tan Q, Wang FH, Li YH. Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Women: A Randomized Clinical Trial. JAMA Netw Open 2021; 4:e215250. [PMID: 33835174 PMCID: PMC8035650 DOI: 10.1001/jamanetworkopen.2021.5250] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/27/2022] Open
Abstract
IMPORTANCE The prevention of chemotherapy-induced nausea and vomiting has an important role in the overall management of cancer treatment. OBJECTIVE To evaluate whether adding aprepitant to palonosetron and dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by FOLFIRI (fluorouracil, leucovorin, and irinotecan) or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) chemotherapy regimens among women with gastrointestinal cancer at higher risk. DESIGN, SETTING, AND PARTICIPANTS This phase 3, double-blind, placebo-controlled randomized clinical trial recruited young women (age ≤50 years) who drank little or no alcohol and had gastrointestinal cancer for which they received FOLFOX or FOLFIRI chemotherapy. A total of 248 women were enrolled and assigned in the ratio 1:1 to intervention and control groups from August 4, 2015, to March 31, 2020. Intention-to-treat analysis was used to evaluate patient baseline characteristics and efficacy. The analysis was conducted on October 30, 2020. INTERVENTIONS Patients were randomly assigned to the aprepitant group (aprepitant, 125 mg, orally 60 minutes before initiation of chemotherapy on day 1 and 80 mg orally each morning of days 2 and 3; palonosetron, 0.25 mg, intravenously; and dexamethasone, 6 mg, orally 30 minutes before chemotherapy initiation on day 1) or the placebo group (placebo, 125 mg, orally 60 minutes before initiation of chemotherapy on day 1 and 80 mg orally on each morning of days 2 and 3; palonosetron, 0.25 mg, intravenously; and dexamethasone, 12 mg, orally 30 minutes before chemotherapy initiation on day 1). MAIN OUTCOMES AND MEASURES The primary end point was the complete response (CR) rate, defined as the proportion of patients without emesis episodes or rescue medication use during the overall phase of the first cycle. Other efficacy indicators, such as no vomiting and no nausea, were measured as the secondary and exploratory end points. RESULTS A total of 248 women from 4 clinical centers in China entered this study, and 243 patients (aprepitant regimen, 125 patients [51.4%]; placebo regimen, 118 patients [48.5%]) were evaluable for efficacy and safety; mean (SD) age of the total population was 40.1 (7.3) years. The CR rate was significantly higher in the aprepitant group vs the control group overall (107 [87.0%] vs 80 [66.7%]; P < .001) and in the acute (114 [92.7%] vs 91 [75.8%]; P = .001) and delayed (109 [88.6%] vs 84 [70.0%]; P = .001) phases of the trial. The incidence of adverse events was similar between the 2 groups (100 [80.0%] vs 96 [81.3%]; P = .79), and no grade 3 or 4 aprepitant treatment-related adverse events were observed. Multivariable analysis revealed that aprepitant use was the only independent factor associated with CR during the overall phase. CONCLUSIONS AND RELEVANCE The combination of aprepitant with palonosetron and dexamethasone provided increased antiemetic efficacy in the FOLFOX or FOLFIRI chemotherapy regimen and was well tolerated by younger women with gastrointestinal cancer who have a history of little or no alcohol consumption. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03674294.
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Affiliation(s)
- De-Shen Wang
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Ming-Tao Hu
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Zhi-Qiang Wang
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Chao Ren
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Miao-Zhen Qiu
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Hui-Yan Luo
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Ying Jin
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - William Pat Fong
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Shu-bin Wang
- Department of Oncology, Peking University Shenzhen Hospital, Shenzhen, People’s Republic of China
| | - Jie-wen Peng
- Chemotherapy Department, Zhongshan People’s Hospital, Zhongshan, Guangdong Province, People’s Republic of China
| | - Qing-feng Zou
- Section 3 of Internal Medicine, Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, People’s Republic of China
| | - Qiong Tan
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Feng-Hua Wang
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
| | - Yu-Hong Li
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University, Guangzhou, People’s Republic of China
- Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, People’s Republic of China
- Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People’s Republic of China
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23
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Hough S, McDevitt R, Nachar VR, Kraft S, Brown A, Christen C, Frame D, Smerage JB. Chemotherapy Remote Care Monitoring Program: Integration of SMS Text Patient-Reported Outcomes in the Electronic Health Record and Pharmacist Intervention for Chemotherapy-Induced Nausea and Vomiting. JCO Oncol Pract 2021; 17:e1303-e1310. [PMID: 33534634 DOI: 10.1200/op.20.00639] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
PURPOSE Chemotherapy-induced nausea and vomiting (CINV) is a common cause of unplanned healthcare utilization. The University of Michigan Rogel Cancer Center initiated the chemotherapy remote care monitoring program (CRCMP) to proactively identify patients experiencing CINV and intervene before the need for urgent evaluation. METHODS High-risk patients for CINV are identified by neurokinin-1 (NK-1) antagonist administration, enrolled in the CRCMP, and received a daily text message survey for 7 days after chemotherapy administration to report symptoms. Responses above a set threshold trigger a message to the team pharmacist for intervention. The primary outcome of 14-day unplanned healthcare use was evaluated before and after CRCMP implementation. RESULTS In 8 months, 652 patients received an NK-1 antagonist (2,244 cycles) and 387 patients were enrolled in the CRCMP (59%). Text message response rate was 94%. Clinical pharmacists provided 248 interventions in 121 patient episodes meeting threshold criteria. Fourteen-day unplanned healthcare use was decreased in the CRCMP-enrolled NK-1 episodes (6.68% v 4.53%, P = .02). Admissions were numerically lower for those enrolling in CRCMP when only admissions for nausea were considered (0.63% v 0.35%, P = .33). CONCLUSION The CRCMP allowed for real-time management of patient-reported CINV symptom burden based on patient-reported outcomes (PROs) and an electronic medical record-integrated SMS text questionnaire. Clinical pharmacists were key team members to manage patient symptoms. Enrollment in CRCMP significantly reduced overall unplanned healthcare utilization. Although these changes were numerically small, any reduction in unnecessary care utilizing PROs can contribute to high-value care for patients with cancer.
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Affiliation(s)
- Shannon Hough
- University of Michigan Rogel Cancer Center, Ann Arbor, MI
| | | | | | - Shawna Kraft
- University of Michigan Rogel Cancer Center, Ann Arbor, MI.,University of Michigan College of Pharmacy, Ann Arbor, MI
| | - Anna Brown
- University of Michigan Rogel Cancer Center, Ann Arbor, MI
| | | | - David Frame
- University of Michigan Rogel Cancer Center, Ann Arbor, MI.,University of Michigan College of Pharmacy, Ann Arbor, MI
| | - Jeffrey B Smerage
- University of Michigan Rogel Cancer Center, Ann Arbor, MI.,Division of Hematology and Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI
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24
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Gupta K, Walton R, Kataria SP. Chemotherapy-Induced Nausea and Vomiting: Pathogenesis, Recommendations, and New Trends. Cancer Treat Res Commun 2020; 26:100278. [PMID: 33360668 DOI: 10.1016/j.ctarc.2020.100278] [Citation(s) in RCA: 79] [Impact Index Per Article: 15.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2020] [Revised: 11/23/2020] [Accepted: 12/09/2020] [Indexed: 06/12/2023]
Abstract
The significant physical and emotional effects of chemotherapy-induced nausea and vomiting (CINV) are experienced by cancer patients. Severe symptoms decrease the patient's quality of life and potentially deters further treatment. The five main forms of CINV (i.e., acute, delayed, anticipatory, breakthrough, and refractory) require different treatment regimens, which often include 5-HT3 receptor antagonists, NK1 receptor antagonists, and corticosteroids. Despite a significant amount of research and development of antiemetic agents, management of CINV remains a great challenge with many needs waiting to be adequately addressed, such as controlling non-acute CINV, developing appropriate CINV treatment protocols for multiple-day chemotherapy patients, and providing options for those prone to CINV despite treatment. Further research is required to optimize CINV management for these patients.
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Affiliation(s)
- Kush Gupta
- Kasturba Medical College, Mangalore, Karnataka 575001, India.
| | | | - S P Kataria
- Vardhaman Mahavir Medical College and Safdurjung Hospital, New Delhi 110029, India
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25
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Analysis of pharmacogenomic factors for chemotherapy-induced nausea and vomiting in patients with breast cancer receiving doxorubicin and cyclophosphamide chemotherapy. Cancer Chemother Pharmacol 2020; 87:73-83. [PMID: 33099677 DOI: 10.1007/s00280-020-04177-y] [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: 07/20/2020] [Accepted: 10/09/2020] [Indexed: 02/08/2023]
Abstract
PURPOSE Chemotherapy-induced nausea and vomiting (CINV) can lead to a significant deterioration in the quality of life of cancer patients receiving chemotherapy. This study aimed to determine whether ABCB1 2677G > T/A was associated with complete response (CR; defined as no vomiting and no rescue medication) in acute phase (CR0-24), as well as to explore the genetic factors affecting delayed phase (CR24-120) CINV in cancer patients treated with a standard triple antiemetic regimen that included aprepitant. METHODS This prospective single-center study included a total of 166 chemotherapy-naïve patients with breast cancer who received a standard dose of doxorubicin and cyclophosphamide combination chemotherapy; granisetron, dexamethasone, and aprepitant were administered prior to chemotherapy. CR0-24 was compared between minor allele homozygous (TT, AA, and TA) and major allele homozygous plus heterozygous (GG, GA, and GT) groups of ABCB1 2677G > T/A. In addition, 14 genetic polymorphisms were genotyped and their associations with CRs were investigated. RESULTS The proportion of patients who achieved CR0-24, which was the primary endpoint of this study, was 59% in the minor allele homozygous and 61% in the major allele homozygous plus heterozygous groups of ABCB1 2677G > T/A. Although this difference was not statistically significant, multivariate logistic regression analysis adjusted for potential risk factors showed that TACR1 1323TT (OR, 2.57; P = 0.014) was a significant determinant of CR24-120. CONCLUSION No significant association was found between ABCB1 2677G > T/A and CR0-24. However, it was observed that the polymorphism of TACR1, which encodes the neurokinin 1 receptor, might be a potential genetic risk factor for the development of delayed phase CINV.
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26
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An overview of acute gastrointestinal side effects of systemic anti-cancer therapy and their management. Best Pract Res Clin Gastroenterol 2020; 48-49:101691. [PMID: 33317796 DOI: 10.1016/j.bpg.2020.101691] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2020] [Accepted: 10/06/2020] [Indexed: 01/31/2023]
Abstract
Treatment-related acute gastrointestinal toxicities are a common and often debilitating hurdle encountered in the treatment of cancer patients. While the introduction of targeted therapies such as tyrosine kinase inhibitors has led to improvements in survival outcomes, their use has also been complicated by a high frequency of clinically important adverse effects. Gastrointestinal toxicities such as nausea, vomiting, diarrhoea and hepatotoxicity represent potentially serious adverse events that may necessitate dose reductions, treatment interruptions and cessation of treatment. An improved knowledge of the incidence, pathophysiology, management and prophylaxis of these toxicities is crucial in order to reduce patient morbidity and mortality. In this review, we discuss the main gastrointestinal toxicities associated with chemotherapy and targeted therapies in oncology, outlining their incidence, pathophysiology and expert management guidelines.
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27
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Eakin CM, Norton TJ, Monk BJ, Chase DM. Management of nausea and vomiting from poly(ADP-ribose) polymerase inhibitor therapy for advanced ovarian cancer. Gynecol Oncol 2020; 159:581-587. [PMID: 32972786 DOI: 10.1016/j.ygyno.2020.08.016] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/04/2020] [Accepted: 08/12/2020] [Indexed: 01/09/2023]
Abstract
Poly(ADP-ribose) polymerase (PARP) inhibitors have rapidly emerged as a new class of daily oral chemotherapeutic agents that have the potential to dramatically alter the way in which primary peritoneal, fallopian tube and ovarian cancers are treated. However, the management of nausea and vomiting, the most common toxicities incurred by these agents, remains poorly understood. The purpose of this review is to provide an overview of current guidelines, antiemetic agents and management steps for patients experiencing nausea and vomiting associated with the use of PARP inhibitors.
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Affiliation(s)
- Cortney M Eakin
- Creighton University School of Medicine, Phoenix, AZ, United States of America
| | - Taylor J Norton
- University of Arizona College of Medicine, Phoenix, AZ, United States of America
| | - Bradley J Monk
- Creighton University School of Medicine, Phoenix, AZ, United States of America; University of Arizona College of Medicine, Phoenix, AZ, United States of America; Arizona Oncology (US Oncology Network), Phoenix, AZ, United States of America
| | - Dana M Chase
- Creighton University School of Medicine, Phoenix, AZ, United States of America; University of Arizona College of Medicine, Phoenix, AZ, United States of America; Arizona Oncology (US Oncology Network), Phoenix, AZ, United States of America.
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28
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Eghbali M, Negarandeh R, Ebadi A, Bandari R, Mohammadzadeh F. Psychometric assessment of the Persian version of short clinical scale to measure chemotherapy-induced nausea and vomiting: the MASCC antiemetic tool. Support Care Cancer 2020; 28:4353-4359. [PMID: 31907650 DOI: 10.1007/s00520-019-05281-3] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2019] [Accepted: 12/23/2019] [Indexed: 11/24/2022]
Abstract
INTRODUCTION AND OBJECTIVE Managing chemotherapy-induced nausea and vomiting (CINV) in patients with cancer is still a challenge for the patients and also the clinicians. The Multinational Association of Supportive Care in Cancer (MASCC) has developed a scale for better measurement and management of CINV. Thus, this paper aims at translating the scale into Persian and assessing the psychometric properties of the proposed translated version of MASCC Antiemesis Tool (MAT). METHODS Having received the necessary permissions and complying with the Forward-Backward translation protocol, we conducted a qualitative assessment of the face validity through cognitive interviewing and content validity assess with 5 experts in Persian Literature. Internal consistency using Cronbach's Alpha Coefficient was applied to determine the scale reliability. In order to determine the construct validity, the three methods of exploratory factor analysis, known group analysis, and convergent validity (assessment of the correlation between Rhodes Index of Nausea, Vomiting and Retching (INVR) scale and the Persian version of MAT scale) were conducted on 300 participants. RESULTS About 300 patients with a mean age of 50.73 ± 0.81 participated in the study. The results showed a significant difference in the index of nausea and vomiting between the patients who are below 50 years old and those who are above 50 (P = 0.0001). The Cronbach's Alpha Coefficient was reported 0.88 for the whole MAT questionnaire. Due to the low factor load (fewer than 0.5) for question 1, it was removed in the factor analysis. Besides, exploratory factor analysis (EFA) led to the exploration of the two factors of nausea and vomiting. CONCLUSION According to the results of the study, the Persian version of the MAT questionnaire is considered as a highly reliable and valid tool, in order to efficiently and accurately measure chemotherapy-induced nausea and vomiting and to better manage this side effect.
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Affiliation(s)
- Mohammad Eghbali
- Department of Nursing, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran
- Student Research Committee, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran
| | - Reza Negarandeh
- Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.
| | - Abbas Ebadi
- Behavioral Sciences Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran
- Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran
| | - Razieh Bandari
- Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran
| | - Faeze Mohammadzadeh
- Medical laboratory science, Hasheminejad Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
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Vaswani B, Bhagat S, Patil S, Barkate H. Effectiveness of a novel, fixed dose combination of netupitant and palonosetron in prevention of chemotherapy induced nausea and vomiting: A real-life study from India. World J Clin Oncol 2020; 11:606-613. [PMID: 32879847 PMCID: PMC7443837 DOI: 10.5306/wjco.v11.i8.606] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/17/2020] [Revised: 04/09/2020] [Accepted: 07/26/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND A new, oral fixed dose combination of highly selective neurokinin-1 receptor antagonist, netupitant with 5HT3 receptor antagonist, netupitant and palonosetron (NEPA) was approved in India for prevention of chemotherapy induced nausea and vomiting (CINV).
AIM To assess effectiveness of NEPA in real-world scenario.
METHODS We retrospectively assessed the medical records and patient dairies of adult patients who received highly emetogenic or moderately emetogenic chemotherapy (HEC/MEC) and treated with NEPA (Netupitant 300 mg + Palanosetron 0.50 mg) for prevention of CINV. Complete response (CR) was defined as no emesis or no requirement of rescue medication in overall phase (0 to 5 d), acute phase (0-24 h) and delayed phase (2 to 5 d).
RESULTS In 403 patients included in the analysis, mean age was 56.24 ± 11.11 years and 55.09% were females. Breast cancer (25.06%) was most common malignancy encountered. HEC and MEC were administered in 54.6% and 45.4% patients respectively. CR in overall phase was 93.79% whereas it was 98.01% in acute CINV and 93.79% in delayed CINV. Overall CR in HEC and MEC groups was 93.63% and 93.98% respectively. CR was more than 90% in different chemotherapy cycles except in group of patients of cycle 4 where CR was 88.88%.
CONCLUSION NEPA is a novel combination that is effective in preventing CINV in up to 93% cases treated with highly emetogenic or moderately emetogenic chemotherapy. This study brings the first real-life evidence of its effectiveness in India population.
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Affiliation(s)
- Bharat Vaswani
- Medical Oncology, Yashoda Cancer Institute, Secunderabad 500003, India
| | - Sagar Bhagat
- Medical Services, Glenmark Pharmaceutical limited, Mumbai 400099, India
| | - Saiprasad Patil
- Medical Services, Glenmark Pharmaceutical limited, Mumbai 400099, India
| | - Hanmant Barkate
- Medical Services, Glenmark Pharmaceutical limited, Mumbai 400099, India
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Ince Y, Yildirim Usta Y. The Effect on Nausea and Vomiting of Structured Education Given to Male Lung Cancer Patients Receiving Chemotherapy. JOURNAL OF CANCER EDUCATION : THE OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER EDUCATION 2020; 35:788-795. [PMID: 31037505 DOI: 10.1007/s13187-019-01531-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/09/2023]
Abstract
The objective of this study was to investigate the effect on nausea and vomiting of structured education given to male lung cancer patients receiving chemotherapy. This quasi-experimental research study had pre- and post-tests control groups. The estimated sample size was at least 20 subjects per group. Data were collected in the chest diseases clinic and outpatient chemotherapy unit of a university hospital in Turkey. An education booklet and structured education were given 30 mins for each patient before chemotherapy. In post-test 1, nausea severity was significantly lower in the experimental group than in the control group (mean difference - 2.50, 95% CI - 1.46 to - 0.17, d = 0.82, p = 0.05). This was also the case in post-test 2 (mean difference - 2.10, 95% CI - 1.50 to - 0.21, d = 0.85, p = 0.01). According to this, the sizes of Cohen's d effect were large (0.82 and 0.85 for post-test 1 and post-test 2 respectively). However, vomiting frequency did not differ significantly between the experimental group and the control group in either post-test 1 or post-test 2 (p > 0.05). Structured education given by nurses had a positive effect on the severity of nausea. Nurses may be able to raise nausea management in cancer patients to a better level by education intervention.
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Affiliation(s)
- Yasemin Ince
- Sterilization Unit, Izzet Baysal Training and Research Hospital, Bolu Abant Izzet Baysal University, PO 14280, Golkoy/Bolu, Turkey.
| | - Yasemin Yildirim Usta
- Department of Internal Medicine Nursing, Bolu Health School, Bolu Abant Izzet Baysal University, PO 14280, Golkoy/Bolu, Turkey
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van der Vorst MJ, Toffoli EC, Beusink M, van Linde ME, van Voorthuizen T, Brouwer S, van Zweeden AA, Vrijaldenhoven S, Berends JC, Berkhof J, Verheul HM. Metoclopramide, Dexamethasone, or Palonosetron for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy (MEDEA): A Randomized, Phase III, Noninferiority Trial. Oncologist 2020; 26:e173-e181. [PMID: 32735029 PMCID: PMC7794169 DOI: 10.1634/theoncologist.2020-0305] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2020] [Accepted: 07/09/2020] [Indexed: 11/17/2022] Open
Abstract
BACKGROUND For the prevention of chemotherapy-induced nausea and vomiting (CINV) during the delayed phase (24-120 hours) after moderately emetogenic chemotherapy (MEC), the use of 3-day dexamethasone (DEX) is often recommended. This study compared the efficacy and safety of two DEX-sparing regimens with 3-day DEX, focusing on delayed nausea. PATIENTS AND METHODS This open-label, randomized, phase III study was designed to demonstrate noninferiority of two DEX-sparing regimens: ondansetron + DEX on day 1 + metoclopramide on days 2-3 (MCP arm), and palonosetron + DEX on day 1 (PAL arm) versus ondansetron on day 1 + DEX on days 1-3 (DEX arm) in chemotherapy-naïve patients receiving MEC. Primary efficacy endpoint was total control (TC; no emetic episodes, no use of rescue medication, no nausea) in the delayed phase. Noninferiority was defined as a lower 95% CI greater than the noninferiority margin set at -20%. Secondary endpoints included no vomiting, no rescue medication, no (significant) nausea, impact of CINV on quality of life, and antiemetics-associated side effects. RESULTS Treatment arms were comparable for 189 patients analyzed: predominantly male (55.7%), median age 65.0 years, colorectal cancer (85.7%), and oxaliplatin-based chemotherapy (81.5%). MCP demonstrated noninferiority to DEX for delayed TC (MCP 56.1% vs. DEX 50.0%; 95% CI, -11.3%, 23.5%). PAL also demonstrated noninferiority to DEX (PAL 55.6% vs. DEX 50.0%; 95% CI, -12.0%, 23.2%). There were no statistically significant differences for all secondary endpoints between treatment arms. CONCLUSION This study showed that DEX-sparing regimens are noninferior to multiple-day DEX in terms of delayed TC rate in patients undergoing MEC. ClinicalTrials.gov identifier. NCT02135510. IMPLICATIONS FOR PRACTICE Chemotherapy-induced nausea and vomiting (CINV) in the delayed phase (24-120 hours after chemotherapy) remains one of the most troublesome adverse effects associated with cancer treatment. In particular, delayed nausea is often poorly controlled. The role of dexamethasone (DEX) in the prevention of delayed nausea after moderately emetogenic chemotherapy (MEC) is controversial. This study is the first to include nausea assessment as a part of the primary study outcome to better gauge the effectiveness of CINV control and patients' experience. Results show that a DEX-sparing strategy does not result in any significant loss of overall antiemetic control: DEX-sparing strategies incorporating palonosetron or multiple-day metoclopramide are safe and at least as effective as standard treatment with a 3-day DEX regimen with ondansetron in controlling delayed CINV-and nausea in particular-following MEC.
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Affiliation(s)
- Maurice J.D.L. van der Vorst
- Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
- Department of Internal Medicine, Rijnstate HospitalArnhemThe Netherlands
| | - Elisa C. Toffoli
- Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
| | - Marlien Beusink
- Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
| | - Myra E. van Linde
- Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
| | | | - Saskia Brouwer
- Department of Internal Medicine, Rijnstate HospitalArnhemThe Netherlands
| | | | - Suzan Vrijaldenhoven
- Department of Internal Medicine, Noordwest ZiekenhuisgroepAlkmaarThe Netherlands
| | - Johan C. Berends
- Department of Internal Medicine, Noordwest ZiekenhuisgroepDen HelderThe Netherlands
| | - Johannes Berkhof
- Department of Epidemiology and Biostatistics, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
| | - Henk M.W. Verheul
- Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit AmsterdamAmsterdamThe Netherlands
- Department of Medical Oncology, RadboudumcNijmegenThe Netherlands
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Roeland EJ, Ruddy KJ, LeBlanc TW, Nipp RD, Binder G, Sebastiani S, Potluri R, Schmerold L, Papademetriou E, Schwartzberg L, Navari RM. What the HEC? Clinician Adherence to Evidence-Based Antiemetic Prophylaxis for Highly Emetogenic Chemotherapy. J Natl Compr Canc Netw 2020; 18:676-681. [DOI: 10.6004/jnccn.2019.7526] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2019] [Accepted: 12/19/2019] [Indexed: 11/17/2022]
Abstract
Background: Clinician adherence to antiemetic guidelines for preventing chemotherapy-induced nausea and vomiting (CINV) caused by highly emetogenic chemotherapy (HEC) remains poorly characterized. The primary aim of this study was to evaluate individual clinician adherence to HEC antiemetic guidelines. Patients and Methods: A retrospective analysis of patients receiving HEC was conducted using the IBM Watson Explorys Electronic Health Record Database (2012–2018). HEC antiemetic guideline adherence was defined as prescription of triple prophylaxis (neurokinin-1 receptor antagonist [NK1 RA], serotonin type-3 receptor antagonist, dexamethasone) at initiation of cisplatin or anthracycline + cyclophosphamide (AC). Clinicians who prescribed ≥5 HEC courses were included and individual guideline adherence was assessed, noting the number of prescribing clinicians with >90% adherence. Results: A total of 217 clinicians were identified who prescribed 2,543 cisplatin and 1,490 AC courses. Patients (N=4,033) were primarily women (63.3%) and chemotherapy-naïve (92%) with a mean age of 58.6 years. Breast (36%) and thoracic (19%) cancers were the most common tumor types. Guideline adherence rates of >90% were achieved by 35% and 58% of clinicians using cisplatin or AC, respectively. Omission of an NK1 RA was the most common practice of nonadherence. Variation in prophylaxis guideline adherence was considerable for cisplatin (mean, 71%; SD, 29%; coefficient of variation [CV], 0.40) and AC (mean, 84%; SD, 26%; CV, 0.31). Conclusions: Findings showed substantial gaps in clinician adherence to HEC CINV guidelines, including a high variability across clinicians. Clinicians should review their individual clinical practices and ensure adherence to evidence-based CINV guidelines to optimize patient care.
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Affiliation(s)
- Eric J. Roeland
- 1Massachusetts General Hospital Cancer Center, Boston, Massachusetts
| | | | | | - Ryan D. Nipp
- 1Massachusetts General Hospital Cancer Center, Boston, Massachusetts
| | - Gary Binder
- 4Helsinn Therapeutics US, Iselin, New Jersey
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Patel MP, Woodring S, Randazzo DM, Friedman HS, Desjardins A, Healy P, Herndon JE, McSherry F, Lipp ES, Miller E, Peters KB, Affronti ML. Randomized open-label phase II trial of 5-day aprepitant plus ondansetron compared to ondansetron alone in the prevention of chemotherapy-induced nausea-vomiting (CINV) in glioma patients receiving adjuvant temozolomide. Support Care Cancer 2020; 28:2229-2238. [PMID: 31440823 DOI: 10.1007/s00520-019-05039-x] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2019] [Accepted: 08/09/2019] [Indexed: 11/24/2022]
Abstract
PURPOSE CINV remains a distressing side effect experienced by glioma patients receiving multi-day temozolomide therapy, in spite of guideline-based antiemetic therapy with selective serotonin-receptor-antagonists. Antiemetic research with aprepitant has routinely excluded glioma patients. In this randomized open-label phase II study, use of a nonstandard 5-day regimen of aprepitant for glioma patients was investigated. METHODS One hundred thirty-six glioma patients receiving their first cycle of adjuvant temozolomide (150-200 mg/m2/day × 5 days every 28 days) were randomized to Arm-A (ondansetron 8 mg days 1-5 with aprepitant day 1: 125 mg, days 2-5: 80 mg) or Arm-B (ondansetron). Randomization was stratified by tumor grade and number of prior chemotherapy regimens. The primary endpoint was the percentage of patients achieving complete control (CC), defined as no emetic episode or antiemetic rescue medication over the 7-day study period. Secondary endpoints included CINV efficacy in the acute phase (≤ 24 h) and delayed phase (days 2-7), as well as safety and quality of life (QoL). RESULTS Patients were 61% male, 97% white, 48% with KPS > 90%, 60% non-smokers, mean age 54, 92% with low alcohol use, and 46% with a CINV history. The CC was 58.6% (Arm-A) and 54.5% (Arm-B). Acute-complete response (CR) rates, defined as CC on day 1 in Arm-A and -B, were 97.1% and 87.9%, respectively (p = 0.056). Treatment-related toxicities were mild or moderate in severity. CONCLUSIONS Aprepitant plus ondansetron may increase acute-CR, may have benefit regarding CINV's effect on QoL, and is safe for 5-day temozolomide compared to ondansetron. This study provides no evidence that aprepitant increases CC rate over ondansetron alone.
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Affiliation(s)
- Mallika P Patel
- Department of Pharmacy, Duke University Hospital, Durham, USA
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
| | - Sarah Woodring
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
| | - Dina M Randazzo
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
- Department of Neurology, Duke University School of Medicine, Durham, NC, USA
| | - Henry S Friedman
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
| | - Annick Desjardins
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
- Department of Neurology, Duke University School of Medicine, Durham, NC, USA
| | | | - James E Herndon
- Duke Cancer Center Biostatistics, Durham, NC, USA
- Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA
| | | | - Eric S Lipp
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
| | - Elizabeth Miller
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
| | - Katherine B Peters
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA
- Department of Neurology, Duke University School of Medicine, Durham, NC, USA
| | - Mary Lou Affronti
- Department of Neurosurgery, The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.
- Duke Health, Duke University School of Nursing, Durham, NC, 27710, USA.
- Duke School of Nursing Faculty, Primary Investigator, Department of Neuro-Surgery, The Preston Robert Tisch Brain Tumor Center, 047 Baker House, Trent Drive, DUMC Box 3624, Durham, NC, 27710, USA.
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Vaid AK, Gupta S, Doval DC, Agarwal S, Nag S, Patil P, Goswami C, Ostwal V, Bhagat S, Patil S, Barkate H. Expert Consensus on Effective Management of Chemotherapy-Induced Nausea and Vomiting: An Indian Perspective. Front Oncol 2020; 10:400. [PMID: 32292721 PMCID: PMC7120415 DOI: 10.3389/fonc.2020.00400] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2019] [Accepted: 03/05/2020] [Indexed: 11/25/2022] Open
Abstract
Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and feared side effects in cancer patients undergoing chemotherapy. Scientific evidence proves its detrimental impact on a patient's quality of life (QoL), treatment compliance, and overall healthcare cost. Despite the CINV-management landscape witnessing a radical shift with the introduction of novel, receptor-targeting antiemetic agents, this side effect remains a chink in the armor of a treating oncologist. Though global guidelines acknowledge patient-specific risk factors and chemotherapeutic agent emetogenic potential in CINV control, a "one-fit-for-all" approach cannot be followed across all geographies. Hence, in a pioneering attempt, India-based oncologists conveyed easily implementable, region-specific, consensus-based statements on CINV prevention and management. These statements resulted from integrating the analysis of scientific evidence and guidelines on CINV by the experts, with their clinical experience. The statements will strengthen decision-making abilities of Indian oncologists/clinicians and help in achieving consistency in CINV prevention and management in the country. Furthermore, this document shall lay the foundation for developing robust Indian guidelines for CINV prevention and control.
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Affiliation(s)
- Ashok K. Vaid
- Medical Oncology and Hematology, Medanta – The Medicity, Gurugram, India
| | | | - Dinesh C. Doval
- Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India
| | - Shyam Agarwal
- Medical Oncology, Sir Ganga Ram Hospital, New Delhi, India
| | - Shona Nag
- Medical Oncology, Sahyadri Hospital, Pune, India
| | - Poonam Patil
- Medical Oncologist, Manipal Hospital, Bangalore, India
| | - Chanchal Goswami
- Oncology Services, MEDICA Super Speciality Hospital, Kolkata, India
| | - Vikas Ostwal
- Medical Oncology, TATA Memorial Hospital, Mumbai, India
| | - Sagar Bhagat
- Medical Services, HO IF, Glenmark Pharmaceuticals Ltd., Mumbai, India
| | - Saiprasad Patil
- Medical Services, IF, Glenmark Pharmaceuticals Ltd., Mumbai, India
| | - Hanmant Barkate
- Medical Services, IF & MEA, Glenmark Pharmaceuticals Ltd., Mumbai, India
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Han P, Hales R, Lakshminarayanan P, Cheng Z, Elledge C, Negron A, Hazell S, Hu C, Friedes C, Anderson L, Hoff J, Marrone K, Quon H, McNutt T, Voong KR. Exploring the Relationship of Radiation Dose Exposed to the Length of Esophagus and Weight Loss in Patients with Lung Cancer. Pract Radiat Oncol 2020; 10:255-264. [PMID: 32201321 DOI: 10.1016/j.prro.2020.03.002] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2019] [Revised: 02/28/2020] [Accepted: 03/04/2020] [Indexed: 12/25/2022]
Abstract
PURPOSE We investigate whether esophageal dose-length parameters (Ldose) can robustly predict significant weight loss-≥5% weight loss during radiation therapy (RT) compared with the weight before RT-in patients with lung cancer treated with definitive intent. METHODS AND MATERIALS Patients with lung cancer treated with conventionally fractionated RT between 2010 and 2018 were retrospectively identified. LFdose and LPdose, the length of full- and partial-circumferential esophagus receiving greater than a threshold dose in Gy, respectively, were created. Multivariate logistic regression examined the associations between individual Ldose and weight loss after adjusting for clinical parameters and correcting for multiple comparisons. Ridge logistic regression examined the relative importance of Ldose compared with dose-volume (Vdose), mean dose (Dmean), and clinical parameters in determining weight loss. Univariate logistic regression examined the unadjusted probability of weight loss for important Ldose parameters. RESULTS Among the 214 patients identified, median age was 66.9 years (range, 31.5-88.9 years), 50.5% (n = 108) were male, 68.2% (n = 146) had stage III lung cancer, median RT dose was 63 Gy (range, 60-66 Gy), and 88.3% (n = 189) received concurrent chemotherapy. Esophagus lengths receiving high full-circumferential (LF50-LF60) and high partial-circumferential doses (LP60) were associated with significant weight loss (P ≤ .05). LF65 and LP65 reached near significance (P = .06 and .053, respectively). LF65 > LF60 > LP65 were the most important dose parameters in determining weight loss compared with other Ldose, Vdose, and Dmean parameters. CONCLUSIONS Esophageal Ldose parameters are an efficient way of interpreting complex dose parameters in relation to weight loss toxicity among patients with lung cancer receiving definitive RT.
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Affiliation(s)
- Peijin Han
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland.
| | - Russell Hales
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Pranav Lakshminarayanan
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Zhi Cheng
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Christen Elledge
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Alex Negron
- University of Puerto Rico, Medical Sciences Campus, School of Medicine, San Juan, Puerto Rico
| | - Sarah Hazell
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Chen Hu
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Cole Friedes
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Lori Anderson
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Jeffrey Hoff
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Kristen Marrone
- Department of Oncology, Johns Hopkins University, Baltimore, Maryland
| | - Harry Quon
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - Todd McNutt
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
| | - K Ranh Voong
- Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland
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Bossi P, Airoldi M, Aloe Spiriti MA, Antonuzzo A, Bonciarelli G, Campagna A, Cassano A, Murialdo R, Musio D, Silvano G. A multidisciplinary expert opinion on CINV and RINV, unmet needs and practical real-life approaches. Expert Opin Drug Saf 2020; 19:187-204. [PMID: 32005072 DOI: 10.1080/14740338.2020.1724955] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Abstract
Introduction: A range of combination chemotherapy regimens are currently used in clinical practice. However, international antiemetic guidelines often only categorize the emetogenic potential of single agents rather than the emetogenicity of combination chemotherapy regimens. To manage the nausea and vomiting induced by antineoplastic combinations, guidelines suggest antiemetics that are appropriate for the component drug with the highest emetogenic potential. Furthermore, antiemetic guidelines generally do not consider the influence of other factors, including individual patient characteristics, on the emetic effects of cancer treatments. Similarly, the emetogenic potential of radiotherapy is stratified only according to the site of radiation, while other factors contributing to emetic risk are overlooked.Areas covered: An Expert Panel was convened to examine unresolved issues and summarize the current clinical research on managing nausea and vomiting associated with combination chemotherapy and radiotherapy.Expert opinion: The panel identified the incidence of nausea and vomiting induced by multi-drug combination therapies currently used to treat cancer at different anatomic sites and by radiotherapy in the presence of other risk factors. Based on these data and the clinical experience of panel members, several suggestions are made for a practical approach to prevent or manage nausea and vomiting due to chemotherapy regimens and radiation therapy.
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Affiliation(s)
- Paolo Bossi
- Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health University of Brescia, ASST-Spedali Civili, Brescia, Italy
| | - Mario Airoldi
- Oncology Departement, Città della Salute e della Scienza Hospital of Turin, Turin, Italy
| | - Maria Antonietta Aloe Spiriti
- Department of Clinical and Molecular Medicine, Azienda Universitaria Ospedaliera Sant'Andrea, "Sapienza" University of Rome, Rome, Italy
| | - Andrea Antonuzzo
- Medical Oncology Unit 1 SSN, Pisa University Hospital, Pisa, Italy
| | | | - Alessia Campagna
- Department of Hematology, Azienda Universitaria Ospedaliera Sant'Andrea, "Sapienza" University of Rome, Rome, Italy
| | - Alessandra Cassano
- Division of Medical Oncology, Catholic University of the Sacred Heart, Rome, Italy
| | - Roberto Murialdo
- Department of Internal Medicine and Medical Specialties (Di.M.I.), University of Genoa and IRCCS AOU San Martino-IST, Genoa, Italy
| | - Daniela Musio
- Department of Radiotherapy, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy
| | - Giovanni Silvano
- Radiation Oncology Unit, San Giuseppe Moscati Hospital, Taranto, Italy
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Borner T, Shaulson ED, Ghidewon MY, Barnett AB, Horn CC, Doyle RP, Grill HJ, Hayes MR, De Jonghe BC. GDF15 Induces Anorexia through Nausea and Emesis. Cell Metab 2020; 31:351-362.e5. [PMID: 31928886 PMCID: PMC7161938 DOI: 10.1016/j.cmet.2019.12.004] [Citation(s) in RCA: 151] [Impact Index Per Article: 30.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2019] [Revised: 11/01/2019] [Accepted: 12/12/2019] [Indexed: 01/03/2023]
Abstract
Growth differentiation factor 15 (GDF15) is a cytokine that reduces food intake through activation of hindbrain GFRAL-RET receptors and has become a keen target of interest for anti-obesity therapies. Elevated endogenous GDF15 is associated with energy balance disturbances, cancer progression, chemotherapy-induced anorexia, and morning sickness. We hypothesized that GDF15 causes emesis and that its anorectic effects are related to this function. Here, we examined feeding and emesis and/or emetic-like behaviors in three different mammalian laboratory species to help elucidate the role of GDF15 in these behaviors. Data show that GDF15 causes emesis in Suncus murinus (musk shrews) and induces behaviors indicative of nausea/malaise (e.g., anorexia and pica) in non-emetic species, including mice and lean or obese rats. We also present data in mice suggesting that GDF15 contributes to chemotherapy-induced malaise. Together, these results indicate that GDF15 triggers anorexia through the induction of nausea and/or by engaging emetic neurocircuitry.
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Affiliation(s)
- Tito Borner
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Evan D Shaulson
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Misgana Y Ghidewon
- School of Arts and Sciences, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Amanda B Barnett
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Charles C Horn
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA; UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA 15213, USA
| | - Robert P Doyle
- Department of Chemistry, Syracuse University, Syracuse, NY 13244, USA; Department of Medicine, Upstate Medical University, State University of New York, Syracuse, NY 13244, USA
| | - Harvey J Grill
- School of Arts and Sciences, University of Pennsylvania, Philadelphia, PA 19104, USA; Institute of Diabetes, Obesity and Metabolism, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Matthew R Hayes
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Institute of Diabetes, Obesity and Metabolism, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Bart C De Jonghe
- Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA; Institute of Diabetes, Obesity and Metabolism, University of Pennsylvania, Philadelphia, PA 19104, USA.
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Wang X, Wang J, Zhang ZY, Kansra V. Population Pharmacokinetics of Rolapitant in Patients With Chemotherapy-Induced Nausea and Vomiting. Clin Pharmacol Drug Dev 2019; 8:850-860. [PMID: 31418538 DOI: 10.1002/cpdd.733] [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: 05/16/2018] [Accepted: 07/24/2019] [Indexed: 11/10/2022]
Abstract
Population pharmacokinetics of rolapitant and its active metabolite M19 were studied in 482 patients receiving this neurokinin-1 receptor antagonist in combination with a 5-hydroxytryptamine-3 receptor antagonist and dexamethasone for prevention of chemotherapy-induced nausea and vomiting (CINV). Patients received a single dose of rolapitant (range, 9-180 mg) before administration of moderately or highly emetogenic chemotherapy. Population pharmacokinetic analysis was performed via nonlinear mixed-effects modeling. Rolapitant pharmacokinetics was best characterized by a 2-compartment model. Population typical values were estimated to be 0.962 L/h for apparent oral clearance and 214 L for central compartment volume of distribution. The intercompartment clearance and peripheral compartment volume of distribution was estimated to be 2.79 L/h and 164 L, respectively. Metabolite M19 pharmacokinetics was described by a 1-compartment model with an apparent metabolite clearance of 1.83 L/h. Intersubject variability was moderate for pharmacokinetics parameters. Weight positively correlated with central compartment volume of distribution and peripheral compartment volume of distribution but not with apparent oral clearance. No other demographic, clinical, or pathophysiologic covariates, including liver and renal function, influenced rolapitant pharmacokinetics. A slight positive trend was observed between rolapitant exposure and efficacy (ie, complete response defined as no emesis and no use of rescue medication) in the delayed phase of CINV (>24-120 hours after chemotherapy). This further supports the 180-mg dose of rolapitant in CINV patients. In summary, this validated population pharmacokinetic model satisfactorily describes pharmacokinetics of rolapitant and M19 in patients with CINV. These results support the recommendation that no dose adjustment for patient variables investigated is necessary.
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Affiliation(s)
| | - Jing Wang
- TESARO Inc., Waltham, Massachusetts, USA
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Chemotherapy-induced nausea and vomiting in patients with breast cancer: a prospective cohort study. Breast Cancer 2019; 27:122-128. [PMID: 31407150 PMCID: PMC6954145 DOI: 10.1007/s12282-019-01001-1] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2017] [Accepted: 08/07/2019] [Indexed: 11/24/2022]
Abstract
Purpose To explore the actual status of chemotherapy-induced nausea and vomiting (CINV) through a multicenter prospective cohort study. Methods Patients with breast cancer treated with moderately emetogenic (MEC) or highly emetogenic (HEC) chemotherapy were eligible. A 7-day diary was provided for all patients. Acute and delayed CINV were defined as nausea and vomiting that developed ≤ 24 or > 24 h after the start of chemotherapy, respectively. The severity of nausea was evaluated with a visual analog scale (VAS). We also assessed the accuracy of estimations of CINV by medical staff. Results In total, 426 patients were included; 352 patients (82.6%) received HEC, and 74 (17.3%) received MEC. In the acute phase, 44.9% of patients receiving HEC and 5.4% receiving MEC experienced nausea, and 12.8% receiving HEC and none receiving MEC experienced vomiting. More patients experienced nausea in both groups and vomiting in MEC during the delayed phase (nausea: 59.4% in HEC and 44.6% in MEC group; vomiting: 11.1% in HEC; and 13.5% in MEC group) than during the acute phase. Estimations of CINV by medical staff were not accurate, with a kappa coefficient of 0.10 and 0.08 for acute nausea and vomiting and 0.02 and 0.01 for delayed. The VAS scores showed that in the HEC group, the degree of nausea was worst on the first day. Conclusions The degree of nausea was worst in the acute phase, although delayed nausea was more in proportion in HEC. Estimation by medical staff is not accurate.
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Kleckner AS, Kleckner IR, Kamen CS, Tejani MA, Janelsins MC, Morrow GR, Peppone LJ. Opportunities for cannabis in supportive care in cancer. Ther Adv Med Oncol 2019; 11:1758835919866362. [PMID: 31413731 PMCID: PMC6676264 DOI: 10.1177/1758835919866362] [Citation(s) in RCA: 50] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2019] [Accepted: 07/03/2019] [Indexed: 12/17/2022] Open
Abstract
Cannabis has the potential to modulate some of the most common and debilitating symptoms of cancer and its treatments, including nausea and vomiting, loss of appetite, and pain. However, the dearth of scientific evidence for the effectiveness of cannabis in treating these symptoms in patients with cancer poses a challenge to clinicians in discussing this option with their patients. A review was performed using keywords related to cannabis and important symptoms of cancer and its treatments. Literature was qualitatively reviewed from preclinical models to clinical trials in the fields of cancer, human immunodeficiency virus (HIV), multiple sclerosis, inflammatory bowel disease, post-traumatic stress disorder (PTSD), and others, to prudently inform the use of cannabis in supportive and palliative care in cancer. There is a reasonable amount of evidence to consider cannabis for nausea and vomiting, loss of appetite, and pain as a supplement to first-line treatments. There is promising evidence to treat chemotherapy-induced peripheral neuropathy, gastrointestinal distress, and sleep disorders, but the literature is thus far too limited to recommend cannabis for these symptoms. Scant, yet more controversial, evidence exists in regard to cannabis for cancer- and treatment-related cognitive impairment, anxiety, depression, and fatigue. Adverse effects of cannabis are documented but tend to be mild. Cannabis has multifaceted potential bioactive benefits that appear to outweigh its risks in many situations. Further research is required to elucidate its mechanisms of action and efficacy and to optimize cannabis preparations and doses for specific populations affected by cancer.
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Affiliation(s)
- Amber S Kleckner
- Cancer Control and Survivorship, University of Rochester Medical Center, CU 420658, 265 Crittenden Blvd., Rochester, NY 14642, USA
| | - Ian R Kleckner
- Cancer Control and Survivorship, University of Rochester Medical Center, Rochester, NY, USA
| | - Charles S Kamen
- Cancer Control and Survivorship, University of Rochester Medical Center, Rochester, NY, USA
| | - Mohamedtaki A Tejani
- Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA
| | - Michelle C Janelsins
- Cancer Control and Survivorship, University of Rochester Medical Center, Rochester, NY, USA
| | - Gary R Morrow
- Cancer Control and Survivorship, University of Rochester Medical Center, Rochester, NY, USA
| | - Luke J Peppone
- Cancer Control and Survivorship, University of Rochester Medical Center, Rochester, NY, USA
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Karthaus M, Schiel X, Ruhlmann CH, Celio L. Neurokinin-1 receptor antagonists: review of their role for the prevention of chemotherapy-induced nausea and vomiting in adults. Expert Rev Clin Pharmacol 2019; 12:661-680. [PMID: 31194593 DOI: 10.1080/17512433.2019.1621162] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]
Abstract
Introduction: The addition of neurokinin-1 receptor antagonists (NK1RAs) to standard prophylaxis of 5-hydroxytryptamine-3 RA (5-HT3RA) plus dexamethasone more effectively prevents chemotherapy-induced nausea and vomiting (CINV) associated with highly and moderately emetogenic chemotherapy. Areas covered: This review presents the evidence base for the use of oral and intravenous (IV) NK1RAs, focusing on the pharmacologic and clinical properties as a class, and highlighting differences between agents. A PubMed literature search was conducted from 2000 to 2018. Expert opinion: Adherence to international antiemetic guidelines remains a clinical challenge. Strategies to simplify antiemetic regimens and facilitate their administration may improve compliance and treatment outcomes. The use of fixed-combination antiemetics offers clinical utility, in combining an NK1RA with a 5-HT3RA in a single oral dose. The use of long-lasting NK1RAs and administering CINV prophylaxis closer to the time of chemotherapy may also assist with guideline and treatment compliance, diminishing the need for home-based administration, and potentially reducing resource utilization. The availability of IV and oral formulations of NK1RAs and NK1RA-5-HT3RA fixed combinations offers further utility, particularly for those patients unsuited for oral administration. However, safety considerations with respect to injection site toxicity and hypersensitivity reactions of the new NK1RA IV formulations deserve close attention.
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Affiliation(s)
- Meinolf Karthaus
- a Department of Hematology, Oncology and Palliative Care , Klinikum Neuperlach , Munich , Germany.,b Department of Hematology, Oncology and Palliative Care , Klinikum Harlaching , Munich , Germany
| | - Xaver Schiel
- b Department of Hematology, Oncology and Palliative Care , Klinikum Harlaching , Munich , Germany
| | | | - Luigi Celio
- d Department of Medical Oncology and Hematology , Fondazione IRCCS Istituto Nazionale dei Tumori , Milan , Italy
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Schwartzberg L, Karthaus M, Rossi G, Rizzi G, Borroni ME, Rugo HS, Jordan K, Hansen V. Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies. Cancer Med 2019; 8:2064-2073. [PMID: 30968588 PMCID: PMC6536946 DOI: 10.1002/cam4.2091] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2018] [Accepted: 01/15/2019] [Indexed: 01/29/2023] Open
Abstract
AIM To assess the efficacy of oral NEPA (netupitant-palonosetron 300/0.50 mg) over multiple chemotherapy cycles. METHODS Two randomized phase III studies evaluated a single dose of oral NEPA given on day 1 in chemotherapy-naive patients receiving anthracycline-cyclophosphamide (AC)-based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy (safety Study 2). Oral NEPA was compared with oral palonosetron 0.50 mg (Study 1) or oral aprepitant 125 mg day 1, 80 mg days 2-3/palonosetron 0.50 mg (Study 2; no formal statistical comparisons). Oral dexamethasone was administered in all treatment groups. Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates during acute (0-24 h) and delayed (>24-120 h) phases of chemotherapy cycles 1-4 in each study were evaluated. RESULTS In Study 1, 1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles. In each study, ≥75% of patients completed 4 or more cycles. In Study 1, oral NEPA was superior to palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases of cycle 1, with higher rates of CR (all P < 0.05), no emesis (all P < 0.05), and NSN (delayed phase P < 0.05 cycles 1, 2, and 4) reported across 4 cycles. In Study 2, oral NEPA had numerically higher CR and NSN rates in the acute and delayed phases than aprepitant-palonosetron in MEC/HEC patients. CONCLUSION Oral NEPA was highly effective in preventing both acute and delayed CINV over multiple chemotherapy cycles of HEC, AC, and MEC regimens. CLINICAL TRIAL REGISTRATION NUMBERS Study 1, NCT01339260; Study 2, NCT01376297.
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Affiliation(s)
| | | | | | | | | | - Hope S. Rugo
- University of California San Francisco Comprehensive Cancer CenterSan FranciscoCalifornia
| | - Karin Jordan
- Department of Medicine V, Hematology, Oncology and RheumatologyUniversity of HeidelbergGermany
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Aapro M, Zhang L, Yennu S, LeBlanc TW, Schwartzberg L. Preventing chemotherapy-induced nausea and vomiting with netupitant/palonosetron, the first fixed combination antiemetic: current and future perspective. Future Oncol 2019; 15:1067-1084. [PMID: 30860400 DOI: 10.2217/fon-2018-0872] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
Chemotherapy-induced nausea and vomiting (CINV) can be prevented in most patients receiving appropriate antiemetic treatment. However, inadequate uptake of current antiemetic guideline recommendations by physicians, and poor treatment adherence by patients, lead to suboptimal CINV control. There is an unmet need to optimize guideline-consistent use of antiemetics to improve CINV management and prevention. Herein, we provide an overview of CINV, then discuss oral and intravenous NEPA, the first fixed combination antiemetic, composed of netupitant/fosnetupitant and palonosetron. We describe the main pharmacologic and pharmacokinetic characteristics of NEPA, and review the clinical evidence supporting its use in the prevention of CINV.
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Affiliation(s)
- Matti Aapro
- Genolier Cancer Centre, Clinique de Genolier, Genolier, Switzerland
| | - Li Zhang
- State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology Sun Yat-sen University Cancer Center, Guangzhou, PR China
| | - Sriram Yennu
- Department of Palliative, Rehabilitation and Integrative Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
| | - Thomas W LeBlanc
- Division of Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine, Durham, NC 27705, USA
| | - Lee Schwartzberg
- Department of Hematology and Oncology, The West Clinic, Germantown, TN 38138, USA
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Radiation-induced nausea and vomiting: a comparison between MASCC/ESMO, ASCO, and NCCN antiemetic guidelines. Support Care Cancer 2019; 27:783-791. [DOI: 10.1007/s00520-018-4586-2] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2018] [Accepted: 12/05/2018] [Indexed: 10/27/2022]
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De Laurentiis M, Bonfadini C, Lorusso V, Cilenti G, Di Rella F, Altavilla G, Otero M, Ardizzoia A, Marchetti P, Peverelli G, Amoroso D, Vecchio S, Fiorio E, Orecchia S. Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study. Support Care Cancer 2018; 26:4021-4029. [PMID: 29943152 DOI: 10.1007/s00520-018-4259-1] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/13/2017] [Accepted: 05/06/2018] [Indexed: 10/28/2022]
Abstract
PURPOSE Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes. METHODS Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression. RESULTS The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, "significant nausea," and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90). CONCLUSIONS CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice.
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Affiliation(s)
- Michelino De Laurentiis
- Division of Breast Medical Oncology, Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Napoli, Italy.
| | - Chiara Bonfadini
- Medical Oncology Department, "A.O.U. Città della Scienza e della Salute di Torino", Turin, Italy
| | - Vito Lorusso
- Medical Oncology Department, National Cancer Institute, Giovanni Paolo II, Bari, Italy
| | - Giuseppina Cilenti
- Oncohematology Hospital "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy
| | - Francesca Di Rella
- Medical Oncology, Department of Senology, National Cancer Institute, Fondazione G.Pascale Naples, Naples, Italy
| | - Giuseppe Altavilla
- Human Pathology Department, Medical Oncology, University of Messina, Messina, Italy
| | | | | | - Paolo Marchetti
- Clinical and Molecular Medicine Department, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy
| | - Giorgia Peverelli
- Medical Oncology Department, IRCCS Istituto Nazionale dei Tumori, Milan, Italy
| | - Domenico Amoroso
- Medical Oncology, Ospedale Versilia, Tuscan Tumor Institute (ITT), Lido di Camaiore, Italy
| | | | - Elena Fiorio
- Department of Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy
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Uchida M, Nakamura T, Shima T, Yoshimoto G, Kato K, Hosohata K, Miyamoto T, Akashi K. Comparative Quantification of Chemotherapy-Induced Nausea and Emesis between the Common Terminology Criteria for Adverse Events and the Multinational Association of Supportive Care in Cancer Antiemesis Tool. Biol Pharm Bull 2018; 41:1667-1671. [PMID: 30381666 DOI: 10.1248/bpb.b18-00336] [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: 11/22/2022]
Abstract
Chemotherapy-induced nausea and vomiting (CINV) are generally evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). The Multinational Association for Supportive Care in Cancer (MASCC) developed the MASCC Antiemesis Tool (MAT) to facilitate recognition for CINV between patients and oncology specialists. In the present study, MAT and CTCAE were comparatively assessed in Japanese patients with hematological malignancies. A total of 61 patients were eligible for this study. The CTCAE data were collected from an electronic medical record system. The patients were asked to complete the Japanese version of MAT in the hospital, on the first and fourth days after the start of chemotherapy. The percentages of patients in whom nausea was completely controlled, with severity scores of zero, ranged from 70.5 to 82.0% for CTCAE and from 59.0 to 75.4% for MAT, during the first five days after the chemotherapy. The percentages of patients who had no vomiting ranged from 93.4 to 96.7% for CTCAE and from 90.2 to 98.4% for MAT. During the observation periods, the day-to-day response profiles of patients who received antiemetic treatment were comparable between CTCAE and MAT cohorts, and these two assessment tools showed good, positive correlations for nausea severity scores. The present study shows that the MAT is a useful tool for assessing the severity of CINV in patients with hematological malignancy, is comparable to CTCAE, and facilitates the identification of poor cancer care conditions by medical staff.
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Affiliation(s)
- Mayako Uchida
- Department of Pharmacy, Kyushu University Hospital.,Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences
| | - Tsutomu Nakamura
- Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences
| | - Takahiro Shima
- Department of Medicine and Biosystemic Science and, Kyushu University Graduate School of Medical Sciences
| | - Goichi Yoshimoto
- Department of Medicine and Biosystemic Science and, Kyushu University Graduate School of Medical Sciences
| | - Koji Kato
- Department of Medicine and Biosystemic Science and, Kyushu University Graduate School of Medical Sciences
| | - Keiko Hosohata
- Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences
| | - Toshihiro Miyamoto
- Department of Medicine and Biosystemic Science and, Kyushu University Graduate School of Medical Sciences
| | - Koichi Akashi
- Department of Medicine and Biosystemic Science and, Kyushu University Graduate School of Medical Sciences
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The Preliminary Effects of Massage and Inhalation Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting. Cancer Nurs 2018; 41:359-366. [DOI: 10.1097/ncc.0000000000000496] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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49
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LaPorte J, Leone K, Zhang X, Holland K, Morris L, Bashey A, Solh M, Solomon S. A unique schedule of palonosetron, ondansetron, and dexamethasone for the prevention of delayed nausea and vomiting in patients receiving myeloablative chemotherapy. J Oncol Pharm Pract 2018; 25:1336-1342. [PMID: 30058442 DOI: 10.1177/1078155218790345] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Myeloablative chemotherapy administered prior to autologous stem cell transplantation (auto-SCT) is associated with a significant amount of chemotherapy-induced nausea and vomiting (CINV). We conducted a phase II trial to assess the safety, efficacy, and impact on quality of life when palonosetron (PAL) 0.25 mg combined with dexamethasone were given on the final or only day of myeloablative chemotherapy for auto-SCT. The primary end point of this study was the incidence of achieving a delayed CINV complete response defined as no emetic episode and no use of rescue medications during the 24-120 h period post chemotherapy. Eighty-five patients were enrolled in the study and received PAL. A delayed CINV complete response was achieved in 15% of patients. A multivariate analysis demonstrated no associated differences between age, gender, diagnosis, or regimen. By day 5 after PAL, the mean nausea severity was 0.91 ± 2.45 vs. 0.09 ± 1.58 at baseline (p = 0.012). Quality of life measurements demonstrated similar quality of life between baseline and day 3. By day 6 however, nausea alone had a statistically significant impact on quality of life. In our study, PAL controlled nausea severity and sustained quality of life, but further strategies are needed to control delayed CINV associated with the auto-SCT process.
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Affiliation(s)
- J LaPorte
- 1 Northside Hospital, Department of Pharmacy, Atlanta, GA, USA
| | - K Leone
- 1 Northside Hospital, Department of Pharmacy, Atlanta, GA, USA
| | - X Zhang
- 2 The University of Texas School of Public Health, Houston, TX, USA
| | - K Holland
- 3 Blood and Marrow Transplant Group of Georgia, Atlanta, GA, USA
| | - L Morris
- 3 Blood and Marrow Transplant Group of Georgia, Atlanta, GA, USA
| | - A Bashey
- 3 Blood and Marrow Transplant Group of Georgia, Atlanta, GA, USA
| | - M Solh
- 3 Blood and Marrow Transplant Group of Georgia, Atlanta, GA, USA
| | - S Solomon
- 3 Blood and Marrow Transplant Group of Georgia, Atlanta, GA, USA
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Zhang ZY, Wang J, Kansra V, Wang X. Absorption, metabolism, and excretion of the antiemetic rolapitant, a selective neurokinin-1 receptor antagonist, in healthy male subjects. Invest New Drugs 2018; 37:139-146. [DOI: 10.1007/s10637-018-0638-1] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2018] [Accepted: 07/06/2018] [Indexed: 10/28/2022]
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