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Buscombe J, Cwikla J, Quigley AM, Navalkissoor S, Yu D. Selective Internal Radiotherapy in Liver Tumors: Early Promise Yet to be Fulfilled. Semin Nucl Med 2024; 54:530-536. [PMID: 38627159 DOI: 10.1053/j.semnuclmed.2024.03.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2024] [Accepted: 03/25/2024] [Indexed: 08/05/2024]
Abstract
Selective intra-arterial radiotherapy (SIRT) is a technique which has evolved over the past 30 years. In present this is primarily used to treat primary and secondary tumors in the liver. The technique normally depends on the delivery of a therapeutic radiopharmaceutical or radiolabeled particulate via a radiologically placed intra-arterial catheter in the hepatic artery. This is because most of these tumors have a single arterial blood supply but normal hepatocytes are supplied by both the hepatic artery and portal vein. Initially, this was done with I-131 labelled poppy seed oil but this technique was only used in a few centers. The technique became more popular when Y-90 particulates become widely available. Early results were promising but in phase 3 randomized controlled trials resulted in disappointing results compared to systemic chemotherapy. More recent work however, have shown that increasing the radiation dose to the tumor to at least 60Gy and combining with more effective systemic therapies are starting to produce better clinical results. There have also been advances in the angiographic methods used to make this into a day-case technique and the use of new radionuclides such as Ho-166 and Re-188 provides a wider range of possible SIRT techniques.
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Affiliation(s)
- John Buscombe
- Department of Nuclear Medicine, Cambridge University Hospitals, Cambridge, UK.
| | - Jaroslaw Cwikla
- Nuclear Medicine, University of Warmia and Mazury, Olsztyn, Poland
| | | | | | - Dominic Yu
- Department of Radiology, Royal Free Hospital, London, UK
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Schulze-Zachau V, Verset G, De Bondt P, De Keukeleire K, Gühne F, Heuschkel M, Hoffmann RT, Bozzi E, Sciuto R, Lam M, Deportós Moreno J, Debrus R, Zech CJ. Safety and efficacy of Holmium-166 selective internal radiotherapy of primary and secondary liver cancer confirmed by real-world data. Front Oncol 2024; 14. [DOI: https:/doi.org/10.3389/fonc.2024.1404621] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/17/2025] Open
Abstract
PurposeHolmium-166 has emerged as a promising option for selective internal radiotherapy (SIRT) for hepatic malignancies, but data on routine clinical use are lacking. The purpose of this study was to describe the safety and effectiveness of Holmium-166 SIRT in real-world practice through retrospective analysis of a multicenter registry.MethodsRetrospective analysis was conducted on Holmium-166 SIRT procedures performed between July 15, 2019, and July 15, 2021, across seven European centers. Treatment planning, treatment realization and post-treatment follow-up were conducted according to routine local practice. Safety and effectiveness data were extracted from the patients’ health records. Primary endpoint analysis was assessed for the entire study population with separate analysis for subgroups with hepatocellular carcinoma, metastatic colorectal cancer and intrahepatic cholangiocarcinoma.ResultsA total of 167 SIRT procedures in 146 patients (mean age 66 ± 11 years, 68% male) were retrospectively evaluated. Most common tumor entities were hepatocellular carcinoma (n=55), metastatic colorectal cancer (n=35), intrahepatic cholangiocarcinoma (n=19) and metastatic neuroendocrine tumors (n=10). Nine adverse events grade ≥ 3 according to Common Terminology Criteria for Adverse Events were recorded, including one fatal case of radioembolization-induced liver disease. Response rates and median overall survival for the above mentioned subgroups were comparable to results from previous Holmium-166 trials as well as to results from Yttrium-90 registries.ConclusionThis study confirms that the safety and effectiveness of Holmium-166 SIRT derived from prospective trials also applies in routine clinical practice, reinforcing its potential as a viable treatment option for primary and secondary liver cancer.
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Schulze-Zachau V, Verset G, De Bondt P, De Keukeleire K, Gühne F, Heuschkel M, Hoffmann RT, Bozzi E, Sciuto R, Lam M, Deportós Moreno J, Debrus R, Zech CJ. Safety and efficacy of Holmium-166 selective internal radiotherapy of primary and secondary liver cancer confirmed by real-world data. Front Oncol 2024; 14:1404621. [PMID: 38919523 PMCID: PMC11197077 DOI: 10.3389/fonc.2024.1404621] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2024] [Accepted: 05/24/2024] [Indexed: 06/27/2024] Open
Abstract
PURPOSE Holmium-166 has emerged as a promising option for selective internal radiotherapy (SIRT) for hepatic malignancies, but data on routine clinical use are lacking. The purpose of this study was to describe the safety and effectiveness of Holmium-166 SIRT in real-world practice through retrospective analysis of a multicenter registry. METHODS Retrospective analysis was conducted on Holmium-166 SIRT procedures performed between July 15, 2019, and July 15, 2021, across seven European centers. Treatment planning, treatment realization and post-treatment follow-up were conducted according to routine local practice. Safety and effectiveness data were extracted from the patients' health records. Primary endpoint analysis was assessed for the entire study population with separate analysis for subgroups with hepatocellular carcinoma, metastatic colorectal cancer and intrahepatic cholangiocarcinoma. RESULTS A total of 167 SIRT procedures in 146 patients (mean age 66 ± 11 years, 68% male) were retrospectively evaluated. Most common tumor entities were hepatocellular carcinoma (n=55), metastatic colorectal cancer (n=35), intrahepatic cholangiocarcinoma (n=19) and metastatic neuroendocrine tumors (n=10). Nine adverse events grade ≥ 3 according to Common Terminology Criteria for Adverse Events were recorded, including one fatal case of radioembolization-induced liver disease. Response rates and median overall survival for the above mentioned subgroups were comparable to results from previous Holmium-166 trials as well as to results from Yttrium-90 registries. CONCLUSION This study confirms that the safety and effectiveness of Holmium-166 SIRT derived from prospective trials also applies in routine clinical practice, reinforcing its potential as a viable treatment option for primary and secondary liver cancer.
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Affiliation(s)
- Victor Schulze-Zachau
- Radiology and Nuclear Medicine Clinic, University Hospital Basel, Basel, Switzerland
| | - Gontran Verset
- Hôpital Universitaire de Bruxelles (HUB)-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | - Pieter De Bondt
- Department of Nuclear Medicine, Onze-Lieve-Vrouwziekenhuis (OLV) Aalst, Aalst, Belgium
| | | | - Falk Gühne
- Jena University Hospital, Clinic of Nuclear Medicine, Jena, Germany
| | - Martin Heuschkel
- Nuclear Medicine Clinic, Rostock University Medical Center, Rostock, Germany
| | - Ralf-Thorsten Hoffmann
- Diagnostic and Interventional Radiology Institute, University Hospital Carl Gustav Carus Technische Universität (TU) Dresden, Dresden, Germany
| | - Elena Bozzi
- Interventional Radiology Department, University Hospital Pisa, Pisa, Italy
| | - Rosa Sciuto
- Nuclear Medicine Clinic, Istituti Fisioterapici Ospitalieri (IFO) Regina Elena Hospital Roma, Rome, Italy
| | - Marnix Lam
- Nuclear Medicine Clinic, University Medical Center Utrecht, Utrecht, Netherlands
| | | | | | - Christoph J. Zech
- Radiology and Nuclear Medicine Clinic, University Hospital Basel, Basel, Switzerland
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Kesim S, Balaban Genc ZC, Soydemir E, Baltacioglu F, Kissa TN, Ozdemir B, Ozguven S, Filizoglu N, Niftaliyeva K, Engur CO, Kostek O, Akdeniz E, Turoglu HT, Erdil TY, Cimsit C, Ones T. Evaluating therapeutic efficacy of extended shelf-life 90 Y glass microspheres in transarterial radioembolization for colorectal cancer: a quantitative FDG PET/CT analysis. Nucl Med Commun 2024; 45:268-277. [PMID: 38214074 DOI: 10.1097/mnm.0000000000001813] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2024]
Abstract
OBJECTIVES There is a lack of sufficient evidence regarding the use of extended shelf-life (ExSL) Yttrium-90 ( 90 Y) glass radiomicrospheres in metastatic colorectal cancer (mCRC) patients. We aimed to investigate the efficacy of ExSL 90 Y glass radiomicrospheres with a personalized treatment approach by analyzing 18 F-FDG PET/CT quantitative parameters [metabolic tumor volume (MTV) and total lesion glycolysis (TLG)] separately before and after the treatment. METHODS A total of 93 radioembolization sessions involving 77 patients were included. Simplicit 90 Y software was utilized to perform multicompartmental voxel-based dosimetry. Adverse events were recorded using the CTCAE v5.0 criteria. The survival data were recorded in detail. RESULTS The overall disease control rate was 84.9%, with a median overall survival (OS) of 12.7 months and median progression-free survival (PFS) of 8.3 months. A statistically significant increase in treatment response rate was observed when there was an increase in absorbed tumor dose for pre-treatment unit MTV ( P = 0.005) and TLG ( P = 0.004) values. We didn't observe any additional side effects/vital risks that could be considered clinically significant. CONCLUSION Our study has provided evidence on the therapeutic effectiveness and safety in terms of dose-toxicity profile of ExSL 90 Y glass microspheres in a large cohort of mCRC patients. With a personalized treatment approach, the increase in radiation dose absorbed by the tumor has shown a significant contribution to treatment response rate, as indicated by quantitative measurements obtained through 18 F-FDG PET/CT.
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Affiliation(s)
- Selin Kesim
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | | | - Efe Soydemir
- Department of Radiology, Pendik Research and Training Hospital, Marmara University,
| | - Feyyaz Baltacioglu
- Department of Radiology, Pendik Research and Training Hospital, Marmara University,
| | - Tugba Nergiz Kissa
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | - Berdan Ozdemir
- Department of Radiology, Pendik Research and Training Hospital, Marmara University,
| | - Salih Ozguven
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | - Nuh Filizoglu
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | - Khanim Niftaliyeva
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | - Ceren Ozge Engur
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | - Osman Kostek
- Department of Internal Medicine, Division of Medical Oncology, Pendik Research and Training Hospital, Marmara University and
| | - Esra Akdeniz
- Department of Medical Education, Faculty of Medicine, Marmara University, Istanbul, Turkey
| | - Halil Turgut Turoglu
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | - Tanju Yusuf Erdil
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
| | - Cagatay Cimsit
- Department of Radiology, Pendik Research and Training Hospital, Marmara University,
| | - Tunc Ones
- Department of Nuclear Medicine, Pendik Research and Training Hospital, Marmara University,
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Roll W, Masthoff M, Köhler M, Rahbar K, Stegger L, Ventura D, Morgül H, Trebicka J, Schäfers M, Heindel W, Wildgruber M, Schindler P. Radiomics-Based Prediction Model for Outcome of Radioembolization in Metastatic Colorectal Cancer. Cardiovasc Intervent Radiol 2024; 47:462-471. [PMID: 38416178 DOI: 10.1007/s00270-024-03680-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/26/2023] [Accepted: 01/31/2024] [Indexed: 02/29/2024]
Abstract
PURPOSE To evaluate the benefit of a contrast-enhanced computed tomography (CT) radiomics-based model for predicting response and survival in patients with colorectal liver metastases treated with transarterial Yttrium-90 radioembolization (TARE). MATERIALS AND METHODS Fifty-one patients who underwent TARE were included in this single-center retrospective study. Response to treatment was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 3-month follow-up. Patients were stratified as responders (complete/partial response and stable disease, n = 24) or non-responders (progressive disease, n = 27). Radiomic features (RF) were extracted from pre-TARE CT after segmentation of the liver tumor volume. A model was built based on a radiomic signature consisting of reliable RFs that allowed classification of response using multivariate logistic regression. Patients were assigned to high- or low-risk groups for disease progression after TARE according to a cutoff defined in the model. Kaplan-Meier analysis was performed to analyze survival between high- and low-risk groups. RESULTS Two independent RF [Energy, Maximal Correlation Coefficient (MCC)], reflecting tumor heterogeneity, discriminated well between responders and non-responders. In particular, patients with higher magnitude of voxel values in an image (Energy), and texture complexity (MCC), were more likely to fail TARE. For predicting treatment response, the area under the receiver operating characteristic curve of the radiomics-based model was 0.75 (95% CI 0.48-1). The high-risk group had a shorter overall survival than the low-risk group (3.4 vs. 6.4 months, p < 0.001). CONCLUSION Our CT radiomics model may predict the response and survival outcome by quantifying tumor heterogeneity in patients treated with TARE for colorectal liver metastases.
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Affiliation(s)
- Wolfgang Roll
- Department of Nuclear Medicine, University Hospital Münster, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Max Masthoff
- Clinic for Radiology, University Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Michael Köhler
- Clinic for Radiology, University Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Kambiz Rahbar
- Department of Nuclear Medicine, University Hospital Münster, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Lars Stegger
- Department of Nuclear Medicine, University Hospital Münster, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - David Ventura
- Department of Nuclear Medicine, University Hospital Münster, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Haluk Morgül
- Department for General, Visceral and Transplantation Surgery, University Hospital Münster, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Jonel Trebicka
- Department of Gastroenterology and Hepatology, University Hospital Münster, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Michael Schäfers
- Department of Nuclear Medicine, University Hospital Münster, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Walter Heindel
- Clinic for Radiology, University Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany
| | - Moritz Wildgruber
- Clinic for Radiology, University Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany
- Department of Radiology, University Hospital LMU, Munich, Munich, Germany
| | - Philipp Schindler
- Clinic for Radiology, University Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany.
- West German Cancer Centre (WTZ), Münster Site, Münster, Germany.
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Boshell D, Bester L. Radioembolisation of liver metastases. J Med Imaging Radiat Oncol 2023; 67:842-852. [PMID: 37343147 DOI: 10.1111/1754-9485.13549] [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: 01/15/2023] [Accepted: 06/05/2023] [Indexed: 06/23/2023]
Abstract
This review aims to present contemporary data for SIRT in the treatment of secondary hepatic malignancies including colorectal, neuroendocrine, breast and uveal melanoma.
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Affiliation(s)
- David Boshell
- Department of Radiology, St Vincent's Hospital, Sydney, New South Wales, Australia
| | - Lourens Bester
- Department of Radiology, University of Notre Dame, Sydney, New South Wales, Australia
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Wang X, Yu J, Wen H, Yan J, Peng K, Zhou H. Antioxidative stress protein SRXN1 can be used as a radiotherapy prognostic marker for prostate cancer. BMC Urol 2023; 23:148. [PMID: 37726767 PMCID: PMC10507967 DOI: 10.1186/s12894-023-01319-1] [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: 08/06/2022] [Accepted: 09/04/2023] [Indexed: 09/21/2023] Open
Abstract
PURPOSE To explore the mechanisms of radiotherapy resistance and search for prognostic biomarkers for prostate cancer. METHODS The GSE192817 and TCGA PRAD datasets were selected and downloaded from the GEO and UCSC Xena databases. Differential expression and functional annotation analyses were applied to 52 tumour cell samples from GSE192817. Then, the ssGSEA or GSVA algorithms were applied to quantitatively score the biological functional activity of samples in the GSE192817 and TCGA PRAD datasets, combined with specific gene sets collected from the Molecular Signatures Database (MSigDB). Subsequently, the Wilcoxon rank-sum test was used to compare the differences in ssGSEA or GSVA scores among cell types or PRAD patients. Moreover, radiotherapy resistance-associated gene screening was performed on DU145 and PC3 cells (prostate cancer cells), and survival analysis was used to evaluate the efficacy of these genes for predicting the prognosis of PRAD patients. RESULTS A total of 114 genes that were differentially expressed in more than two different cancer cell types and associated with either sham surgery or radiotherapy treatment (X-ray or photon irradiation) were detected in cancer cells from GSE192817. Comparison of DNA damage-related ssGSEA scores between sham surgery and radiotherapy treatment in prostate cancer cells (DU145 and PC3) showed that photon irradiation was potentially more effective than X-ray treatment. In the TCGA PRAD dataset, patients treated with radiotherapy had much higher "GOBP_CELLULAR_RESPONSE_TO_DNA_DAMAGE_STIMULUS", "GOBP_G2_DNA_DAMAGE_CHECKPOINT" and "GOBP_INTRA_S_DNA_DAMAGE_CHECKPOINT" GSVA scores, and the Wilcoxon rank-sum test p values were 0.0005, 0.0062 and 0.0800, respectively. Furthermore, SRXN1 was upregulated in DU145 cells (resistant to X-ray irradiation compared to PC3 cells) after radiotherapy treatment, and low SRXN1 expression in patients was beneficial to radiotherapy outcomes. The log-rank test p value for PFS was 0.0072. CONCLUSIONS Radiotherapy can damage DNA and induce oxidative stress to kill tumour cells. In this study, we found that SRXN1, as an antioxidative stress gene, plays an important role in radiotherapy for prostate cancer treatment, and this gene is also a potential biomarker for predicting the prognosis of patients treated with radiotherapy.
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Affiliation(s)
- Xing Wang
- Department of Urology, Zhejiang Hospital, # 1229, Gudun Road, Hangzhou, 310030, China
| | - Jiandi Yu
- Department of Urology, Zhejiang Hospital, # 1229, Gudun Road, Hangzhou, 310030, China
| | - Huali Wen
- Department of Urology, Zhejiang Hospital, # 1229, Gudun Road, Hangzhou, 310030, China
| | - Junfeng Yan
- Department of Urology, Zhejiang Hospital, # 1229, Gudun Road, Hangzhou, 310030, China
| | - Kun Peng
- Department of Urology, Zhejiang Hospital, # 1229, Gudun Road, Hangzhou, 310030, China
| | - Haiyong Zhou
- Department of Urology, Zhejiang Hospital, # 1229, Gudun Road, Hangzhou, 310030, China.
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Schaefer N, Grözinger G, Pech M, Pfammatter T, Soydal C, Arnold D, Kolligs F, Maleux G, Munneke G, Peynircioglu B, Sangro B, Pereira H, Zeka B, de Jong N, Helmberger T. Prognostic Factors for Effectiveness Outcomes After Transarterial Radioembolization in Metastatic Colorectal Cancer: Results From the Multicentre Observational Study CIRT. Clin Colorectal Cancer 2022; 21:285-296. [PMID: 36270925 DOI: 10.1016/j.clcc.2022.09.002] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2022] [Revised: 08/31/2022] [Accepted: 09/14/2022] [Indexed: 01/26/2023]
Abstract
BACKGROUND Transarterial radioembolisation (TARE) with Yttrium-90 resin microspheres is a treatment option for patients with metastatic colorectal cancer in the liver (mCRC). A better understanding of the prognostic factors and treatment application can improve survival outcomes. METHODS We analysed the safety and effectiveness of 237 mCRC patients included in the prospective observational study CIRSE Registry for SIR-Spheres Therapy (CIRT) for independent prognostic factors for overall survival (OS), progression-free survival (PFS) and hepatic progression-free survival (hPFS) using the Cox proportional-hazard model. RESULTS The median OS was 9.8 months, median PFS was 3.4 months and median hPFS was 4.2 months. Independent prognostic factors for an improved overall survival were the absence of extra-hepatic disease (P= .0391), prior locoregional procedures (P= .0037), an Aspartate transaminase to Platelet Ratio Index (APRI) value of ≤0.40 (P< .0001) and International Normalized Ratio (INR) ≤1 (P= .0078). Partition model dosimetry resulted in improved OS outcomes compared to the body surface area model (P = .0120). Independent predictors for PFS were APRI >0.40 (P = .0416) and prior ablation (P = .0323), and for hPFS these were 2 to 5 tumor nodules (P = .0148), Albumin-bilirubin (ALBI) grade 3 (P = .0075) and APRI >0.40 (P = .0207). During the study, 95 of 237 (40.1%) patients experienced 197 adverse events, with 28 of 237 (11.8%) patients having a grade 3 or higher adverse events. CONCLUSION Including easy-to-acquire laboratory markers INR, APRI, ALBI and using partition model dosimetry can identify mCRC patients that may benefit from TARE.
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Affiliation(s)
- Niklaus Schaefer
- Service de médecine nucléaire et imagerie moléculaire, University Hospital of Lausanne (CHUV), Lausanne, Switzerland
| | - Gerd Grözinger
- Eberhard Karls University, Department of Diagnostic and Interventional Radiology, Tübingen, Germany
| | - Maciej Pech
- Department of Radiology and Nuclear Medicine, University of Magdeburg, Magdeburg, Germany
| | - Thomas Pfammatter
- Institute of Diagnostic and Interventional Radiology, UniversitätsSpital Zürich, Zürich, Switzerland
| | - Cigdem Soydal
- Ankara University, Medical School, Department of Nuclear Medicine, Cebeci, Ankara, Turkey
| | - Dirk Arnold
- Oncology and Hematology, Asklepios Tumorzentrum Hamburg, Hamburg, Germany
| | - Frank Kolligs
- Department of Internal Medicine and Gastroenterology, Helios Klinikum Berlin-Buch, Berlin, Germany
| | - Geert Maleux
- Radiology, Universitair Ziekenhuis Leuven, Leuven, Belgium
| | - Graham Munneke
- Interventional Oncology, University College London Hospitals NHS Foundation Trust, London, United Kingdom
| | - Bora Peynircioglu
- Department of Radiology, School of Medicine, Hacettepe University, Ankara, Turkey
| | - Bruno Sangro
- Liver Unit and HPB Oncology Area, Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain
| | - Helena Pereira
- Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Paris, France; INSERM, Centre d'Investigation Clinique 1418 (CIC1418), Paris, France
| | - Bleranda Zeka
- Clinical Research Department, Cardiovascular and Interventional Radiological Society of Europe, Vienna Austria
| | - Niels de Jong
- Clinical Research Department, Cardiovascular and Interventional Radiological Society of Europe, Vienna Austria.
| | - Thomas Helmberger
- Department of Radiology, Neuroradiology and Minimal-Invasive Therapy, Klinikum Bogenhausen, Munich, Germany
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Role of Transhepatic Arterial Radioembolization in Metastatic Colorectal Cancer. Cardiovasc Intervent Radiol 2022; 45:1579-1589. [PMID: 36104632 DOI: 10.1007/s00270-022-03268-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2021] [Accepted: 08/25/2022] [Indexed: 11/28/2022]
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Brennan VK, Colaone F, Shergill S, Pollock RF. A cost-utility analysis of SIR-Spheres Y-90 resin microspheres versus best supportive care in the treatment of unresectable metastatic colorectal cancer refractory to chemotherapy in the UK. J Med Econ 2020; 23:1588-1597. [PMID: 33084466 DOI: 10.1080/13696998.2020.1839273] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
Abstract
BACKGROUND Limited treatment options are available in chemotherapy-refractory or -intolerant metastatic colorectal cancer (mCRC). The objective of the present analysis was to evaluate the cost-utility of SIR-Spheres Y-90 resin microspheres relative to best supportive care (BSC) in the treatment of chemotherapy refractory mCRC from the perspective of the UK national healthcare payer. METHODS A cost-utility model was developed in Microsoft Excel to simulate transitions from progression-free survival to post-progression survival and death in patients with mCRC. Unit costs were captured in 2019 pounds sterling (GBP) based on the literature, formulary listings, and National Health Service (NHS) England reference costs. Future costs and effects were discounted at 3.5% per annum. A series of one-way sensitivity analyses, and probabilistic sensitivity analysis (PSA) were conducted. RESULTS The base case analysis showed that SIR-Spheres Y-90 resin microspheres would result in an increase in discounted quality-adjusted life years gained from 0.69 quality-adjusted life years (QALYs) to 1.50 QALYs, with an associated increase in cost from GBP 15,268 to GBP 34,168 yielding an incremental cost-utility ratio of GBP 23,435 per QALY. PSA showed that there would be a 56% likelihood that SIR-Spheres Y-90 resin microspheres would be cost-effective relative to BSC at a willingness-to-pay threshold of GBP 30,000 per QALY gained. CONCLUSIONS This cost-utility analysis showed that, relative to BSC, SIR-Spheres Y-90 resin microspheres would be a cost-effective treatment option for patients with mCRC in the UK setting from the national healthcare payer perspective.
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Affiliation(s)
- V K Brennan
- Sirtex Medical United Kingdom Ltd, London, UK
| | - F Colaone
- Sirtex Medical United Kingdom Ltd, London, UK
| | - S Shergill
- Sirtex Medical United Kingdom Ltd, London, UK
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Schindler P, Masthoff M, Harders F, Schmidt HH, Stegger L, Pascher A, Rahbar K, Wildgruber M, Köhler M. Efficacy of 90Y-Radioembolization in Metastatic Colorectal Cancer Depending on the Primary Tumor Side. Dig Dis 2020; 39:351-357. [PMID: 33142291 DOI: 10.1159/000512744] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/14/2020] [Accepted: 11/02/2020] [Indexed: 02/02/2023]
Abstract
BACKGROUND Metastatic colorectal cancer (mCRC) is associated with different molecular biology, clinical characteristics, and outcome depending on the primary tumor localization. We aimed to evaluate the effectiveness of 90Y-radioembolization (RE) for therapy of colorectal liver metastases depending on the primary tumor side. METHODS We performed a retrospective analysis of n = 73 patients with mCRC and RE in our university liver center between 2009 and 2018. Patients were stratified according to the primary tumor side (left vs. right hemicolon), treatment response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) at follow-up after 3 months. Kaplan-Meier analysis was performed to analyze survival followed by Cox regression to determine independent prognostic factors for survival. RESULTS Prior to RE, all patients had received systemic therapy, with either stable or progressive disease, but no partial or complete response. In n = 22/73 (30.1%) patients, the primary tumor side was in the right colon; in n = 51/73 (69.9%) patients, in the left colon. Hepatic tumor burden was ≤25% in n = 36/73 (49.3%) patients and >25% in n = 37/73 (50.7%) patients. At 3 months, n = 21 (33.8%) patients showed treatment response (n = 2 [3.2%]; complete response, n = 19 [30.6%]; partial response), n = 13 (21.0%) stable disease, and n = 28 (45.2%) progressive disease after RE. The median survival in case of primary tumor side in the left colon was significantly higher than for primary tumors in the right colon (8.7 vs. 6.0 months, p = 0.033). The median survival for a hepatic tumor burden ≤25% was significantly higher than that of >25% (13.9 vs. 4.3 months, p < 0.001). The median overall survival was 6.1 months. CONCLUSION The median survival after RE in hepatic-mCRC depends on the primary tumor side and the preprocedural hepatic tumor burden.
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Affiliation(s)
- Philipp Schindler
- Institute of Clinical Radiology, University Hospital Münster, Münster, Germany,
| | - Max Masthoff
- Institute of Clinical Radiology, University Hospital Münster, Münster, Germany
| | - Fabian Harders
- Institute of Clinical Radiology, University Hospital Münster, Münster, Germany
| | - Hartmut H Schmidt
- Department of Gastroenterology and Hepatology, University Hospital Münster, Münster, Germany
| | - Lars Stegger
- Department of Nuclear Medicine, University Hospital Münster, Münster, Germany
| | - Andreas Pascher
- Department for General, Visceral and Transplantation Surgery, University Hospital Münster, Münster, Germany
| | - Kambiz Rahbar
- Department of Nuclear Medicine, University Hospital Münster, Münster, Germany
| | - Moritz Wildgruber
- Institute of Clinical Radiology, University Hospital Münster, Münster, Germany.,Klinik und Poliklinik für Radiologie, Klinikum der Universität München, Munich, Germany
| | - Michael Köhler
- Institute of Clinical Radiology, University Hospital Münster, Münster, Germany
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12
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Martin J, Petrillo A, Smyth EC, Shaida N, Khwaja S, Cheow HK, Duckworth A, Heister P, Praseedom R, Jah A, Balakrishnan A, Harper S, Liau S, Kosmoliaptsis V, Huguet E. Colorectal liver metastases: Current management and future perspectives. World J Clin Oncol 2020; 11:761-808. [PMID: 33200074 PMCID: PMC7643190 DOI: 10.5306/wjco.v11.i10.761] [Citation(s) in RCA: 135] [Impact Index Per Article: 27.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/27/2020] [Revised: 05/14/2020] [Accepted: 08/31/2020] [Indexed: 02/06/2023] Open
Abstract
The liver is the commonest site of metastatic disease for patients with colorectal cancer, with at least 25% developing colorectal liver metastases (CRLM) during the course of their illness. The management of CRLM has evolved into a complex field requiring input from experienced members of a multi-disciplinary team involving radiology (cross sectional, nuclear medicine and interventional), Oncology, Liver surgery, Colorectal surgery, and Histopathology. Patient management is based on assessment of sophisticated clinical, radiological and biomarker information. Despite incomplete evidence in this very heterogeneous patient group, maximising resection of CRLM using all available techniques remains a key objective and provides the best chance of long-term survival and cure. To this end, liver resection is maximised by the use of downsizing chemotherapy, optimisation of liver remnant by portal vein embolization, associating liver partition and portal vein ligation for staged hepatectomy, and combining resection with ablation, in the context of improvements in the functional assessment of the future remnant liver. Liver resection may safely be carried out laparoscopically or open, and synchronously with, or before, colorectal surgery in selected patients. For unresectable patients, treatment options including systemic chemotherapy, targeted biological agents, intra-arterial infusion or bead delivered chemotherapy, tumour ablation, stereotactic radiotherapy, and selective internal radiotherapy contribute to improve survival and may convert initially unresectable patients to operability. Currently evolving areas include biomarker characterisation of tumours, the development of novel systemic agents targeting specific oncogenic pathways, and the potential re-emergence of radical surgical options such as liver transplantation.
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Affiliation(s)
- Jack Martin
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Angelica Petrillo
- Department of Precision Medicine, Division of Medical Oncology, University of Campania "L. Vanvitelli", Napoli 80131, Italy, & Medical Oncology Unit, Ospedale del Mare, 80147 Napoli Italy
| | - Elizabeth C Smyth
- Department of Oncology, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Nadeem Shaida
- Department of Radiology, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB22 0QQ, United Kingdom
| | - Samir Khwaja
- Department of Radiology, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB22 0QQ, United Kingdom
| | - HK Cheow
- Department of Nuclear Medicine, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Adam Duckworth
- Department of Pathology, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Paula Heister
- Department of Pathology, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Raaj Praseedom
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Asif Jah
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Anita Balakrishnan
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Simon Harper
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Siong Liau
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Vasilis Kosmoliaptsis
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
| | - Emmanuel Huguet
- Department of Surgery, Addenbrookes Hospital, NIHR Comprehensive Biomedical Research and Academic Health Sciences Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, United Kingdom
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13
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Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol 2020; 44:36-49. [PMID: 32975600 PMCID: PMC7728633 DOI: 10.1007/s00270-020-02643-x] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2020] [Accepted: 09/02/2020] [Indexed: 01/03/2023]
Abstract
PURPOSE Radioembolization has emerged as a treatment modality for patients with primary and secondary liver tumours. This observational study CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France) aims to evaluate real-life clinical practice on all patients treated with transarterial radioembolization (TARE) using SIR-Spheres yttrium-90 resin microspheres in France. In this interim analysis, safety and quality of life data are presented. Final results of the study, including secondary effectiveness outcomes, will be published later. Overall, CIRT-FR is aiming to support French authorities in the decision making on reimbursement considerations for this treatment. METHODS Data on patients enrolled in CIRT-FR from August 2017 to October 2019 were analysed. The interim analysis describes clinical practice, baseline characteristics, safety (adverse events according to CTCTAE 4.03) and quality of life (according to EORTC QLQ C30 and HCC module) aspects after TARE. RESULTS This cohort included 200 patients with hepatocellular carcinoma (114), metastatic colorectal cancer (mCRC; 38) and intrahepatic cholangiocarcinoma (33) amongst others (15). TARE was predominantly assigned as a palliative treatment (79%). 12% of patients experienced at least one adverse event in the 30 days following treatment; 30-day mortality was 1%. Overall, global health score remained stable between baseline (66.7%), treatment (62.5%) and the first follow-up (66.7%). CONCLUSION This interim analysis demonstrates that data regarding safety and quality of life generated by randomised-controlled trials is reflected when assessing the real-world application of TARE. TRIAL REGISTRATION Clinical Trials.gov NCT03256994.
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14
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Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT). Cardiovasc Intervent Radiol 2020; 44:21-35. [PMID: 32959085 PMCID: PMC7728645 DOI: 10.1007/s00270-020-02642-y] [Citation(s) in RCA: 56] [Impact Index Per Article: 11.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/01/2020] [Accepted: 09/02/2020] [Indexed: 01/27/2023]
Abstract
Purpose To address the lack of prospective data on the real-life clinical application of trans-arterial radioembolization (TARE) in Europe, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the prospective observational study CIRSE Registry for SIR-Spheres® Therapy (CIRT). Materials and Methods Patients were enrolled from 1 January 2015 till 31 December 2017. Eligible patients were adult patients treated with TARE with Y90 resin microspheres for primary or metastatic liver tumours. Patients were followed up for 24 months after treatment, whereas data on the clinical context of TARE, overall survival (OS) and safety were collected. Results Totally, 1027 patients were analysed. 68.2% of the intention of treatment was palliative. Up to half of the patients received systemic therapy and/or locoregional treatments prior to TARE (53.1%; 38.3%). Median overall survival (OS) was reported per cohort and was 16.5 months (95% confidence interval (CI) 14.2–19.3) for hepatocellular carcinoma, 14.6 months (95% CI 10.9–17.9) for intrahepatic cholangiocarcinoma. For liver metastases, median OS for colorectal cancer was 9.8 months (95% CI 8.3–12.9), 5.6 months for pancreatic cancer (95% CI 4.1–6.6), 10.6 months (95% CI 7.3–14.4) for breast cancer, 14.6 months (95% CI 7.3–21.4) for melanoma and 33.1 months (95% CI 22.1–nr) for neuroendocrine tumours. Statistically significant prognostic factors in terms of OS include the presence of ascites, cirrhosis, extra-hepatic disease, patient performance status (Eastern Cooperative Oncology Group), number of chemotherapy lines prior to TARE and tumour burden. Thirty-day mortality rate was 1.0%. 2.5% experienced adverse events grade 3 or 4 within 30 days after TARE. Conclusion In the real-life clinical setting, TARE is largely considered to be a part of a palliative treatment strategy across indications and provides an excellent safety profile. Level of evidence Level 3. Trial registration ClinicalTrials.gov NCT02305459. Electronic supplementary material The online version of this article (10.1007/s00270-020-02642-y) contains supplementary material, which is available to authorized users.
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15
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Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A. Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc 2020; 9:e16296. [PMID: 32319960 PMCID: PMC7203613 DOI: 10.2196/16296] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2019] [Revised: 01/30/2020] [Accepted: 02/21/2020] [Indexed: 12/22/2022] Open
Abstract
Background Radioembolization, also known as transarterial radioembolization or selective internal radiation therapy with yttrium-90 (90Y) resin microspheres, is an established treatment modality for patients with primary and secondary liver tumors. However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking. Objective The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting. Methods Eligible patients are 18 years or older and receiving radioembolization for primary and secondary liver tumors as part of routine practice, as well as have signed informed consent. Data is collected at baseline, directly after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. Secondary objectives include safety, effectiveness in terms of overall survival, progression-free survival (PFS), liver-specific PFS, imaging response, and change in quality of life. Results Between January 2015 and December 2017, 1047 patients were included in the study. The 24-month follow-up period ended in December 2019. The first results are expected in the third quarter of 2020. Conclusions The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes. Trial Registration ClinicalTrials.gov NCT02305459; https://clinicaltrials.gov/ct2/show/NCT02305459 International Registered Report Identifier (IRRID) DERR1-10.2196/16296
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Affiliation(s)
- Thomas Helmberger
- Department of Radiology, Neuroradiology and Minimal-Invasive Therapy, Klinikum Bogenhausen, München, Germany
| | - Dirk Arnold
- Oncology and Hematology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg, Germany
| | - José I Bilbao
- Interventional Radiology, Clinica Universidad de Navarra, Pamplona, Spain
| | - Niels de Jong
- Cardiovascular and Interventional Radiological Society of Europe, Vienna, Austria
| | - Geert Maleux
- Radiologie, Universitair Ziekenhuis Leuven, Leuven, Belgium
| | | | - Bora Peynircioglu
- Department of Radiology, School of Medicine, Hacettepe University, Ankara, Turkey
| | - Bruno Sangro
- Liver Unit, Clínica Universidad de Navarra, Pamplona, Spain.,Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.,Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas, Pamplona, Spain
| | - Ricky A Sharma
- National Institute for Health Research University College London Hospitals Biomedical Research Centre, University College London Cancer Institute, University College London, London, United Kingdom
| | - Agnes Walk
- Cardiovascular and Interventional Radiological Society of Europe, Vienna, Austria
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16
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Jeyarajah DR, Doyle MBM, Espat NJ, Hansen PD, Iannitti DA, Kim J, Thambi-Pillai T, Visser BC. Role of yttrium-90 selective internal radiation therapy in the treatment of liver-dominant metastatic colorectal cancer: an evidence-based expert consensus algorithm. J Gastrointest Oncol 2020; 11:443-460. [PMID: 32399284 DOI: 10.21037/jgo.2020.01.09] [Citation(s) in RCA: 21] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022] Open
Abstract
Surgical resection of colorectal liver metastases is associated with greater survival compared with non-surgical treatment, and a meaningful possibility of cure. However, the majority of patients are not eligible for resection and may require other non-surgical interventions, such as liver-directed therapies, to be converted to surgical eligibility. Given the number of available therapies, a general framework is needed that outlines the specific roles of chemotherapy, surgery, and locoregional treatments [including selective internal radiation therapy (SIRT) with Y-90 microspheres]. Using a data-driven, modified Delphi process, an expert panel of surgical oncologists, transplant surgeons, and hepatopancreatobiliary (HPB) surgeons convened to create a comprehensive, evidence-based treatment algorithm that includes appropriate treatment options for patients stratified by their eligibility for surgical treatment. The group coined a novel, more inclusive phrase for targeted locoregional tumor treatment (a blanket term for resection, ablation, and other emerging locoregional treatments): local parenchymal tumor destruction therapy. The expert panel proposed new nomenclature for 3 distinct disease categories of liver-dominant metastatic colorectal cancer that is consistent with other tumor types: (I) surgically treatable (resectable); (II) surgically untreatable (borderline resectable); (III) advanced surgically untreatable (unresectable) disease. Patients may present at any point in the algorithm and move between categories depending on their response to therapy. The broad intent of therapy is to transition patients toward individualized treatments where possible, given the survival advantage that resection offers in the context of a comprehensive treatment plan. This article reviews what is known about the role of SIRT with Y-90 as neoadjuvant, definitive, or palliative therapy in these different clinical situations and provides insight into when treatment with SIRT with Y-90 may be appropriate and useful, organized into distinct treatment algorithm steps.
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Affiliation(s)
| | | | - N Joseph Espat
- Department of Surgery, Roger Williams Medical Center, Boston University School of Medicine, Providence, RI, USA
| | - Paul D Hansen
- HPB Surgery, Providence Portland Center, Portland, OR, USA
| | - David A Iannitti
- HPB Surgery, Atrium Health, Carolinas Medical Center, Charlotte, NC, USA
| | - Joseph Kim
- Department of Surgery, University of Kentucky, Lexington, KY, USA
| | - Thavam Thambi-Pillai
- Department of Surgery, University of South Dakota Sanford School of Medicine, Sioux Falls, SD, USA
| | - Brendan C Visser
- Department of Surgery, Stanford University Medical Center, CA, USA
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17
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Palmer DH, Hawkins NS, Vilgrain V, Pereira H, Chatellier G, Ross PJ. Tumor burden and liver function in HCC patient selection for selective internal radiation therapy: SARAH post-hoc study. Future Oncol 2019; 16:4315-4325. [PMID: 31797680 DOI: 10.2217/fon-2019-0658] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022] Open
Abstract
Aim: To determine whether a liver tumor burden ≤25% and well-preserved liver function (albumin-bilirubin grade 1) are appropriate criteria for identifying patients with unresectable hepatocellular carcinoma who may benefit from selective internal radiation therapy (SIRT) using 90yttrium resin microspheres versus sorafenib. Patients & methods: Post-hoc analysis of patients in the intention-to-treat population of the SARAH trial (SIRT vs sorafenib) with ≤25% tumor burden and albumin-bilirubin grade 1. Primary end point: overall survival. Results: Median overall survival was 21.9 months (95% CI: 15.2-32.5, n = 37) with SIRT and 17.0 months (11.6-20.8, n = 48) with sorafenib (hazard ratios: 0.73; 95% CI: 0.44-1.21; p = 0.22). Conclusion: A combination of good liver function and low tumor burden may be relevant for selection of hepatocellular carcinoma patients for SIRT.
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Affiliation(s)
- Daniel H Palmer
- Liverpool CR UK/NIHR Experimental Cancer Medicine Centre, University of Liverpool, Liverpool, L69 3BX, United Kingdom
| | - Neil S Hawkins
- Institute of Health & Wellbeing, University of Glasgow, Glasgow, G12 8RZ, United Kingdom
| | - Valérie Vilgrain
- Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Paris Nord Val de Seine, Hôpital Beaujon, 92118 Clichy, France.,Centre de Recherche de l'Inflammation, INSERM U1149, Université Paris Sorbonne Cité, Paris, France
| | - Helena Pereira
- Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges-Pompidou, Unité d'épidémiologie et de Recherche Clinique, Paris, 75015 France.,Module Épidémiologie Clinique, Centre d'Investigation Clinique 1418, INSERM, Paris, France
| | - Gilles Chatellier
- Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges-Pompidou, Unité d'épidémiologie et de Recherche Clinique, Paris, 75015 France.,Module Épidémiologie Clinique, Centre d'Investigation Clinique 1418, INSERM, Paris, France
| | - Paul J Ross
- Department of Medical Oncology, Guy's & St Thomas' NHS Foundation Trust, London, SE1 9RT, United Kingdom.,Department of Oncology, King's College Hospital NHS Foundation Trust, London, SE5 9RS, United Kingdom
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18
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Yttrium-90 Transarterial Radioembolization for Chemotherapy-Refractory Intrahepatic Cholangiocarcinoma: A Prospective, Observational Study. J Vasc Interv Radiol 2019; 30:1185-1192. [PMID: 31255499 DOI: 10.1016/j.jvir.2019.03.018] [Citation(s) in RCA: 34] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2018] [Revised: 02/14/2019] [Accepted: 03/11/2019] [Indexed: 01/06/2023] Open
Abstract
PURPOSE To evaluate the safety and efficacy of yttrium-90 transarterial radioembolization (TARE) for the treatment of unresectable, chemotherapy-refractory intrahepatic cholangiocarcinoma (ICC). METHODS A prospective, observational study was carried out in 10 centers between 2013 and 2017. TARE plus standard care was delivered to patients with unresectable, chemotherapy-refractory or chemotherapy-intolerant ICC. Primary outcome was overall survival. Secondary outcomes included safety, progression-free survival (PFS), and liver-specific progression-free survival (LPFS). RESULTS Sixty-one patients were treated with TARE. Patients were 53% male; median age was 64 years; 91% had performance status 0/1; 92% had received prior chemotherapy; and 59% had no extrahepatic disease. Median follow-up was 13.9 months (95% confidence interval [CI], 9.6-18.1). Overall survival was 8.7 months (95% CI, 5.3-12.1), and 37% of patients survived to 12 months. PFS was 2.8 months (95% CI, 2.6-3.1), and LPFS was 3.1 months (95% CI, 1.3-4.8). One severe complication (abdominal pain) occurred at the time of the TARE procedure. Thirty patients experienced a total of 49 adverse events, of which 8% were grade ≥3; most common were grade 1-2 fatigue and abdominal pain. A total of 77 abnormal laboratory value events were recorded, of which 4% were grade ≥3. CONCLUSIONS Patients with advanced ICC have limited therapeutic options and a poor prognosis. This prospective study examined the survival of patients with unresectable, chemotherapy-refractory primary ICC treated with TARE in real-world practice. The results demonstrate that this treatment merits further investigation in this patient cohort in a larger study, including collection of patient-reported outcomes.
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