학술논문
First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study.
Document Type
Academic Journal
Author
Van Cutsem E; University Hospitals Leuven and KU Leuven, Leuven, Belgium. eric.vancutsem@uzleuven.be.; Danielewicz I; Wojewodzkie Hospitals in Gdyni/Gdansk Medical University, Gdynia, Poland.; Saunders MP; Christie Hospital NHS Foundation Trust, Manchester, UK.; Pfeiffer P; Odense University Hospital, Odense, Denmark.; Argilés G; Vall d'Hebrón Institute of Oncology and Vall d'Hebrón University Hospital, Barcelona, Spain.; Borg C; University Hospital Besançon, Besançon, France.; Glynne-Jones R; Mount Vernon Hospital, Northwood, UK.; Punt CJA; Amsterdam University Medical Centres, Amsterdam, The Netherlands.; Julius Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.; Van de Wouw AJ; VieCuri Medical Centre, Noord-Limburg, Venlo, The Netherlands.; Fedyanin M; NN Blokhin National Medical Research Centre of Oncology, Moscow, Russia.; Stroyakovskiy D; Moscow City Oncology Hospital N62, Moscow, Russia.; Kroening H; Group Practice for Haematology and Oncology, Magdeburg, Germany.; Garcia-Alfonso P; Gregorio Marañón General University Hospital, Madrid, Spain.; Wasan H; Hammersmith Hospital, Imperial College London, London, UK.; Falcone A; Department of Oncology, University Hospital of Pisa, Pisa, Italy.; Fougeray R; Servier International Research Institute, Suresnes, France.; Egorov A; Servier International Research Institute, Suresnes, France.; Amellal N; Servier International Research Institute, Suresnes, France.; Moiseyenko V; Saint Petersburg Scientific Practical Centre for Specialized Medical Care, St Petersburg, Russia.
Source
Publisher: Nature Publishing Group on behalf of Cancer Research UK Country of Publication: England NLM ID: 0370635 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1827 (Electronic) Linking ISSN: 00070920 NLM ISO Abbreviation: Br J Cancer Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Therapeutic options are limited in patients with unresectable metastatic colorectal cancer (mCRC) ineligible for intensive chemotherapy. The use of trifluridine/tipiracil plus bevacizumab (TT-B) in this setting was evaluated in the TASCO1 trial; here, we present the final overall survival (OS) results.
Methods: TASCO1 was an open-label, non-comparative phase II trial. Patients (n = 153) were randomised 1:1 to TT-B (trifluridine/tipiracil 35 mg/m2 orally twice daily on days 1-5 and 8-12, and bevacizumab intravenously 5 mg/kg on days 1 and 15 of each 28-day cycle) or capecitabine plus bevacizumab (C-B; capecitabine, 1250 mg/m 2 orally twice daily on days 1-14 and bevacizumab 7.5 mg/kg intravenously on day 1 of each 21-day cycle). Final OS was analysed when all patients had either died or withdrawn from the study. Adjusted multivariate regression was used to investigate the effects of pre-specified variables on OS.
Results: At 1 September 2020, median OS was 22.3 months (95% CI: 18.0-23.7) with TT-B and 17.7 months (95% CI: 12.6-19.8) with C-B (adjusted HR 0.78; 95% CI: 0.55-1.10). No variables negatively affected OS with TT-B. Safety results were consistent with prior findings.
Conclusions: TT-B is a promising therapeutic regimen in mCRC patients ineligible for intensive chemotherapy.
Clinical Trial Information: NCT02743221 (clinicaltrials.gov).
(© 2022. The Author(s).)
Methods: TASCO1 was an open-label, non-comparative phase II trial. Patients (n = 153) were randomised 1:1 to TT-B (trifluridine/tipiracil 35 mg/m
Results: At 1 September 2020, median OS was 22.3 months (95% CI: 18.0-23.7) with TT-B and 17.7 months (95% CI: 12.6-19.8) with C-B (adjusted HR 0.78; 95% CI: 0.55-1.10). No variables negatively affected OS with TT-B. Safety results were consistent with prior findings.
Conclusions: TT-B is a promising therapeutic regimen in mCRC patients ineligible for intensive chemotherapy.
Clinical Trial Information: NCT02743221 (clinicaltrials.gov).
(© 2022. The Author(s).)