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- Title
First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study.
- Authors
Van Cutsem, E; Danielewicz, I; Saunders, M P; Pfeiffer, P; Argilés, G; Borg, C; Glynne-Jones, R; Punt, C J A; Van de Wouw, A J; Fedyanin, M; Stroyakovskiy, D; Kroening, H; Garcia-Alfonso, P; Wasan, H; Falcone, A; Fougeray, R; Egorov, A; Amellal, N; Moiseyenko, V
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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/m2 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 Final OS was analysed when all patients had either died or withdrawn from the study.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.<bold>Results: </bold>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.<bold>Conclusions: </bold>TT-B is a promising therapeutic regimen in mCRC patients ineligible for intensive chemotherapy.<bold>Clinical Trial Information: </bold>NCT02743221 (clinicaltrials.gov).
- Subjects
THERAPEUTIC use of antineoplastic agents; COLON tumors; RESEARCH; COMBINATION drug therapy; RECTUM tumors; HETEROCYCLIC compounds; DEOXYRIBONUCLEOSIDES; RESEARCH methodology; EVALUATION research; COLORECTAL cancer; COMPARATIVE studies; RANDOMIZED controlled trials; SURVIVAL analysis (Biometry)
- Publication
British Journal of Cancer, 2022, Vol 126, Issue 10, p1548
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-022-01737-2