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First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study
Van Cutsem, E. Danielewicz, I. Saunders, Mark P Pfeiffer, P. Argilés, G. Borg, C. Glynne-Jones, R. Punt, C. J. A. Van de Wouw, A. J. Fedyanin, M.
Van Cutsem, E.
Danielewicz, I.
Saunders, Mark P
Pfeiffer, P.
Argilés, G.
Borg, C.
Glynne-Jones, R.
Punt, C. J. A.
Van de Wouw, A. J.
Fedyanin, M.
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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/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 Final OS was analysed when all patients had either died or withdrawn from the study.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.
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.
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2022
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Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argilés G, Borg C, et al. First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. Vol. 126, British Journal of Cancer. Springer Science and Business Media LLC; 2022. p. 1548–54.