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Trifluridine/Tipiracil plus Bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study
Van Cutsem, E Danielewicz, I Saunders, Mark P Pfeiffer, P Argiles, G Borg, C Glynne-Jones, R Punt, CJA Van de Wouw, AJ Fedyanin, M
Van Cutsem, E
Danielewicz, I
Saunders, Mark P
Pfeiffer, P
Argiles, G
Borg, C
Glynne-Jones, R
Punt, CJA
Van de Wouw, AJ
Fedyanin, M
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Abstract
Purpose: We designed an open-label, non-comparative phase II study to assess the safety and efficacy of first-line treatment with trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B) in untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies.
Patients and methods: From 29 April 2016 to 29 March 2017, 153 patients were randomly assigned (1:1) to either TT-B (n=77) or C-B (n=76). The primary endpoint was progression-free survival (PFS). The primary PFS analysis was performed after 100 events (radiological progression or death) were observed. Secondary endpoints included overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires) and safety.
Results: Median duration of treatment was 7.8 [6.0;9.7] months and 6.2 [4.1;9.1] months in the TT-B and C-B groups, respectively. Median PFS was 9.2 [7.6;11.6] and 7.8 [5.5;10.1] months, respectively. Median OS was 18 [15.2;NA] and 16.2 [12.5;NA] months, respectively. QoL questionnaires showed no relevant changes over time for either treatment. Therapies were well tolerated. Patients receiving TT-B had more grade ?3 neutropenia (47% vs. 5% with C-B). Patients receiving C-B had more grade ?3 hand-foot syndrome (12% vs. 0% with TT-B) and grade ?3 diarrhea (8% vs. 1% with TT-B), consistent with the known safety profiles of these agents.
Conclusion: TT-B treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL.
Keywords: TASCO1 study; Trifluridine/tipiracil; bevacizumab; capecitabine; intensive therapy; metastatic colorectal cancer.
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Date
2020
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Citation
Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, et al. Trifluridine/Tipiracil plus Bevacizumab in Patients with Untreated Metastatic Colorectal Cancer Ineligible for Intensive Therapy: the Randomized TASCO1 Study. Ann Oncol. 2020.