Trifluridine/Tipiracil plus Bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study
AuthorsVan Cutsem, E
Saunders, Mark P
Van de Wouw, AJ
AffiliationUniversity Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: email@example.com.
MetadataShow full item record
AbstractPurpose: 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.
CitationVan 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.
JournalAnnals of Oncology
- First-line trifluridine/tipiracil plus bevacizumab for unresectable metastatic colorectal cancer: SOLSTICE study design.
- Authors: André T, Saunders M, Kanehisa A, Gandossi E, Fougeray R, Amellal NC, Falcone A
- Issue date: 2020 Feb
- Rationale and design of the TRUSTY study: a randomised, multicentre, open-label phase II/III study of trifluridine/tipiracil plus bevacizumab versus irinotecan, fluoropyrimidine plus bevacizumab as second-line treatment in patients with metastatic colorectal cancer progressive during or following first-line oxaliplatin-based chemotherapy.
- Authors: Yoshino T, Oki E, Nozawa H, Eguchi-Nakajima T, Taniguchi H, Morita S, Takenaka N, Ozawa D, Shirao K
- Issue date: 2018
- Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer.
- Authors: Kotani D, Kuboki Y, Horasawa S, Kaneko A, Nakamura Y, Kawazoe A, Bando H, Taniguchi H, Shitara K, Kojima T, Tsuji A, Yoshino T
- Issue date: 2019 Dec 27
- Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study.
- Authors: Bachet JB, Wyrwicz L, Price T, Cremolini C, Phelip JM, Portales F, Ozet A, Cicin I, Atlan D, Becquart M, Vidot L, Mounedji N, Van Cutsem E, Taieb J, Falcone A
- Issue date: 2020 Jun
- Combination chemotherapy with TAS-102 plus bevacizumab in salvage-line treatment of metastatic colorectal cancer: A single-center, retrospective study examining the prognostic value of the modified Glasgow Prognostic Score in salvage-line therapy of metastatic colorectal cancer.
- Authors: Matsuhashi N, Takahashi T, Fujii H, Suetsugu T, Fukada M, Iwata Y, Tokumaru Y, Imai T, Mori R, Tanahashi T, Matsui S, Imai H, Tanaka Y, Yamaguchi K, Futamura M, Yoshida K
- Issue date: 2019 Oct