First-line trifluridine/tipiracil plus bevacizumab for unresectable metastatic colorectal cancer: SOLSTICE study design
AffiliationSorbonne Universite & Saint-Antoine Hospital, Paris, France
MetadataShow full item record
AbstractTrifluridine/tipiracil (TT) is an orally administered combination of the thymidine-based nucleoside analogue trifluridine and the thymidine phosphorylase inhibitor tipiracil hydrochloride, which increases the bioavailability of cytotoxic trifluridine. Encouraging antitumor activity of first-line TT + bevacizumab (TT-B) has been observed in a Phase II study in patients with unresectable metastatic colorectal cancer ineligible for combination oxaliplatin- or irinotecan-based therapy. Here, we describe the design of SOLSTICE (NCT03869892), an open-label, Phase III trial in unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy. The 854 patients were randomized 1:1 to receive first-line TT-B versus capecitabine + bevacizumab. The primary objective is to demonstrate superior progression-free survival with TT-B over capecitabine + bevacizumab. The first patient was enrolled in March 2019.
CitationAndre T, Saunders M, Kanehisa A, Gandossi E, Fougeray R, Amellal NC, et al. First-line trifluridine/tipiracil plus bevacizumab for unresectable metastatic colorectal cancer: SOLSTICE study design. Future Oncol. 2020;16(4):21-9.
- Trifluridine/tipiracil plus bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design.
- Authors: Tabernero J, Taieb J, Prager GW, Ciardiello F, Fakih M, Leger C, Fougeray R, Amellal N, van Cutsem E
- Issue date: 2021 Jun
- TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial.
- Authors: Pfeiffer P, Yilmaz M, Möller S, Zitnjak D, Krogh M, Petersen LN, Poulsen LØ, Winther SB, Thomsen KG, Qvortrup C
- Issue date: 2020 Mar
- Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study.
- Authors: Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argilés G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Kanehisa A, Egorov A, Aubel P, Amellal N, Moiseenko V
- Issue date: 2020 Sep
- Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme.
- Authors: Iveson T, Carter AM, Shiu KK, Spooner C, Stevens D, Mullamitha S
- Issue date: 2020 Feb 3
- Trifluridine/tipiracil plus bevacizumab as a first-line treatment for elderly patients with metastatic colorectal cancer (KSCC1602): A multicenter phase II trial.
- Authors: Oki E, Makiyama A, Miyamoto Y, Kotaka M, Kawanaka H, Miwa K, Kabashima A, Noguchi T, Yuge K, Kashiwada T, Ando K, Shimokawa M, Saeki H, Akagi Y, Baba H, Maehara Y, Mori M
- Issue date: 2021 Jan