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    First-line trifluridine/tipiracil plus bevacizumab for unresectable metastatic colorectal cancer: SOLSTICE study design

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    Authors
    Andre, T
    Saunders, Mark P
    Kanehisa, A
    Gandossi, E
    Fougeray, R
    Amellal, NC
    Falcone, A
    Affiliation
    Sorbonne Universite & Saint-Antoine Hospital, Paris, France
    Issue Date
    2020
    
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    Show full item record
    Abstract
    Trifluridine/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.
    Citation
    Andre 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.
    Journal
    Future Oncology
    URI
    http://hdl.handle.net/10541/622708
    DOI
    10.2217/fon-2019-0786
    PubMed ID
    31914811
    Additional Links
    https://dx.doi.org/10.2217/fon-2019-0786
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.2217/fon-2019-0786
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