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Clinical Trial
. 2025 Sep 9:227:115644.
doi: 10.1016/j.ejca.2025.115644. Epub 2025 Jul 12.

Impact of trifluridine/tipiracil plus bevacizumab on tumor shrinkage and depth of response in refractory metastatic colorectal cancer: analysis of the SUNLIGHT trial

Julien Taieb  1 , Dominik P Modest  2 , Marwan Fakih  3 , Fortunato Ciardiello  4 , Eric Van Cutsem  5 , Elena Elez  6 , Cristina Gravalos  7 , Arinilda Campos Bragagnoli  8 , Valentine Barboux  9 , Lucas Roby  9 , Nadia Amellal  9 , Gerald W Prager  10
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Free article
Clinical Trial

Impact of trifluridine/tipiracil plus bevacizumab on tumor shrinkage and depth of response in refractory metastatic colorectal cancer: analysis of the SUNLIGHT trial

Julien Taieb et al. Eur J Cancer. .
Free article

Abstract

Objectives: This post hoc analysis of the SUNLIGHT trial sought to assess the response to treatment with trifluridine/tipiracil (FTD/TPI) + bevacizumab and FTD/TPI in patients with refractory metastatic colorectal cancer using tumor shrinkage (TS), early TS (ETS), duration of TS (DTS) and depth of response (DpR) as response-related parameters.

Methods: TS was defined as any decrease from baseline of the sum of the longest diameter of target lesions. TS at first assessment was specified as ETS. DpR was defined as the maximum percentage change from baseline of the sum of the longest diameters of target lesions. DTS was defined as the time from first TS to first increase in tumor size, progressive disease, or death.

Results: In the FTD/TPI + bevacizumab group, 48 % had TS and 39 % had ETS. In the FTD/TPI group, 21 % had TS and 17 % had ETS. In patients achieving ETS, median DTS was prolonged with FTD/TPI + bevacizumab compared to FTD/TPI (3.8 versus 2.1 months; HR: 0.34 [95 % CI: 0.22, 0.53]; P < 0.0001). Magnitude of DpR was greater with FTD/TPI + bevacizumab than with FTD/TPI.

Conclusion: The survival benefit of treatment with FTD/TPI + bevacizumab versus FTD/TPI is likely associated with the improvement of ETS and DpR.

Keywords: Bevacizumab; Colorectal cancer; Depth of response; Response parameters; Trifluridine/tipiracil.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Julien Taieb: Reports personal fees for speaker bureau and/or advisory role from Merck KGaA, Sanofi, Roche Genentech, MSD, BMS, Novartis, Astellas, Takeda, Ono Pharmaceutical, Boehringer-Ingelheim, Pierre Fabre and Amgen, outside the submitted work and from Servier. Dominik P Modest: Reports personal fees for speaker bureau and/or advisory role from Merck, KGaA, Sanofi, Amgen, Astra Zeneca, MSD, BMS, Incyte IKF, Takeda, Taiho, GSK, Pierre Fabre, Regeneron, Boehringer-Ingelheim. Marwan Fakih: Consultancy/advisory for Amgen, Taiho Pharm., Bayer, Pfizer, Seagen, GSK, Incyte, Nouscom, Roche/Genentech, Mirati Ther. BMS, Eisai, and Merck. Speaker’s bureau for Guardant Health; Honoraria, Amgen; Research Funding, Amgen, Verastem. Fortunato Ciardiello: Consulting/advisory for Amgen, Merck KGaA, Pfizer, Roche/Genentech, Bayer US, LLC. Receives research funding from Amgen, BMS, Ipsen, Merck KGaA, Merck Sharp & Dohme, Roche/Genentech, Servier, Symphogen and Bayer US, LLC. Eric Van Cutsem: Participation to advisory boards for Abbvie, Agenus, ALX, Amgen, Arcus Biosciences, Astellas, Astrazeneca, Bayer, Beigene, Bexon Clinical, Biontech, Boehringer Ingelheim, Bristol-Myers Squibb, Canfour, Daiichi, Debiopharma, Elmedix, Eisai, Galapagos, GSK, Hookipa Biotech, Incyte, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Mirati, Novartis, Nordic, Pierre Fabre, Pfizer, Roche, Seattle Genetics, Servier, Simcere, Takeda, Taiho, and Terumo. Elena Elez: Reports personal financial interest in Agenus, Amgen, Bayer, BMS, Boehringer Ingelheim, Cure Teq AG, GlaxoSmithKline, Hoffman La-Roche, Janssen, Lilly, Medscape, Merck Serono, MSD, Novartis, Organon, Pfizer, Pierre Fabre, Repare Therapeutics Inc., RIN Institute Inc., Sanofi, Seagen International GmbH, Servier, and Takeda Cristina Gravalos: Reports personal fees for speaker bureau and/or advisory role from Servier, Merck, Amgen, Incyte and PierreFabre. Arinilda Campos Bragagnoli: Reports speaker fees from Servier, Ipsen, BMS, Amgen, and Astrazeneca. Valentine Barboux, Lucas Roby and Nadia Amellal: Employees of Servier. Gerald W. Prager: Consulting/advisory for Amgen, Daiichi Sanyo Europe GmbH, Incyte, Merck Serono, Pierre Fabre, Roche/Genentech, Servier, Lilly O., Arcus Bioscience, and Bayer US LLC.

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