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Clinical Trial
. 2025 Jun;24(2):180-187.e4.
doi: 10.1016/j.clcc.2024.12.002. Epub 2024 Dec 11.

Impact of Treatment With Trifluridine/Tipiracil in Combination With Bevacizumab on Health-Related Quality of Life and Performance Status in Refractory Metastatic Colorectal Cancer: An Analysis of the Phase III SUNLIGHT Trial

Julien Taieb  1 , Marwan Fakih  2 , Josep Tabernero  3 , Fortunato Ciardiello  4 , Eric Van Cutsem  5 , Gemma Soler  6 , Elizabeth Calleja  7 , Valentine Barboux  8 , Lucas Roby  8 , Nadia Amellal  8 , Gerald W Prager  9
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Free article
Clinical Trial

Impact of Treatment With Trifluridine/Tipiracil in Combination With Bevacizumab on Health-Related Quality of Life and Performance Status in Refractory Metastatic Colorectal Cancer: An Analysis of the Phase III SUNLIGHT Trial

Julien Taieb et al. Clin Colorectal Cancer. 2025 Jun.
Free article

Abstract

Background: The efficacy of trifluridine/tipiracil (FTD/TPI) + bevacizumab compared to FTD/TPI for treatment of refractory metastatic colorectal cancer (mCRC) was demonstrated in the SUNLIGHT trial. This analysis of SUNLIGHT investigated the impact of treatment with FTD/TPI + bevacizumab on patient quality of life (QoL) and Eastern Cooperative Oncology Group performance status (ECOG PS).

Methods: Questionnaires (EORTC QLQ-C30 and EQ-5D-5L) and ECOG PS assessments were conducted at baseline and on Day 1 of each treatment cycle. Time to definitive deterioration (TTDD) of QoL and time to ECOG PS worsening between treatment arms was assessed. A repeated-measures mixed-effects model was used to compare changes in QoL and ECOG PS from baseline. Kaplan-Meier and Cox regression methods were used to assess TTDD of QoL, time to ECOG PS worsening to ≥ 2, and overall survival (OS) and progression-free survival (PFS) in patients maintaining an ECOG PS of 0-1.

Results: Both treatment arms showed similar QoL scores from baseline to cycle 6, with no clinically relevant change over time. Patients receiving FTD/TPI + bevacizumab had a longer TTDD of QoL than patients receiving FTD/TPI, as well as longer time to ECOG PS worsening. In patients with maintained ECOG PS, median OS and PFS was prolonged in the FTD/TPI + bevacizumab arm compared to the FTD/TPI arm.

Conclusion: This analysis of SUNLIGHT showed that patients treated with FTD/TPI + bevacizumab had no clinically relevant changes in QoL, and prolonged TTDD and time to ECOG PS worsening, compared to patients treated with FTD/TPI.

Keywords: CRC; Chemotherapy; Global health status; Patient-reported outcomes; VEGF inhibitor.

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Conflict of interest statement

Disclosure Julien Taieb: Advisory/speaker for Astellas, Roche, Merck Serono, Amgen, Servier, Pierre Fabre, BMS, Astra Zeneca, Novartis, Takeda and MSD. 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. Josep Tabernero: Consulting/advisory for Alentis Therapeutics, Amgen, AstraZeneca, Aveo Oncology, Boehringer Ingelheim, Cardiff Oncology, CARSgen Therapeutics, Chugai, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Genentech Inc, hC Bioscience, Immodulon Therapeutics, Inspirna Inc, Lilly, Menarini, Merck Serono, Merus, MSD, Mirati, Neophore, Novartis, Ona Therapeutics, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Sanofi, Scandion Oncology, Scorpion Therapeutics, Seattle Genetics, Servier, Sotio Biotech, Taiho, Takeda Oncology and Tolremo Therapeutics. Stocks: Oniria Therapeutics, Alentis Therapeutics, Pangaea Oncology and 1TRIALSP. Educational collaboration: Medscape Education, PeerView Institute for Medical Education and Physicians Education Resource (PER). 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 & Dome, Roche/Genetech, Servier, Symphogen and Bayer US, LLC. Eric Van Cutsem: Consulting/advisory for Bayer, Lilly, Roche, Servier, BMS, MSD, Merck KGaA, Novartis, AstraZeneca, Array BioPharm, Daiichi Sankyo, Pierre Fabre, Taiho Pharm., Incyte, Astellas, GSK, Nordic Gp, Pfizer, Takeda, ALX Oncol. Abbvie, BeiGene, BI, Mirati Ther., Seagen, Terumo, Zymeworks and Ipsen. Receives research funding from Amgen, Bayer, BI, Lilly, Novartis, Roche, Ipsen, Merck, Merck KGaA, Servier, and BMS. Gemma Soler: No financial or nonfinancial interest to declare in relation to this manuscript. Elizabeth Calleja: Employee of Taiho. 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/Genetech, Servier, Lilly O., AstraZeneca, Arcus Bioscience and Bayer US LLC. The conceptualization of this analysis and funded statistical analyses.

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