Health-related quality of life associated with fruquintinib in patients with metastatic colorectal cancer: Results from the FRESCO-2 study
- PMID: 39952149
- DOI: 10.1016/j.ejca.2025.115268
Health-related quality of life associated with fruquintinib in patients with metastatic colorectal cancer: Results from the FRESCO-2 study
Abstract
Introduction: Maintaining or improving health-related quality of life (HRQoL) is as important as extending survival in metastatic colorectal cancer. We report an HRQoL analysis from FRESCO-2 (NCT04322539).
Methods: Patients were randomized to fruquintinib +best supportive care (BSC; n = 461) or placebo +BSC (n = 230). Instruments of EORTC QLQ-C30 and 5-level EQ-5D, and ECOG performance status (PS) were assessed. Changes from baseline scores for QLQ-C30 and EQ-5D were evaluated and minimally important difference thresholds were used to define stable, improved, or deteriorated QoL. Time to deterioration (TTD) was assessed.
Results: With fruquintinib versus placebo, baseline QLQ-C30 global health status (GHS) and EQ-5D visual analog scale (VAS) scores were 65.2 versus 64.6 and 67.0 versus 66.6, respectively. Least-squares mean changes from baseline fluctuated throughout treatment. At end of treatment (EOT), mean scores with fruquintinib versus placebo were 53.8 versus 52.3 (QLQ-C30 GHS) and 58.9 versus 58.5 (EQ-5D VAS). For QLQ-C30 GHS, 38.3 % versus 36.5 % of patients receiving fruquintinib versus placebo had stable or improved scores at EOT; median TTD was 2.1 versus 1.8 months (HR, 0.9; 95 % CI, 0.7-1.0). For EQ-5D VAS, 47.9 % versus 42.7 % had stable or improved scores at EOT; median TTD was 2.6 versus 1.9 months (HR, 0.8; 95 % CI, 0.6-0.9). Median TTD to ECOG PS ≥ 2 or death within 30+ /7 days after EOT was 6.6 versus 2.9 months with fruquintinib versus placebo (HR, 0.6; 95 % CI, 0.4-0.7).
Conclusions: Fruquintinib delayed TTD of ECOG PS and did not negatively impact HRQoL versus placebo.
Keywords: EORTC QLQ-C30; EQ-5D-5L; Fruquintinib; Health-related quality of life; Metastatic colorectal cancer.
Copyright © 2025 The Authors. Published by Elsevier Ltd.. All rights reserved.
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: A.S. reports the ownership of stock/shares with Amgen; and an advisory council or committee position for and honoraria from Bayer, Servier, Bristol Myers Squibb (BMS), MSB, Glaxosmithkline (GSK), and Takeda. A.D. has received consulting fees from Eisai, Enterome, Guardant Health, HUTCHMED, Natera, Neogenomics, Personalis, Taiho, and Xencor; and grants or funds from BMS, Exelixis, Illumina, Lantheus, Personalis, Taiho, and Takeda. S.L. reports receiving honoraria (as invited speaker) from Roche, Eli Lilly, BMS, Servier, Merck Serono, Pierre Fabre, GSK, and Amgen; consulting fee (advisory boards) from Amgen, Astellas, Bayer, Merck Serono, Eli Lilly, AstraZeneca, Incyte, Daiichi-Sankyo, BMS, Servier, Merck Sharp & Dohme (MSD), GSK, Takeda, Rottapharm, and Beigene; as well as grants or funds (to institution) from Amgen, Merck Serono, Bayer, Roche, Eli Lilly, AstraZeneca, and BMS. R.G.C has received honoraria from AAA-Novartis, Advanz Pharma, Astellas, Bayer, BMS, Boerhinger Ingelheim, Esteve, GSK, HUTCHMED, Ipsen, Merck, Midatech Pharma, MSD, PharmaMar, Pierre Fabre, Roche, and Servier; and has received grants or funds from BMS, and MSD. E.E. has been on an advisory council or committee for, and has received honoraria as well as consulting fees from Agenus, Amgen, Bayer, BMS, Boehringer Ingelheim, Cureteq AG, GSK, 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; has received grants or funds (to institution) from AbbVie Deutschland Gmbh & Co KG, Amgen Inc., Array Biopharma Inc., AstraZeneca Pharmaceuticals LP, Bayer, BeiGene, Bioncotech, Therapeutics, S.L., BioNtech RNA Pharmacuticals GMBH, BioNtech Small Molecules GMBH, Boehringer Ingelheim, Boehringer Ingelheim de España S.A., BMS International Corporation, Celgene International Sàrl, Daiichi Sankyo, Debiopharm International S.A., Genentech Inc., Gercor, HalioDX SAS, Roche, HUTCHMED, Iovance Biotherapeutics Inc., Janssen Research & Development, Janssen-Cilag S.A., MedImmune, Menarini, Menarini Ricerche SPA, Merck Health KGAA, Merck, Sharp & Dohme de España S.A., Merus NV, Mirati, Nouscom S.R.L., Novartis Farmacéutica S.A., Pfizer, PharmaMar S.A., Pledpharma A.B., Redx Pharma Plc, Sanofi Aventis Recherche & Développement, Scandion Oncology, Seattle Genetics Inc., Servier, Sotio A.S., Taiho Pharma USA Inc., Wntresearch AB and non-financial conflicts with American Society for Clinical Oncology (ASCO), Leadership Role, Member of the Scientific Program Committee and Developmental Therapeutics-Immunotherapy Track Leader, 2023–2024 term. European Society for Medical Oncology (ESMO), Member of the Scientific Committee 2024. ESMO, Speaker of the ESMO Academy. Sociedad Española de Oncología Médica (SEOM), Coordinator of the SEOM +MIR Section of Residents and Young Assistants. T.Y. declares receiving honoraria from Chugai Pharmaceutical, Takeda, Merck Biopharma, Bayer Yakuhin, Ono Pharmaceutical, and MSD K.K.; a consulting fee from Sumitomo Corp.; and grants or funds from Amgen, BMS, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, FALCO biosystems, Genomedia, Medical & Biological Laboratories, Merus N.V., Molecular Health GmbH, MSD, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Pfizer Japan, Roche Diagnostics, Sanofi, Sysmex, Taiho Pharmaceutical, and Takeda. J.Y. reports consulting fees from HUTCHMED. A.S.B. has received consulting fees from Bayer, Pierre-Fabre, Servier, and Takeda. T.S. reports receiving honoraria from Eli-Lilly, Ono Pharmaceutical, BMS, and Daiichi-Sankyo; as well as grants or funds from Ono Pharmaceutical, BMS, Daiichi-Sankyo, and Shionogi Pharmaceutical. V.R. has received honoraria from Takeda. J.To. reports employment for Masaryk Memorial Cancer Institute, Brno, Czech Republic; receiving honoraria from Amgen, and Merck; and consulting fees from Merck. G.C. has held an advisory council or committee position for Regeneron, Takeda, and BMS; and reports research funding from HUTCHMED, Regeneron, BMS, AstraZeneca, Amgen, Roche, Bayer, Pharmacyclics, Incyte, Dizal Pharma, and Merck. T.P. has been on an advisory council or committee for Takeda, BMS, MSD, and Amgen. Z.Yu., A.G., and L.C. are employees of and hold stocks and shares with Takeda. Z.Ya., W.R.S., and M.K. are employees of and hold stocks and shares with HUTCHMED. J.Ta. reports the ownership of stock/shares with Oniria Therapeutics, Alentis Therapeutics, Pangaea Oncology, and 1TRIALSP; educational collaboration with Medscape Education, PeerView Institute for Medical Education, and Physicians Education Resource (PER); and has received consulting fees from Alentis Therapeutics, AstraZeneca, Aveo Oncology, Boehringer Ingelheim, Cardiff Oncology, CARSgen Therapeutics, Chugai, Daiichi Sankyo, Roche, Genentech Inc., hC Bioscience, Immodulon Therapeutics, Inspirna Inc., Lilly, Menarini, Merck Serono, Merus, MSD, Mirati, Neophore, Novartis, Ona Therapeutics, Ono Pharma USA, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Scandion Oncology, Scorpion Therapeutics, Seattle Genetics, Servier, Sotio Biotech, Taiho, Takeda, and Tolremo Therapeutics. C.E. has been on an advisory council or committee for AbbVie, Amgen, GSK, IGM, Merck, Natera, Pfizer, Seagen, and Taiho. J.A., P.G.A., J.K., A.C.G., have no potential conflicts of interest to report.
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