Efficacy and safety of trifluridine/tipiracil in combination with bevacizumab in older and younger patients with refractory metastatic colorectal cancer: A subgroup analysis of the phase 3 SUNLIGHT trial.

Authors

Julien Taieb

Julien Taieb

Université Paris-Cité, (Paris Descartes), Georges Pompidou European Hospital, SIRIC CARPEM, Paris, France

Julien Taieb , Gerald W. Prager , Marwan Fakih , Fortunato Ciardello , Eric Van Cutsem , Elena Elez , Felipe Melo Cruz , Lucjan S. Wyrwicz , Daniil Stroyakovskiy , Zsuzsanna Papai , Pierre-Guillaume Poureau , Gabor Liposits , Chiara Cremolini , Igor Bondarenko , Dominik Paul Modest , Lucas Roby , Valentine Barboux , Nadia Amellal , Josep Tabernero

Organizations

Université Paris-Cité, (Paris Descartes), Georges Pompidou European Hospital, SIRIC CARPEM, Paris, France, Medical University of Vienna, Vienna, Austria, Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, Università degli Studi della Campania Luigi Vanvitelli, Naples, Italy, University Hospitals Leuven and KU Leuven, Leuven, Belgium, Vall d’Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain, Núcleo de Pesquisa e Ensino da Rede São Camilo, Sao Paulo, Brazil, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, Moscow City Oncology Hospital 62, Moscow, Russian Federation, Medical Oncology, Duna Medical Centre, Budapest, Hungary, Institut de Cancérologie, Brest, France, Department of Clinical Research, University of Southern Denmark, Odense, Denmark, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy, Dnipro State Medical University, Dnipro, Ukraine, Charité Universitaetsmedizin Berlin, Berlin, Germany, Servier International Research Institute, Gif-Sur-Yvette, France, Medical Oncology Department, Vall d’Hebron Hospital Campus & Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain

Research Funding

Institut de Recherches Internationales Servier
Taiho Oncology

Background: SUNLIGHT, an international, open-label, randomized, phase 3 study comparing trifluridine/tipiracil (FTD/TPI) + bevacizumab (FTD/TPI + bev) to FTD/TPI monotherapy in patients with refractory metastatic colorectal cancer (mCRC), demonstrated a 3.3-month increase in overall survival from 7.5 months with FTD/TPI monotherapy to 10.8 months with FTD/TPI + bev (HR, 0.61; 95% CI: 0.49–0.77; P<0.001). This subgroup analysis of SUNLIGHT examined efficacy and safety outcomes by age. Methods: In SUNLIGHT, patients with mCRC with ECOG PS of 0-1 and two prior treatment regimens were randomized to receive FTD/TPI + bev or FTD/TPI. A subgroup analysis was performed to evaluate efficacy and safety outcomes in patients aged <65, 65-74, and ≥75 years. Results: Among 492 randomized patients (n=246 FTD/TPI + bev; n=246 FTD/TPI), 56%, 32%, and 12% were aged <65, 65-74, and ≥75 years, respectively. Concerning overall survival, hazard ratios for FTD/TPI + bev vs FTD/TPI monotherapy were 0.65 (95% CI: 0.48–0.87), 0.64 (95% CI: 0.43–0.94), and 0.49 (95% CI: 0.27–0.90) in patients aged <65, 65-74, and ≥75 years, respectively. Regardless of age, patients receiving FTD/TPI + bev experienced improved progression-free survival and improved time to worsening of ECOG PS to ≥2. Among FTD/TPI + bev treated patients, frequency of any-cause severe adverse events (AEs) was slightly higher in the 65-74 subgroup [69% (<65); 80% (65-74); 67% (≥75 years)]. Frequency of grade 3 and 4 neutropenia was also slightly higher in the 65-74 subgroup [38% (<65); 54% (65-74); 42% (≥75 years)]. AE-related discontinuation rates were similar across age subgroups [11.6% (<65 years), 13.2% (65-74), and 16.7% (≥75 years)]. Conclusions: The results of this subgroup analysis demonstrate the efficacy benefit and tolerability of FTD/TPI + bevacizumab treatment regardless of age in refractory mCRC patients. Clinical trial information: NCT04737187.

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Abstract Details

Meeting

2024 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Colorectal Cancer,Anal Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT04737187

Citation

J Clin Oncol 42, 2024 (suppl 3; abstr 111)

DOI

10.1200/JCO.2024.42.3_suppl.111

Abstract #

111

Poster Bd #

G15

Abstract Disclosures

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