• Gerald W Prager, Julien Taieb, Marwan Fakih, Fortunato Ciardiello, Eric Van Cutsem, Elena Elez, Felipe M Cruz, Lucjan Wyrwicz, Daniil Stroyakovskiy, Zsuzsanna Pápai, Pierre-Guillaume Poureau, Gabor Liposits, Chiara Cremolini, Igor Bondarenko, Dominik P Modest, Karim A Benhadji, Nadia Amellal, Catherine Leger, Loïck Vidot, Josep Tabernero, and SUNLIGHT Investigators.
• From the Department of Medicine I, Comprehensive Cancer Center, Medical University of Vienna, Vienna (G.W.P.); the Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, SIRIC Cancer Research for Personalized Medicine, Université Paris Cité, Paris (J. Taieb), the Department of Oncology, University Hospital, Brest (P.-G.P.), and Servier, Suresnes (N.A., C.L., L.V.) - all in France; City of Hope Comprehensive Cancer Center, Duarte, CA (M.F.); Dipartimento di Medicina di Precisione, Università degli Studi della Campania Luigi Vanvitelli, Naples (F.C.), and the Unit of Medical Oncology, Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa (C.C.) - both in Italy; the Department of Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); the Department of Medical Oncology, Vall d'Hebron Hospital Campus and Institute of Oncology, International Oncology Bureau-Quiron, Barcelona (E.E., J. Tabernero); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.M.C.); the Department of Oncology and Radiotherapy, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (L.W.); Moscow City Oncology Hospital, Moscow Healthcare Department, Moscow (D.S.); the Department of Oncology, Hungarian Defense Forces Medical Center, Budapest, Hungary (Z.P.); the Department of Oncology, Regional Hospital West Jutland, Herning, Denmark (G.L.); Dnipro State Medical University, Dnipro, Ukraine (I.B.); the Medical Department of Hematology, Oncology, and Cancer Immunology, Charité-Universitätsmedizin Berlin, Berlin (D.P.M.); and Taiho Oncology, Princeton, NJ (K.A.B.).
• N. Engl. J. Med. 2023 May 4; 388 (18): 165716671657-1667.

BackgroundIn a previous phase 3 trial, treatment with trifluridine-tipiracil (FTD-TPI) prolonged overall survival among patients with metastatic colorectal cancer. Preliminary data from single-group and randomized phase 2 trials suggest that treatment with FTD-TPI in addition to bevacizumab has the potential to extend survival.MethodsWe randomly assigned, in a 1:1 ratio, adult patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer to receive FTD-TPI plus bevacizumab (combination group) or FTD-TPI alone (FTD-TPI group). The primary end point was overall survival. Secondary end points were progression-free survival and safety, including the time to worsening of the Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 or 1 to 2 or more (on a scale from 0 to 5, with higher scores indicating greater disability).ResultsA total of 246 patients were assigned to each group. The median overall survival was 10.8 months in the combination group and 7.5 months in the FTD-TPI group (hazard ratio for death, 0.61; 95% confidence interval [CI], 0.49 to 0.77; P<0.001). The median progression-free survival was 5.6 months in the combination group and 2.4 months in the FTD-TPI group (hazard ratio for disease progression or death, 0.44; 95% CI, 0.36 to 0.54; P<0.001). The most common adverse events in both groups were neutropenia, nausea, and anemia. No treatment-related deaths were reported. The median time to worsening of the ECOG performance-status score from 0 or 1 to 2 or more was 9.3 months in the combination group and 6.3 months in the FTD-TPI group (hazard ratio, 0.54; 95% CI, 0.43 to 0.67).ConclusionsAmong patients with refractory metastatic colorectal cancer, treatment with FTD-TPI plus bevacizumab resulted in longer overall survival than FTD-TPI alone. (Funded by Servier and Taiho Oncology; SUNLIGHT ClinicalTrials.gov number, NCT04737187; EudraCT number, 2020-001976-14.).Copyright © 2023 Massachusetts Medical Society.

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