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Bevacizumab Added to FTD-TPI in Third-Line Therapy for Metastatic Colorectal Cancer
Trifluridine-tipiracil (FTD-TPI) is an approved late-line therapy in chemotherapy-refractory metastatic colorectal cancer. Bevacizumab is combined with first- and second-line chemotherapy, but its continued use in later-line therapy has not been clearly supported in clinical trials. Investigators now report results of the SUNLIGHT trial, a global, open-label, industry-sponsored, randomized, phase 3 trial evaluating the use of standard-regimen FTD-TPI, given with or without bevacizumab (5 mg/kg) every 2 weeks, in chemotherapy-refractory colorectal cancer.
Of the 492 patients treated, 72% had left-sided primary tumors, 92% had received two prior chemotherapy regimens, 72% had received prior anti–vascular endothelial growth factor (VEGF) therapy, 20% received bevacizumab as part of first- and second-line chemotherapy, and of the 31% with RAS wild-type cancers, 94% had received prior epidermal growth factor (EGFR)–targeted therapy.
At a median follow-up of 14 months, the primary endpoint of median overall survival was significantly longer with the addition of bevacizumab (10.8 vs. 7.5 months; hazard ratio, 0.61). Overall survival at 6 months and at 12 months were also better with bevacizumab added (77% vs. 61% and 43% vs. 30%, respectively). Progression-free survival was significantly longer with bevacizumab (5.6 vs. 2.4 months; HR for disease progression or death, 0.44), and response rate was also better (6.1% vs. 1.2%). No new safety signals were observed; hypertension and neutropenia were more common with bevacizumab.
The SUNLIGHT trial is practice changing and indicates that bevacizumab should be continued into late-line treatment with FTD-TPI, as the addition of bevacizumab was associated with clinically meaningful improvements in all treatment endpoints. Although a cleaner trial comparison would have included only patients with prior first- and second-line bevacizumab therapy, most patients received at least two lines of prior chemotherapy, and nearly all had prior treatment with EGFR or anti-VEGF agents.
Prager GW et al.
Title: Trifluridine–tipiracil and bevacizumab in refractory metastatic colorectal cancer.
Source: N Engl J Med 2023 May 4; [e-pub]. (Abstract/FREE Full Text)