Trifluridine–Tipiracil with and without Bevacizumab in Colorectal Cancer
Menée aux Etats-Unis à partir de données de vie réelle portant sur 3 680 patients atteints d'un cancer colorectal métastatique, cette étude de cohorte évalue l'efficacité, du point de vue de la survie globale, du trifluridine/tipiracil avec ou sans bévacizumab
Background: In the phase 3 SUNLIGHT trial (Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients), trifluridine–tipiracil+bevacizumab (FTD–TPI+bev) improved the overall survival of patients with metastatic colorectal cancer (mCRC) compared with trifluridine–tipiracil (FTD–TPI) monotherapy. We investigated the real-world outcomes of FTD–TPI+bev compared with FTD–TPI for patients with mCRC.
Methods: We analyzed U.S.-based electronic medical records and claims in the ConcertAI RWD360 dataset. Adults with mCRC were grouped by first exposure to FTD–TPI versus FTD–TPI+bev. Propensity score matching was used to balance the cohorts based on patient characteristics. Kaplan–Meier analyses were used to describe the real-world overall survival (rwOS, the primary outcome), time to treatment discontinuation (rwTTD), and time to next treatment or death (rwTTNTD).
Results: This cohort included 3151 patients treated with FTD–TPI and 529 patients treated with FTD–TPI+bev. After propensity score matching, 472 patients were included in each cohort with balanced patient characteristics. The median rwOS was 8.9 months (95% confidence interval [CI], 7.8 to 10.1) for FTD–TPI+bev and 5.8 months (95% CI, 4.9 to 6.7) for FTD–TPI (P<0.001). The median rwTTD was 3.5 months (95% CI, 3.2 to 3.8) in the FTD–TPI+bev group and 2.2 months (95% CI, 1.9 to 2.5) in the FTD–TPI group. The median rwTTNTD among the FTD–TPI+bev group was 4.9 months (95% CI, 4.5 to 5.4) and in the FTD–TPI group it was 3.5 months (95% CI, 3.1 to 3.7).
Conclusions: This U.S.-based real-world observational study found that FTD–TPI+bev was associated with longer rwOS compared with FTD–TPI in patients with mCRC. These findings align with the results of the SUNLIGHT clinical trial. (Funded by Taiho Oncology, Inc. and others.)
NEJM Evidence , résumé, 2026