Trifluridine–Tipiracil with and without Bevacizumab in Colorectal Cancer

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.).