Real-world clinical outcomes of patients (Pts) with metastatic colorectal cancer (mCRC) who received trifluridine-tipiracil (FTD-TPI) monotherapy or FTD-TPI + bevacizumab (FTD-TPI+bev) combination therapy.
Authors: Maliha Nusrat, Ruizhi Zhao, Nadeem Khan, Yuexi Wang, Dudith Pierre-Victor, Jon G. Tepsick, Sharath R, Christopher G Cann, Tehseen Salimi
Journal: Journal of Clinical Oncology (2025)

79 Background: FTD-TPI+bev has shown survival benefit when compared to FTD-TPI alone in pts with mCRC and was approved in the U.S. in 2023. However, there is a lack of real-world data on outcomes for pts who received FTD-TPI+bev as compared to pts who received FTD-TPI. Methods: This retrospective study used data abstracted from electronic medical records and claims in the ConcertAI RWD360 dataset. Adult pts with a diagnosis of mCRC and exposure to FTD-TPI were included. Pts were categorized as having received FTD-TPI or FTD-TPI+bev based on first exposure to FTD-TPI (index date). Kaplan-Meier analyses were used to describe the overall survival (rwOS), real-world time to discontinuation (rwTTD), and time to next treatment or death (rwTTNTD) from the index date. Multivariate Cox regression analyses were used to control for patient characteristics, including demographics, ECOG performance status (PS), comorbidities, sites of metastatic disease, time from mCRC to index date, lab results, and receipt of prior regorafenib. Results: This study included 3,680 pts. The FTD-TPI cohort included 3,151 pts (median age 62 years; male 56.3%; White 63.3%; any comorbidities 40.6%; ECOG PS 0-1 34.8%; 2+ metastatic sites 25.4%; median time from mCRC diagnosis to index date 699 days). The FTD-TPI+bev cohort included 529 pts (median age 60 years; male 53.9%; White 68.1%; any comorbidities 34.4%; ECOG PS 0-1 51.4%; 2+ metastatic sites 25.1%; median time from mCRC diagnosis to index date 609 days). Prior to index date, 18.5% and 6.9% of pts had been exposed to regorafenib in the FTD-TPI and FTD-TPI+bev cohorts, respectively. FTD-TPI+bev significantly increased rwOS (median 9.4 [95% CI 8.0-10.1] vs 6.4 [95% CI 6.1-6.6] months; p&lt;0.0001) and significantly decreased the risk of death (HR=0.68; p&lt;0.0001) in the adjusted model. Other significant factors for rwOS included 2+ metastatic sites (vs.1 site, HR=1.16; p=0.002) and no receipt of regorafenib prior to index date of FTD-TPI (HR=0.80; p&lt;0.0001). FTD-TPI+bev also significantly prolonged rwTTD as compared to FTD-TPI (median 3.5 [95% CI: 3.3-3.8] vs 2.4 [95% CI: 2.3-2.6] months; p&lt;0.0001) and decreased risk of discontinuation (HR=0.65; p&lt;0.0001) after adjusting for patient demographic and clinical characteristics. Additionally, the FTD-TPI+bev cohort had a significantly longer rwTTNTD as compared to the FTD-TPI cohort (median 5.0 [95% CI: 4.6-5.5] vs 3.9 [95%CI: 3.8-4.1] months; p&lt;0.0001) in the adjusted model (HR=0.73; p&lt;0.0001). Conclusions: This is the largest study to compare the clinical outcomes of pts receiving FTD-TPI and FTD-TPI+bev in the real-world setting. FTD-TPI+bev improved clinical outcomes including rwOS, rwTTD, and rwTTNTD, as compared to FTD-TPI in pts with mCRC. These findings align with the results of the SUNLIGHT trial.