Real-world clinical outcomes among metastatic colorectal cancer (mCRC) patients with liver metastases who received trifluridine/tipiracil (FTD/TPI) or FTD/TPI + bevacizumab (FTD/TPI+bev) combination therapy.

60 Background: FTD/TPI+bev has shown clinical benefit compared with FTD/TPI monotherapy in clinical trials and was approved in the U.S. for patients with refractory mCRC in 2023. The liver is the most common site of metastasis in mCRC. A study from the SUNLIGHT trial showed mCRC patients treated with FTD/TPI+bev had numerically longer overall survival than patients treated with FTD/TPI, irrespective of the presence of liver metastases. This study aimed to describe clinical outcomes of patients with liver metastases treated with FTD/TPI+bev or FTD/TPI in a real-world setting. Methods: Adult patients with a mCRC diagnosis and at least 2 lines of therapy in the ConcertAI Patient360 electronic medical records dataset were included (N=2,210). Exposure was defined as FTD/TPI alone or FTD/TPI+bev based on first receipt of FTD/TPI (index date) in second line (2L) or later. Patients were restricted to those with liver metastases at mCRC diagnosis and with an index 2020-2025. Kaplan-Meier analyses and log-rank tests were used to compare real-world overall survival (rwOS) and real-world time to treatment discontinuation (rwTTD) for FTD/TPI and FTD/TPI+bev patients; additionally, outcomes were assessed among patients with no sites of metastases except liver. Adjusted Cox proportional hazards models were used to analyze the association between the index therapy and the outcomes in the overall cohort. Results: Liver metastases at mCRC diagnosis were reported in 185 and 130 patients treated with FTD/TPI and FTD/TPI+bev, respectively. Patients treated with FTD/TPI and FTD/TPI+bev had a median age at index of 62 and 59 years, respectively. 62.7% (N=116) of FTD/TPI and 52.3% (N=68) of FTD/TPI+bev patients had metastases to the liver only at mCRC diagnosis. Approximately 63% of all patients received index therapy in 2L or 3L. Among patients with liver metastasis, FTD/TPI+bev patients compared to FTD/TPI patients had statistically significantly longer median rwOS (9.6 vs. 5.9 months, p=0.02) and median rwTTD (3.2 vs. 2.1 months; p<0.01). Results for rwOS and rwTTD were similar when examined in patients with metastases to only the liver. After adjustment for age and ECOG at index, race, number of sites of metastases, and line of index therapy, FTD/TPI+bev compared to FTD/TPI was statistically significantly associated with rwOS (HR=0.76, 95% CI: 0.57–1.00) and rwTTD (HR=0.64, 95% CI: 0.49–0.82). Conclusions: This study examined clinical outcomes among patients with liver metastases receiving FTD/TPI and FTD/TPI+bev in the real-world setting. Though active liver metastases at FTD/TPI initiation could not be confirmed, patients with liver metastases at mCRC diagnosis treated with FTD/TPI+bev had longer rwOS and rwTTD compared with FTD/TPI, suggesting that these patients experience the benefits of FTD/TPI+bev.