Real-world Outcomes of Trifluridine/Tipiracil With or Without Bevacizumab in Metastatic Colorectal Cancer: A Retrospective Cohort Study.

BACKGROUND/AIM: Trifluridine/tipiracil (FTD/TPI) is an established treatment for refractory metastatic colorectal cancer (mCRC), and recent clinical trials have demonstrated improved survival with the addition of bevacizumab. However, real-world evidence regarding this combination therapy, particularly in patients previously treated with bevacizumab and its positioning in later-line treatment strategies, remains limited.

PATIENTS AND METHODS: We conducted a retrospective cohort study of patients with mCRC treated with FTD/TPI with or without bevacizumab at our institution. Overall survival (OS) and progression-free survival (PFS) were compared between the two groups using the Kaplan-Meier method and log-rank test. A Cox proportional hazards model was used to estimate hazard ratio (HR). Subgroup analyses were performed according to prior bevacizumab exposure. Additionally, exploratory analyses were conducted to evaluate treatment sequencing with regorafenib.

RESULTS: A total of 101 patients were included (FTD/TPI: n=42; FTD/TPI plus bevacizumab: n=59). The combination therapy was associated with significantly improved OS (HR=0.53, 95%CI=0.33-0.86, p=0.009) and PFS (HR=0.44, 95%CI=0.28-0.69, p<0.001). These associations remained significant in multivariate analyses. Subgroup analyses showed a consistent benefit of the combination therapy. In exploratory analyses, prior regorafenib use was associated with longer PFS (HR=0.32, p=0.002).

CONCLUSION: In this real-world study, the addition of bevacizumab to FTD/TPI was associated with improved survival outcomes in patients with metastatic colorectal cancer, including those previously treated with bevacizumab. These findings support the clinical utility of FTD/TPI plus bevacizumab as an effective later-line treatment option. Further studies are warranted to clarify optimal treatment sequencing strategies.