Real-world Outcomes of Trifluridine/Tipiracil With or Without Bevacizumab in Metastatic Colorectal Cancer: A Retrospective Cohort Study
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 101 participants or records.
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