Efficacy and Safety of Trifluridine/Tipiracil in Patients with Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis
Background: Trifluridine/tipiracil (TAS-102) is an oral cytotoxic agent approved for metastatic colorectal cancer (mCRC) after failure of standard therapies. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of TAS-102 in patients with mCRC. Methods: We searched PubMed, Embase, and Cochrane Library for randomized controlled trials (RCTs) and observational studies comparing TAS-102 with placebo or other treatments. The primary outcomes were overall survival (OS) and progression-free survival (PFS). Secondary outcomes included objective response rate (ORR), disease control rate (DCR), and adverse events. Results: A total of 5 RCTs and 4 observational studies involving 2,345 patients were included. TAS-102 significantly improved OS (HR 0.68, 95% CI 0.61-0.76) and PFS (HR 0.48, 95% CI 0.42-0.55) compared with placebo. The ORR was 1.6% and DCR was 44.0%. Common grade 3/4 adverse events included neutropenia (38.2%), leukopenia (23.5%), and anemia (18.7%). Conclusion: TAS-102 is an effective and tolerable treatment option for patients with mCRC who have progressed after standard therapies. Further research is needed to identify biomarkers for patient selection and combination strategies.