Abstract
BACKGROUND: Previous meta-analyses have shown TAS-102's potential in metastatic colorectal cancer (mCRC). Thus, we conducted a meta-analysis to investigate the efficacy and safety of TAS-102 combined with bevacizumab versus TAS-102 monotherapy in the treatment of mCRC. METHODS: A thorough search in four databases was conducted from inception to August, 2024. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were incorporated to explore the efficacy. Subgroup analysis and sensitivity analysis were then carried out to determine the sources of heterogeneity. Funnel plots and Egger's test were employed to assess publication bias. RESULTS: A total of 9 studies with 1,509 participants were included after screening. Compared with monotherapy, TAS-102 plus bevacizumab demonstrated encouraging outcomes both in OS (hazard ratio [HR] = 0.52, 95% confidence interval [CI] = 0.39-0.70, p < 0.001) and PFS (HR = 0.49, 95% CI = 0.39-0.62, p < 0.001). And ORR (relative ratio [RR] = 3.28, 95% CI = 1.67-6.32, p < 0.001) and DCR (RR = 1.58, 95% CI = 1.26-1.97, p < 0.001) both favored the combination group. In terms of hematological toxicity, combination group had an increased incidence of neutropenia (all grade RR = 1.51, 95% CI = 1.00-1.32; grade ≥ 3 RR = 1.38, 95% CI = 1.21-1.58) and thrombocytopenia (all grade RR = 1.44, 95% CI = 1.06-1.94). CONCLUSIONS: TAS-102 plus bevacizumab showed superior efficacy and acceptable safety over monotherapy, particularly in RAS-mutant patients, prior bevacizumab use, multiple metastases, and poorer performance status.