Abstract
OBJECTIVES: To evaluate fruquintinib's efficacy and safety in the treatment of colorectal cancer. METHODS: Studies assessing fruquintinib for colorectal cancer were included. Outcomes were overall survival (OS) and progression-free survival (PFS), and adverse reactions. A random-effects model was employed, and sensitivity analysis assessed the stability of the results and potential heterogeneity. Review Manager 5.4 and STATA 15.0 were used for analysis. RESULTS: Eleven studies with 2,367 patients were included. Fruquintinib significantly improved OS (HR: 0.69; 95% CI: 0.58, 0.81; P < 0.00001) and PFS (HR: 0.44; 95% CI: 0.30, 0.64; P < 0.0001). No significant increase in adverse events, serious adverse events, fatigue, or hypertension. However, sensitivity analysis suggested that the risk of hypertension might be unstable, requiring further validation. CONCLUSION: Fruquintinib improves OS and PFS in colorectal cancer patients without elevating the risk of overall or serious adverse events; however, its potential impact on hypertension risk requires further investigation. Due to limitations such as small sample size, missing data, and regional bias, larger, multicenter, double-blind RCTs are needed to validate these findings. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/, CRD420251002004.