Evaluation of fruquintinib’s efficacy and safety in refractory metastatic colorectal cancer: a systematic review and meta-analysis of phase II and III randomized controlled trials

Metastatic colorectal cancer (mCRC) remains a significant cause of mortality despite advancements in treatments. Fruquintinib, a potent VEGFR inhibitor, has shown promise as an advanced therapy for mCRC. This review evaluates the efficacy and safety of fruquintinib compared to placebo in patients with refractory mCRC, focusing on Phase II and III trials.

This study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. A literature search was performed using PubMed, EBSCOHost, ProQuest, and Google Scholar. The analysis of overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety was pooled using hazard ratios (HR) and risk ratios (RR) in RevMan 5.4 software.

Three RCTs comprising 1,178 patients were included. Fruquintinib significantly improved OS (HR: 0.66; 95% CI 0.57–0.76) and PFS (HR: 0.30; 95% CI 0.26–0.35) compared to placebo. ORR (RR: 5.91; 95% CI 1.09–32.16) and DCR (RR: 3.83; 95% CI 3.00–4.90) were also higher with fruquintinib. Grade 3 or higher adverse events were more frequent with fruquintinib (RR: 1.31; 95% CI 1.02–1.70). No significant difference was observed in serious adverse events or treatment-related deaths.

Fruquintinib significantly improves survival and tumor response in patients with refractory mCRC. While associated with an increased risk of high-grade adverse events, fruquintinib remains a viable and relatively safe treatment option for mCRC patients. Further studies are needed to confirm its efficacy and safety across diverse populations.