The efficacy and safety of third-line regorafenib versus fruquintinib in the treatment of metastatic colorectal cancer: A meta-analysis.

Abstract

171 Background: Colorectal cancer (CRC) is the second most common cause of cancer-related mortality after lung cancer. Third-line treatments for metastatic CRC (mCRC) consists of regorafenib, fruquintinib, trifluridine-tipiracil plus bevacizumab. This study aims to compare the safety and efficacy of regorafenib versus fruquintinib in the treatment of mCRC. Methods: We retrieved data from phase II/III and phase III clinical trials published between (2012-2021). A meta-analysis was conducted for the patients’ demographics, overall survival (OS), progression-free survival (PFS), and the incidence of adverse events (AEs). We reconstructed individual patient data (IPD) from Kaplan-Meier (KM) curves to allow for indirect comparisons between studies. This study strictly adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: Our study included studies with 1389 patients. Of these, 650 patients received regorafenib and 739 received fruquintinib as third line for mCRC. Analysis revealed a median OS of 7.04 months (95% CI: 6.09-8.29) in the regorafenib arm versus a median OS of 7.96 months (95% CI: 7.40-8.77), with a hazard ratio (HR) of 0.87 (95% CI: 0.76-1.01; p= 0.07) in the fruquintinib arm. On the other hand, median PFS for both regorafenib and fruquintinib arms were 2.11 months (95% CI: 1.92-2.88) and 3.70 months (95% CI: 3.67-3.78), respectively. HR 0.71 (95% CI: 0.62-0.82, p<0.001). Conclusions: The results of our study revealed PFS analyses has shown superior outcomes in the fruquintinib arm compared to regorafenib. These findings suggest that fruquintinib may offer a more favorable disease control profile. Further studies are needed to confirm these findings and to better define the optimal selection of therapy in this patient population.