Safety of fruquintinib mono- and combo therapy in metastatic colorectal cancer: real-world subgroup analysis from China

BACKGROUND: Fruquintinib, a highly selective vascular endothelial growth factor receptor 1, 2, 3 inhibitors, has demonstrated significant efficacy in phase III trials for metastatic colorectal cancer (mCRC). However, real-world evidence is essential to confirm its safety profile across diverse treatment settings. AIM: This subgroup analysis of a phase IV study aims to evaluate the safety of fruquintinib both as monotherapy and combination therapy in a real-world setting. METHODS: Phase IV-study data were categorized by treatment regimen into fruquintinib monotherapy and combination therapy groups. Safety profiles including TEAEs and TRAEs were recorded. RESULTS: = 77), with overlap between combination groups. Drug exposure was the shortest with monotherapy (2.50 months) and longest with fruquintinib + ICI + chemotherapy (4.70 months). Monotherapy subgroup reported the lowest incidence of TEAEs (74.47%) and grade ≥3 TEAEs (23.94%), while the fruquintinib + chemotherapy subgroup reported the highest incidence (85.52%). CONCLUSION: Fruquintinib combination therapy demonstrated a satisfactory safety profile within the treatment groups.