Comparison Of The Efficacy And Safety Of Fruquintinib And Regorafenib In The Treatment Of Metastatic Colorectal Cancer: A Real-world Study

Objective: To evaluate the efficacy and safety of fruquintinib and regorafenib in the real world for metastatic colorectal cancer(m CRC),and analyze the appropriate sequence of use and the difference in efficacy in efficacy of combined with immunocheckpoint inhibitors.Methods: The clinical data of patients with m CRC who were treated with fruquintinib or regorafenib after the standard chemotherapy in Zhejiang Provincial People’s Hospital from October 2018 to November 2021 were collected and analyzed,and the efficacy and safety of fruquintinib and regorafenib were compared through Kaplan-Meier survival curve and chi-square test analysis,and the appropriate sequence of use,efficacy differences in combined immunotherapy,and dominant populations were explored.Results: A total of 105 patients were enrolled in this study.The objective response rate(ORR)and disease control rate(DCR)of fruquintinib group(n=55)and regorafenib group(n=50)were 6.1%,65.3%,and 2.0%,54.3%,respectively.There was no significant difference in overall survival(OS)and progression free survival(PFS)between the two groups(median OS: 14.2 vs12.0 months,P=0.057;median PFS: 4.4 vs 3.5 months,P=0.150).Combined immunotherapy showed a synergistic effect.The PFS and OS of fruquintinib combined with anti-PD-1 therapy were longer than those of fruquintinib monotherapy(median PFS: 5.9 vs 3.0 months,P=0.009;median OS: 17.5 vs 11.3 months,P=0.008).The median OS of patients treated with regorafenib combined with anti-PD-1 therapy was 14.8 months higher than that of regorafenib monotherapy(P=0.045).When combined with anti-PD-1 therapy,the PFS and OS of fruquintinib was significantly longer than regorafenib(median PFS: 5.9 vs3.8 months,P=0.018;median OS: 17.5 vs 14.8 months,P=0.044).In the treatment sequence,sequential fruquintinib treatment after the progression of regorafenib treatment significantly prolonged the overall survival time of patients compared to the opposite treatment sequence(15.0 months vs 8.3 months,P=0.019).The overall incidence of adverse reactions was 78.2% in the fruquintinib treatment group and88.0% in the regorafenib treatment group,respectively,with no statistically significant difference.However,the incidence of regorafenib hand-foot syndrome was significantly higher than that of fruquintinib(44.0% vs 21.8%),and fruquintinib was more prone to III-IV hypertension events(P=0.040),with no treatment-related deaths occurring in either group.Conclusion: Fruquintinib monotherapy showed better disease control rate and objective remission rate in the post-line therapy of metastasis colorectal cancer.Notably,the combination of PD-1 immunotherapy brought the additional effect,especially in the fruquintinib combined with anti-PD-1 therapy.The survival time of patients treated with sequential fruquintinib was significantly longer than those in the opposite treatment sequence group.Overall,the toxicity of fruquintinib and regorafenib is similar.