呋喹替尼联合信迪利单抗治疗晚期微卫星稳定型结直肠癌疗效观察

Efficacy and Safety of Fruquintinib Combined with Sintilimab in Treatment of Advanced Microsatellite Stable Colorectal Cancer

目的观察呋喹替尼联合信迪利单抗治疗晚期微卫星稳定型结直肠癌的临床治疗效果及安全性。方法收集44例晚期微卫星稳定型结直肠癌患者,根据治疗方法分为呋喹替尼单药组(n=22)和呋喹替尼联合信迪利单抗组(n=22)。治疗方案:呋喹替尼单药组口服呋喹替尼5 mg,每日1次,服用3周停药1周,每28天为1周期;呋喹替尼联合信迪利单抗组静脉滴注信迪利单抗200 mg,每3周1次、呋喹替尼方案同单药组,并分析临床效果及不良反应。结果呋喹替尼单药组患者客观缓解率(ORR)为9.09%,疾病控制率(DCR)为45.45%;呋喹替尼联合信迪利单抗组患者ORR为18.18%,DCR为63.64%;呋喹替尼单药组中位无进展生存期(mPFS)为4.4(2.1,8.2)个月,呋喹替尼联合信迪利单抗组患者中位PFS为6.7(3.9,12.6)个月,两组差异有统计学意义(χ2=4.372,P=0.037)。两组患者治疗过程中的不良反应多为1~2级,且差异均无统计学意义(P>0.05)。结论呋喹替尼联合信迪利单抗较呋喹替尼单药治疗可给经标准治疗失败后的晚期微卫星稳定型结直肠癌患者带来更好的临床获益,且安全性良好。

Objective To investigate the clinical efficacy and safety of fruquintinib combined with sintilimab in the treatment of advanced microsatellite stable(MSS)colorectal cancer.Methods A retrospective study of 44 patients with MSS colorectal cancer treated with fruquintinib and sintilimab was conducted.The patients were divided into the fruquintinib alone(n=22)and fruquintinib combined with sintilimab(n=22)groups.The treatment regimen was as follows:The patients in the fruquintinib alone group consumed oral fruquintinib capsules at 5 mg/d once for three consecutive weeks with a one week stop in 28 day cycles.The patients in the fruquintinib combined sintilimab group were injected intravenously with sintilimab(200 mg)once per three weeks,and fruquintinib was used in the same manner as the fruquintinib alone group.Results The objective response rate(ORR)of the fruquintinib alone group was 9.09%,the disease control rate(DCR)of the fruquintinib alone group was 45.45%.The ORR of the fruquintinib combined with sintilimab group was 18.18%,and the DCR was 63.64%.The median PFS of the fruquintinib alone and fruquintinib combined with sintilimab groups were 4.4 months(IQR:2.1-8.2)and 6.7 months(IQR:3.9-12.6),respectively(χ2=4.372,P=0.037).Most of the adverse reactions during the treatment of the two groups were grades 1-2.In addition,no significant difference in the incidence of adverse reactions was found between two groups(P>0.05).Conclusion Compared with fruquintinib alone,fruquintinib combined with sintilimab in the treatment of patients with MSS colorectal cancer after the failure of standard treatment has better clinical efficacy,and adverse drug reactions can be controlled.