信迪利单抗联合呋喹替尼对结直肠癌肝转移的疗效及安全性

Efficacy and safety of sintilimab combined with fruquintinib in treatment of colorectal cancer liver metastasis

目的探讨信迪利单抗联合呋喹替尼对结直肠癌肝转移的疗效及安全性。方法将台州市中心医院2021年1月至2023年12月收治的90例结直肠癌肝转移患者,根据随机数字表法分为对照组(n=45)和联合组(n=45)。对照组予以呋喹替尼胶囊口服,联合组加用信迪利单抗静脉滴注,治疗12周后评价两组患者的临床疗效,比较两组治疗前后肿瘤标志物[癌胚抗原(CEA)、糖类抗原125(CA-125)、糖类抗原199(CA-199)水平],记录两组胃肠道不良反应、手足皮肤反应、高血压、天冬氨酸氨基转移酶(AST)升高、蛋白尿等不良反应发生情况。结果治疗12周后,联合组ORR(20.00%)与DCR(88.89%)均高于对照组ORR(4.44%)与DCR(68.89%)(χ^(2)=5.075,5.404,均P<0.05);治疗12周后,联合组CEA、CA-125、CA-199[分别为(19.44±2.18)μg·L^(-1)、(35.82±4.66)U·mL^(-1)、(31.23±4.15)kU·mL^(-1)]均低于对照组[分别为(23.68±2.89)μg·L^(-1)、(40.29±5.07)U·mL^(-1)、(36.49±4.54)kU·mL^(-1)](t=7.857,4.354,5.737,均P<0.05)。两组胃肠道不良反应、手足皮肤反应、高血压、AST升高、蛋白尿不良反应发生情况差异均无统计学意义(χ^(2)=0.257,0.476,0.800,0.104,0.304,均P>0.05)。结论对于结直肠癌肝转移患者,信迪利单抗与呋喹替尼联合应用疗效显著,可降低患者肿瘤标志物水平,且不会增加不良反应的发生,安全可控。

Objective To explore the efficacy and safety of sintilimab with fruquintinib in the treatment of colorectal cancer liver metastasis.Methods A total of 90 patients with colorectal cancer liver metastasis admitted to Taizhou Central Hospital from January 2021 to December 2023 were divided into the control group(n=45)and combination group(n=45)randomly.The patients in the control group were given oral fruquintinib capsules and those in the combination group were given intravenous infusion of sintilimab.After 12 weeks of treatment,the clinical efficacy of the two groups was evaluated,and the levels of carcinoembryonic antigen(CEA),carbohydrate antigen 125(CA-125),and carbohydrate antigen 199(CA-199)in the two groups before and after treatment were compared and recorded.Gastrointestinal adverse reactions,hand-foot skin reaction,hypertension,elevated aspartate aminotransferase(AST)and proteinuria were also recorded and compared between the two groups.Results After 12 weeks of treatment,the levels of ORR and DCR were significantly higher in the combination group than in the control(20.00%vs 4.44%,88.89%vs 68.89%,χ^(2)=5.075,5.404,both P<0.05).The levels of CEA,CA-125 and CA-199 were(19.44±2.18)μg·L^(-1),(35.82±4.66)U·mL^(-1) and(31.23±4.15)kU·mL^(-1) in the combination group,which were lower than those of(23.68±2.89)μg·L^(-1),(40.29±5.07)U·mL^(-1),(36.49±4.54)kU·mL^(-1) in the control(t=7.857,4.354,5.737,all P<0.05).There was no remarkable difference in the occurrence of adverse reactions between the two groups(χ^(2)=0.257,0.476,0.800,0.104,0.304,all P>0.05).Conclusion Sintilimab combined with fruquintinib has good efficacy in the treatment of patients with colorectal cancer liver metastasis because it can effectively reduce the level of tumor markers but does not increase the incidence of adverse reactions.Meanwhile,it is safe and controllable.