摘要
目的观察贝伐珠单抗联合伊立替康与雷替曲塞方案在氟尿嘧啶类药物耐药后的晚期结直肠癌患者中的疗效及安全性。方法收集中国医科大学附属第一医院2014—2019年收治的氟尿嘧啶类耐药的60例晚期结直肠癌患者,对照组30例,应用伊立替康联合雷替曲塞方案(IR);实验组30例,应用IR联合贝伐珠单抗方案。分析比较两组患者的客观有效率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS)及不良反应发生情况。结果实验组和对照组ORR分别为6.67%和3.33%,DCR分别为66.67%和53.33%,两组ORR和DCR比较差异无统计学意义。实验组和对照组中位PFS分别为6.0个月和3.1个月,差异有统计学意义(P=0.0204)。两组不良反应以Ⅰ/Ⅱ级多见,Ⅲ/Ⅳ级不良反应发生率低,实验组蛋白尿的发生率高于对照组,差异有统计学意义(P=0.001)。其余如出血、转氨酶升高、恶心、呕吐、腹泻、发热、皮疹、高血压等不良反应发生率均为实验组高于对照组,但差异无统计学意义。结论贝伐珠单抗联合伊立替康与雷替曲塞方案可提高既往氟尿嘧啶类治疗耐药后的晚期结直肠癌患者的疗效,无进展生存期增加,不良反应可耐受,值得进一步研究。
Objective To compare the efficacy and safety of the combination of irinotecan/raltitrexed with bevacizumab in patients with fluorouracil-refractory advanced colorectal cancer.Methods A total of 60 patients with colorectal cancer who failed treatment of fluorouracil chemotherapy and admitted to the First Affiliated Hospital of China Medical University from 2014 to 2019 were selected for further study.30 patients in control group received IR regimen and 30 patients in experimental group received bevacizumab and IR regimen.Objective response rate(ORR),disease control rate(DCR),progress free surviral(PFS)and adverse reactions between the two groups were evaluated.Results The results demonstrated that the ORR of experimental and control group were 6.7%and 3.3%respectively,DCR of the two groups were 66.7%and 53.33%respectively.There was no significant difference in ORR and DCR between experimental and control group.The median PFS of the two groups were 6.0 months and 3.1 months respectively(P=0.0204),and the difference was statistically significant.Most of the adverse reactions were gradeⅠ/Ⅱ.The incidence of gradeⅢ/Ⅳadverse reactions was low.The incidence of proteinuria in the experimental group was higher than that in the control group,and the difference was statistically significant(P=0.001).The adverse reactions of bleeding,transaminase elevation(ALT and AST),nausea,vomiting,diarrhea,fever,rash and hypertension were higher in the experimental group with no statistically significant difference.Conclusion The combination of bevacizumab with irinotecan/raltitrexed has certain curative effect in patients with advanced colorectal cancer after treatment failure of fluorouracil.The PFS was increased and the adverse reactions were tolerated,which is worthy of further clinical study.
作者
易涵
古再丽努尔·如则托合提
姜明燕
王佳妮
YI Han;RUZETUOHETI Guzailinuer;JIANG Mingyan;WANG Jiani(Department of Pharmacy,The First Hospital of China Medical University,Shenyang 110001,China;School of Pharmaceutical Science,China Medical University,Shenyang 110122,China;Shenyang Pharmaceutical University,Shenyang 110016,China;Department of Gastroenterology,the First Hospital of China Medical University,Shenyang 10001,China)
出处
《药物评价研究》
CAS
2020年第2期293-298,共6页
Drug Evaluation Research
