卡瑞利珠单抗联合白蛋白紫杉醇二线治疗晚期胃癌的疗效及安全性

目的:评估卡瑞利珠单抗联合白蛋白紫杉醇(以下简称白紫)对比阿帕替尼联合白紫二线治疗晚期胃癌的疗效与不良反应，进一步探讨胃癌后线免疫治疗的获益人群。方法:随机选择2019年06月至2021年05月我院局部进展/远处转移胃癌一线应用L-OHP+卡培他滨/替吉奥，或者FOLFOX方案治疗进展后的112例患者分为两组，研究组55例予卡瑞利珠单抗联合白紫，对照组57例予白紫联合阿帕替尼二线治疗，观察客观缓解率(objective response rate, ORR)、疾病控制率(disease control rate, DCR)、无进展生存期(progression-free survival, PFS)、生存时间(overall survival, OS)和不良反应。采用Kaplan-Meier及COX回归分析进行生存分析。结果:平均随访12.8个月，研究组和对照组的ORR为45.5%、26.3%,DCR为76.4%、57.9%(P<0.05);mPFS为5.6个月、4.4个月(P<0.05),mOS为13.1个月、11.6个月(P<0.05)。ECOG PS评分=0、E...

Efficacy and safety of camrelizumab combined with albumin paclitaxel in second-line treatment of advanced gastric cancer

Objective:To evaluate the efficacy and adverse effects of camrelizumab combined with albumin bound paclitaxel(abraxane) of second-line treatment for advanced gastric cancer,and further explore the benefit population.Methods:Patients with locally advanced/distant metastatic gastric cancer in our hospital from June 2019 to May 2021，and progression of first-line chemotherapy were treated with L-OHP+capecitabine/S-1.All 112 patients was randomly divided into two groups,study group of 55 cases(camrelizumab combined abraxane),control group 57 cases(abraxane combined apatinib).Efficacy was evaluated using the RECIST criteria and(NCI-CTCAE) 4.0 criteria and adverse reactions,respectively.Survival analysis was performed using the Kaplan-Meier and COX regression analysis.Results:ORR(objective response rate) were 45.5% and 26.3%,DCR(disease control rate） were 76.4% and 57.9%(P＜0.05),mPFS(median progression-free survival) were 5.6 and 4.4 months(P＜0.05),mOS(median overall survival) were 13.1 and 11.6 months(P＜0.05) in the study and control groups.ECOG=0，EBV positive,PD-L1 CPS ≥5，were more significant and statistically significant in study group(P＜0.05).In terms of safety,the main grade 2 adverse reactions were leukocytopia,digestive tract reaction,RCCEP,hypertension,immune adverse reactions,no fatal AE.Conclusion:Second-line treatment of camrelizumab and abraxane can significantly prolong PFS and OS，and toxic response can be in control.It is also excellent for patients after second-line therapy.