中国药物评价2025，Vol.42Issue(1)：61-67,7.
PD-1/PD-L1抑制剂联合化疗治疗晚期乳腺癌疗效的Meta分析
Meta Analysis of The Efficacy of Pd-1/Pd-L1 Inhibitor Combined with Chemotherapy In The Treatment of Advanced Breast Cancer
摘要
Abstract
Objective:Meta analysis method was used to evaluate the efficacy and safety of PD-1/PD-L1 inhibitor combined chemotherapy and chemotherapy alone for advanced breast cancer,providing theoretical basis for clinical diagnosis and treatment.Methods:The Pubmed,Embase,and Cochrane libraries were searched for the literature on PD-1/PDL1 inhibitors combined with chemo-therapy for advanced breast cancer from the establishment of the database to March 2024.After the two researchers independently screened the literature,extracted the data,and evaluated the risk of bias,the RevMan5.3 software was used for statistical analysis.Results:A total of 7 articles were included in this study.The summary results showed that the Overall Survival,Progression-free Survival and Overall Remission Rate of the ITT population in the combination therapy group were significantly better than those of patients receiving chemother-apy alone(OS:HR=0.90,95％CI 0.82-0.99,P＜0.05.PFS:HR=0.80,95％CI 0.74-0.87,P＜0.001;ORR:HR=1.17,95％CI 1.07-1.29,P＜0.001).Subgroup analysis further showed that immunotherapy had no significant effect on PFS in the PD-L1 positive population,and there was no significant difference between the results(HR=0.67,95％CI 0.27-1.63,P=0.37).Immuno-therapy significantly prolonged OS in the PD-L1 positive population(HR=1.36,95％CI 1.01-1.85,P=0.004).This suggests that the incidence of adverse reactions at any level in the combination group was significantly higher than that in the control group(RR=1.12,95％CI 1.02-1.22,P=0.02),and the incidence of adverse reactions ≥ grade 3 in the combination group was significantly higher than that in the control group(RR=1.12,95％CI 1.01-1.85),Z=3.64,P=0.000 3＜0.05).The incidence of hypothyroidism,hyper-thyroidism(RR,3.78;95％CI,2.85-5.02,P＜0.000 01),cough(RR,1.28;95％CI,2.51-12.99,P=0.000 2),and cough(RR,1.28;95％CI,1.07-1.53,P=0.006)in the combined treatment group were significantly increased(RR,3.78;95％CI,2.85-5.02,P＜0.000 01).Conclusion:PD-1/PD-L1 inhibitor combined with chemotherapy is more effective than chemotherapy alone in the treatment of advanced breast cancer,but the combined treatment has a higher incidence of adverse reactions.关键词
免疫治疗/PD-1/PD-L1/化疗/晚期乳腺癌/Meta分析Key words
Immunotherapy/PD-1/PD-L1/Chemotherapy/Advanced breast cancer/Meta analysis分类
医药卫生引用本文复制引用
张雪莲,王冠杰,孙清海,王振华,谭帅..PD-1/PD-L1抑制剂联合化疗治疗晚期乳腺癌疗效的Meta分析[J].中国药物评价,2025,42(1):61-67,7.基金项目
院内课题项目:基于Meta分析探讨PD-1/PD-L1抑制剂治疗晚期乳腺癌的有效性和安全性研究(2022WHCM015) （2022WHCM015）
