程序性死亡受体1/程序性死亡配体1免疫抑制剂联合化疗治疗晚期转移性三阴性乳腺癌的疗效  

Efficacy of PD-1/PD-L1 Immunosuppressant Combined with Chemotherapy in the Treatment of Advanced Metastatic Triple Negative Breast Cancer

作　　者：钱钰婷 夏俊贤[2] 李梦君 Qian Yuting;Xia Junxian;Li Mengjun(Jinan University,Guangzhou Guangdong 510632,China;The Second Clinical Medical College of Jinan University,Shenzhen Guangdong 518020,China)

机构地区：[1]暨南大学,广东广州510632 [2]暨南大学第二临床医学院,广东深圳518020

出　　处：《医疗装备》2023年第14期160-164,共5页Medical Equipment

基　　金：深圳自然科学基金(JCYJ20170307095828424)。

摘　　要：目的 IMPassion 131试验的阴性结果表明免疫治疗在转移性三阴性乳腺癌(mTNBC)中的应用效果仍不明确。该研究旨在分析程序性死亡受体1(PD-1)/程序性死亡配体1(PD-L1)免疫抑制剂联合化疗对mTNBC的疗效及安全性。方法 通过检索PubMed、Embase和The Cochrane Library数据库,筛选出2022年3月前发表PD-1/PD-L1免疫抑制剂联合化疗治疗m TNBC的随机对照临床试验(RCT),主要研究结果包括无进展生存期(PFS)、客观缓解率(ORR)、总生存(OS)和安全性。应用Review Manager version5.4进行统计分析。结果 共纳入3项Ⅲ期RCT进行荟萃分析,纳入2 400例晚期mTNBC患者。在意向性人群(ITT)中,免疫联合化疗组较单纯化疗组显著延长PFS{风险比(HR):0.82[0.74,0.90],P<0.0001}和提高ORR{优势比(OR):1.38[1.16,1.63],P=0.0002}。在PD-L1(+)的亚组中同样可以观察到免疫联合化疗组较单纯化疗组延长PFS{HR:0.73[0.64,0.85],P<0.0001}和提高ORR{OR:1.58[1.25,1.99],P=0.0001}。免疫联合化疗组较单纯化疗组没有提高OS{ITT:HR:0.97[0.75,1.25],P=0.80;PD-L1+:HR:0.87[0.56,1.34],P=0.53}。免疫联合化疗组更容易发生3级不良反应{OR:1.32[1.11,1.57],P=0.002}和严重不良事件{OR:1.40[1.08,1.80],P=0.01}。免疫治疗相关不良事件是导致毒性激增的主要因素{OR:2.35[1.26,4.36],P=0.007}。结论 免疫联合化疗延长了mTNBC患者的PFS,并提高了mTNBC患者的ORR,且毒性可控,总体生存优势尚未确立。Objective The negative results of the IMPassion 131 test indicated that the efficacy of immunotherapy in metastatic triple negative breast cancer(mTNBC)was still unclear.The purpose of this study was to analyze the efficacy and safety of programmed cell death protein 1(PD-1)/programmed cell death 1 ligand 1(PD-L1)immunosuppressant combined with chemotherapy on mTNBC.Methods By searching PubMed,Embase and the Cochrane Library databases,the randomized controlled clinical trials(RCT)of PD-1/PDL1 immunosuppressant combined with chemotherapy for mTNBC were screened,and the main research findings included progression free survival(PFS),objective response rate(ORR),overall survival(OS)and safety,with application of Review Manager version 5.4 for statistical analysis.Results A total of 3 Phase III RCTs were included for meta-analysis,including 2400 patients with advanced mTNBC.In the intention-to-treat population(ITT),compared with the simple chemotherapy group,PFS was significantly prolonged{hazard ratio(HR):0.82[0.74,0.90],P<0.001},and ORR was increased{odds ratio(OR):1.38[1.16,1.63],P=0.0002}in the immunochemotherapy group.In the subgroup of PD-L1(+),it was also observed that in the immunochemotherapy group,PFS was prolonged{HR:0.73[0.64,0.85],P<0.001}and ORR was increased{OR:1.58[1.25,1.99],P=0.0001},compared with the simple chemotherapy group.The immunochemotherapy group showed no improvement in OS compared to the simple chemotherapy group{ITT:HR:0.97[0.75,1.25],P=0.80;PD-L1+:HR:0.87[0.56,1.34],P=0.53}.Grade 3 adverse reactions{OR:1.32[1.11,1.57],P=0.002}and Serious adverse event{OR:1.40[1.08,1.80],P=0.01}were more likely to occur in the immunochemotherapy group.Immunotherapy related adverse events are the main factor leading to a surge in toxicity{OR:2.35[1.26,4.36],P=0.007}.Conclusion Immunotherapy combined with chemotherapy prolonged the PFS and increased the ORR of mTNBC patients,with the controllable toxicity.Overall survival advantage is yet to be established.

关 键 词：程序性死亡受体1/程序性死亡配体1 免疫抑制剂 化疗 乳腺癌 无进展生存期 不良事件 

分 类 号：R737.9[医药卫生—肿瘤]