PD-1/PD-L1抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性研究OA
Efficacy and safety of PD-1/PD-L1 inhibitors combined with chemotherapy in the treatment of advanced biliary malignancies in the first line of chemotherapy
目的:探索程序性细胞死亡蛋白-1/其配体-1(programmed cell death protein-1/its ligand-1,PD-1/PD-L1)抑制剂联合化疗一线治疗晚期胆道恶性肿瘤的疗效及安全性.方法:回顾性收集2020年 8月至 2022年 8月安徽医科大学第一附属医院收治的 33例经组织病理学确诊的晚期胆道恶性肿瘤患者,根据一线治疗中是否应用PD-1/PD-L1抑制剂分为常规化疗组和联合免疫治疗组,每 2周期进行疗效评价,每周期评价安全性,主要研究终点为无进展生存期(progression-free survival,PFS),次要终点为治疗的安全性.结果:33例患者无完全缓解(complete response,CR)病例,常规化疗组 16例患者,其中部分缓解(partial response,PR)3例、疾病稳定(stable disease,SD)6例、疾病进展(progressive dis-ease,PD)7例,客观有效率(objective response rate,ORR)为 18.8%,疾病控制率(disease con-trol rate,DCR)为 56.2%.中位 PFS为 13.1周.联合免疫治疗组 17例患者,其中 PR8例、SD 5例、PD4例,ORR为 47.1%,DCR为 76.5%,中位PFS为 21.9周,优于常规化疗组,且差异具有统计学意义.两组不良反应多为 1-2级,可耐受,差异均无统计学意义.结论:PD-1/PD-L1抑制剂联合化疗和/或抗血管药物治疗晚期胆道恶性肿瘤疗效确切,安全性良好,PD-1/PD-L1抑制剂联合化疗治疗晚期胆道恶性肿瘤的治疗模式值得临床进一步探索.
AIM:To explore the efficacy and safe-ty of programmed cell death protein-1/its ligand-1(PD-1/PD-L1)inhibitors combined with chemothera-py in the treatment of advanced biliary malignan-cies in the first line of chemotherapy.METHODS:A retrospective collection of 33 patients with ad-vanced biliary malignant tumors confirmed by histopathology in the First Affiliated Hospital of An-hui Medical University from August 2020 to August 2022 were retrospectively collected,and they were divided into chemotherapy group and chemothera-py combined with PD-1/PD-L1 inhibitor group,and the efficacy was evaluated every 2 treatment cycles,and the safety was evaluated every cycle.The first outcome is PFS and the secondary endpoint is the safety of treatment.RESULTS:Among 16 patients in the chemotherapy group,there were 3 PR cases,6 SD cases and 7 PD cases,with an ORR rate of 18.8%and a DCR rate of 56.2%.The median PFS was 13.1 weeks.Among 17 patients in the immunotherapy group,there were 8 PR cases,5 SD cases and 4 PD cases.The ORR rate was 47.1%,the DCR rate was 76.5%,and the median PFS was 21.9 weeks,which was better than the chemotherapy alone.Most of the adverse effects in the two groups were 1-2 grade tolerable,and the difference was not statisti-cally significant.CONCLUSION:PD-1/PD-L1 in-hibitors combined with chemotherapy and/or anti-vascular drugs for advanced biliary malignancies have a definite efficacy and is safety,and the treat-ment with PD-1/PD-L1 inhibitors combined with chemotherapy for advanced biliary malignancies deserves further clinical exploration.
王荣;周昳欣;薛璟;郝吉庆;黄帆;邢江浩
安徽医科大学第一附属医院肿瘤内科,合肥 230022,安徽安徽医科大学第一附属医院肿瘤内科,合肥 230022,安徽安徽医科大学第一附属医院肿瘤内科,合肥 230022,安徽安徽医科大学第一附属医院肿瘤内科,合肥 230022,安徽安徽医科大学第一附属医院肝胆外科,合肥 230022,安徽安徽医科大学第一附属医院肿瘤内科,合肥 230022,安徽
医药卫生
晚期胆道恶性肿瘤免疫检查点抑制剂化疗PD-1/PD-L1
advanced biliary malignanciesIm-mune checkpoint inhibitorschemotherapyPD-1/PD-L1
《中国临床药理学与治疗学》 2026 (8)
1076-1084,9
白求恩·精医求精-晚期实体瘤科研项目(STLKY2-140)2022年安徽省临床医学研究转化专项项目(202204295107020016)
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