晚期肾癌系统性治疗不良反应评估:200例临床分析  

Evaluation of adverse reactions of systemic therapy for advanced renal cell carcinoma: clinical analysis of 200 cases

作　　者：胡青岳 侯乃侨 李宇轩 翟栓峰 曹登峰 郑军华 翟炜 HU Qingyue;HOU Naiqiao;LI Yuxuan;ZHAI Shuanfeng;CAO Dengfeng;ZHENG Junhua;ZHAI Wei(Department of Urology,Renji Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,200127,China;Department of Pathology,Renji Hospital,Shanghai Jiao Tong University School of Medicine)

机构地区：[1]上海交通大学医学院附属仁济医院泌尿科,上海200127 [2]上海交通大学医学院附属仁济医院病理科

出　　处：《临床泌尿外科杂志》2024年第11期974-980,共7页Journal of Clinical Urology

基　　金：上海市2023年度“科技创新行动计划”医学创新研究专项项目(No:23Y21900400);促进市级医院临床技能与临床创新三年行动计划(2023-2025年)临床研究数据共享和模拟RCT项目(No:SHDC2024CRI042)。

摘　　要：目的:评估晚期肾癌系统性治疗不良反应发生情况及其与疗效的相关性。方法:回顾性分析2018年6月—2023年12月于上海交通大学医学院附属仁济医院一线接受靶向或靶向联合免疫治疗的200例晚期肾癌患者临床资料。分析不良事件的种类及发生率差异。分析≥3级治疗相关不良事件与客观缓解率(objective response rate, ORR)及无进展生存期(progression free survival, PFS)的相关性。结果:200例患者中,靶向治疗组一线治疗总体不良反应发生率为99.21%,靶免联合治疗组为100%。靶向治疗组≥3级不良反应发生率为61.64%,靶免联合治疗组为65.35%。靶向治疗组因不良反应停药发生率为17.32%,靶免联合治疗组为20.55%。一线治疗常见不良反应有蛋白尿、贫血、肌酐升高、高血压、腹泻、肝功能异常、血小板减少、甲状腺功能减退、高脂血症和手足综合征。≥3级不良反应主要为高血压、肝功能异常、蛋白尿和贫血。常见血液学不良反应有贫血、血小板减少、白细胞减少、中性粒细胞减少及淋巴细胞减少。2组治疗方案中出现≥3级不良反应都与更好的ORR及PFS获益相关(P<0.05)。结论:靶向治疗和靶免联合治疗在中国晚期肾癌患者中安全性可控且相似,用药期间应加强不良事件的随访和管理,发生较严重不良反应与更好的治疗预后相关。Objective To evaluate the occurrence of adverse reactions of systemic therapy for advanced renal cell carcinoma and their correlation with efficacy.Methods Clinical data of 200 patients with advanced renal cell carcinoma who received targeted or targeted immunotherapy in the first line in Renji Hospital, Shanghai Jiao Tong University School of Medicine from June 2018 to December 2023 were retrospectively analyzed. Treatment-related adverse events and grade ≥3 adverse events were analyzed. The correlation between grade≥3 treatment-related adverse events and objective response rate(ORR) and progression-free survival(PFS) was analyzed.Results The overall adverse reaction rate of first-line treatment in 200 patients was 99.21% in the targeted therapy group and 100% in the targeted immunotherapy group. The incidence of grade ≥3 adverse reactions was 61.64% in the targeted therapy group and 65.35% in the targeted immunotherapy group. The incidence of discontinuation due to adverse reactions was 17.32% in the targeted therapy group and 20.55% in the targeted immunotherapy group. The common adverse reactions of first-line treatment were proteinuria, anemia, blood creatinine elevation, hypertension, diarrhea, abnormal hepatic function, platelet count decline, hypothyroidism, hyperlipidemia, and hand-foot syndrome. Grade ≥3 adverse reactions were primarily hypertension, abnormal hepatic function, proteinuria, and anemia. Common hematologic adverse reactions were anemia, platelet count decline, leukopenia, neutropenia, and lymphopenia. The presence of grade ≥3 adverse reactions was associated with better ORR and PFS benefit in both treatment groups (P < 0.05).Conclusion Targeted therapy and targeted immunotherapy have controllable and similar safety profiles in Chinese patients with advanced renal cell carcinoma. The follow-up and management of adverse events should be strengthened during the medication, and the occurrence of serious adverse reactions is associated with a better therapeutic prognosis.

关 键 词：晚期肾细胞癌 靶向治疗 免疫治疗 不良反应 

分 类 号：R737.11[医药卫生—肿瘤]