转移性肾细胞癌免疫治疗多中心真实世界研究  

A multicenter retrospective study of immunotherapy for metastatic renal cell carcinoma

作　　者：麦海星[1] 张瑜[1] 马鑫[1] 顾良友 陈志强 董文[2] 管维[3] 翟炜 王龙 薛蔚[4] 陈立军[1] 王少刚 黄健[2] 张旭[1] Mai Haixing;Zhang Yu;Ma Xin;Gu Liangyou;Chen Zhiqiang;Dong Wen;Guan Wei;Zhai Wei;Wang Long;Xue Wei;Chen Lijun;Wang Shaogang;Huang Jian;Zhang Xu(Senior Department of Urology,the Third Medical Center,PLA General Hospital,Beijing 100039,China;Department of Urology,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,China;Department of Urology,Tongji Hospital,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Urology,Renji Hospital,Shanghai Jiaotong University,Shanghai 200127,China;Department of Urology,Xiangya Third Hospital,Central South University,Changsha 410013,China)

机构地区：[1]解放军总医院第三医学中心泌尿外科医学部,北京100039 [2]中山大学孙逸仙纪念医院泌尿外科,广州510120 [3]华中科技大学同济医学院附属同济医院泌尿外科,武汉430030 [4]上海交通大学医学院附属仁济医院泌尿外科,上海200127 [5]中南大学湘雅三医院泌尿外科,长沙410013

出　　处：《中华泌尿外科杂志》2022年第5期368-373,共6页Chinese Journal of Urology

基　　金：国家自然科学基金面上项目(81872090,82173259)。

摘　　要：目的评估国内应用程序性细胞死亡蛋白1(PD-1)单抗治疗晚期转移性肾细胞癌(mRCC)的疗效和不良反应。方法回顾性分析2016年10月至2022年2月解放军总医院第三医学中心、解放军总医院第五医学中心、华中科技大学同济医学院附属同济医院、中南大学湘雅三医院、上海交通大学医学院附属仁济医院、中山大学孙逸仙纪念医院共117例应用PD-1单抗治疗的晚期mRCC患者的临床资料。男87例(74.4%),女30例(25.6%);年龄(57.9±10.9)岁,体质指数(23.6±3.4)kg/m^(2);有吸烟史79例(67.5%),高血压病44例(37.6%),糖尿病19例(16.2%)。美国东部肿瘤协作组(ECOG)评分0分70例(59.8%),1分39例(33.3%),2分5例(4.3%),3分3例(2.5%)。101例(86%)既往行肾切除术。病理类型为肾透明细胞癌104例(88.9%),乳头状肾细胞癌8例(6.8%),嫌色细胞癌2例(0.9%),集合管癌2例(0.9%),嗜酸细胞癌1例(0.08%)。患者诊断为mRCC后行PD-1单抗单药或联合靶向药物治疗。分析总体人群和相关亚组的总生存时间(OS)、无进展生存时间(PFS)、客观缓解率(ORR)、治疗相关不良事件(trAE)等。结果117例中40例(34.2%)行PD-1单抗单药治疗,其中信迪利单抗15例,卡瑞丽珠单抗13例,替雷利珠单抗8例,特瑞普利单抗4例。77例(65.8%)选择靶向药物联合PD-1单抗治疗,其中应用阿昔替尼63例,舒尼替尼14例;PD-1单抗为替雷利珠单抗29例,信迪利单抗20例,特瑞普利单抗13例,卡瑞丽珠单抗10例,帕博丽珠单抗5例。初始治疗后23例因疾病进展更换药物,其中PD-1单抗单药治疗者中8例换为另一种PD-1单抗治疗;PD-1单抗联合靶向药物治疗者中15例更换PD-1单抗或靶向药物类型。总体人群的中位OS为35.6(19~60)个月,PFS为12.1(1~60)个月;5例完全缓解,51例部分缓解,20例疾病稳定,总体ORR为47.8%(56/117)。单药PD-1单抗初始治疗的中位PFS为10.5(1~60)个月,初始靶向药物联合PD-1单抗治疗的中位PFS为12.6(1~30)个月。更换治疗方�Objective To evaluate the efficacy and side effects of PD-1 monoclonal antibody in the treatment of advanced metastatic renal cell carcinoma in China.Methods The clinical data of 117 patients with advanced metastatic renal cell carcinoma(mRCC)treated with PD-1 monoclonal antibody from October 2016 to February 2022 were retrospectively analyzed.There were 87 males(74.4%)and 30 females(25.6%),with an average age of(57.9±10.9)years old,BMI of(23.6±3.4)kg/m^(2)and smoking history of 79(67.5%).There were 44 cases(37.6%)with hypertension,19(16.2%)cases of diabetes.The ECOG score of 59.8%(70/117)patients was 0,33.3%(39/117)was 1,4.3%(5/117)was 2,and 2.5%(3/117)was 3.The pathological type of 104 cases were renal clear cell carcinoma(ccRCC),8 cases of papillary renal cell carcinoma,2 cases of chromophobe cell carcinoma,2 cases of collecting duct carcinoma and 1 case of eosinophilic cell carcinoma.The general condition of the overall population and the overall survival(OS)of relevant subgroups were analyzed.Secondary goals included progression free survival(PFS),objective response rate(ORR),adverse reactions,overall survival(OS),and progression free survival(PFS).Results 65.8%(77/117)of the patients chose targeted combined with PD-1 monoclonal antibody in the first-line treatment.The main targeted drugs were acitinib(81.8%,63/77),tirelizumab(37.6%,29/77)and cindilimab(25.9%,20/77).After first-line treatment,19.6.1%(23/117)patients needed to be converted to second-line treatment,and 15 patients changed the type of PD-1 antibody during treatment.In addition,the targeted drug of combined therapy was replaced by acitinib in 8 patients.The main causes of drug withdrawal were disease progression(70.7%,29/41)and death(29.2%,12/41).The median OS of the overall population was 35.6(19-60)months and PFS was 12.1(1-60)months.The ORR of the overall population was 47.8%(56/117).4.2%(5/117)patients had complete remission,another 17.0%(20/117)patients were in stable condition,and 43.5%(51/117)patients were in partial remission.In the fi

关 键 词：癌 肾细胞 转移性 免疫治疗 程序性细胞死亡蛋白1 靶向治疗 真实世界研究 不良反应 

分 类 号：R737.11[医药卫生—肿瘤]