替雷利珠单抗联合化疗一线治疗局部晚期或转移性非鳞状非小细胞肺癌的肿瘤缓解特征  

Response characteristics of tislelizumab combined with chemotherapy in first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer

作　　者：陆舜[1] 余新民[2] 胡艳萍[3] 马智勇 李醒亚[5] 李卫东 刘云鹏[7] 王东 王秀问[9] 王哲海[10] 吴敬勋[11] 钟殿胜[12] 李高峰[13] 何婉毓 包圆媛 袁园 范静慧 Lu Shun;Yu Xinmin;Hu Yanping;Ma Zhiyong;Li Xingya;Li Weidong;Liu Yunpeng;Wang Dong;Wang Xiuwen;Wang Zhehai;Wu Jingxun;Zhong Diansheng;Li Gaofeng;He Wanyu;Bao Yuanyuan;Yuan Yuan;Fan Jinghui(Shanghai Chest Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai 200030,China;Department of Thoracic Oncology,Zhejiang Cancer Hospital,Hangzhou 310022,China;Department of Thoracic Oncology,Hubei Cancer Hospital,Wuhan 430079,China;Department of Respiratory Medicine,The Affiliated Cancer Hospital of Zhengzhou University&Henan Cancer Hospital,Zhengzhou University,Zhengzhou 450003,China;Department of Oncology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Department of Medical Oncology,Affiliated Cancer Hospital of Guangzhou Medical University,Guangzhou 510095,China;Department of Medical Oncology,The First Hospital of China Medical University,Shenyang 110001,China;Department of Oncology,Army Sepcialty Medical Center,Chongqing 400042,China;Department of Medical Oncology,Qilu Hospital of Shandong University,Jinan 250012,China;Department of Medical Oncology,Shandong Cancer Hospital,Jinan 250117,China;Department of Medical Oncology,The First Affiliated Hospital of Xiamen University,Xiamen 361003,China;Department of Medical Oncology,Tianjin Medical University General Hospital,Tianjin 300052,China;Department of Thoracic Surgery,Yunnan Cancer Hospital,Kunming 650118,China;BeiGene(Beijing)Co.,Ltd.,Beijing 100022,China;BeiGene(Shanghai)Co.,Ltd.,Shanghai 200020,China)

机构地区：[1]上海市胸科医院、上海交通大学医学院附属胸科医院,上海200030 [2]浙江省肿瘤医院胸部内科,杭州310022 [3]湖北省肿瘤医院胸部肿瘤内科,武汉430079 [4]郑州大学附属肿瘤医院、河南省肿瘤医院呼吸内科,郑州450003 [5]郑州大学第一附属医院肿瘤科,郑州450052 [6]广州医科大学附属肿瘤医院肿瘤内科,广州510095 [7]中国医科大学附属第一医院肿瘤内科,沈阳110001 [8]陆军特色医学中心肿瘤科,重庆400042 [9]山东大学齐鲁医院肿瘤内科,济南250012 [10]山东省肿瘤医院肿瘤内科,济南250117 [11]厦门大学附属第一医院肿瘤内科,厦门361003 [12]天津医科大学总医院肿瘤内科,天津300052 [13]云南省肿瘤医院胸外科,昆明650118 [14]百济神州(北京)生物科技有限公司,北京100022 [15]百济神州(上海)生物科技有限公司,上海200020

出　　处：《中华肿瘤杂志》2023年第4期358-367,共9页Chinese Journal of Oncology

摘　　要：目的:探讨替雷利珠单抗联合化疗一线治疗局部晚期/转移性非鳞状非小细胞肺癌(NSCLC)患者的肿瘤缓解特征。方法:选取RATIONALE 304研究中替雷利珠单抗联合化疗或单独化疗治疗后经独立评审委员会评估获得完全缓解或部分缓解的非鳞状NSCLC患者,分析其缓解特征和安全性特征。至缓解时间(TTR)定义为从随机到获得首次客观缓解的时间。肿瘤缓解深度定义为与基线靶病变长径总和相比的最大肿瘤缩小百分比。结果:截至2020年1月23日,共计128例替雷利珠单抗联合化疗治疗的患者获得肿瘤客观缓解(应答者),占意向治疗人群的57.4%(128/223),TTR为5.1~33.3周,中位TTR为7.9周。在应答者(128例)中,50.8%(65例)在首次疗效评估(第6周)时获得首次缓解,31.3%(40例)在第2次疗效评估(第12周)时获得首次缓解,18.0%(23例)在第3次及之后的肿瘤评估中获得首次缓解。肿瘤缓解深度达到30%~<50%、50%~<70%和70%~100%的应答者比例分别为45.3%(58/128)、28.1%(36/128)和26.6%(34/128),中位无进展生存时间(PFS)分别为9.0个月(95% CI: 7.7~9.9个月)、11.5个月(95% CI: 7.7个月~不可估计)和未达到(95% CI: 11.8个月~不可估计)。应答者整体耐受性良好,与总体安全性人群类似。 结论:替雷利珠单抗联合化疗治疗非鳞状NSCLC的应答者中,82.0%(105/128)的患者在前2次肿瘤评估(12周)内获得缓解,18.0%(23/128)的患者在更晚期(18~33周)的评估中获得缓解,且肿瘤缓解深度较深的应答者其PFS有延长趋势。Objective To investigate the response characteristics of patients with locally advanced/metastatic non-squamous non-small cell lung cancer(nsq-NSCLC)treated with tislelizumab in combination with chemotherapy in the first line.Methods Patients with nsq-NSCLC who achieved complete or partial remission after treatment with tislelizumab in combination with chemotherapy or chemotherapy alone in the RATIONALE 304 study,as assessed by an independent review board,were selected to analyze the response characteristics and safety profile of the responders.Time to response(TTR)was defined as the time from randomization to the achievement of first objective response.Depth of response(DpR)was defined as the maximum percentage of tumor shrinkage compared with the sum of the baseline target lesion length diameters.Results As of January 23,2020,128 patients treated with tislelizumab in combination with chemotherapy achieved objective tumor response(responders),representing 57.4%(128/223)of the intention-to-treat population,with a TTR of 5.1 to 33.3 weeks and a median TTR of 7.9 weeks.Of the responders(128),50.8%(65)achieved first remission at the first efficacy assessment(week 6),31.3%(40)at the second efficacy assessment(week 12),and 18.0%(23)at the third and subsequent tumor assessments.The percentages of responders who achieved a depth of tumor response of 30%to<50%,50%to<70%and 70%to 100%were 45.3%(58/128),28.1%(36/128)and 26.6%(34/128),respectively,with median progression-free survival(PFS)of 9.0 months(95%CI:7.7 to 9.9 months),11.5 months(95%CI:7.7 months to not reached)and not reached(95%CI:11.8 months to not estimable),respectively.Tislelizumab plus chemotherapy were generally well tolerated in responders with similar safety profile to the overall safety population.Conclusion Among responders to tislelizumab in combination with chemotherapy for nsq-NSCLC,82.0%(105/128)achieves response within the first two tumor assessments(12 weeks)and 18.0%(23/128)achieves response at later(18 to 33 weeks)assessments,and there is a tren

关 键 词：肺肿瘤 非鳞状非小细胞肺癌 替雷利珠单抗 免疫治疗联合化疗 至缓解时间 肿瘤缓解深度 

分 类 号：R734.2[医药卫生—肿瘤]