Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer

作者：Ying Cheng, Liang Han, Lin Wu, Jun Chen, Hongmei Sun, Guilan Wen, Yinghua Ji, Mikhail Dvorkin, Jianhua Shi, Zhijie Pan, Jinsheng Shi, Xicheng Wang, Yuansong Bai, Tamar Melkadze, Yueyin Pan, Xuhong Min, Maksym Viguro, Xingya Li, Yanqiu Zhao, Junquan Yang, Tamta Makharadze, Ekaterine Arkania, Wenying Kang, Qingyu Wang, Jun Zhu, ASTRUM-005 Study Group, Xiubao Ren, Vladimer Kuchava, Guoping Sun, Gaofeng Li, Lin Wen, Tao Zhang, Hakan Harputluoğlu, İrfan Çiçin, Guosheng Feng, Yanrong Hao, Kejing Ying, Ping Sun, Aihong Zhong, Guangyu An, Yan Wang, Chun Chen, Sheng Yang, Zhendong Chen, Konstantin Penkov, Yuriy Semegen, Oleg Kobziev, Feng Luo, Peiguo Cao, Zhixiong Yang, Min Fan, Wen Li, Robert Mróz, А. Л. Акопов, Tuncay Göksel, Mahmut Gümüş, Wenlei Zhuo, Jian Fang, Hui Zhao, Lin Zhong, Yanping Hu, Yarong Li, Shuqun Zhang, Jiuwei Cui, Н. В. Коваленко, Çağatay Arslan, Devrim Cabuk, Alev Türker, Igor Bondarenko, Yevhen Hotko, O. Goloborodko, Dongji Chen, Mengzhao Wang, Zhuang Yu, Jun‐Guo Lu, Liyan Jiang, Hao Xiong, Davit Giorgadze, Sergey Orlov, Ahmet Bılıcı, Ivan Sinelnikov, Gongyan Chen, Yue Lu, Xiaoli Zhu, Liqin Lu, Mariam Zhvania, Małgorzata Ułańska, Igor Lifirenko, Timur Andabekov, Maria Smagina, Fedor Moiseenko, Yüksel Ürün, Ligong Nie, Bangwei Cao, Zhenyu You, Haixin Huang, Shenpeng Ying, Alexandre Tavartkiladze, Tariel Kitiashvili, Amiran Matitashvili, Tsira Kortua, Eugeny P. Kulikov, Sergey Cheporov, Vadim Shirinkin, Mustafa Özgüroğlu, Mehmet Artaç, Oleksii Kolesnik, Andrii Gardashnikov, Denys Pominchuk · 发表于：JAMA · 年份：2022 · DOI：10.1001/jama.2022.16464 · 被引用次数：473 · 研究领域：Lung Cancer Research Studies、Lung Cancer Treatments and Mutations、Advanced Breast Cancer Therapies

Importance: Programmed cell death ligand 1 inhibitors combined with chemotherapy has changed the approach to first-line treatment in patients with extensive-stage small cell lung cancer (SCLC). It remained unknown whether adding a programmed cell death 1 (PD-1) inhibitor to chemotherapy provided similar or better benefits in patients with extensive-stage SCLC, which would add evidence on the efficacy of checkpoint inhibitors in the treatment of extensive-stage SCLC. Objective: To evaluate the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with extensive-stage SCLC. Design, Setting, and Participants: This international, double-blind, phase 3 randomized clinical trial (ASTRUM-005) enrolled patients at 114 hospital sites in 6 countries between September 12, 2019, and April 27, 2021. Of 894 patients who were screened, 585 with extensive-stage SCLC who had not previously received systemic therapy were randomized. Patients were followed up through October 22, 2021. Interventions: Patients were randomized 2:1 to receive either 4.5 mg/kg of serplulimab (n = 389) or placebo (n = 196) intravenously every 3 weeks. All patients received intravenous carboplatin and etoposide every 3 weeks for up to 12 weeks. Main Outcomes and Measures: The primary outcome was overall survival (prespecified significance threshold at the interim analysis, 2-sided P < .012). There were 13 secon...