Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial

危险系数 内科学 医学 中期分析 肺癌 安慰剂 肿瘤科 卡铂 化疗 养生 临床终点 依托泊苷 不利影响 无进展生存期 随机对照试验 胃肠病学 外科 置信区间 病理 替代医学 顺铂
作者
Ying Cheng,Jianhua Chen,Wei Zhang,Chao Xie,Qun Hu,Ningning Zhou,Chi‐Chou Huang,Shihong Wei,Hong Sun,Xingya Li,Yan Yu,Jinhuo Lai,Huaping Yang,Haohui Fang,Hualin Chen,Peng Zhang,Kangsheng Gu,Qiming Wang,Jianhua Shi,Tienan Yi,Xingxiang Xu,Xian-Wei Ye,Daqing Wang,Conghua Xie,Liu Cl,Yulong Zheng,Daren Lin,Wu Zhuang,Ping Lu,Guohua Yu,Jinzhang Li,Yuhai Gu,Baolan Li,Rong Wu,Ou Jiang,Zaiyi Wang,Guowu Wu,Haifeng Lin,Diansheng Zhong,Yanhua Xu,Yongqian Shu,Di Wu,Xingwu Chen,Jie Wang,Minghui Wang,Runxiang Yang
出处
期刊:Nature Medicine [Springer Nature]
被引量:3
标识
DOI:10.1038/s41591-024-03132-1
摘要

Abstract Immunochemotherapy is the first-line standard for extensive-stage small-cell lung cancer (ES-SCLC). Combining the regimen with anti-angiogenesis may improve efficacy. ETER701 was a multicenter, double-blind, randomized, placebo-controlled phase 3 trial that investigated the efficacy and safety of benmelstobart (a novel programmed death-ligand 1 (PD-L1) inhibitor) with anlotinib (a multi-target anti-angiogenic small molecule) and standard chemotherapy in treatment-naive ES-SCLC. The ETER701 trial assessed two primary endpoints: Independent Review Committee-assessed progression-free survival per RECIST 1.1 and overall survival (OS). Here the prespecified final progression-free survival and interim OS analysis is reported. Patients randomly received benmelstobart and anlotinib plus etoposide/carboplatin (EC; n = 246), placebo and anlotinib plus EC ( n = 245) or double placebo plus EC (‘EC alone’; n = 247), followed by matching maintenance therapy. Compared with EC alone, median OS was prolonged with benmelstobart and anlotinib plus EC (19.3 versus 11.9 months; hazard ratio 0.61; P = 0.0002), while improvement of OS was not statistically significant with anlotinib plus EC (13.3 versus 11.9 months; hazard ratio 0.86; P = 0.1723). The incidence of grade 3 or higher treatment-related adverse events was 93.1%, 94.3% and 87.0% in the benmelstobart and anlotinib plus EC, anlotinib plus EC, and EC alone groups, respectively. This study of immunochemotherapy plus multi-target anti-angiogenesis as first-line treatment achieved a median OS greater than recorded in prior randomized studies in patients with ES-SCLC. The safety profile was assessed as tolerable and manageable. Our findings suggest that the addition of anti-angiogenesis therapy to immunochemotherapy may represent an efficacious and safe approach to the management of ES-SCLC. ClinicalTrials.gov identifier: NCT04234607 .
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