南方医科大学吴一龙课题组完成不可切除型III期非小细胞肺癌的新辅助SHR-1701化疗或不化疗临床试验。2024年6月20日，《癌细胞》杂志在线发表了这项成果。

研究人员开展了一项概念验证2期试验，评估新辅助SHR-1701联合或不联合化疗、手术或放疗以及SHR-1701巩固治疗不可切除型III期非小细胞肺癌（NSCLC）的疗效。在接受新辅助联合疗法的主要患者队列（n=97）中，两个主要终点均已达到，诱导后客观反应率为58%（95%置信区间[CI]，47-68），18个月无事件生存率（EFS）为56.6%（95%CI，45.2-66.5）。共有27例（25%）患者接受了手术，全部实现了R0切除。其中，有12例（44%）主要病理反应和7例（26%）病理完全反应。

手术患者的18个月EFS率为74.1%（95%CI，53.2-86.7），放疗患者的18个月EFS率为57.3%（43.0-69.3）。在不可切除型III期NSCLC患者中，新辅助SHR-1701化疗后再进行手术或放疗显示出良好的疗效和可耐受的安全性。相当一部分患者可以接受手术治疗，而且生存率更高。

附：英文原文

Title: Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial

Author: Qing Zhou, Yi Pan, Xuening Yang, Yanqiu Zhao, Guang Han, Qingsong Pang, Zhenfa Zhang, Qifeng Wang, Jun Yao, Hui Wang, Weihua Yang, Baogang Liu, Qixun Chen, Xianghui Du, Kaican Cai, Baosheng Li, Yunchao Huang, Xiao Li, Li Song, Wei Shi, Yi-Long Wu

Issue&Volume: 2024-06-20

Abstract: We conducted a proof-of-concept, phase 2 trial to assess neoadjuvant SHR-1701 with or without chemotherapy, followed by surgery or radiotherapy, and then consolidation SHR-1701 in unresectable stage III non-small-cell lung cancer (NSCLC). In the primary cohort of patients receiving neoadjuvant combination therapy (n = 97), both primary endpoints were met, with a post-induction objective response rate of 58% (95% confidence interval [CI] 47–68) and an 18-month event-free survival (EFS) rate of 56.6% (95% CI 45.2–66.5). Overall, 27 (25%) patients underwent surgery; all achieved R0 resection. Among them, 12 (44%) major pathological responses and seven (26%) pathological complete responses were recorded. The 18-month EFS rate was 74.1% (95% CI 53.2–86.7) in surgical patients and 57.3% (43.0–69.3) in radiotherapy-treated patients. Neoadjuvant SHR-1701 with chemotherapy, followed by surgery or radiotherapy, showed promising efficacy with a tolerable safety profile in unresectable stage III NSCLC. Surgical conversion was feasible in a notable proportion of patients and associated with better survival outcomes.

DOI: 10.1016/j.ccell.2024.05.024

Source: https://www.cell.com/cancer-cell/fulltext/S1535-6108(24)00192-2