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<p>Immunochemotherapy has shown promising outcomes in treating small-cell lung cancer. To explore whether surgery after immunochemotherapy benefits patients with stage I‒III small-cell lung cancer, we conducted a phase II trial (NCT04539977). Eligible patients received four cycles of anti-PD-L1 antibody (TQB2450) therapy and chemotherapy, followed by surgery or radiotherapy and one-year maintenance immunotherapy (TQB2450). Forty patients were enrolled between December 2020 and January 2023. Thirty-eight (95.0%) patients had stage III disease. We found that the objective response rate, as the primary endpoint of this study, was 92.5% (95% CI: 83.9%‒100%) in the intention-to-treat population. At a median follow-up of 25.8 months, the median event-free survival (EFS) was 16.2 months. The median overall survival (OS) was not reached. The major pathological response and pathological complete response rate of operative patients (<i>n</i> = 21) were 61.9% and 42.9%, respectively. The 24-month EFS and 24-month OS of operative patients were 61.9% and 85.7%, respectively. All patients with N1 disease (<i>n</i> = 9) underwent surgery, with the 24-month EFS of 66.7% and 24-month OS of 88.9%. The most common TQB2450-specific adverse event was rash of grade 1‒2 (12.5%). We further explored the biomarker of immunochemotherapy and molecular changes during immunochemotherapy through bulk-RNA sequencing and whole-exome sequencing. We demonstrated that <i>PRSS8</i> was a potential biomarker for poor effectiveness of immunochemotherapy. In conclusion, surgery after neoadjuvant immunochemotherapy is feasible for treating patients with stage I‒III small-cell lung cancer.</p>

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Surgery after induced anti-PD-L1 therapy and chemotherapy for stage I‒III small-cell lung cancer: a phase 2 trial (LungMate-005)

  • 期刊论文

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  • 发表日期：

    2025年11月25日

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  • Fenghuan Sun,
  • Lele Zhang,
  • Liangdong Sun,
  • Di Wang,
  • Nan Song,
  • Liang Duan,
  • Dongliang Bian,
  • Junjie Hu,
  • Yilv Yan,
  • Jie Yang,
  • Wenxin He,
  • Yong Yang,
  • Xiaogang Liu,
  • Bin Chen,
  • Jun Ma,
  • Lixin Wang,
  • Ming Liu,
  • Xiaoxiong Xu,
  • Cong Ye,
  • Yirui Zhou,
  • Huansha Yu,
  • ZhaoXia Dai,
  • Chang Chen,
  • Deping Zhao,
  • Jie Luo,
  • Shuyan Meng,
  • Gening Jiang,
  • Peng Zhang

摘要

Immunochemotherapy has shown promising outcomes in treating small-cell lung cancer. To explore whether surgery after immunochemotherapy benefits patients with stage I‒III small-cell lung cancer, we conducted a phase II trial (NCT04539977). Eligible patients received four cycles of anti-PD-L1 antibody (TQB2450) therapy and chemotherapy, followed by surgery or radiotherapy and one-year maintenance immunotherapy (TQB2450). Forty patients were enrolled between December 2020 and January 2023. Thirty-eight (95.0%) patients had stage III disease. We found that the objective response rate, as the primary endpoint of this study, was 92.5% (95% CI: 83.9%‒100%) in the intention-to-treat population. At a median follow-up of 25.8 months, the median event-free survival (EFS) was 16.2 months. The median overall survival (OS) was not reached. The major pathological response and pathological complete response rate of operative patients (n = 21) were 61.9% and 42.9%, respectively. The 24-month EFS and 24-month OS of operative patients were 61.9% and 85.7%, respectively. All patients with N1 disease (n = 9) underwent surgery, with the 24-month EFS of 66.7% and 24-month OS of 88.9%. The most common TQB2450-specific adverse event was rash of grade 1‒2 (12.5%). We further explored the biomarker of immunochemotherapy and molecular changes during immunochemotherapy through bulk-RNA sequencing and whole-exome sequencing. We demonstrated that PRSS8 was a potential biomarker for poor effectiveness of immunochemotherapy. In conclusion, surgery after neoadjuvant immunochemotherapy is feasible for treating patients with stage I‒III small-cell lung cancer.