Real-world serplulimab plus chemotherapy for extensive-stage small cell lung cancer in china: an external validation of ASTRUM-005 trial

作者：Wu L, Hu C, Su W, Zhu H, Hong W, Su H, Yu Y, Luo T, Liu Z, Liu Z, Pu Q, Wang C, Min X, Guo H, Chen Y · 发表于：BMC medicine · 年份：2026 · DOI：10.1186/s12916-026-05055-9

BACKGROUND: In the randomized phase 3 ASTRUM-005 trial, adding serplulimab to chemotherapy improved survival in extensive-stage small cell lung cancer (ES-SCLC), but whether these results generalize to routine practice remains uncertain. To evaluate the real-world effectiveness and safety of first-line serplulimab plus chemotherapy in China and to benchmark outcomes against the pivotal trial using a matching-adjusted indirect comparison (MAIC). METHODS: This nationwide, observational study enrolled ES-SCLC patients treated with serplulimab and investigator-selected chemotherapy across 14 sites in China. For subsequent analyses, patients were grouped by alignment with the ASTRUM-005 trial regimen: an RCT-regimen cohort and a real-world regimen cohort. The primary endpoints were overall survival (OS) and real-world progression-free survival (rwPFS); secondary endpoints included objective response rate (ORR) and safety. The MAIC weighted eligible real-world patients to the aggregate baseline profile of the pivotal trial. RESULTS: Among 635 patients, the median OS was 17.20 months (95% CI, 15.43-19.77) and the median rwPFS was 8.17 months (95% CI, 7.40-9.20). The ORR was 69.05%, with comparable efficacy observed between RCT-regimen and real-world cohorts. Poor performance status and liver metastases independently predicted higher mortality. In the MAIC, OS in the RCT-regimen cohort was comparable to the serplulimab arm of the pivotal ASTRUM-005 trial (weighted log-rank P = 0.78...