ORIGINAL RESEARCH article
Front. Med.
Sec. Gastroenterology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1637458
Real-world First-line Serplulimab Therapy for Advanced Esophageal Cancer: Effectiveness, Safety, and Clinical Implications
Provisionally accepted
- 1Jiangsu Cancer Hospital, Nanjing Medical University, Nanjing, China
- 2The First Affiliated Hospital of Anhui Medical University, Hefei, China
- 3Taizhou People’s Hospital, Taizhou, China
- 4Sichuan Cancer Hospital and Institute, Chengdu, China
- 5Subei People’s Hospital of Jiangsu Province, Yangzhou, China
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Objective The phase III ASTRUM-007 trial demonstrated significant clinical benefit in patients with PD-L1-positive esophageal squamous cell carcinoma (ESCC) treated with first-line serplulimab plus chemotherapy. This multicenter, observational cohort study aimed to evaluate the real-world outcomes, and address evidence gaps in broader patient populations. Methods This multicenter real-world cohort study collected the data of patients with locally advanced or metastatic esophageal cancer who received first-line serplulimab treatment, regardless of histologic type and PD-L1 expression. The outcomes included real-world progression-free survival (rwPFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. Results Among 104 included patients, the median number of serplulimab treatment cycles was four; 10 patients (9.6%) concurrently received targeted therapy, 21 (20.2%) received radiotherapy, and 97 received chemotherapy (93.3%). The confirmed ORR was 40.0% (95% confidence interval [CI]: 29.8-50.9%) and the DCR was 97.8% (95% CI: 92.2-99.7%). With a median follow-up time of 6.8 months, the median rwPFS was 12.00 months (95% CI: 8.87-not reached [NR]). The median OS was not reached (95% CI: 13.27-NR), with a 1-year OS rate of 73.5% (95% CI: 60.4-89.3%). Subgroup analysis showed prolonged median PFS in patients aged ≥65 years than those <65 years (12.00 vs. 6.87 months, P=0.022). Only two serious adverse events were reported (one hyperkalemia and one decreased white blood cell count). Conclusion This real-world study supports the effectiveness and safety of serplulimab-based regimens as a first-line treatment for patients with locally advanced or metastatic esophageal cancer, regardless of their diverse characteristics.
Keywords: esophageal cancer, Advanced cancer, serplulimab, treatment efficacy, Safety, Real-world evidence
Received: 29 May 2025; Accepted: 21 Jul 2025.
Copyright: © 2025 YAN, Zhu, Wu, Ren, Yu, Sun, Liu, Sun and Sun. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yan Sun, Jiangsu Cancer Hospital, Nanjing Medical University, Nanjing, China
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