舒格利单抗一线治疗非小细胞肺癌的疗效和安全性分析

Efficacy and safety analysis of sugemalimab as first-line treatment for non-small cell lung cancer

摘要

目的: 基于真实世界数据分析舒格利单抗一线治疗非小细胞肺癌的疗效和安全性,为临床安全合理应用舒格利单抗提供指导。方法: 回顾性收集2022年6月—2024年12月某肿瘤专科医院住院接受舒格利单抗一线治疗的非小细胞肺癌患者的临床资料,对其疗效和安全性资料及影响因素进行统计分析。结果: 舒格利单抗一线治疗 81 例非小细胞肺癌患者的中位无进展生存期（progression-free survival,PFS）为13.6个月（10.6~NA, 95%CI）,客观有效率（objective response rate,ORR）为58.0％,疾病控制率（disease control rate,DCR）达 95%。肺腺癌比肺鳞癌患者 PFS 更长(17.2 vs 11.3, P=0.036)。所有级别不良反应发生率为33.3%, 3~4级不良反应发生率为7.6%,未发生 5 级不良反应,所有级别和严重级别不良反应主要表现为骨髓抑制。COX 回归分析发现病理类型、转移部位、首次治疗前白蛋白水平可能是影响患者预后的因素。结论: 舒格利单抗一线治疗非小细胞肺癌在真实世界表现出良好的疗效和安全性。

Abstract

Objective: To analyze the efficacy and safety of sugemalimab as first-line treatment for non- small cell lung cancer（NSCLC）based on real-world data and provide guidance for its rational clinical application. Methods: The clinical data of NSCLC patients hospitalized at a specialized cancer hospital from June 2022 to December 2024 and receiving first-line sugemalimab treatment were retrospectively collected.Statistical analyses were performed on efficacy,safety profiles,and influencing factors. Results: Among 81 NSCLC patients treated with sugemalimab,the median progression-free survival（PFS）was 13.6 months（10.6-NA,95％CI）,with an objective response rate（ORR）of 58.0% and a disease control rate（DCR）of 95.0％.Patients with lung adenocarcinoma exhibited longer PFS compared to those with squamous cell carcinoma(17.2 vs 11.3 months,P=0.036）.The incidence of all-grade adverse drug reactions（ADRs）was 33.3%,with grade 3~4 ADRs occurring in 7.6% of patients.No grade 5 ADRs were observed.Myelosuppression was the most common ADR across all grades and severe cases.COX regression analysis identified pathological type,metastatic sites,and pre-treatment albumin levels as potential prognostic factors. Conclusion: Sugemalimab demonstrates favorable efficacy and safety as a first-line treatment for NSCLC in real-world clinical practice.

关键词

真实世界研究 / 舒格利单抗 / 非小细胞肺癌

Key words

real-world study / sugemalimab / non-small cell lung cancer

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基金资助

湖南省卫生健康委卫生科研课题资助项目（D202313017815）;湖南省肿瘤医院攀登计划项目（YF2021004）;湖南省自然科学基金资助项目（2024JJ8218）