免疫检查点抑制剂在乙肝表面抗原阳性肺癌患者中的疗效与安全性：一项真实世界队列研究
Efficacy and safety of immune checkpoint inhibitors in lung cancer patients with hepatitis B surface antigen positivity: a real-world cohort study.
作者
作者单位
- Department of Thoracic Surgery and Oncology, China State Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China; Guangzhou Institute of Respiratory Health, Guangzhou 510120, China.
- Department of Thoracic Surgery and Oncology, China State Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China; Guangzhou Institute of Respiratory Health, Guangzhou 510120, China; Nanshan School, Guangzhou Medical University, Jinxiu Road, Panyu District, Guangzhou 511436, China.
- Department of Thoracic Surgery and Oncology, China State Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China; Guangzhou Institute of Respiratory Health, Guangzhou 510120, China. Electronic address: liuliping529@163.com.
- Department of Thoracic Surgery and Oncology, China State Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China; Guangzhou Institute of Respiratory Health, Guangzhou 510120, China. Electronic address: chengbodoctor@163.com.
- Department of Thoracic Surgery and Oncology, China State Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China; Guangzhou Institute of Respiratory Health, Guangzhou 510120, China; Department of Oncology Medical Center, The First People's Hospital of Zhaoqing, Zhaoqing City, Guangdong Province, China; Hengqin Hospital, First Affiliated Hospital of Guangzhou Medical University, No. 118 Baoxing Road, Hengqin, Guangdong 519031, China. Electronic address: liangwh1987@163.com.
摘要
中文
本研究评估了根据基线乙肝表面抗原（HBsAg）状态分层的一线化疗联合免疫治疗在肺癌患者中的疗效和肝脏安全性，并探讨在HBsAg阴性/抗-HBc阳性患者中基线抗-HBs水平是否与预后相关。我们开展了一项单中心回顾性观察性队列研究，纳入2019年6月1日至2024年7月31日期间接受一线化疗联合免疫治疗的连续肺癌患者。根据基线HBsAg状态分组。终点包括客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和免疫相关肝脏不良事件（肝炎和黄疸）。采用Kaplan-Meier法和Cox回归分析评估生存结局。在HBsAg阴性/抗-HBc阳性患者中按基线抗-HBs水平进行亚组分析。497例筛选患者中纳入411例：HBsAg阳性53例，HBsAg阴性358例。HBsAg阳性与阴性患者的ORR（30.2%对比35.8%；P=0.428）和DCR（54.7%对比54.5%；P=0.973）相当。中位PFS分别为14.0个月和13.8个月，中位OS分别为27.6个月和35.3个月。多因素调整后HBsAg阳性与PFS或OS无显著相关性（PFS：调整后HR 1.08；95% CI 0.69–1.70；P=0.727；OS：调整后HR 1.07；95% CI 0.71–1.60；P=0.755）。≥3级免疫相关肝炎在HBsAg阳性患者中更为常见（P<0.001）。在HBsAg阴性/抗-HBc阳性患者（n=266）中，抗-HBs水平与PFS、OS或肝脏安全性无显著相关性。基线HBsAg阳性与疗效或生存降低无关，但与重度免疫相关肝炎发生率增加相关。基线抗-HBs水平与临床结局或肝脏安全性无显著相关性。这些结果支持在适当筛选的HBV感染肺癌患者中使用基于ICI的治疗。
English
This study evaluated the efficacy and hepatic safety of first-line chemoimmunotherapy in lung cancer patients according to baseline hepatitis B surface antigen (HBsAg) status, and explored whether baseline anti-HBs level was associated with outcomes among HBsAg-negative/anti-HBc-positive patients. We conducted a single-center retrospective observational cohort study of consecutive lung cancer patients who received first-line chemoimmunotherapy between June 1, 2019 and July 31, 2024. Patients were grouped by baseline HBsAg status. Outcomes included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and immune-related hepatic adverse events (hepatitis and jaundice). Survival outcomes were assessed using Kaplan-Meier and Cox regression analyses. Subgroup analyses were performed by baseline anti-HBs level among HBsAg-negative/anti-HBc-positive patients. Among 497 screened patients, 411 were included: 53 HBsAg-positive and 358 HBsAg-negative. ORR (30.2% vs 35.8%; P = 0.428) and DCR (54.7% vs 54.5%; P = 0.973) were comparable between HBsAg-positive and HBsAg-negative patients. Median PFS was 14.0 and 13.8 months, respectively; median OS was 27.6 and 35.3 months, respectively. HBsAg positivity was not significantly associated with PFS or OS after multivariable adjustment (PFS: adjusted HR, 1.08; 95% CI, 0.69-1.70; P = 0.727; OS: adjusted HR, 1.07; 95% CI, 0.71-1.60; P = 0.755). Grade ≥ 3 immune-related hepatitis was more frequent in HBsAg-positive patients (P < 0.001). Among HBsAg-negative/anti-HBc-positive patients (n = 266), anti-HBs level was not significantly associated with PFS, OS, or hepatic safety. Baseline HBsAg positivity was not associated with inferior efficacy or survival but was associated with increased severe immune-related hepatitis. Baseline anti-HBs level showed no significant association with clinical outcomes or hepatic safety. These findings support the use of ICI-based therapy in appropriately selected HBV-infected lung cancer patients.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 5.3
- 新锐分区
- 2区