食管癌或胃食管交界处癌辅助纳武利尤单抗的耐受性：一项真实世界研究
Tolerability of Adjuvant Nivolumab in Esophageal or Gastroesophageal Junction Cancer: A Real-World Study.
作者
作者单位
- Department of Medical Oncology, University Medical Center Groningen (UMCG), Groningen, the Netherlands.
- Department of Medical Oncology, Amsterdam University Medical Center, Location University of Amsterdam, Amsterdam, the Netherlands.
- Department of Medical Oncology, Erasmus Medical Center (EMC), Rotterdam, the Netherlands.
- Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, the Netherlands.
摘要
中文
辅助纳武利尤单抗已被批准用于新辅助放化疗和切除术后的食管癌或胃食管交界处癌。在CheckMate-577试验中，3-5级纳武利尤单抗相关不良事件（AEs）发生率为5%，因毒性导致早期停药的比例为9%。然而，关于免疫治疗相关不良事件（irAEs）的真实世界数据有限。本研究评估了真实世界中irAEs的累积发生率。在这项回顾性队列研究中，纳入了在荷兰三个胃食管癌中心接受≥1周期辅助纳武利尤单抗的所有患者。临床数据从电子记录中提取。主要结局是3-5级irAEs的累积发生率。次要结局包括3-5级irAEs的预测因素、时间和临床结局，以及2级irAEs的累积发生率。在142例中位随访27.9个月的患者中，3-5级irAEs发生率为15%。最常见的为肝炎（3%）、肺炎（2%）和心肌炎（2%）。发生2例致死性irAEs（1%）。首次发生3-5级irAE的中位时间为2.0个月（IQR 0.7-6.4）。3-5级irAEs导致9%的患者住院，11%需要全身性皮质类固醇，8%出现临床后遗症。未发现3-5级irAEs的预测因素。因任何irAE导致的早期停药发生率为24%。总之，严重irAEs（3-5级）的发生率高于CheckMate-577，且常需要住院和免疫抑制，相当比例的患者出现后遗症。因irAE导致停药的比例高于CheckMate-577（24% vs. 9%）。在辅助纳武利尤单抗治疗期间，应进行谨慎的风险-获益评估和积极监测。
English
Adjuvant nivolumab is approved for esophageal or gastroesophageal junction cancer after neoadjuvant chemoradiotherapy and resection. In the CheckMate-577 trial, Grade 3-5 nivolumab-related adverse events (AEs) occurred in 5% of patients, with early discontinuation due to toxicity in 9%. However, real-world data on immunotherapy-related adverse events (irAEs) are limited. This study assessed the cumulative incidence of irAEs in a real-world setting. In this retrospective cohort study, all patients receiving ≥ 1 cycle of adjuvant nivolumab at three Dutch gastroesophageal cancer centers were included. Clinical data were extracted from electronic records. The primary outcome was the cumulative incidence of Grade 3-5 irAEs. Secondary outcomes included predictors, timing, and clinical outcomes of Grade 3-5 irAEs, and cumulative incidence of Grade 2 irAEs. Among 142 patients with median follow-up 27.9 months, Grade 3-5 irAEs occurred in 15%. Hepatitis (3%), pneumonitis (2%), and myocarditis (2%) were most common. Two fatal irAEs occurred (1%). Median time to first Grade 3-5 irAE was 2.0 months (IQR 0.7-6.4). Grade 3-5 irAEs led to hospitalization in 9%, required systemic corticosteroids in 11%, and resulted in clinical sequelae in 8%. No predictors for Grade 3-5 irAEs were identified. Early discontinuation due to any irAE occurred in 24%. In conclusion, severe irAEs (Grade 3-5) occurred more frequently than in CheckMate-577 and often required hospitalization and immunosuppression, with sequelae in a significant proportion. Discontinuation due to irAEs was higher than in CheckMate-577 (24% vs. 9%). Careful risk-benefit assessment and active monitoring during adjuvant nivolumab therapy are warranted.
分类与指标
- 研究类型
- 临床研究
- 病种
- 食管癌
- JCR 分区
- Q2
- 影响因子
- 4.9
- 新锐分区
- 2区