Department of Pharmacy, Section of Oncology, Yale New Haven Hospital, New Haven, CT.
Department of Pharmacy, Section of Oncology, Yale New Haven Hospital, New Haven, CT.
Clin Lung Cancer. 2022 Jan;23(1):34-42. doi: 10.1016/j.cllc.2021.08.006. Epub 2021 Aug 16.
INTRODUCTION/BACKGROUND: Durvalumab is a programmed cell death ligand 1 (PD-L1) inhibitor indicated for stage III, unresectable non-small cell lung cancer (NSCLC) consolidation therapy following concurrent platinum-based chemoradiation based on results of the PACIFIC trial. Safety data of durvalumab demonstrates an increased risk of immune-related adverse effects (irAEs), most notably pneumonitis. Pneumonitis is a serious and potentially fatal complication of immunotherapy. It is important to investigate the incidence of pneumonitis in clinical practice to evaluate the generalizability of published data. The objective of this study is to assess and characterize real-world incidence of pneumonitis in patients with NSCLC receiving durvalumab.
This retrospective study included patients who were initiated on durvalumab for unresectable stage III NSCLC from February 2018 through November 2019. The data analysis utilized descriptive statistics to determine the incidence of pneumonitis associated with durvalumab.
Of the 83 patients who were evaluated, 21 patients (25.3%) experienced pneumonitis, with 5 cases (6%) being grade 3/4. Seven patients were re-challenged with durvalumab, while 14 patients permanently discontinued durvalumab. There were no clearly identifiable risk factors leading to an increased incidence of pneumonitis.
The results of this study indicate that real-world incidence of pneumonitis in stage III NSCLC patients receiving durvalumab consolidation therapy is congruent with the incidence reported in the PACIFIC trial.
简介/背景:度伐利尤单抗是一种程序性死亡配体 1(PD-L1)抑制剂,基于 PACIFIC 试验结果,被批准用于同步铂类放化疗后不可切除的 III 期非小细胞肺癌(NSCLC)的巩固治疗。度伐利尤单抗的安全性数据显示免疫相关不良事件(irAEs)风险增加,尤其是肺炎。肺炎是免疫治疗的一种严重且潜在致命的并发症。调查肺炎在临床实践中的发生率对于评估已发表数据的普遍性非常重要。本研究的目的是评估和描述接受度伐利尤单抗治疗的 NSCLC 患者中肺炎的真实世界发生率。
本回顾性研究纳入了 2018 年 2 月至 2019 年 11 月期间因不可切除的 III 期 NSCLC 而开始接受度伐利尤单抗治疗的患者。数据分析采用描述性统计方法确定与度伐利尤单抗相关的肺炎发生率。
在评估的 83 名患者中,21 名(25.3%)发生了肺炎,其中 5 例(6%)为 3/4 级。7 名患者重新接受了度伐利尤单抗治疗,而 14 名患者永久停止了度伐利尤单抗治疗。没有明显可识别的导致肺炎发生率增加的危险因素。
本研究结果表明,接受度伐利尤单抗巩固治疗的 III 期 NSCLC 患者的真实世界肺炎发生率与 PACIFIC 试验报告的发生率一致。