一项关于同步放化疗后接受度伐利尤单抗治疗的非小细胞肺癌患者肺炎的真实世界研究。

A real-world study of pneumonitis in non-small cell lung cancer patients receiving durvalumab following concurrent chemoradiation.

作者信息

Akkad Neha, Thomas Theodore S, Luo Suhong, Knoche Eric, Sanfilippo Kristen M, Keller Jesse W

机构信息

Washington University School of Medicine/Barnes Jewish Hospital, St. Louis, MO, USA.

St. Louis Veterans Health Administration Medical Center Research Service, St. Louis, MO, USA.

出版信息

J Thorac Dis. 2023 Dec 30;15(12):6427-6435. doi: 10.21037/jtd-22-1604. Epub 2023 Nov 23.

DOI:10.21037/jtd-22-1604

PMID:38249904

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10797388/

Abstract

BACKGROUND

Locally advanced non-small cell lung cancer (LA-NSCLC) treated with the programmed death-ligand 1 inhibitor durvalumab has been associated with significant rates of pneumonitis, which has led to higher rates of discontinuation of therapy in real-world populations. Thus far there has been no consensus in the literature on the impact of pneumonitis on survival.

METHODS

This is a retrospective cohort study of veterans receiving durvalumab between 12/5/2017 and 4/15/2020. Participants were identified using VINCI data services. Patients were followed through 9/14/2021. Development of clinical pneumonitis was assessed through review of documentation and graded using CTCAE 4.0 criteria. Univariate logistic regression analysis evaluated for associations between body mass index (BMI), age, race, co-morbidity index, chemotherapy regimen, chronic obstructive pulmonary disease (COPD) severity, and development of clinical pneumonitis. Progression-free survival (PFS) and overall survival (OS) were evaluated using Kaplan-Meier methods. Cox proportional hazards models were utilized to evaluate the association between risk of death at 1 and 2 years and candidate predictor variables.

RESULTS

A total of 284 patients were included in this study. Sixty-one patients developed clinically significant pneumonitis, 7 patients developed grade 5 pneumonitis (death from pneumonitis). The median OS in patients that developed pneumonitis was 27.8 36.9 months in patients that did not develop pneumonitis (P=0.22). BMI was found to be a clinical predictor of pneumonitis (P=0.04). COPD severity, race, age at durvalumab start date, chemotherapy regimen, and Romano comorbidity index were not significant predictors of pneumonitis. Cox proportional hazards analysis failed to demonstrate an association between the development of pneumonitis and risk of death in this population.

CONCLUSIONS

The incidence of clinically significant pneumonitis is higher than noted in the PACIFIC trial in this cohort, however this high rate of pneumonitis does not have an impact on OS or PFS. Obesity was found to be a significant predictor of pneumonitis in this patient population.

摘要

背景

接受程序性死亡配体1抑制剂度伐利尤单抗治疗的局部晚期非小细胞肺癌（LA-NSCLC）患者中，肺炎发生率较高，这导致在现实世界人群中治疗中断率更高。迄今为止，关于肺炎对生存率的影响，文献中尚未达成共识。

方法

这是一项对2017年12月5日至2020年4月15日期间接受度伐利尤单抗治疗的退伍军人的回顾性队列研究。使用VINCI数据服务识别参与者。对患者进行随访至2021年9月14日。通过审查病历评估临床肺炎的发生情况，并根据CTCAE 4.0标准进行分级。单因素逻辑回归分析评估体重指数（BMI）、年龄、种族、合并症指数、化疗方案、慢性阻塞性肺疾病（COPD）严重程度与临床肺炎发生之间的关联。采用Kaplan-Meier方法评估无进展生存期（PFS）和总生存期（OS）。使用Cox比例风险模型评估1年和2年死亡风险与候选预测变量之间的关联。

结果

本研究共纳入284例患者。61例患者发生具有临床意义的肺炎，7例患者发生5级肺炎（因肺炎死亡）。发生肺炎的患者中位OS为27.8个月，未发生肺炎的患者为36.9个月（P=0.22）。发现BMI是肺炎的临床预测因素（P=0.04）。COPD严重程度、种族、开始使用度伐利尤单抗时的年龄、化疗方案和罗马诺合并症指数不是肺炎的显著预测因素。Cox比例风险分析未能证明该人群中肺炎的发生与死亡风险之间存在关联。