Interstitial Pneumonitis Associated With EGFR-TKI and Combined With PD-1/PD-L1: A Retrospective Observational Study In Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67,818
- 主要终点
- Incidence of reported interstitial pneumonitis and adjusted odds ratios (aORs) derived from multivariable logistic regression analyses.
研究概览
简要总结
Importance:
EGFR tyrosine kinase inhibitors (EGFR-TKIs) and PD-1/PD-L1 immune checkpoint inhibitors are widely used in the treatment of non-small cell lung cancer (NSCLC). However, the safety profile of their combination-particularly the risk of interstitial pneumonitis (IP)-remains unclear.
Objective:
To evaluate the incidence and risk of interstitial pneumonitis associated with EGFR-TKIs when combined with PD-1/PD-L1 inhibitors, using real-world pharmacovigilance data.
Design, Setting, and Participants:
This retrospective observational study analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS) between January 1, 2015, and December 31, 2024. A total of 67,818 NSCLC cases were included, categorized by treatment with EGFR-TKIs, PD-1/PD-L1 inhibitors, combined therapy, or the other therapies.
Exposure:
NSCLC patients receiving EGFR-TKI PD-1/PD-L1 inhibitors, combined therapy, or the other therapies were compared to those not receiving such treatment.
Main Outcome and Measures:
Incidence of reported interstitial pneumonitis and adjusted odds ratios (aORs) derived from multivariable logistic regression analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-small cell lung cancer (NSCLC).
- •Received at least one EGFR-TKI (gefitinib, erlotinib, afatinib, osimertinib). Or received at least one PD-1/PD-L1 inhibitor (nivolumab, pembrolizumab, atezolizumab, durvalumab). Or received combination therapy with both EGFR-TKIs and PD-1/PD-L1 inhibitors. Or received the other therapies.
- •Cases reported in the FDA Adverse Event Reporting System (FAERS) between January 1, 2015, and December 31, 2024.
排除标准
- •Non-NSCLC Indications: Cases not related to NSCLC (e.g., other cancer types).
- •Incomplete Treatment Data: Patients with missing or unclear treatment exposure information (e.g., use of unrelated therapies).
- •Duplicate Reports: Duplicate adverse event reports were excluded.
研究组 & 干预措施
EGFR-TKI
干预措施: EGFR-TKI (Drug)
PD-1/PD-L1
干预措施: PD-1/PD-L1 inhibitor (Drug)
EGFR-TKI combined with PD-1/PD-L1
干预措施: EGFR-TKI combined with PD-1/PD-L1 (Drug)
结局指标
主要结局
Incidence of reported interstitial pneumonitis and adjusted odds ratios (aORs) derived from multivariable logistic regression analyses.
时间窗: From January 1, 2015, and December 31, 2024
次要结局
未报告次要终点