PD-L1 作为评估 durvalumab 治疗 III 期 EGFR 突变 NSCLC 疗效的生物标志物。
PD-L1 as a Biomarker for the Efficacy of Durvalumab in Stage III EGFR Mutant NSCLC.
机构信息
Department of Internal Medicine, College of Medicine, Dong-A University, Busan, Republic of Korea.
Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.
出版信息
Anticancer Res. 2024 Oct;44(10):4505-4516. doi: 10.21873/anticanres.17279.
BACKGROUND/AIM: Durvalumab consolidation is less effective in patients with epidermal growth factor receptor mutant (EGFR M+) NSCLC. Studies of durvalumab on EGFR M+ NSCLC as an expression of programmed death-ligand 1 (PD-L1) expression are limited. The purpose of this study was to determine the effect of durvalumab on PD-L1 expression in EGFR M+ patients.
PATIENTS AND METHODS
This study included 249 unresectable stage III NSCLC patients treated with durvalumab. The primary outcome was progression-free survival (PFS). Cox multivariate analysis was performed based on EGFR and PD-L1 statuses: EGFR M-, PD-L1 ≥50% (cohort A); EGFR M-, PD-L1 <50% (cohort B); EGFR M+, PD-L1 ≥50% (cohort C); and EGFR M+, PD-L1 <50% (cohort D).
RESULTS
Overall, 31 of 249 (12.4%) and 218 of the 249 (87.6%) patients had EGFR M+ and EGFR M- NSCLC, respectively. Median PFSs and OSs did not differ (PFS: 16.6 vs. 18.7 months, p=0.591; OS: 37.4 vs. 35.7 months, p=0.271). Median PFS of cohort A did not significantly differ from the median PFSs of cohorts B and C, but it was significantly longer than the median PFS of cohort D (23.7 vs. 15.2 months, p=0.045). Cox multivariate analysis revealed that cohort D exhibited a worse PFS (adjusted hazard ratio=2.27, 95% confidence interval=1.11-4.66, p=0.025) compared with cohort A. Median OSs were not different between the four cohorts.
CONCLUSION
Durvalumab consolidation provided similar benefit in EGFR M+ patients with PD-L1 ≥50% compared with EGFR M- patients. A therapeutic role of durvalumab in patients with EGFR M+, high PD-L1 unresectable stage III NSCLC should be considered.
背景/目的：durvalumab 巩固治疗对表皮生长因子受体突变（EGFR M+）非小细胞肺癌患者效果较差。关于 durvalumab 在 EGFR M+ NSCLC 中的研究仅限于程序性死亡配体 1（PD-L1）表达。本研究旨在确定 durvalumab 对 EGFR M+患者 PD-L1 表达的影响。
患者和方法
本研究纳入了 249 例不可切除的 III 期非小细胞肺癌患者，接受 durvalumab 治疗。主要结局为无进展生存期（PFS）。基于 EGFR 和 PD-L1 状态进行 Cox 多变量分析：EGFR M-，PD-L1≥50%（队列 A）；EGFR M-，PD-L1<50%（队列 B）；EGFR M+，PD-L1≥50%（队列 C）；EGFR M+，PD-L1<50%（队列 D）。
结果
总体而言，249 例患者中，31 例（12.4%）和 218 例（87.6%）患者分别患有 EGFR M+和 EGFR M-非小细胞肺癌。中位 PFS 和 OS 无差异（PFS：16.6 与 18.7 个月，p=0.591；OS：37.4 与 35.7 个月，p=0.271）。队列 A 的中位 PFS 与队列 B 和 C 的中位 PFS 无显著差异，但显著长于队列 D 的中位 PFS（23.7 与 15.2 个月，p=0.045）。Cox 多变量分析显示，队列 D 的 PFS 较差（调整后的危险比=2.27，95%置信区间=1.11-4.66，p=0.025）。四组的中位 OS 无差异。
结论
与 EGFR M-患者相比，durvalumab 巩固治疗在 PD-L1≥50%的 EGFR M+患者中提供了相似的获益。durvalumab 治疗 EGFR M+、高 PD-L1 不可切除 III 期非小细胞肺癌患者的治疗作用应予以考虑。
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