Department of Respiratory Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan;
Division of Respiratory Medicine, Mito Medical Center, Mito, Japan.
Anticancer Res. 2022 May;42(5):2583-2590. doi: 10.21873/anticanres.15736.
BACKGROUND/AIM: Real-world data on the clinical outcomes of first-line osimertinib treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations is lacking. This study aimed to reveal the treatment outcomes and prognostic factors of osimertinib as first-line therapy in clinical practice settings.
We retrospectively evaluated clinical outcomes of patients with EGFR-mutated NSCLC treated with osimertinib as first-line therapy across 12 institutions in Japan between August 2018 and March 2020.
Among 158 enrolled patients, the objective response rate (ORR) was 68%, and the estimated median progression-free survival (PFS) was 17.1 months [95% confidence interval (CI)=14.5-19.7]. Subgroup analysis showed that PFS in the group with high programmed death-ligand 1 (PD-L1) expression was significantly shorter than that in groups with low or no PD-L1 expression (10.1 vs. 16.1 vs. 19.0 months; p=0.03). Univariate and multivariate analyses demonstrated that high PD-L1 expression was the only independent adverse prognostic factor of osimertinib outcome related to PFS (hazard ratio=2.71; 95%CI=1.26-5.84; p=0.01). In terms of anti-tumor response, there was no statistically significant correlation between PD-L1 expression and the ORR (67% vs. 76% vs. 65%; p=0.51). No significant correlation was also found between PD-L1 and the incidence of de novo resistance to osimertinib (p=0.39).
Although PD-L1 expression was not associated with either the ORR or frequency of de novo resistance, high PD-L1 expression could be an independent adverse prognostic factor related to PFS in osimertinib treatment.
背景/目的：缺乏表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）一线奥希替尼治疗的临床结局的真实数据。本研究旨在揭示奥希替尼作为一线治疗在临床实践环境中的治疗结果和预后因素。
我们回顾性评估了 2018 年 8 月至 2020 年 3 月期间，日本 12 家机构的 158 例接受奥希替尼一线治疗的 EGFR 突变型 NSCLC 患者的临床结局。
在纳入的 158 例患者中，客观缓解率（ORR）为 68%，估计中位无进展生存期（PFS）为 17.1 个月[95%置信区间（CI）=14.5-19.7]。亚组分析显示，高程序性死亡配体 1（PD-L1）表达组的 PFS 明显短于低表达或无 PD-L1 表达组（10.1 对 16.1 对 19.0 个月；p=0.03）。单因素和多因素分析表明，高 PD-L1 表达是与 PFS 相关的奥希替尼结局的唯一独立不良预后因素（风险比=2.71；95%CI=1.26-5.84；p=0.01）。在抗肿瘤反应方面，PD-L1 表达与 ORR 之间无统计学显著相关性（67%对 76%对 65%；p=0.51）。PD-L1 与奥希替尼新发耐药的发生率之间也没有显著相关性（p=0.39）。
尽管 PD-L1 表达与 ORR 或新发耐药的频率均无相关性，但高 PD-L1 表达可能是奥希替尼治疗中与 PFS 相关的独立不良预后因素。
