Takashima Kenta, Wakabayashi Hiroki, Murakami Yu, Saiki Atsuhito, Matsuzawa Yasuo
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Graduate School of Medicine, Ota-ku, Tokyo, Japan.
Department of Internal Medicine, Toho University Sakura Medical Center, 564-1 Shimoshidu, Sakura-shi, Chiba, 285-8741, Japan.
Drugs Real World Outcomes. 2024 Dec;11(4):603-615. doi: 10.1007/s40801-024-00449-8. Epub 2024 Aug 29.
The prognosis of patients with epidermal growth factor receptor (EGFR) mutation-positive lung cancer has improved significantly since the advent of EGFR tyrosine kinase inhibitors (EGFR-TKIs). We aimed to investigate the relationship between patient characteristics, EGFR genotype, therapeutic agents, and the prognosis of the patients with EGFR mutation-positive lung cancer.
This retrospective cohort study analyzed 198 Japanese patients with unresectable EGFR mutation-positive lung cancer who were treated with EGFR-TKIs at Toho University Sakura Medical Center from April 2006 to December 2021. Factors associated with overall survival (OS) were analyzed using Cox proportional hazards analysis.
Patients who received osimertinib had a significantly longer OS than did those not receiving it (median OS, 36.2 versus 20.7 months; p < 0.001).There were significant differences in OS between patients with EGFR mutation who received osimertinib as first-line treatment, T790M-positive patients who received osimertinib as second- or later-line treatment, and those who did not receive it (median OS, 28.2 versus 40.2 versus 20.7 months; p = 0.003). However, in T790M-negative patients, no significant difference in OS was noted between those who did and did not receive osimertinib as post-treatment (median OS, 28.0 versus 40.0 months; p = 0.619). Multivariate Cox proportional hazards analysis showed that osimertinib treatment was associated with longer OS (hazard ratio, 0.480; 95% confidence interval, 0.326-0.707; p < 0.001).
The patients who were T790M-positive in the first-line treatment with first or second-generation EGFR-TKIs and were given osimertinib as the second or later line treatment had a better prognosis than the patients who were T790M-negative in the first-line treatment with first or second-generation EGFR-TKIs and could not receive osimertinib.
自表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（EGFR-TKIs）问世以来，EGFR突变阳性肺癌患者的预后有了显著改善。我们旨在研究患者特征、EGFR基因型、治疗药物与EGFR突变阳性肺癌患者预后之间的关系。
这项回顾性队列研究分析了2006年4月至2021年12月在东邦大学樱花医疗中心接受EGFR-TKIs治疗的198例无法切除的EGFR突变阳性日本肺癌患者。使用Cox比例风险分析来分析与总生存期（OS）相关的因素。
接受奥希替尼治疗的患者的总生存期明显长于未接受该治疗的患者（中位总生存期，36.2个月对20.7个月；p<0.001）。在接受奥希替尼作为一线治疗的EGFR突变患者、接受奥希替尼作为二线或更后线治疗的T790M阳性患者以及未接受该治疗的患者之间，总生存期存在显著差异（中位总生存期，28.2个月对40.2个月对20.7个月；p=0.003）。然而，在T790M阴性患者中，接受和未接受奥希替尼作为后续治疗的患者之间，总生存期没有显著差异（中位总生存期，28.0个月对40.0个月；p=0.619）。多因素Cox比例风险分析表明，奥希替尼治疗与更长的总生存期相关（风险比，0.480；95%置信区间，0.326-0.707；p<0.001）。
在一线使用第一代或第二代EGFR-TKIs治疗时T790M阳性且在二线或更后线接受奥希替尼治疗的患者，其预后优于在一线使用第一代或第二代EGFR-TKIs治疗时T790M阴性且无法接受奥希替尼治疗的患者。
