Background/Objectives: Osimertinib is a standard sequential therapy for advanced and recurrent Epidermal Growth Factor Receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) patients with the T790M mutation, following treatment with first- or second-generation EGFR Tyrosine Kinase Inhibitors (TKIs). This study aims to investigate the differences in clinical outcomes between osimertinib as a 2nd-line treatment and as a ≥3rd-line treatment in this patient population. Methods: Between September 2014 and March 2023, we enrolled advanced and recurrent T790M + NSCLC patients who had received osimertinib as sequential treatment for analysis. All patients had previously been treated with gefitinib, erlotinib, or afatinib as first-line therapy. Results: A total of 158 patients who received osimertinib as sequential treatment were included in the final analysis. Of these, 99 patients (62.7%) received osimertinib as a 2nd-line treatment, while 59 patients (37.3%) were treated with osimertinib as ≥3rd-line therapy. The median progression-free survival (PFS) was 10.7 months for the 2nd-line group and 8.9 months for the ≥3rd-line group. The median overall survival (OS) from first-line treatment was 73.2 months in the 2nd-line group and 57.5 months in the ≥3rd-line group. No statistically significant differences in PFS or OS were observed between the two groups. Conclusions: Our research demonstrated that osimertinib is effective not only as a 2nd-line therapy but also as a ≥3rd-line treatment, offering promising clinical benefits for advanced and recurrent EGFR-mutant NSCLC patients with acquired T790M mutations who have developed resistance to first- and second-generation EGFR-TKI therapy.
背景/目的:奥希替尼是经第一代或第二代表皮生长因子受体酪氨酸激酶抑制剂治疗后,携带T790M突变的晚期及复发性表皮生长因子受体突变非小细胞肺癌患者的标准序贯治疗方案。本研究旨在探讨奥希替尼作为二线治疗与作为≥三线治疗在该患者群体中的临床结局差异。方法:在2014年9月至2023年3月期间,我们纳入了接受奥希替尼作为序贯治疗的晚期及复发性T790M阳性非小细胞肺癌患者进行分析。所有患者既往均接受过吉非替尼、厄洛替尼或阿法替尼作为一线治疗。结果:共有158例接受奥希替尼序贯治疗的患者被纳入最终分析。其中,99例患者(62.7%)将奥希替尼作为二线治疗,59例患者(37.3%)将奥希替尼作为≥三线治疗。二线治疗组的中位无进展生存期为10.7个月,≥三线治疗组为8.9个月。从一线治疗开始计算的中位总生存期在二线治疗组为73.2个月,在≥三线治疗组为57.5个月。两组间在无进展生存期或总生存期方面均未观察到统计学显著差异。结论:我们的研究表明,奥希替尼不仅作为二线治疗有效,作为≥三线治疗同样有效,为对第一代和第二代表皮生长因子受体酪氨酸激酶抑制剂产生耐药性并获得性T790M突变的晚期及复发性表皮生长因子受体突变非小细胞肺癌患者提供了具有前景的临床获益。