Service de Pneumologie et Oncologie Thoracique, Hôpital F. Quesnay, 2 Boulevard de Sully, 78200, Mantes-la-Jolie, France.
Pneumologie, CH François Quesnay, Mantes-la-Jolie, France.
Target Oncol. 2019 Jun;14(3):307-314. doi: 10.1007/s11523-019-00646-4.
The resistance mutation T790M is reported in 50-60% of patients pretreated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Osimertinib has been approved in these patients, but data in octogenarians remain rare.
The objective of this retrospective analysis was to evaluate in real life the efficacy of osimertinib in a population of octogenarian patients.
This retrospective multicentric study included pretreated octogenarian patients with EGFR T790M-mutated advanced non-small cell lung cancer (NSCLC) in the setting of the French early access program for osimertinib. The primary endpoints were progression-free survival (PFS) and overall survival (OS) from osimertinib initiation.
In total, 43 patients were included (mean age 84.6 years; women 90.7%: adenocarcinoma 100%; never smokers 90.5%; at osimertinib initiation: performance status ≥ 2, 42.4%; stage 4, 93.0%; brain metastases 16.3%). Patients received a median of two lines of treatment before osimertinib initiation, and all received first- or second-generation EGFR TKIs before osimertinib (first line in 79.1%). Osimertinib was used as a second-line treatment in 41.9% of cases and third line or more in 58.1%. Median PFS was 17.5 (95% confidence interval [CI] 12.2-19.0) months for the entire population: 20.6 (95% CI 18.8-not reached) months in patients with brain metastases and 16.7 (95% CI 10.4-18.9) months in patients without (p = 0.1). There was no significant difference for osimertinib treatment as second or third line or more (17.1 vs. 18.6 months, respectively). OS was 22.8 (95% CI 15.7-not reached) months from osimertinib initiation.
The efficacy of osimertinib as second-line treatment or more in octogenarian pretreated patients with EGFR T790M-mutated advanced NSCLC in a real-life setting was similar to that in randomized controlled trials.
表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）预处理的患者中，约有 50-60%存在 T790M 耐药突变。奥希替尼已在这些患者中获批，但 80 岁以上患者的数据仍然很少。
本回顾性分析旨在评估奥希替尼在 80 岁以上患者人群中的真实疗效。
本回顾性多中心研究纳入了法国奥希替尼早期准入计划中接受 EGFR T790M 突变的晚期非小细胞肺癌（NSCLC）预处理的 80 岁以上患者。主要终点是从奥希替尼起始的无进展生存期（PFS）和总生存期（OS）。
共纳入 43 例患者（平均年龄 84.6 岁；女性占 90.7%：腺癌 100%；从不吸烟者占 90.5%；奥希替尼起始时：体能状态≥2 占 42.4%，IV 期占 93.0%，脑转移占 16.3%）。患者在起始奥希替尼前接受了中位数为两线的治疗，且所有患者均在奥希替尼前接受了第一代或第二代 EGFR-TKIs（一线治疗中占 79.1%）。奥希替尼二线治疗占 41.9%，三线及以上治疗占 58.1%。全人群的中位 PFS 为 17.5（95%置信区间 [CI] 12.2-19.0）个月：有脑转移的患者为 20.6（95%CI 18.8-未达到）个月，无脑转移的患者为 16.7（95%CI 10.4-18.9）个月（p=0.1）。奥希替尼作为二线或三线及以上治疗时，其疗效无显著差异（分别为 17.1 和 18.6 个月）。从奥希替尼起始的 OS 为 22.8（95%CI 15.7-未达到）个月。
奥希替尼作为二线或三线及以上治疗在真实环境中预处理的 EGFR T790M 突变的晚期 NSCLC 80 岁以上患者中的疗效与随机对照试验相似。
