National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Number 17 Panjiayuan Nan Li, Chao Yang District, Beijing, 100021, China.
Clin Transl Oncol. 2019 Oct;21(10):1424-1431. doi: 10.1007/s12094-019-02071-5. Epub 2019 Mar 12.
Central nervous system (CNS) metastases are very common in patients with non-small-cell lung cancer (NSCLC). We aimed to explore the clinical impact of osimertinib, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), on CNS metastases in patients with advanced NSCLC in real-world setting.
Patients with advanced NSCLC who received osimertinib after progression of early-generation EGFR-TKIs and CNS metastases on baseline brain scan were retrospectively collected. Primary outcomes were disease control rate (DCR) and progression-free survival (PFS), and secondary objectives were objective response rate (ORR), time to tumor response, median best percentage change from baseline in CNS target lesion (TL) size and safety.
Between Apr 1, 2017, and Dec 30, 2017, 22 patients met selection criteria, 15 with ≥ 1 measurable CNS lesion (RECIST 1.1) were included in CNS evaluable for response (cEFR) set. Among the 22 patients, ORR and DCR were 40.9% and 86.4%, respectively, with median PFS of 8.5 months (95% CI 4.1, 13.0). Median intracranial PFS was not reached. Of 15 patients in cEFR set, CNS DCR was 80.0% with complete response reported in 3 patients (20.0%). Median best percentage change from baseline in CNS TL size was - 40% (range - 100 to + 60%) and median time to CNS tumor response was 1.3 months. CNS ORR was 53.3%. The safety profile was acceptable and no new unexpected findings were found.
This real-world analysis further confirmed that osimertinib indeed demonstrated clinically meaningful efficacy against CNS metastases in Chinese patients with advanced NSCLC.
中枢神经系统（CNS）转移在非小细胞肺癌（NSCLC）患者中非常常见。我们旨在探索第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）奥希替尼对真实世界中晚期 NSCLC 患者 CNS 转移的临床影响。
回顾性收集了在基线脑扫描时进展期 EGFR-TKI 治疗后且出现 CNS 转移的晚期 NSCLC 患者接受奥希替尼治疗的病例。主要结局为疾病控制率（DCR）和无进展生存期（PFS），次要结局为客观缓解率（ORR）、肿瘤反应时间、基线时 CNS 靶病灶（TL）大小的最佳百分比变化中位数和安全性。
2017 年 4 月 1 日至 2017 年 12 月 30 日期间，共 22 例患者符合入选标准，其中 15 例具有≥1 个可测量的 CNS 病灶（RECIST 1.1），被纳入 CNS 可评估反应（cEFR）组。22 例患者中，ORR 和 DCR 分别为 40.9%和 86.4%，中位 PFS 为 8.5 个月（95%CI 4.1，13.0）。中位颅内 PFS 尚未达到。在 cEFR 组的 15 例患者中，CNS DCR 为 80.0%，其中 3 例患者（20.0%）报告完全缓解。基线时 CNS TL 大小的最佳百分比变化中位数为-40%（范围-100%至+60%），中位 CNS 肿瘤反应时间为 1.3 个月。CNS ORR 为 53.3%。安全性特征可接受，未发现新的意外发现。
这项真实世界分析进一步证实，奥希替尼在中国晚期 NSCLC 患者中对 CNS 转移具有显著的临床疗效。
