Service de Pneumologie et Oncologie Thoracique, Center Hospitalier (CH) François Quesnay, 2, Boulevard de Sully, 78200, Mantes-la-Jolie, France.
Centre Hospitalier Intercommunal de Créteil (CHI), Créteil, France.
Target Oncol. 2017 Dec;12(6):833-838. doi: 10.1007/s11523-017-0520-7.
Chromosomal translocations involving the anaplastic lymphoma kinase gene (ALK) are rare oncogenic events found in 3-5% of non-small-cell lung cancers (NSCLC). Limited data have been published on the management of these patients outside clinical trials.
To investigate the clinical characteristics and management of patients with NSCLC harboring ALK translocations (ALK+) in a real-life setting in France.
This multicenter, observational, retrospective study included all NSCLC patients harboring ALK translocations diagnosed in participating centers between January 2012 and December 2014. Patient data include clinical characteristics, disease management, and outcomes [progression-free survival (PFS) and overall survival (OS)].
The 31 participating centers reported data on 132 patients, of whom 51% (n = 67) were male. The median age was 60.1 ± 14.5 (standard deviation) years; 89% (n = 106/119) had performance status 0/1 at diagnosis; 79% (n = 103/130) were non- or former smokers; 93% (n = 120/129) had adenocarcinomas and 74%(n = 97)/19%(n = 25)/7%(n = 10) had disease stages IV/III/I-II at diagnosis, respectively; co-mutations included EGFR (n = 2), BRAF (n = 2), KRAS (n = 1), and HER2 (n = 1). Of the patients with stage IV NSCLC (n = 97), 96% received first-line treatment [75% chemotherapy-based, 21% ALK tyrosine kinase inhibitor (TKI)], with an associated response rate (RR), disease-control rate (DCR), and PFS of 42%, 64%, and 7.5 [95% confidence interval (CI) 5.9-9.5] months, respectively; 62% received second-line treatment (28% chemotherapy, 72% ALK TKI) with an associated RR, DCR, and PFS of 43.4%, 70%, and 4.7 (95% CI 4.0-8.1) months, respectively. The 2-year OS was 56.7% (95% CI 45.5-70.4%); median OS was not reached.
The results of this real-life analysis suggest that the prognosis of NSCLC patients with theALK translocation may be better than that of the overall NSCLC population, but the outcomes were poorer than those of ALK+ NSCLC patients included in clinical studies.
染色体易位涉及间变性淋巴瘤激酶基因（ALK）在 3-5%的非小细胞肺癌（NSCLC）中是罕见的致癌事件。在临床试验之外，关于这些患者的治疗管理，仅有有限的数据发表。
研究法国真实环境中携带 ALK 易位（ALK+）的 NSCLC 患者的临床特征和管理方法。
这是一项多中心、观察性、回顾性研究，纳入了 2012 年 1 月至 2014 年 12 月期间参与中心诊断的所有携带 ALK 易位的 NSCLC 患者。患者数据包括临床特征、疾病管理和结局[无进展生存期（PFS）和总生存期（OS）]。
31 个参与中心报告了 132 名患者的数据，其中 51%（n=67）为男性。中位年龄为 60.1±14.5（标准差）岁；89%（n=106/119）在诊断时的表现状态为 0/1；79%（n=103/130）为非吸烟者或前吸烟者；93%（n=120/129）为腺癌，74%（n=97/）、19%（n=25/）和 7%（n=10/）分别在诊断时处于疾病 IV/III/I-II 期；合并突变包括 EGFR（n=2）、BRAF（n=2）、KRAS（n=1）和 HER2（n=1）。97 名患有 IV 期 NSCLC 的患者中，96%接受了一线治疗[75%基于化疗，21%ALK 酪氨酸激酶抑制剂（TKI）]，相应的缓解率（RR）、疾病控制率（DCR）和 PFS 分别为 42%、64%和 7.5[95%置信区间（CI）5.9-9.5]个月；62%接受了二线治疗（28%化疗，72%ALK TKI），相应的 RR、DCR 和 PFS 分别为 43.4%、70%和 4.7（95%CI 4.0-8.1）个月。2 年 OS 为 56.7%（95%CI 45.5-70.4%）；中位 OS 未达到。
这项真实分析的结果表明，ALK 易位 NSCLC 患者的预后可能优于总体 NSCLC 人群，但结局比临床研究中纳入的 ALK+ NSCLC 患者更差。
