西班牙携带 EGFR 突变的晚期 NSCLC 患者的临床管理和结局。

Clinical management and outcome of patients with advanced NSCLC carrying EGFR mutations in Spain.

机构信息

Medical Oncology Department, Hospital del Mar, Passeig Marítim, 25-29, 08018, Barcelona, Spain.

Hospital General Universitario Gregorio Marañón, Madrid, Spain.

出版信息

BMC Cancer. 2018 Jan 30;18(1):106. doi: 10.1186/s12885-018-4004-7.

DOI:10.1186/s12885-018-4004-7

PMID:29382302

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5791371/

Abstract

BACKGROUND

Although the benefit of first-line epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors (TKIs) over chemotherapy has been demonstrated in several clinical trials, data from clinical practice is lacking and the optimal EGFR TKI to be used remains unclear. This study aims to assess the real-life diagnostic and clinical management and outcome of patients with advanced non-small-cell lung cancer (NSCLC) carrying EGFR mutations in Spain.

METHODS

All consecutive patients recently diagnosed with advanced or metastatic NSCLC from April 2010 to December 2011 in 18 Spanish hospitals and carrying EGFR mutations were retrospectively evaluated.

RESULTS

Between March and November 2013, a total of 187 patients were enrolled (98.3% Caucasian, 61.9% female, 54.9% never-smokers, 89.0% adenocarcinoma). Mutation testing was mainly performed on biopsy tumour tissue specimens (69.0%) using a qPCR-based test (90%) (47.0% Therascreen EGFR PCR Kit). Common sensitising mutations were detected in 79.8% of patients: 57.1% had exon 19 deletions and 22.6% exon 21 L858R point mutations. The vast majority of patients received first-line therapy (n = 168; 92.8%). EGFR TKIs were the most commonly used first-line treatment (81.5%), while chemotherapy was more frequently administered as a second- and third-line option (51.9% and 56.0%, respectively). Of 141 patients who experienced disease progression, 79 (56.0%) received second-line treatment. After disease progression on first-line TKIs (n = 112), 33.9% received chemotherapy, 8.9% chemotherapy and a TKI, and 9.8% continued TKI therapy. Most patients received first-line gefitinib (83.0%), while erlotinib was more frequently used in the second-line setting (83.0%). Progression-free survival (PFS) and overall survival (OS) in patients harbouring common mutations were 11.1 months and 20.1 months respectively (exon 19 deletions: 12.4 and 21.4 months; L858R: 8.3 and 14.5 months), and 3.9 months and 11.1 months respectively for those with rare mutations.

CONCLUSION

EGFR TKIs (gefitinib and erlotinib) are used as the preferred first-line treatment while chemotherapy is more frequently administered as a second- and third-line option in routine clinical practice in Spain. In addition, efficacy data obtained in the real-life setting seem to concur with data from EGFR TKI phase III pivotal studies in NSCLC.

摘要

背景

虽然表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）一线治疗比化疗更有优势，已经在多项临床试验中得到证实，但目前缺乏临床实践数据，哪种 EGFR TKI 为最佳选择仍不明确。本研究旨在评估西班牙 EGFR 突变型晚期非小细胞肺癌（NSCLC）患者的真实诊断、临床管理和预后。

方法

本研究回顾性分析了 2010 年 4 月至 2011 年 12 月间西班牙 18 家医院收治的经组织学或细胞学确诊的晚期或转移性 NSCLC 患者，这些患者携带 EGFR 突变且接受了 EGFR TKI 一线治疗。

结果

2013 年 3 月至 11 月期间，共纳入 187 例患者（98.3%为白种人，61.9%为女性，54.9%为从不吸烟者，89.0%为腺癌）。大多数患者（69.0%）的肿瘤组织标本通过基于 qPCR 的检测方法（90%）进行了基因突变检测（47.0%使用 Therascreen EGFR PCR Kit）。79.8%的患者检测到常见的敏感突变：57.1%患者存在外显子 19 缺失，22.6%患者存在外显子 21 L858R 点突变。绝大多数患者接受了一线治疗（n=168；92.8%）。EGFR TKI 是最常用的一线治疗药物（81.5%），而化疗作为二线和三线治疗的频率更高（分别为 51.9%和 56.0%）。141 例疾病进展的患者中，79 例（56.0%）接受了二线治疗。在一线 TKI 治疗后疾病进展（n=112）的患者中，33.9%接受了化疗，8.9%接受了化疗联合 TKI，9.8%继续 TKI 治疗。大多数患者接受了第一代 EGFR TKI 吉非替尼（83.0%），而厄洛替尼在二线治疗中更为常用（83.0%）。携带常见突变的患者的无进展生存期（PFS）和总生存期（OS）分别为 11.1 个月和 20.1 个月（外显子 19 缺失：12.4 和 21.4 个月；L858R：8.3 和 14.5 个月），而携带罕见突变的患者的 PFS 和 OS 分别为 3.9 个月和 11.1 个月。