Department of Respiratory Medicine, Allergology and Sleep Medicine, Paracelsus Medical University Nuernberg, General Hospital Nuernberg, Prof.-Ernst-Nathan-Str. 1, Nuremberg, Germany.
Lung Clinic Lostau, Department of Thoracic Oncology, Lindenstr. 2, Lostau, Nuremberg, Germany.
BMC Cancer. 2018 Mar 27;18(1):333. doi: 10.1186/s12885-018-4208-x.
In this prospective non-interventional study, the effectiveness and tolerability of erlotinib in elderly patients with non-small-cell lung cancer (NSCLC) after ≥1 platinum-based chemotherapy were assessed.
A total of 385 patients ≥65 years of age with advanced NSCLC receiving erlotinib were observed over 12 months. The primary endpoint was the 1-year overall survival (OS) rate.
Patients were predominantly Caucasian (99.2%), a mean of 73 years old; 24.7% had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2. Most common tumor histologies were adenocarcinoma (64.9%) and squamous cell carcinoma (22.3%). Of 119 patients tested, 15.1% had an activating epidermal growth factor receptor gene (EGFR) mutation. The 1-year OS rate was 31% (95% CI 25-36) with a median OS of 7.1 months (95% CI 6.0-7.9). OS was significantly better in females than males (p = 0.0258) and in patients with an EGFR mutation compared to EGFR wild-type patients (p = 0.0004). OS was not affected by age (p = 0.3436) and ECOG PS (p = 0.5364). Patients with squamous NSCLC tended to live longer than patients with non-squamous EGFR wild-type tumors (median OS: 8.6 vs 5.5 months). Cough and dyspnea improved during the observation period. The erlotinib safety profile was comparable to that in previous studies with rash (45.2%) and diarrhea (22.6%) being the most frequently reported adverse events.
Erlotinib represents a suitable palliative treatment option in further therapy lines for elderly patients with advanced NSCLC. The results obtained under real-life conditions add to our understanding of the benefits and risks of erlotinib in routine clinical practice.
BfArM ( https://www.bfarm.de ; ML23023); ClinicalTrials.gov (NCT01535729; 20 Feb 2012).
在这项前瞻性、非干预性研究中，评估了厄洛替尼在≥1 线铂类化疗后老年非小细胞肺癌（NSCLC）患者中的疗效和耐受性。
共观察了 385 名年龄≥65 岁、接受厄洛替尼治疗的晚期 NSCLC 患者，观察时间为 12 个月。主要终点为 1 年总生存率（OS）。
患者主要为白种人（99.2%），平均年龄 73 岁；24.7%的患者东部肿瘤协作组体力状况（ECOG PS）≥2。最常见的肿瘤组织学类型为腺癌（64.9%）和鳞状细胞癌（22.3%）。在 119 例接受检测的患者中，15.1%有激活的表皮生长因子受体基因（EGFR）突变。1 年 OS 率为 31%（95%CI 25-36），中位 OS 为 7.1 个月（95%CI 6.0-7.9）。女性的 OS 明显优于男性（p=0.0258），EGFR 突变患者的 OS 明显优于 EGFR 野生型患者（p=0.0004）。OS 不受年龄（p=0.3436）和 ECOG PS（p=0.5364）的影响。鳞状 NSCLC 患者的中位 OS 长于非鳞状 EGFR 野生型肿瘤患者（中位 OS：8.6 与 5.5 个月）。咳嗽和呼吸困难在观察期间有所改善。厄洛替尼的安全性与既往研究一致，皮疹（45.2%）和腹泻（22.6%）是最常见的不良反应。
厄洛替尼是晚期 NSCLC 老年患者进一步治疗的合适姑息治疗选择。在真实环境下获得的结果，增加了我们对厄洛替尼在常规临床实践中的获益和风险的理解。
BfArM（https://www.bfarm.de；ML23023）；ClinicalTrials.gov（NCT01535729；2012 年 2 月）。
