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Observational study on the efficacy and safety of erlotinib in patients with non-small cell lung cancer

机译：厄洛替尼治疗非小细胞肺癌疗效和安全性的观察研究

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To evaluate the efficacy and safety of erlotinib for non-small cell lung cancer (NSCLC), we performed a population-based observational study. The study involved 307 patients treated with erlotinib at 14 sites (17 departments) in Ibaraki (Japan) between December 2007 and December 2010. The tumor response and disease control rates were 11.1 and 46.3% in all patients, respectively. The median time to treatment failure and survival time were 1.6 months (95% confidence interval, 41-57 days) and 5.3 months (134-181 days) in all patients, respectively. Survival was significantly prolonged in EGFR mutation-positive patients compared with negative patients. EGFR mutation-negative patients who presented with a skin rash had significantly prolonged survival compared with those without a skin rash. The most common adverse event was skin disorder, followed by diarrhea. Although 45.6% of the patients in this study received erlotinib as a fourth-line or subsequent treatment, the results from this study were similar to those of clinical studies. We deduce that erlotinib is effective against NSCLC and is tolerated in clinical practice.
机译：为了评估厄洛替尼对非小细胞肺癌（NSCLC）的疗效和安全性，我们进行了一项基于人群的观察性研究。该研究于2007年12月至2010年12月在日本茨城县的14个地点（17个部门）纳入307例接受厄洛替尼治疗的患者。所有患者的肿瘤反应率和疾病控制率分别为11.1和46.3％。所有患者的中位治疗失败时间和生存时间分别为1.6个月（95％置信区间，41-57天）和5.3个月（134-181天）。与阴性患者相比，EGFR突变阳性患者的生存期显着延长。与没有皮疹的患者相比，出现皮疹的EGFR突变阴性患者的生存期显着延长。最常见的不良事件是皮肤疾病，然后是腹泻。尽管该研究中有45.6％的患者接受了厄洛替尼作为四线治疗或后续治疗，但该研究的结果与临床研究相似。我们推论厄洛替尼对NSCLC有效，并且在临床实践中可以耐受。

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