多中心观察性研究厄洛替尼治疗非小细胞肺癌（OBSTAR）：GFPC 研究。

Multicenter observational study of erlotinib therapy (OBSTAR) for non small-cell lung cancer: a GFPC study.

机构信息

Service de Pneumologie, Hôpital du Cluzeau, et Unité de Recherche Clinique et Biostatistique, CHU - Limoges, France.

出版信息

Lung Cancer. 2011 Nov;74(2):264-7. doi: 10.1016/j.lungcan.2011.03.007. Epub 2011 May 14.

DOI:10.1016/j.lungcan.2011.03.007

PMID:21571389

Abstract

CONTEXT

Erlotinib therapy for non small-cell lung cancer (NSCLC) has mainly been evaluated in randomized trials.

METHOD

OBSTAR was a multicenter, retrospective, observational study involving all patients treated with erlotinib in 18 French centers between June 2005 and September 2007. The analyses focused on the patients' characteristics, previous treatments, and treatment efficacy during a three-year follow-up period.

RESULTS

534 patients were included in this study. The median survival times were respectively 5.2 [3.7-7.4] and 4.7 [4.1-5.7] months, depending to whether erlotinib was used as second- (n=190), or ≥ third-line treatment (n=305). The disease control rate were 39.1% [30.2-48.7] and 29.9% [29.6-36.9] according to the line of treatment. Factors predictive of an objective response were gender, age, and smoking status. Factors predictive of progression were age, sex, smoking status, the line of treatment, and the number of metastases. Treatment had to be interrupted for toxicity in 8.5% of cases.

CONCLUSION

This study of erlotinib therapy in 2005-2007 confirms, in the general NSCLC patient population, the results of pivotal trials.

摘要

背景

厄洛替尼治疗非小细胞肺癌（NSCLC）主要在随机试验中进行评估。

方法

OBSTAR 是一项多中心、回顾性、观察性研究，涉及 2005 年 6 月至 2007 年 9 月在法国 18 个中心接受厄洛替尼治疗的所有患者。分析重点是患者的特征、先前的治疗和三年随访期间的治疗效果。

结果

本研究共纳入 534 例患者。中位生存时间分别为 5.2 [3.7-7.4] 和 4.7 [4.1-5.7] 个月，取决于厄洛替尼是否作为二线（n=190）或≥三线治疗（n=305）。根据治疗线，疾病控制率分别为 39.1% [30.2-48.7] 和 29.9% [29.6-36.9]。客观缓解的预测因素为性别、年龄和吸烟状况。疾病进展的预测因素为年龄、性别、吸烟状况、治疗线和转移灶数量。由于毒性，8.5%的病例需要中断治疗。