Retrospective analysis of the predictive factors associated with the response and survival benefit of gefitinib in patients with advanced non-small-cell lung cancer
Retrospective analysis of the predictive factors associated with the response and survival benefit of gefitinib in patients with advanced non-small-cell lung cancer
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DOI：
10.1016/j.lungcan.2004.04.032
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发表时间：
2004-11-01
期刊：
影响因子：
5.3
通讯作者：
Fukuoka, M
中科院分区：
文献类型：
--
作者：
Kaneda, H;Tamura, K;Fukuoka, M
背景资料：该研究的目的是确定与吉非替尼给药的反应和生存获益相关的潜在预测特征。方法：回顾性分析1998年8月至2003年7月在我院接受吉非替尼单药治疗的101例非小细胞肺癌（NSCLC）患者的临床资料。与吉非替尼反应相关的潜在因素包括吸烟指数、性别、组织学、体能状态（PS）、预治疗次数、年龄和分期。单因素分析采用Fisher精确检验，多因素分析采用Logistic回归模型。结果：总有效率为19.8%。单变量分析显示，显著的预测因素与“腺癌”、“女性”、"PS良好“（0- 1）和”非吸烟者“类别的反应相关。多变量分析限制了与“女性”（P = 0.0032）、"PS良好“（P < 0.02）和”非吸烟者“（P = 0.0417）反应相关的预测因素。在生存分析中，“女性”（P < 0.005），“良好PS”（P < 0.0001），低吸烟指数（P < 0.05）者生存期明显延长。老年患者的缓解和生存数据与年轻患者相当。不良事件（AE）通常为轻度，几乎总是皮肤反应和腹泻。间质性肺病（ILD）发生在4%的组下observation.Conclusions：吉非替尼提供了以下因素的临床效益“女性”，“良好的PS”和“非吸烟者”。据报道，低吸烟指数是吉非替尼单药治疗后的一种新的预测预后因素。(C)2004爱思唯尔爱尔兰有限公司保留所有权利。
Background: The purpose of the study was to identify the potential predictive features associated with the response and survival benefit of gefitinib administration. We have retrospectively reviewed data of all patients who received a single regimen of gefitinib in our institution from August 1998 until July 2003.Methods: Overall 101 patients with non-small-cell lung cancer (NSCLC) who have received a single use of gefitinib were analyzed. Potential factors associated with the response of gefitinib included smoking index, gender, histology, performance status (PS), number of pre-treatments, age and stage. Univariate analysis was performed for these strata by Fisher's exact test and multivariate analysis was then performed using the Logistic regression model.Results: The overall response rate was 19.8%. Univariate analysis revealed that significant predictive factors were associated with the response for 'adenocarcinoma', 'female', 'good PS' (0-l) and 'non-smoker' categories. Multivariate analysis limited the predictive factors associated with the response for 'female' (P = 0.0032), 'good PS' (P < 0.02) and 'non-smoker' (P = 0.0417). In survival analyses, 'female' (P < 0.005), 'good PS' (P < 0.0001.), and a low level of the smoking index (P < 0.05) indicated significantly prolonged survival. Response and survival data in elderly patients were equivalent to those in younger patients. Adverse events (AEs) were generally mild and were almost always skin reactions and diarrhea. Interstitial lung disease (ILD)occurred in 4% of the group under observation.Conclusions: Gefitinib provided clinical benefit for the following factors 'female', 'good PS' and 'non-smoker'. A low smoking index is reported as a novel predictive prognostic factor following a single regimen of gefitinib. (C) 2004 Elsevier Ireland Ltd. All rights reserved.