BACKGROUND:Gender, smoking history, adenocarcinoma histology, performance status, and East Asian ethnicity were predictive factors of gefitinib response in previous analysis. However, these factors tend to be correlated with each other; it is not clear whether gender, smoking history, and adenocarcinoma histology were all independent predictors for response in East Asian populations.
METHODS:Tumor response, survival and predictive factors of gefitinib response of advanced non-small cell lung cancer patients treated between May of 2002 and November of 2004 were collected retrospectively from three medical centers in Taiwan. Univariate and multivariate logistic regression models were used to test potential predictive factors associated with response to gefitinib. Overall survivals between groups with different predictive factors were compared by log-rank tests. Multivariate analyses were performed to identify factors that independently predict for survival.
RESULTS:A total of 428 patients were analyzed. The median follow-up duration for living patients was 19.5 months (range, 10.2-39.9). Objective tumor response was observed in 114 patients (26.6%, 95% confidence interval [CI]: 22.4%-30.8%) and disease stabilization in 129 patients (30.2%). Response rate was statistically significant higher in adenocarcinoma, good performance status, and chemonaive patients in multivariate analysis. The median survival was 7.4 months (95% CI: 5.8-9.0) and 1-year survival was 34.3% (95% CI: 29.0%-38.0%). Significant independent predictive factors associated with longer survival in multivariate analysis were good performance status (p < 0.001) and responsiveness to gefitinib (p < 0.001). In 286 chemotherapy-treated patients, the response rate was 22.7%. Median and 1-year survival was 7.9 months and 36.7%, respectively. Good performance status was predictive of tumor response (p < 0.001) and better survival (p < 0.001) in multivariate analysis. Response to gefitinib was predictive of better survival (p < 0.001).
CONCLUSIONS:Gender and smoking status were not, but good performance status (PS), no previous chemotherapy, and adenocarcinoma histology were independent predictive factors in multivariate analysis for gefitinib response in Taiwanese advanced non-small cell lung cancer population. In patients previously treated with chemotherapy, only good PS was an independent predictor for tumor response in multivariate analysis.
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【Predictive factors of gefitinib antitumor activity in East Asian advanced non-small cell lung cancer patients.].
【东亚晚期非小细胞肺癌患者吉非替尼抗肿瘤活性的预测因素。】
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背景：性别，吸烟史，腺癌组织学，行为状态和东亚种族是吉非替尼反应的预测因素。但是，这些因素往往相互关联。目前尚不清楚性别，吸烟史和腺癌组织学是否都是东亚人群反应的独立预测因素。
方法：回顾性收集台湾2002年5月至2004年11月间接受治疗的晚期非小细胞肺癌患者的肿瘤反应，生存率和吉非替尼反应的预测因素。单因素和多因素逻辑回归模型用于测试与吉非替尼反应相关的潜在预测因素。通过对数秩检验比较具有不同预测因素的组之间的总体生存率。进行多变量分析以鉴定独立预测生存的因素。
结果：共分析428例患者。在职患者的中位随访时间为19.5个月（范围10.2-39.9）。在114例患者中观察到客观的肿瘤反应（26.6％，95％置信区间[CI]：22.4％-30.8％），在129例患者中观察到疾病稳定（30.2％）。在多因素分析中，腺癌，良好的工作状态和趋化性患者的应答率在统计学上显着较高。中位生存期为7.4个月（95％CI：5.8-9.0），一年生存率为34.3％（95％CI：29.0％-38.0％）。多变量分析中与更长生存期相关的重要独立预测因素是良好的表现状态（p <0.001）和对吉非替尼的反应性（p <0.001）。在286例经化学疗法治疗的患者中，缓解率为22.7％。中位生存期和1年生存期分别为7.9个月和36.7％。在多变量分析中，良好的表现状态可预测肿瘤反应（p <0.001）和更好的生存率（p <0.001）。对吉非替尼的反应可预示更好的生存率（p <0.001）。
结论：在台湾晚期非小细胞肺癌人群的吉非替尼反应多因素分析中，性别和吸烟状况并非如此，但良好的表现状态（PS），既往无化疗和腺癌组织学是吉非替尼反应多变量分析的独立预测因素。在先前接受过化疗的患者中，多变量分析中只有良好的PS是肿瘤反应的独立预测因子。
方法：回顾性收集台湾2002年5月至2004年11月间接受治疗的晚期非小细胞肺癌患者的肿瘤反应，生存率和吉非替尼反应的预测因素。单因素和多因素逻辑回归模型用于测试与吉非替尼反应相关的潜在预测因素。通过对数秩检验比较具有不同预测因素的组之间的总体生存率。进行多变量分析以鉴定独立预测生存的因素。
结果：共分析428例患者。在职患者的中位随访时间为19.5个月（范围10.2-39.9）。在114例患者中观察到客观的肿瘤反应（26.6％，95％置信区间[CI]：22.4％-30.8％），在129例患者中观察到疾病稳定（30.2％）。在多因素分析中，腺癌，良好的工作状态和趋化性患者的应答率在统计学上显着较高。中位生存期为7.4个月（95％CI：5.8-9.0），一年生存率为34.3％（95％CI：29.0％-38.0％）。多变量分析中与更长生存期相关的重要独立预测因素是良好的表现状态（p <0.001）和对吉非替尼的反应性（p <0.001）。在286例经化学疗法治疗的患者中，缓解率为22.7％。中位生存期和1年生存期分别为7.9个月和36.7％。在多变量分析中，良好的表现状态可预测肿瘤反应（p <0.001）和更好的生存率（p <0.001）。对吉非替尼的反应可预示更好的生存率（p <0.001）。
结论：在台湾晚期非小细胞肺癌人群的吉非替尼反应多因素分析中，性别和吸烟状况并非如此，但良好的表现状态（PS），既往无化疗和腺癌组织学是吉非替尼反应多变量分析的独立预测因素。在先前接受过化疗的患者中，多变量分析中只有良好的PS是肿瘤反应的独立预测因子。
