吉非替尼治疗局部晚期或转移性非小细胞肺癌患者疗效及生存的临床预测因素——两项Ⅱ期临床研究的综合分析

Predictive factors for response and survival of gefitinib-treated locally advanced or metastatic non-small cell lung cancer patients:a retrospective analysis of two phase II clinical trials

背景与目的:研究显示临床因素和分子生物学指标可以预测接受吉非替尼治疗的局部晚期或转移性非小细胞肺癌患者的预后。我们对两项研究中接受吉非替尼治疗的晚期非小细胞肺癌患者进行回顾性分析,以找出可以更加准确地预测吉非替尼治疗中国肺癌患者疗效及生存的临床因素。方法:集合吉非替尼记名供药计划(expanded access program)和注册临床试验两项研究的病例,共256例患者,回顾性分析疗效和生存的相关资料,用单因素和多因素分析确定疗效和生存的预测因子。结果:吉非替尼治疗化疗失败的局部晚期或转移性非小细胞肺癌患者的客观有效率和疾病控制率分别为24.6%和54.7%,中位生存期11.4个月(95%CI8.6～14.2个月),1年生存率48.0%(95%CI41%～55%),腺癌和出现皮疹的患者疗效较好,PS评分0～1和吉非替尼治疗后疾病得到控制(CR+PR+SD)的患者生存期较长。结论:中国患者中腺癌、皮疹是影响吉非替尼治疗疗效的独立预测因子,而PS评分0～1和吉非替尼治疗后疾病控制是影响生存的独立预测因子。

Background and Objective. Clinical factors and molecular markers can be used to predict the prognosis of gefitinib-treated locally advanced or metastatic non-small cell lung cancer （NSCLC）. This study was to identify predictive factors for the response and survival of gefitinib-treated Focally advanced or metastatic NSCLC patients in China. Methods. Clinical data of 256 gefitinib-treated Chinese NSCLC patients from two existing clinical trials were analyzed. Univariate and multivariate analyses were performed to determine predictive factors of response and survival. Results. The objective response rate was 24.6%; the disease control rate was 54.7%. Median survival time was tl.43 months （95% CI, 8.64-14.22 months）. The 1-year survival rate was 48.0% （95% CI, 41.0%-55.0%）. Adenocarcinoma and skin rash were associated with better response. The patients with lower performance status （PS） score （0-1） and those with disease control （complete remission, partial remission, and stable disease） had longer survival when compared with their counterparts. Conclusions. Adenocarcinoma and skin rash are predictors of better response to gefitinib. Low PS score and disease control are predictors of longer survival after treatment of gefitinib.