Lai Shiue-Wei, Ho Ching-Liang, Dai Ming-Shen, Chen Wei-Liang, Chang Ping-Ying, Wu Yi-Ying, Perng Cherng-Lih, Lai Chung-Yu
Division of Hematology-Oncology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
J BUON. 2014 Apr-Jun;19(2):459-65.
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) represent a new treatment option for patients with advanced lung adenocarcinoma. In this article we assessed the treatment response and tried to identify prognostic factors which may provide some information different from previously published reports in groups with better performance status (PS) than our enrolled patients.
The records of 85 patients with EGFR-mutated advanced lung adenocarcinoma who received gefitinib 250 mg once daily as front-line monotherapy between October 2007 and October 2012 were analysed. Direct sequencing methods were used for detecting EGFR mutations. SPSS (version 20) software was used for all data analysis.
The median overall survival (OS) and progression free survival (PFS) were 25.6 and 6.9 months, respectively. No statistical significance between the two groups of exon 19 and exon 21 in OS and PFS was registered (p=0.414 and p=0.519, respectively). The group of patients treated > 3 months had a better median OS survival compared with those treated < 3 months (25.6 vs 4.9 months, p<0.001). In multivariate analysis, significant benefit on OS was observed in patients with ECOG PS scores of 0-2 (p=0.002) and those treated for longer time periods (p<0.001), rather than age, sex and smoking. Among the adverse effects (AEs), skin manifestation was correlated with significantly better OS (p=0.007) but insignificant effect on PFS (p=0.131).
Good ECOG PS, longer TKI use and skin rash were significant factors predictive for gefitinib antitumor activity.
表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKIs）是晚期肺腺癌患者的一种新的治疗选择。在本文中，我们评估了治疗反应，并试图确定预后因素，这些因素可能提供一些与之前发表的报告不同的信息，这些报告针对的是体能状态（PS）优于我们纳入患者的群体。
分析了2007年10月至2012年10月期间85例接受吉非替尼250mg每日一次作为一线单药治疗的EGFR突变晚期肺腺癌患者的记录。采用直接测序方法检测EGFR突变。使用SPSS（20版）软件进行所有数据分析。
中位总生存期（OS）和无进展生存期（PFS）分别为25.6个月和6.9个月。在OS和PFS方面，第19外显子和第21外显子两组之间未发现统计学差异（分别为p=0.414和p=0.519）。治疗时间>3个月的患者组中位OS生存期优于治疗时间<3个月的患者组（25.6个月对4.9个月，p<0.001）。在多变量分析中，观察到美国东部肿瘤协作组（ECOG）体能状态评分为0 - 2的患者（p=0.002）以及治疗时间较长的患者（p<0.001）在OS方面有显著获益，而非年龄、性别和吸烟情况。在不良反应（AE）中，皮肤表现与显著更好的OS相关（p=0.007），但对PFS无显著影响（p=0.131）。
良好的ECOG体能状态、较长时间使用TKI和皮疹是吉非替尼抗肿瘤活性的重要预测因素。
