ASCO2013：山东省肿瘤医院刘静发现厄洛替尼可用于预防III/IV期 NSCLC患者脑转移

背景：非小细胞肺癌(NSCLC)脑转移(BM)导致的死亡风险高于因颅外病情进展而造成的死亡率。业已证实，厄洛替尼可有效用于NSCLC患者。本研究对厄洛替尼在预防III/IV期 NSCLC患者脑转移方面的价值进行了评价。
方法：本研究纳入对象为经病理学确诊的III/IV期NSCLC患者，根据参数患者是否曾接受过厄洛替尼一线、二线治疗(治疗时间至少1个月)情况，将患者分入厄洛替尼组或对照组。本研究排除了存在BM的IV期患者。曾接受任何EGFR-TKI治疗的患者也被从对照组中排除。本研究对对照组中患者出现BM、死亡或至随访截止时对应的一线、二线化疗次数进行了记录。本研究终点为至出现BM的时间、1年及2年BM发生率。
结果：本研究共纳入140例患者(厄洛替尼组68 例，对照组72 例)，并对两组间的所有临床特征参数进行了平衡。在中位随访期为20.0个月时，所有患者出现BM的中位时间为28.0个月。1年及2年BM发生率分别为17.8% 及 38.8%。厄洛替尼组患者与对照组患者至出现BM时的中位时间分别为42.0个月及19.0个月。厄洛替尼组在BM发生率方面低于对照组。多变量分析表明，厄洛替尼组及III期病情患者发生BM的时间间隔较长。
结论：厄洛替尼可改善III/IV 期NSCLC患者出现BM的时间间隔以及2年BM发生率。对于整个患者群体而言，厄洛替尼给药及III期病情均为较低BM发生率的预测因素。
Development of brain metastases in stage III/IV non-small cell lung cancer patients treated with or without erlotinib
Abstract
Background: Non-small cell lung cancer (NSCLC) has a risk of death from brain metastases (BM) that exceeds potential mortality from extracranial disease progression. Erlotinib has been proved to be effective for NSCLC patients. We hold a study to evaluate value of erlotinib in preventing BM in stage III/IV NSCLC patients. Methods: Pathologically confirmed NSCLC stage III/IV patients were included and divided into erlotinib group and control group according to whether erlotinib administration (at least one month) in 1- or 2-line therapy or not. Stage IV patients with BM were excluded. Patients with any EGFR-TKI treatment were excluded from control group. Times of erlotinib administration to BM and to death or last follow-up were recorded for erlotinib group. Times of corresponding 1- or 2-line chemotherapy to BM and to death or last follow-up were recorded for control group correspondingly. Time to BM, 1- and 2-year incidence of BM were end points. Results: 140 patients were included (68 in erlotinib group and 72 in control group) and all clinical characteristics between two groups were balanced. At a median follow-up of 20.0 months, the median time to BM for all patients was 28.0 months (95% CI, 23.795-32.205 months). 1- and 2-year incidence of BM were 17.8% (95% CI, 10.744-24.856%) and 38.8% (95% CI, 27.236-50.364%) respectively. The median time to BM were 42.0 months (95% CI, 15.567-68.433 months) and 19.0 months (95% CI, 11.305-26.695 months) (P=0.028) for erlotinib group and control group. Erilotinib group has a lower BM incidence than control group (1-year: 14.4%, 95% CI: 4.992%-23.808%, vs 21.1%, 95% CI: 10.712%-31.488%, P=0.384; 2-year: 26.2%, 95% CI: 18.712%-33.688%, vs 50.2%, 95% CI: 34.128%-66.272%, P=0.005). Multivariate analysis shows interval to BM were longer for erlotinib group (HR, 2.531; 95% CI, 1.272-5.051; P=0.008) and stage III disease (HR, 2.093; 95% CI, 1.035-4.231; P=0.040). Conclusions: Erlotinib administration improves time to BM and 2-year incidence of BM of stage III/IV NSCLC patients. Erlotinib administration and stage III disease predicts lower incidence of BM in all patients.