吉非替尼治疗非小细胞肺癌脑转移的初步结果

Primary result of the efficacy and tolerance of gefitinib in advanced non-small cell lung cancer patients with brain metastasis

背景与目的 吉非替尼是一种口服的表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），是治疗晚期非小细胞肺癌（NSCLC）的有效靶向药物之一。本研究的目的是探讨吉非替尼治疗NSCLC脑转移的疗效和耐受性。方法 对18例资料完整的NSCLC脑转移患者的临床特点、治疗效果及生存时间进行了回顾性分析。所有患者发生脑转移后均口服吉非替尼250mg／天，直到病变进展或其他原因停药。其中12例患者做了脑部放疗（A组），另6例单纯服用吉非替尼（B组）。结果 吉非替尼治疗NSCLC脑转移的总有效率为27．8％，疾病控制率为88．9％（1例CR，4例PR，11例SD，2例PD）。未观察到疗效与性别、病理类型、吸烟、是否做过脑部放疗等临床特点有相关性。中位随访期6月（1～24月），两组患者生存的差异无统计学意义（P=0．192）。吉非替尼的不良反应可耐受，主要表现为轻度皮疹和腹泻。结论 吉非替尼治疗NSCLC脑转移有效，有必要进一步开展随机对照临床研究，以明确靶向治疗对脑转移的作用。

Background and objective Gefitinib, an orally active epidermal growth factor receptor tyrosine kinase inhihitor （EGFR-TKI）, has shown targeted antitumor activity in patients with advanced non-small cell lung cancer （NSCLC）. The aim of this study is to evaluate the efficacy and tolerance of gefitinib on brain metastasis in patients with NSCLC. Methods The clinical characteristics, response to treatment and outcome of survival were retrospectively reviewed in eighteen NSCLC patients with brain metastasis. All these patients received gefitinib of 250 mg/d after brain metastasis was diagnosed. They would discontinued the targeted treatment because of disease progression or other reasons. Twelve of them received intracranial irradiation （group A）, while the other six patients didn＇t （group B）. Results The overall response rate and disease controlled rate of gcfitinib for brain lesions were 27.8% and 88.9% respectively （one complete remission, 4 partial remission, 11 stable disease, 2 progressive disease）. No correlation among gender, smoking status, intracranial irradiation and the response of gefitinib was observed. There was no survival difference between the two groups （P=0. 192）, with the median follow-up time of 6 months （range 1-24 months）. Rash and diarrhea were the most common adverse events. Conclusion Gefitinib is active in patients with brain metastasis from NSCLC. It is feasible to conduct randomized clinical trials to demonstrate the role of targeted treatment for NSCLC patients with metastatic brain lesions.