【摘要】 目的　比较分析吉非替尼对不同体能表现、既往不同化疗次数、有或无脑部转移病灶的非小细胞肺癌患者的治疗结果。方法　总共有 76例患者参加试验。结果　患者的疾病控制率为 63 .2 %( 95 %CI为5 2 .1%～ 74.3 %) ,无疾病恶化生存期的中位数为 5 .0个月 ( 95 %CI为 3 .5～ 6.6个月 ) ,整体生存期的中位数为 9.9个月 ( 95 %CI为 4.9～ 14 .8个月 )。其中具有可测量病灶的 5 7例患者的客观反应率为 3 3 .3 %( 95 %CI为 2 0 .7%～ 46.0 %)。 76例患者中有 2 1例患者同时具有可评估的颅内及颅外病灶 ,其中 17例 ( 81.0 %)对吉非替尼有相同的颅内及颅外肿瘤反应 ,而出现脑部转移并不影响患者的生存期。药物引起的副作用大部分是中等反应 ,仅 5例患者发生不可耐受的毒性 ,其中 4例 ( 5 .8%)为间质性肺炎。结论　吉非替尼对非小细胞肺癌的脑部转移有疗效 ,值得进一步设计随机临床试验观察单剂吉非替尼治疗或加上其它形式的治疗在脑部转移的非小细胞肺癌患者中所扮演的角色更多还原

【Abstract】 Objective To explore the efficacy of gefitinib to non small cell lung cancer (NSCLC) patients irrespective of their performance status, number of prior treatment regimens and the presence of brain metastasis.Methods A total of 76 patients were enrolled. Results For all enrolled patients, the disease control rate was 63.2% (95% CI, 52.1% 74.3%) with a median progression free survival of 5.0 months (95% CI, 3.5 6.6 months) and median overall survival of 9.9 months (95% CI, 4.9 14.8 months). Fifty seven patients had measurable lesions and the objective response rate was 33.3% (95% CI, 20.7% 46.0%). Twenty one patients had simultaneously assessable intracranial and extracranial lesions, 17 of them (81.0%) showed comparable tumor response. There was no survival difference between the patients with and without metastatic brain disease. Most drug related adverse events were mild. Intolerable toxicities happened in 5 patients, 4 of them were interstitial pneumonia (5.8%).Conclusion Gefitinib is active in patients with brain metastasis from NSCLC. It is feasible to conduct randomized trials to identify the role of gefitinib alone or in combination with other modality in the treatment of NSCLC patients who have metastatic brain lesion(s).更多还原