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盐酸埃克替尼治疗晚期非小细胞肺癌Ⅲ期临床试验 被引量:30

A phase Ⅲ study on Icotinib Hydrochloride for non-small cell lung cancer
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摘要 目的观察比较盐酸埃克替尼与吉非替尼治疗晚期非小细胞肺癌疗效及毒副反应。方法随机双盲双模拟、阳性药物平行对照的方法,13例患者接受盐酸埃克替尼125mg,口服,3次/日,或对照药为吉非替尼250mg,口服,1次/日。结果治疗晚期非小细胞肺癌,盐酸埃克替尼的疾病进展时间(TTP)108天,吉非替尼的疾病进展时间(TTP)96天,盐酸埃克替尼总生存时间(OS)6月,吉非替尼OS4.8月。两组患者均无严重毒副反应。结论盐酸埃克替尼治疗晚期非小细胞肺癌疗效与吉非替尼疗效等同,毒性反应低。 Abstract:Objective To evaluate and compare the efficacy and toxicity between Icotinib Hydrochlo-- ride and Gefitinab on non-small cell lung cancer. Methods Randomized,double-blind, double-simulation, positive drug, parallel-group was adopted 13 cases administrated Icotinib Hydrochloride Tablets 125 mg, three times per day. Control group administrated Gefitinab, 250 mg once per day. Results Time topwgress (TIP) of Icotinib Hydrochloride was 108 days, TIP of Gefitinab was 96 days, Overall suvival (OS) of Icotinib Hydrochlofide was 6 months, OS of Gefitinal was 4.8 months. All patients were not significantly adverse drug reaction. Conchusions Icotinib Hydrochloride, for the treatment of advanced non-small cell lung cancer, the therapeutic effect and low toxicity are equal to Gefitinab.
出处 《肿瘤药学》 CAS 2011年第5期441-443,共3页 Anti-Tumor Pharmacy
基金 国家自主创新一类新药临床实试验
关键词 盐酸埃克替尼 非小细胞肺癌 吉非替尼 Icotinib hydrochloride Non-small Cell Lung Cancer , Gefitinab
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