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作 者:韩宇[1] 徐建明[1] 宋三泰[1] 李月敏[1] 赵传华[1] 刘烈军[1] 刘建芝[1] 邱卉[1]
机构地区:[1]军事医学科学院附属307医院肿瘤中心,北京市100071
出 处:《中国肿瘤临床》2006年第17期970-973,共4页Chinese Journal of Clinical Oncology
基 金:全军"十一五"科技攻关项目资助(编号:06G140)
摘 要:目的:评价“化疗微效以上序贯给予IRESSA方案”治疗晚期非小细胞肺癌(NSCLC)的临床价值。方法:2002年5月至2005年2月,共有33例患者依次入组。既往接受化疗方案数不限,只要最后一个化疗方案疗效经确认在微效(MR)以上患者,则入组序贯给予口服IRESSA治疗,每日一次,每次250mg,持续服用直到疾病进展。结果:33例患者均可评价疗效和副作用。以入组基线检查结果为参照,总有效率(RR)为24.2%(8/33)(95%可信区间,11%~42%)。症状改善率为54.4%(18/33)(95%可信区间,25%~59%)。中位肿瘤进展时间为(TTP)6.5个月(范围:0.7~16.6),中位生存期(OS)为8.5个月(范围:2.1~18.0),1年生存率为36.4%(95%可信区间,20%~55%)。本研究中出现的毒副作用多数较轻,且可逆。30.3%的患者出现了药物相关毒副反应。主要是Ⅰ、Ⅱ级毒副反应,只有1例患者同时发生了Ⅲ级的恶心、呕吐和Ⅳ级的腹泻。结论:化疗微效以上的患者序贯应用IRESSA的方案,生活质量良好,中位肿瘤进展时间和中位生存期明显延长。其中90%以上都能继续巩固原有疗效,将近1/4患者还可以进一步提高缓解率。Objective: To evaluate the efficacy of sequential administration of gefitinib(Iressa) fol- lowing a response to two to three cycles of chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Thirty-three consecutive patients with advanced NSCLC pretreated with chemotherapeutic regimens, whose response to the last chemotherapy regimen was confirmed as at least a minor response (MR), entered the trial from May 2002 to February 2005. Patients received 250 mg oral dose of gefitinib once daily for 4 weeks. Treatment was repeated every 4 weeks until disease progression. Results: Thirty-three patients were applicable for evaluation of the response and toxicity. Objective response rate was 24.2% (8 of 33) (95% confidence interval [CI], 12.3% to 30.3%). Symptom improvement rate was 54.5% (18 of 33) (95% CI, 25% to 59%). The median time to disease progression (TIP) was 6.5 months. The median overall survival time (OS) was 9.8 months, and the actuarial 1-year survival rate was 36.4%(95% CI, 20% to 55%). Toxicity was relatively mild, and only one patient (3.0%) had grade 4 diarrhea, grade 3 nausea and vomiting. Conclusion: Sequential administration of gefitinib following a response to chemotherapy was better tolerated and could maintain and even enhance the effect of previous chemotherapy for advanced NSCLC.
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