吉西他滨调整方案治疗晚期非小细胞肺癌的Ⅱ期临床试验  

Phase Ⅱ Trial of Improved Regimen with Gemcitabine in Patients with Advanced Non-small Cell Lung Cancer

作　　者：缪璐璐[1] 范云[1] 黄志煜[1] 林能明[1] 罗吕宏[1] 余海峰[1] 

机构地区：[1]浙江省肿瘤医院化疗中心,杭州310022

出　　处：《中国肺癌杂志》2012年第1期1-5,共5页Chinese Journal of Lung Cancer

基　　金：浙江省医药卫生科技计划项目(No.2008B027)资助~~

摘　　要：背景与目的吉西他滨与铂类的联合化疗是晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)最常用的治疗方案。通常3周方案中的吉西他滨需间隔1周给药。为提高依从性,本研究将吉西他滨第8天给药时间调整为第5天,并评价调整方案一线治疗晚期NSCLC的疗效及安全性。方法 2007年10月-2009年10月共入组83例晚期NSCLC患者,采用吉西他滨1,000mg/m2-1,250mg/m2第1天、第5天静脉滴注30min,联合顺铂75mg/m2,或联合卡铂(AUC=5)第1天静滴,每21天为1周期,每例至少完成2周期治疗后评价疗效,观察毒性反应及无进展生存期和总生存期。结果 83例患者的客观有效率为37.3%,中位无进展生存期和中位生存期分别为6.1个月和15.0个月,1年、2年生存率分别为57.8%与16.2%。调整方案的主要不良反应为血液学毒性与胃肠道反应,III度-IV度白细胞、血红蛋白、血小板减少发生率分别为26.5%、10.8%、7.2%,联合顺铂治疗组III度-IV度胃肠道反应发生率为27.5%。无治疗相关死亡。结论吉西他滨联合铂类5天调整方案一线治疗晚期NSCLC疗效肯定,毒副反应可耐受,值得进一步开展随机对照研究。Background and objective Gemcitabine-platinum-combined with chemotherapy is the most common treatment for advanced non-small cell lung cancer （NSCLC）. Gemcitabine is administered once a week in a general three-week schedule. In the present study, gemcitabine is administered on d1 and d5 to improve compliance, and the e cacy and safety of the improved regimen is evaluated in untreated patients with advanced NSCLC. Methods A total of 83 patients were enrolled between October 2007 and October 2009. In each cycle, gemcitabine was administered at a dose of 1,000 mg/m2-1,250 mg/m2 via a 30 min intravenous infusion on d1 and d5 followed by cisplatin at a dose of 75 mg/m2 or carboplatin （AUC=5） on d1 every three weeks. At least two cycles of chemotherapy were completed in each case, and clinical response and toxicity of the regimen were observed. Results e objective response rate was 37.3%. e median progression free survival and overall survival time were 6.1 months and 15.0 months, respectively. e one-year and two-year survival rates were 57.8% and 16.2%, respectively. Myelosuppression and gastrointestinal responses were the main toxicities. e incidence of grade 3/4 of leucopenia, hypohemia, and thrombocytopenia were 26.5%, 10.8% and 7.2%, respectively. A total of 27.5% of the patients in the cisplatin group had grade 3/4 gastrointestinal responses. Treatment related deaths were not observed in this study. Conclusion e regimen is active and well-tolerated in untreated patients with advanced NSCLC. Further randomized controlled studies are necessary.

关 键 词：肺肿瘤 吉西他滨 联合方案 

分 类 号：R734.2[医药卫生—肿瘤]