大剂量法乐通加EP方案与多西他赛单药二线治疗晚期NSCLC的对照研究  

Comparison of high-dose toremifene plus EP regimen versus docetaxel alone in the second-line treatment of advanced non-small cell lung cancer

作　　者：曹小龙[1] 毛志达[2] 胡家柱[1] 郭添胜[1] 黄福喜[1] 张力[2] 

机构地区：[1]广州市番禺区人民医院肿瘤科,广东广州511400 [2]中山大学肿瘤中心内科,广东广州510060

出　　处：《肿瘤防治杂志》2005年第24期1872-1874,共3页China Journal of Cancer Prevention and Treatment

摘　　要：目的:论证大剂量法乐通+EP方案二线治疗对铂类耐药的晚期非小细胞肺癌(NSCLC)的疗效和毒性,并与泰索帝单药进行比较.方法:共98例对铂类耐药的晚期NSCLC非随机化进入A组(法乐通480 mg,连服7.5 d;依托泊苷100mg/m2,静脉滴入,d4～d6,顺铂80 mg/m2静脉滴入,d4)和B组(泰索帝单药75mg/m2,静脉滴入,d1).两组的主要临床特性相平衡,但顺铂的累计量≥320mg/m2只能入B组.结果:可评价的86例患者除B组的白细胞下降和神经毒性显著高于A组外(P＜0.005,P=0.040),其他毒性相仿,差异无统计学意义.A组与B组的中位生存期,中位缓解期,化疗的有效率和1年生存率均差异无统计学意义.结论:大剂量法乐通加EP方案治疗对铂类为主的化疗方案耐药的晚期NSCLC效果好,不良反应轻,耐受性好,达到了单药泰索帝二线治疗的效果.OBJECTIVE： To evealuate the efficacy and toxicities of high-dose toremifene plus EP regimen in the second-line treatment of advanced non-small cell lung cancer（NSCLC） resistant to DDP, compared with docetaxel monotherapy. METHODS. A total of 98 patients with advanced NSCLC resistant to DDP were divided into group A （toremifene 480 mg/day, p. o, d1 -7.5＋Vp-16 100mg/m^2 iv d4-6 ＋DDP 80 mg/m^2 iv d4） and group B （docetaxel 75 mg/m^2 iv d1 ）. The two treatment groups were well-balanced for key patients characteristics. However, the patients with cumulative DDP dose ≥ 320 mg/m^2 were only enrolled to group B. RESULTS： Eighty-six cases were evaluated for efficacy and toxicities. Although the incidence of neurosensory and leucopenia in the group B were significantly higher than that in the group A （P=0. 040, P〈0. 005）, and the other severe toxicities were not significantly different between the two groups. There were no difference between group A and group B in the mudian suruival, median time to disease progression, response rate and one-year survival rate. CONCLUSIONS： The high-dose toremifene plus EP regimen is effective in the second-line treatment of advanced NSCLC resistant to DDP. Its value is equivalent to docetaxel monotherapy. The adverse effects are tolerable.

关 键 词：肺肿瘤/药物疗法 顺铂/治疗应用 法乐通/治疗应用 泰索帝/治疗应用 鬼臼乙叉苷/治疗应用 多剂联用 

分 类 号：R734.2[医药卫生—肿瘤]