拓扑异构酶I抑制剂依沙替康甲磺酸盐(DX-8951f)两种不同剂量给药方案的IIA期研究:在顺铂/紫杉醇耐药性卵巢癌患者中的应用  

Aphase IIA study of the topoiso merase I in-hibitor,exatecan mesylate(DX-8951f ),administered at two different dose schedules in patients with platinum-and taxane-re-sistant /refractory ovarian cancer

作　　者：Clamp A. Adams M. Atkinson R. 李宁 

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2005年第2期51-51,共1页Core Journal in Obstetrics/Gynecology

摘　　要：There is an urgent need for new agents with activity inplatinum -and taxane -resistant epi thelial ovarian can-cer.Exatecan mesylate is a novel top oisomerase I inhibitor with potent activity against ovaria n cancer in vitro.A multicentre phase IIA study was cond ucted in patients with platinum -and taxaneresistant epit helial ovarian cancer.Fifty -seven patients with bidimensionally measurable o-varian cancer,previously exposed t o platinum and taxanes,whose disease had relapsed within 6months of platinum -containing chemotherapy were randomised to one of two intravenous schedules of exatecan m esylate;0.3mg /m 2 daily for 5days every 3weeks(Arm A )or 2.1mg /m 2 weekly for 3weeks out of 4(Arm B ).There were no re-sponses in the weekly arm and a radiological response rate of 5.3%(95%CI 0.3-21.8%)in the daily arm.Principal toxicities were myelosup pression and emesis.Grade 3/4neutropenia occurred in 29%of patients inArm A and 6%patients in Arm B.Seventyone percent of pa-tients in Arm A required red cell tran sfusions while on treatment.Exatecan is well tolerated in this poor prognosis group of patients but only has modest single agent activity when administered in a daily regimen.There is an urgent need for new agents with activity inplatinum -and taxane -resistant epi thelial ovarian can-cer.Exatecan mesylate is a novel top oisomerase I inhibitor with potent activity against ovaria n cancer in vitro.A multicentre phase IIA study was cond ucted in patients with platinum -and taxaneresistant epit helial ovarian cancer.Fifty -seven patients with bidimensionally measurable o-varian cancer,previously exposed t o platinum and taxanes,whose disease had relapsed within 6months of platinum -containing chemotherapy were randomised to one of two intravenous schedules of exatecan m esylate;0.3mg /m 2 daily for 5days every 3weeks(Arm A )or 2.1mg /m 2 weekly for 3weeks out of 4(Arm B ).There were no re-sponses in the weekly arm and a radiological response rate of 5.3%(95%CI 0.3-21.8%)in the daily arm.Principal toxicities were myelosup pression and emesis.Grade 3/4neutropenia occurred in 29%of patients inArm A and 6%patients in Arm B.Seventyone percent of pa-tients in Arm A required red cell tran sfusions while on treatment.Exatecan is well tolerated in this poor prognosis group of patients but only has modest single agent activity when administered in a daily regimen.

关 键 词：耐药性卵巢癌 DX-8951f IIA 给药方案 甲磺酸盐 拓扑异构酶 卵巢上皮癌 周给 化疗有效率 病灶面积 

分 类 号：R737.31[医药卫生—肿瘤]