Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma: Results of a European organization for research and treatment of cancer multicentric double-blind trial
Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma: Results of a European organization for research and treatment of cancer multicentric double-blind trial
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DOI：
10.1200/jco.1998.16.2.411
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发表时间：
1998-02-01
影响因子：
45.3
通讯作者：
Wils, J
中科院分区：
文献类型：
--
作者：
Grimaldi, C;Bleiberg, H;Wils, J
目的：本研究的目的是评估抗雄激素治疗对不可切除肝细胞癌（HCC）总生存期和应答的影响。患者和方法：这项多中心双盲试验共纳入了244例不可切除的HCC患者。根据二乘二因子设计，患者被随机分配接受以下治疗之一：纯抗雄激素加安慰剂（a +P组，60例患者）；黄体生成素释放激素（LHRH）激动剂加安慰剂（LHRH+P组，62例）；纯抗雄激素联合LHRH激动剂（A+LHRH组，62例）；或安慰剂加安慰剂（P+P组，60例患者）。纯抗雄激素包括Anandron （Roussel-Uclaf Laboratory, Romainville, France）口服（每天300毫克，持续1个月，然后每天150毫克）。LHRH由醋酸戈瑟利林（3.6 mg）或雷曲韦林（3.75 mg）组成，每月皮下注射。治疗一直持续到死亡。根据世界卫生组织（WHO）的标准每8周评估一次反应。结果：6例患者被认为不合格。1例患者完全缓解（a +P组），3例患者部分缓解（2例在LHRH+P组，1例在a +LHRH组）。总体log-rank检验未显示四组患者的生存率有显著差异。考虑到因子设计，生存率的比较显示含有Anandron的方案与其他方案，或含有lhrh的方案与其他方案之间没有显著差异。任何一种治疗方案都没有出现严重的副作用。结论：这项对照研究清楚地表明雄激素治疗对不可切除的HCC缺乏疗效。(C)美国临床肿瘤学会1998。
Purpose: The aim of the study was to evaluate the efficacy of antiandrogen therapy on overall survival and response in unresectable hepatocellular carcinoma (HCC).Patients and Methods: A total of 244 patients with unresectable HCC were included in this multicentric double-blind trial. According to a two-by-two factorial design, patients were randomly assigned to receive one of the following treatments: pure antiandrogen plus placebo (A+P group, 60 patients); luteinizing hormone-releasing hormone (LHRH) agonist plus placebo (LHRH+P group, 62 patients); pure antiandrogen plus LHRH agonist (A+LHRH group, 62 patients); or placebo plus placebo (P+P group, 60 patients). Pure antiandrogen consisted of Anandron (Roussel-Uclaf Laboratory, Romainville, France) administered orally (300 mg daily for 1 month, then 150 mg daily). LHRH consisted of goseriline acetate (3.6 mg) or triptoreline (3.75 mg) administered monthly by subcutaneous injection. Treatment was given until death. Response was evaluated every 8 weeks according to World Health Organization (WHO) criteria.Results: Six patients were considered ineligible. One patient had a complete response (A+P arm) and three had a partial response (two in the LHRH+P arm and one in the A+LHRH arm). An overall log-rank test did not demonstrate any significant difference in survival among the four arms. taking the factorial design into account, comparison of survival showed no significant difference between Anandron containing regimens and others, or between LHRH-containing regimens and others. No serious side effects occurred for any regimen.Conclusion: This controlled study shows clearly the lack of efficacy of androgen treatment in unresectable HCC. (C) 1998 by American Society of Clinical Oncology.