Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma.
Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma.
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DOI：
10.1038/bjc.2011.333
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发表时间：
2011-09-27
影响因子：
8.8
通讯作者：
Soo, K-C
中科院分区：
文献类型：
--
作者：
Chow, P. K. H.;Machin, D.;Chen, Y.;Zhang, X.;Win, K-M;Hoang, H-H;Nguyen, B-D;Jin, M-Y;Lobo, R.;Findlay, M.;Lim, C-H;Tan, S-B;Gandhi, M.;Soo, K-C
关键词：
肝细胞癌（HCC）是全球第三大癌症死亡原因。我们测试了醋酸甲地孕酮（MA）与安慰剂在治疗晚期HCC中的作用。从2002年到2007年，这项随机双盲试验从6个亚太国家的专科护理中心招募了204例未经治疗的晚期HCC患者（东部肿瘤协作组（ECOG）性能评分为0-3）。患者接受安慰剂或MA（第1天320毫克）。终点为总生存期（OS）和生活质量。MA组与安慰剂组的OS存在不良但无统计学显著性差异：中位值分别为1.88个月和2.14个月（风险比（HR）=1.25，95% CI=0.92-1.71，P=0.16）。然而，两个治疗组中功能状态良好（Child-Pugh A和ECOG 0、1或2）的患者的OS相似（44.3%），MA的不良反应仅限于状态较差的患者。醋酸甲地孕酮患者的总体健康状况较差（无统计学显著性），但食欲不振和恶心/呕吐水平降低。醋酸甲地孕酮在延长晚期初治HCC的OS方面没有作用。安慰剂组的总生存期与其他地方进行的类似试验显著不同，表明治疗结局可能强烈依赖于ECOG状态和Child-Pugh评分。
Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide. We tested megestrol acetate (MA) against placebo in the treatment of advanced HCC. From 2002 through 2007, this randomised double-blind trial enrolled 204 patients with treatment-naive advanced HCC (Eastern Cooperative Oncology Group (ECOG) performance rating of 0-3) from specialist care centres in six Asia-Pacific nations. Patients received placebo or MA (320 mg day−1). End points were overall survival (OS) and quality of life. An adverse but not statistically significant difference in OS was found for MA vs placebo: median values 1.88 and 2.14 months, respectively (hazard ratio (HR)=1.25, 95% CI=0.92–1.71, P=0.16). However, OS was similar among patients of good functional status (Child-Pugh A and ECOG 0, 1 or 2) (44.3%) in both treatment groups, with the adverse effect of MA confined to those of poor status. Megestrol acetate patients had a worse global health status (not statistically significant) but reduced levels of appetite loss and nausea/vomiting. Megestrol acetate has no role in prolonging OS in advanced treatment-naive HCC. Overall survival with placebo differed markedly from that in similar trials conducted elsewhere, suggesting therapeutic outcomes may be strongly dependent on ECOG status and Child-Pugh score.
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影响因子：
158.5
作者：
Llovet, Josep M.;Ricci, Sergio;Bruix, Jordi
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Parkin, DM;Bray, F;Pisani, P
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索拉非尼对亚太地区晚期肝细胞癌患者的疗效和安全性：一项 III 期随机、双盲、安慰剂对照试验
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通讯作者：
Manenti, F
影响因子：
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作者：
Villa, E;Ferretti, I;Manenti, F
通讯作者：
Manenti, F