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Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma.

Abstract：

BACKGROUND: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. METHODS: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. RESULTS: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. CONCLUSION: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.

journal_name

Br J Cancer

journal_title

British journal of cancer

authors

Chow PK,Machin D,Chen Y,Zhang X,Win KM,Hoang HH,Nguyen BD,Jin MY,Lobo R,Findlay M,Lim CH,Tan SB,Gandhi M,Soo KC,Asia-Pacific Hepatocellular Carcinoma Trials Group.

doi

10.1038/bjc.2011.333

subject

Has Abstract

pub_date

2011-09-27 00:00:00

pages

945-52

issue

7

eissn

0007-0920

issn

1532-1827

pii

bjc2011333

journal_volume

105

pub_type

杂志文章,随机对照试验

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