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

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 Coopera...

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Bibliographic Details
Published in:British journal of cancer 2011-09, Vol.105 (7), p.945-952
Main Authors: CHOW, P. K. H, MACHIN, D, LIM, C.-H, TAN, S.-B, GANDHI, M, SOO, K.-C, CHEN, Y, ZHANG, X, WIN, K.-M, HOANG, H.-H, NGUYEN, B.-D, JIN, M.-Y, LOBO, R, FINDLAY, M
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Hormonal - therapeutic use
Biological and medical sciences
Cancer research
Cancer therapies
Carcinoma, Hepatocellular - drug therapy
Carcinoma, Hepatocellular - pathology
Clinical Study
Double-Blind Method
Female
Follow-Up Studies
Gastroenterology. Liver. Pancreas. Abdomen
Hepatitis
Hospitals
Humans
Liver cancer
Liver Neoplasms - drug therapy
Liver Neoplasms - pathology
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical imaging
Medical research
Medical sciences
Megestrol Acetate - therapeutic use
Middle Aged
Mutation
Neoplasm Staging
Quality of Life
Surgery
Survival Rate
Treatment Outcome
Tumors
Young Adult
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Summary: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.
ISSN:0007-0920
1532-1827
DOI:10.1038/bjc.2011.333