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Title: Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma
Authors: 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.
Keywords: advanced cancer
hepatocellular carcinoma
hormonal therapy
megestrol acetate
randomised controlled trial
Issue Date: 27-Sep-2011
Citation: 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. (2011-09-27). Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma. British Journal of Cancer 105 (7) : 945-952. ScholarBank@NUS Repository.
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. © 2011 Cancer Research UK All rights reserved.
Source Title: British Journal of Cancer
ISSN: 00070920
DOI: 10.1038/bjc.2011.333
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