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Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma
British Journal of Cancer, 08/25/2011
Exclusive author commentary
Chow PKH et al. – Megestrol acetate has no role in prolonging overall survival (OS) in advanced treatment–naive hepatocellular carcinoma (HCC). Overall survival with placebo differed markedly from that in similar trials conducted elsewhere, suggesting therapeutic outcomes may be strongly dependent on Eastern Cooperative Oncology Group(ECOG) status and Child–Pugh score.
PKH Chow (09/19/2011) comments:
The results of this placebo-controlled randomised controled trial in treatment naive inoperable hepatocellular carcinoma (HCC) confirmed a few important observations on systemic therapy in this cancer. Firstly, positive results in patients with good liver function cannot be translated into positive results in all patients. This trial included patients with Child-Pugh (CP) classes A, B and C. The overall results do not favour the treatment arm although post-hoc subset analysis showed that outcomes were favourable in patients with CP A. However patients with poorer liver function actually fared worse on therapy comapred to the placebo arm and thus the overall resulst were negative. Extra-polation of the outcomes from patients with good liver function to those with poorer function cannot be justiifed. Secondly the outcomes of patients on the placebo arm of the trial was significantly poorer than those from the placebo arms of both the SHARP and the Asia-Pacific soreafenib trials. In this trial all patients were treatment-naive and were inoperable from the time of diagnosis with advanced disease. The natural history of such patients is significantly worse than those of patients who originally had relatively early disease and received primary treatment (surgery, RFA, TACE)before progression to become "advanced" HCC. Such adhoc observation have previously been made and discussed, but this is the first time that prospective data have demonstrated the vracity of the observations.
