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Megestrol and embryonic extracts in the treatment of advanced hepatocellular carcinoma: A prospective randomized trial in the pre‐sorafenib era
Author(s) -
Giacomin Anna,
Sergio Adriana,
Vanin Veronica,
Tartaro Pietro,
Paccagnella Daniela,
Mazzucco Mauro,
Farinati Fabio
Publication year - 2010
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/j.1872-034x.2009.00588.x
Subject(s) - medicine , sorafenib , megestrol acetate , hepatocellular carcinoma , megestrol , randomized controlled trial , gastroenterology , oncology , surgery , cancer
Background: Patients with advanced hepatocellular carcinoma (HCC) achieved significant results by the new treatment with sorafenib (a multi‐tyrosine kinase inhibitor), but, because it has been tested mainly in Child A cirrhosis, patients with impaired liver function are not eligible for the treatment. Methods: This study was an open label phase III randomized trial comparing Synchro‐Levels (Alphrema, Varese, Italy) and megestrol, with a 2:1 design, in patients with advanced HCC, planned before the sorafenib registration. End‐points were objective response and impact on performance status (primary) and biochemical response (secondary). Results: The patients enrolled were 61 (43 men, 18 women; Child A in 28 [48%] and B in 33 [52%]). Forty‐three were assigned to Synchro‐Levels, 18 to megestrol. Most patients had multifocal disease (75% in megestrol and 59% in Synchro‐Levels) and there was a significant difference in tumor burden, with more advanced disease in the megestrol arm ( P = 0.0002). At 3 months, tumor burden was more frequently stable with megestrol, while performance status was significantly better in patients treated with Synchro‐Levels. At 6 months, α‐fetoprotein was more frequently stable or reduced with megestrol. An objective response was observed in a megestrol‐treated patient. Mortality was significantly lower and long‐term survival significantly more frequent with megestrol. Conclusion: Megestrol treatment shows good results in advanced HCC and could become part of best supportive care in patients not suitable for other treatments, that, despite sorafenib, remain an important share.