Aims and background: No consolidated medical treatment has yet been es
tablished for unresectable hepatocellular carcinoma (HCC). A possible
interference of hormones in the pathogenesis and cellular growth of HC
C has been suggested. Methods: To evaluate the activity and tolerance
of progestins in HCC, patients were treated with megestrol acetate ora
lly at a dose of 160 mg daily until progression of disease or grade II
I-IV toxicity was observed. Results: Eleven patients entered the study
and were assessable for response and side effects, Median duration of
treatment was 80 days (range 60-150). No major responses were observe
d, 4 patients had stabilization of disease for at least 2 months, and
7 had progressive disease, Median time to disease progression was 3 mo
nths (range 2-5), Three patients required interruption of treatment be
cause of toxicity (2 patients had worsening of concomitant diabetes an
d 1 patient had gastric bleeding), Conclusions: The results of the pre
sent study suggest that hormone therapy with megestrol acetate has no
significant role in HCC.