Background: Hepatocellular carcinoma (HCC) is a male predominant disease and may be an androgen-dependent or androgen-responsive tumor. This Phase 11 study was designed to investigate the clinical activity and toxicity of flutamide in the treatment of patients with advanced HCC.
Methods: Thirty-two patients with measurable advanced HCC were studied. Flutamide, 750 mg per day, was administered orally for 8 weeks. Ten patients died before repeat tumor measurements could be performed.
Results: Twenty-two patients were evaluable for response and toxicities. There were no complete responses nor partial responses. Nine of 22 patients (41%) had stable disease and 13 patients (59%) had progressive disease. Serum alpha-fetoprotein was reduced in three patients. The median survival was 10 weeks (range, one to 35 weeks). Toxicities were minimal and tolerable.
Conclusions: Flutamide is not effective in the treatment of advanced HCC. Clinically, HCC may not be an androgen-responsive tumor. Other new methods of treatment of HCC warrants future clinical investigations.