Phase II study of flutamide in the treatment of hepatocellular carcinoma.

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.