Treatment of Stage D 2 Hormone Refractory Carcinoma of the Prostate with 5-Fluorouracil and Roferon-A®: A Southwest Oncology Group Study

Based upon prior data suggesting that alpha-interferon possesses chemomodulatory activity, the Southwest Oncology Group conducted a study in which patients with hormone refractory, metastatic (stage D₂) adenocarcinoma of the prostate were treated with 5-fluorouracil (5-FU) and Roferon-A®. All patients had bidimensionally measurable disease. Treatment consisted of 5-FU 750 mg/m²/day by continuous i.v. infusion for 5 days with Roferon-A® 9 million units subcutaneously ono days 1, 3 and 5. Roferon-A® was continued three times weekly throughout treatment. Following a one week hiatus from 5-FU (week 2), 5-FU was continued at a dose of 750 mg/m² i.v. bolus weekly. Nineteen patients were evaluable for toxicity. The most common toxicities were gastrointestinal and mucosal, hematologic and a flu-like syndrome. There were no deaths related to treatment. Among the 14 patients evaluable for response, the response rate was 0% (95% confidence interval, 0-18%). Thirteen of the 19 evaluable patients have died with a median survival of 9 months. The combination of 5-FU and Roferon-A® does not have sufficient activity against advanced, hormone refractory prostate cancer to warrant further investigation.