PROSPECTIVE EVALUATION OF HYDROCORTISONE AND SURAMIN IN PATIENTS WITHANDROGEN-INDEPENDENT PROSTATE-CANCER

Purpose: To assess efficacy of intermittent infusion of suramin in pat ients with androgen-independent prostate cancer who have had disease p rogression on hydrocortisone. Patients and Methods: Chemotherapy-naive patients with progressive androgen-independent prostate cancer were g iven hydrocortisone 40 mg/d and monitored for treatment ef feet. At th e time of disease progression, suramin was administered on a pharmacok inetically derived, 2-week dosing schedule. Results: Thirty patients w ith a median Karnofsky performance status (KPS) of 90% were treated wi th hydrocortisone. No responses were seen in 12 patients with measurab le disease or 29 patients with abnormal bone scans. Thirty patients ha d an increasing prostate-specific antigen (PSA) level before treatment and six (20%) had a more than 50% decline in PSA from the baseline va lue for a median of 16 weeks (range, 12 to 52+). Twenty-eight patients had disease progression after a median of 7 weeks (range, 3 to 23), a nd two patients have continued to receive hydrocortisone for 44 and 52 weeks, Twenty-eight patients received hydrocortisone and suramin, wit h median suramin concentrations of 97 to 170 mu g/mL for 4 weeks. No r esponses in measurable disease and no improvements in bone scans were seen, Five patients (18%) showed a more than 50% decline in PSA levels from baseline, of whom three held previously responded to hydrocortis one. Only two of 24 patients who did not show a posttherapy decline in PSA levels offer hydrocortisone had a reduction in PSA levels with th e addition of suramin. Toxicity profiles were acceptable with each age nt, although a higher proportion of subjects showed hematologic, cardi ac, and neurologic events when suramin was added. Conclusion: Suramin hers limited efficacy in patients with androgen-independent prostate c ancer who have had disease progression after hydrocortisone. (C) 1995 by American Society of Clinical Oncology.