Journal of Clinical Oncology, Vol 15, 1470-1477, Copyright © 1997 by American Society of Clinical Oncology
Phase II trial of suramin, leuprolide, and flutamide in previously untreated metastatic prostate cancer
NA Dawson, WD Figg, MR Cooper, O Sartor, RC Bergan, AM Senderowicz, SM Steinberg, A Tompkins, B Weinberger, EA Sausville, E Reed and CE Myers
Division of Clinical Sciences, National Cancer Institute, Bethesda, MD, USA. nancy_a.dawson@wramaa.chcs.amedd.army.mil
PURPOSE: To assess the efficacy and toxicity of suramin, hydrocortisone,
leuprolide, and flutamide in previously untreated metastatic prostate
cancer. PATIENTS AND METHODS: Patients with stage D2 and poor-prognosis
stage D1 prostate cancer were given suramin on a pharmacokinetically
derived dosing schedule to maintain suramin concentrations between 175 and
300 micrograms/mL. Additionally, all patients received flutamide 250 mg
orally three times daily, initiated on day 1 and continued until disease
progression; depot leuprolide 7.5 mg intramuscularly begun on day 5 and
repeated every 4 weeks indefinitely; and replacement doses of
hydrocortisone. RESULTS: Fifty patients were entered onto the study: 48
with stage D2 and two with stage D1 disease. The median age was 59 years
(range, 42 to 79) and 31 patients had a Karnofsky performance status (KPS)
of 100%. Forty-five patients had bone metastases and 25 had measurable soft
tissue disease. Forty-one (82%) had severe disease. The overall response
rate in 49 assessable patients was three complete responses (CRs) and 30
partial responses (PRs) for an overall response rate of 67%. Eighteen
patients have died. The median survival time has not been reached, with a
median potential follow-up duration of 44 months. Grade 3 to 4 toxicity was
seen in 38% of patients and was predominantly hematologic and reversible.
CONCLUSION: The high response rate and prolonged survival in a
poor-prognosis group of patients with metastatic prostate cancer warrant a
phase III randomized comparison of this regimen versus hormonal therapy
alone. Toxicity was moderate and reversible.
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