Journal of Clinical Oncology, Vol 14, 1626-1636, Copyright © 1996 by American Society of Clinical Oncology
Suramin in hormone-refractory metastatic prostate cancer: a drug with limited efficacy
PJ Rosen, EF Mendoza, EM Landaw, B Mondino, MC Graves, JH McBride, P Turcillo, J deKernion and A Belldegrun
Department of Medicine, University of California Los Angeles School of Medicine 90095-7059, USA.
PURPOSE: To confirm the previously reported high response rates and
prolonged survival in hormone-refractory prostate cancer treated with
suramin. PATIENTS AND METHODS: Thirty-six eligible patients with
hormone-refractory prostate cancer with either measurable disease or bone
disease only and a prostate-specific antigen (PSA) level greater than 50
ng/mL were enrolled. Treatment consisted of two 8-week courses of
outpatient-based therapy with an interposed rest period. A bayesian
adaptive control strategy and a three-compartment pharmacokinetic model
that accommodates clearance changes was used to guide individual dosing. A
rapid infusion of 1,000 mg/m2 suramin was followed by five daily infusions
that targeted 285 micrograms/mL peak plasma levels during the first week.
All patients received concomitant hydrocortisone. For the next 7 weeks,
patients received one to two doses per week that targeted levels in the 150
to 285 micrograms/mL range and integrated weekly averages of 200 ug/mL.
RESULTS: Nine patients (28%) had a partial response to suramin based on a
> or = 50% decrease in PSA levels coupled with either relief of bone
pain or by a 50% decrease in measurable disease. The median overall
survival time for all patients is 31 weeks (95% confidence interval [CI],
23 to 51). Treatment was generally well tolerated, with fatigue being the
most common significant toxicity, but fatal idiosyncratic myelosuppression
(grade V) was observed in one patient. CONCLUSION: Using this dosing
schedule, suramin has limited activity against hormone-refractory
metastatic prostate cancer. Recent data suggest that hydrocortisone
administered with suramin may be partly responsible for the benefit
attributed to the drug. Although a small cohort of patients appeared to
benefit, we were unable to confirm the previously reported high rate of
activity and durability of remission using this agent.
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