Androgen deprivation and four courses of fixed-schedule suramin treatment in patients with newly diagnosed metastatic prostate cancer: A southwest oncology group study

Purpose: To assess the feasibility of administering a combination of surami n and hydrocortisone in addition to androgen deprivation in a cooperative g roup setting; to assess the feasibility of treatment with multiple courses of suramin; and to assess progression-free and overall survival in patients with newly diagnosed metastatic prostate cancer who underwent such treatme nt. Patients and Methods: Patients with newly diagnosed metastatic prostate can cer who had adequate hematologic, hepatic, renal, neurologic, and coagulati on parameters were treated by combined androgen deprivation and suramin plu s hydrocortisone. Suramin was administered on a 78-day fixed dosing schedul e (one cycle), and suramin treatment cycles were repeated every 6 months fo r a total of four cycles. The statistical design was developed on the basis of the feasibility of administering suramin, as judged by the number of pa tients who developed neurotoxicity of grade 3 or higher or by treatment int erruption of 4 weeks or longer due to any persistent suramin-related toxici ty. Results: Of the 62 patients enrolled onto the study between August 1994 and January 1997, 59 were eligible and assessable for toxicity on the first cy cle. Thirty-two (54%) of 59 patients received a second cycle, 13 (22%) of 5 9 patients received a third cycle, and only five patients (8%) received a f ourth cycle. During the first cycle, 27 patients were removed from the stud y: 17 because of toxicity, five because of disease progression, two who had died, and three because of other reasons. There was one therapy-related de ath. Grade 4 toxicities were noted in 11 and three patients during first an d second courses, respectively. Neurotoxicity of grade 3 or higher was obse rved in nine and seven patients during the first and second cycles, respect ively. fifteen patients had treatment interruptions of 4 weeks or longer. O verall, only 54% (95% confidence interval, 41% to 67%) of the patients demo nstrated acceptable limits of toxicity. Conclusion: Suramin plus hydrocortisone and androgen deprivation has limite d applicability in the treatment of patients with newly diagnosed metastati c prostate cancer. J Clin Oncol 18:1043-1049. (C) 2000 by American Society of Clinical Oncology.