A Comparison of Estramustine Phosphate Versus Cis-platinum Alone Versus Estramustine Phosphate Plus Cis-platinum in Patients with Advanced Hormone Refractory Prostate Cancer Who Had Had Extensive Irradiation to the Pelvis or Lumbosacral Area

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Abstract
Single and combination chemotherapy was compared in a clinical trial for men with advanced, metastatic prostate cancer who had received prior pelvic irradiation and had had progression of disease despite hormonal therapy. The 149 patients were randomized to receive estramustine phosphate or cis-platinum alone or in combination. Of the 149 patients, 25 (17%) were excluded from the study; 124 were evaluated for response and survival. Entry variables were distributed similarly among patients in each treatment arm. There were no complete or partial responders, but there were nearly twice as many patients whose disease was stabilized (33%) on the combination regimen compared to estramustine phosphate (18%) and .apprx. 1/3 more than for cis-platinum (21%). Analysis of survival revealed some advantage for patients on combination therapy. Major toxicities for all treatments were nausea and vomiting (62-88%) and accompanying anorexia (72-95%). Azotemia developed in 45% of the patients receiving combination therapy. An elevation in serum creatinine occurred in 22% of the patients receiving combination therapy and in 17% of those receiving cis-platinum alone. Myelosuppression occurred infrequently.