Comparison of Estramustine Phosphate, Methotrexate and cis-Platinum: in Patients with Advanced1 Hormone Refractory Prostate Cancer

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Abstract
In this clinical trial of men with advanced prostatic cancer no longer responsive to hormone therapy, 189 were randomized to receive estramustine phosphate, methotrexate [MTX] or cis-platinum. Response evaluations were done in 158 cases. Objective response rates (complete, partial or stabilization of disease) were 34% for estramustine phosphate, 36% for cis-platinum and 41% for MTX. Subjective parameters indicated a substantial advantage for pain improvement with MT or cis-platinum over estramustine phosphate. Probabilities of continued response indicated some advantage for MTX and median response durations at this time were twice as long for MTX (32 wk) as for cis-platinum (16 wk), with estramustine phosphate intermediate (23 wk). Survival rates for the original treatment randomization groups were not different at this time. Side effects of estramustine phosphate consisted primarily of nausea and vomiting and/or anorexia but to a lesser extent than with cis-platinum. These effects were somewhat less for MTX, for which the major side effects were stomatitis and leukopenia, as well as hepatic toxicity reflected by elevated serum glutamic oxaloacetic transaminase levels. Other side effects of cis-platinum were less than for MTX (no stomatitis), except for signs of renal toxicity (elevations in blood urea nitrogen and serum creatinine), which were greater. MTX had a relatively high level of activity against metastatic, progressive, hormone nonresponsive prostatic cnacer, with side effects that were substantial but manageable.