Review of phase II hormone refractory prostate cancer trials

In men with hormone refractory metastatic prostate cancer, single agents ha ve demonstrated an objective response when using a response rate greater th an standard treatment in prior National Prostate Cancer Project (NPCP) tria ls. Among these agents are methotrexate, cisplatin, 5-fluorouracil, cycloph osphamide, doxorubicin, estramustine, methyl N-(2-chloroethyl)-N'-cyclohexy l-Nnitrosourea (CCNU), 5-(3,3-dimethyl-1-triazenyl)1 H-imidazole-4-carboxam ide (DTIC), and vinblastine. Other combinations of protocols have been prev iously evaluated. Currently under review is a 14-year follow-up on an adjuvant trial (NPCP 90 0/1000) where all patients had a bilateral pelvic lymphadenectomy. These pa tients were then randomized to surgery or radiation, and received either cy clophosphamide, estramustine, or no therapy for 2 years. Clinical results s howed there was no difference in disease-free survival or survival rates be tween those patients in the group who had T3 prostate cancer, and those wit h negative pelvic lymph node dissection. The drugs diethylstilbestrol, megestrol, or streptozocin have been used. In clinical trials, the single agent diethylstilbestrol usually had a better effect. Combinations of estramustine with vinblastine were also effective w hen compared with the results of standard treatment. When comparing patient s who relapsed from hormone refractory prostate cancer, there was no signif icant statistical response rate difference (P = < 0.05) in patients who wer e offered either flutamide or estramustine. To determine more accurately the positive results from these trials, the pr e-prostate-specific antigen (PSA) era of stable disease must be re-evaluate d. (C) 1999, Elsevier Science Inc.