Epirubicin plus flutamide and orchidectomy in previously untreated advanced prostatic cancer.

Based on the results of several small clinical studies, the experimental data of J. T. Isaacs, and the theoretical considerations about the heterogeneity of prostatic cancer, we investigated the effect of simultaneous hormone-chemotherapy in previously untreated advanced prostatic cancer. Patients (n = 145; 117 stage D, 28 clinical stage C) up to an age of 80 years with histologically confirmed and previously untreated prostatic cancer were entered into the study. All patients received hormonal therapy with surgical castration and long-term administration of flutamide. Following castration, the patients were divided randomly into two groups. Group I patients received simultaneous chemotherapy starting 4 weeks after castration with weekly administration of 25 mg/m2 of 4-epirubicin intravenously for 18 weeks. Patients in group II initially had only hormonal therapy and did not receive chemotherapy until they progressed. Both groups were assessed at intervals of 3 months with respect to subjective and objective response according to the National Prostatic Cancer Project criteria. Quality of life was assessed monthly by the patients during the first 6 months and every 3 months thereafter. Evaluation of the baseline data showed that both groups were comparable with respect to prognostic factors. The first statistical analysis revealed the significant superiority of the combined treatment with respect to response rates (P = .005), median time to progression (P = .1), and survival time (P = .01). Analysis of the patients' self-assessment data showed that, to date, chemotherapy had not exerted an unfavorable influence on quality of life. These results are very preliminary and should be handled with care. However, the data suggest that an early combined chemotherapy-hormonal treatment is beneficial for at least a subset of patients, and warrants further clinical investigation.