GOSERELIN DEPOT VS GOSERELIN DEPOT + FLUTAMIDE NEL TRATTAMENTO DEL CARCINOMA PROSTATICO IN STADIO AVANZATO. RISULTATI DI UNO STUDIO MULTICENTRICO INTERNAZIONALE RANDOMIZZATO

In the period between April 1986 and May 1987, 568 patients were recruited in ten different European countries taking part in a multi-centre randomized study. The aim was to compare results following the administration of Goserelin depot every 28 days with those following its association with the non-steroid antiandrogen Flutamide in a dose of 250 mg, tid. Patients with locally advanced (T3-T4) and/or metastatic (M1) prostatic carcinoma were included, while previous hormone therapy, chemotherapy or orchiectomy were considered criteria for patient exclusion. Metastasis was present in 65% of the patients. The two groups were homogeneous as regards the T stage and the G grade of the tumor, the presence of metastases and performance status. Analysis of the percentage of subjective and objective response, of the time required for response and for progression, showed no statistically significant difference between the two treatment groups, as did the survival rate after a mean follow-up of 24 months (p = 0.47). Overall, the group receiving Goserelin + Flutamide recorded a larger number of side effects, mainly affecting the gastro-intestinal system.