Therapeutic Research

Abstract

Objective: To evaluate the safety and efficacy of degarelix in patients with prostate cancer under routine medical practice. Methods: A two –year post – marketing sur veillance is being carried out for the patients with prostate cancer who started administration of degarelix as an observational study using a central registration method. Interim analysis for the first year part is reported here. Results: Overall, 301 cases were registered and 297 patients were analyzed for safety. An adverse drug reaction rate was 32.7％（97/297） and injection site reactions（ISRs） were observed most frequently（ 25.6％）. The frequency of ISRs was 21.2％ at first injection, and it decreased to about 5％ thereafter. The number of patients who discontinued treatment due to ISRs was ten. Of those, 271 patients were analyzed for efficacy. Their initial median prostate –specific antigen（PSA） level was 49.2 ng/mL. The median PSA levels decreased by 92.2％ and 50.2％ at week 4 for the patients without pretreatment （71.0 ng/mL at week 0） and those who had pretreatment （14.1 ng/mL at week 0）, respectively. Conclusions: These results indicate the safety and efficacy profile of degarelix obtained from this surveillance did not differ from that observed in its registration clinicaltrials.