Objectives:We conducted a prospective, randomized study to investigate hot flashes and quality of life (QOL) during combined androgen blockade (CAB) therapy using steroidal or nonsteroidal antiandrogens.
Methods:A total of 151 patients with prostate cancer, enrolled into this study between May 2001and June 2003, were randomized to receive CAB therapy using an LHRH agonist (leuprorelin) combined with a steroidal antiandrogen (chlormadinone) or a nonsteroidal antiandrogen (bicalutamide). The incidence of, frequency of, and distress due to hot flashes were evaluated with a self-entry questionnaire over 2 years. General and disease-specific QOL outcomes were also measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.Results: Data were available for analysis on 124 patients. Although the incidence of hot flashes largely tended to be higher in the bicalutamide group than in the chlormadinone group, no significant difference was noted in the cumulative incidence of hot flashes at 2 years. The median frequency of hot flashes per day was 1.3 and 2.2 for warmth/flushing (P = 0.16) and 1.0 and 3.6 for sweating (P = 0.021) in the chlormadinone and bicalutamide groups, respectively. Patients in the chlormadinone group were significantly less likely to be distressed due to warmth/flushing 4 (OR 0.47, P < 0.001) and sweating (OR 0.61, P = 0.01) than those in the bicalutamide group.The time course of FACT-P scores showed no inter-group differences.
Conclusions:Our results suggest that CAB using a steroidal antiandrogen such as chlormadinone may induce fewer and less distressing hot flashes than CAB with bicalutamide.