Munich, Germany (UroToday.com) In today’s hormone therapy for prostate cancer poster session, Dr. Calais da Silva Jr. and associates presented their work on the phase III trial of intermittent monotherapy and continuous combined ADT. M1 patients were started on ciproterone acetate for two weeks followed by monthly Lupron injections which were initiated at the 2-week mark. Patients were then randomized at week 14 to receive continuous Lupron + daily ciproterone vs. intermittent ciproterone alone.
1045 men were included in the trial, of which 40% had PSA>20, 90% had T3 disease, and 14% were M1. 21% had Gleason 8 or higher. 918 reached randomization and had a median PSA of 1 and median follow-up of 5.5 years. There were 601 deaths (65%), of which 191 (21%) were cancer-specific, and median survival was 6.3 years. Those with metastatic disease (HR =1.63, CI 1.27-2.1), those older than 75 (HR=1.95, CI 1.28-2.97 for ref=<60), and those with PSA 2-4 (HR=2.01, CI 1.63-2.49 for ref=<0.5) had an increased risk of death. On multivariable analysis, patients receiving continuous ADT had an increased risk of death, though this did not reach significance (HR =1.17; CI 0.99-1.37, p=0.058).
The authors concluded that the study remains underpowered so caution must be exercised in drawing conclusions. At this iteration of analysis, there does not appear to be a survival advantage using continuous or intermittent ADT.
Reported By:
Nikhil Waingankar, MD, at the 31st Annual EAU Congress - March 12 - 15, 2016 – Munich, Germany
Fox Chase Cancer Center