Large, international trial finds intermittent androgen deprivation is not equivalent to continuous treatment
ANN ARBOR, Mich.
April 4, 2013
/PRNewswire-USNewswire/ -- Taking a break from hormone-blocking prostate cancer treatments once the cancer seems to be stabilized is not equivalent to continuing therapy, a new large-scale international study finds.
Based on previous smaller studies, it looked like an approach called intermittent androgen deprivation therapy might be just as good as continuous androgen deprivation in terms of survival while meanwhile giving patients a breather from the side effects of therapy. In fact, researchers believed intermittent therapy might help overcome treatment resistance that occurs in most patients with metastatic hormone-sensitive prostate cancer.
But this new study, which treated 1,535 patients with metastatic prostate cancer and followed them for a median of 10 years, finds that's not the case. Results appear in the
New England Journal of Medicine
"We tried to see whether intermittent androgen deprivation is as good as continuous androgen deprivation, but we did not prove that. We found that intermittent therapy is certainly not better and moreover we cannot even call it comparable," says lead study author Maha Hussain, M.D., FACP, a prostate cancer expert at the
University of Michigan
Comprehensive Cancer Center.
The study was sponsored by SWOG, a National Cancer Institute-supported cancer clinical trials cooperative group.
In the study, men with metastatic hormone-sensitive prostate cancer were given an initial course of androgen deprivation therapy (hormone therapy), which is standard therapy for this disease. Patients with a stable or declining PSA level equal to or below a cut-off of 4 ng/ml were then randomly assigned either to continue or to discontinue the hormone therapy. Patients were carefully monitored with monthly PSAs and a doctor's evaluation every three months and therapy was resumed in the intermittent arm when PSA climbed to 20 ng/ml. The intermittent cycle continued on-and-off based on the PSA levels.