Publications

Publications

Intermittent versus continuous androgen deprivation in prostate cancer.

By:
Contributors: Bryan Donnelly, MD, MSc, FRCSC, Peter Venner, MD, FRCPC
Urol Oncol. 2014 Aug;32(6):936-7. doi: 10.1016/j.urolonc.2014.01.009.

Abstract

BACKGROUND:

Castration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgendeprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence.

METHODS:

Men with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone-releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization.

RESULTS:

A total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy group and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P<0.001 and P=0.003, respectively) at month 3 but not thereafter. There were no significant differences between the groups in the number of treatment-related high-grade adverse events.

CONCLUSIONS:

Our findings were statistically inconclusive. In patients with metastatic hormone-sensitive prostate cancer, the confidence interval for survival exceeded the upper boundary for noninferiority, suggesting that we cannot rule out a 20% greater risk of death with intermittent therapy than with continuous therapy, but too few events occurred to rule out significant inferiority of intermittent therapy. Intermittent therapy resulted in small improvements in quality of life. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00002651.).

Graph

 PubMed

Download PDF

 

Stay Informed

To stay up to date on all the latest news and publications, subscribe to our newsletter!

Member of the APCaRI Training Program will present a poster at CARO ASM 2017 – Toronto

Congratulations to Dr. Deepak Dinakaran for getting his abstract “Comparison of Post-Radiotherapy Prostate Specific Antigen drop kinetics between External Beam Radiotherapy and Brachytherapy” accepted as a poster presentation at the Canadian Association of Radiation Oncology Annual Scientific Meeting (CARO ASM) 2017.

The 2017 CARO Annual Scientific Meeting will be held at the Hilton Toronto in Toronto, ON September 13-16, 2017.  This conference is for Radiation Oncologists, Medical Physicists, Radiation Therapists, Basic Science Researchers, Oncology Nurses, Administrators, as well as their trainees. All healthcare professionals involved in the care of oncology patients are also welcome to attend.

Dr. Dinakaran extracted and analyzed clinical data from the Alberta Prostate Cancer Registry for this study.

- Unknown