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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.).

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APCaRI 2016 Fall Symposium

On Oct. 20-21, 2016, APCaRI will celebrate its 7th research meeting at the Banff Park Lodge, Alberta.

Over 60 participants including clinicians, scientists, clinical research personnel, trainees, benefactors and representatives of PCa support groups will participate in this fun and enriching event.

The team will benefit from the insight and experience that will be shared by keynote speakers: Drs. Edwin Wang, Professor Depts. of Biochemistry & Molecular Biology, Medical Genetics, and Oncology, McGill University;Roy Duncan, Dept. Microbiology & Immunology and Biochemistry and Pediatrics, Dalhousie University; Susan J. Done, Associate Professor, Departments of Laboratory Medicine and Pathobiology and Medical Biophysics, University of Toronto; and Christopher Bown, Gowlings

In addition, we will have 4 talks from senior scientists Drs. Juan Jovel (Dept Medicine, U of A), Len Luyt (Chemistry Department, U of A), Andries Zijlstra (Dept. of Pathology, Microbiology, and Immunology, Vanderbilt University), Desmond Pink (Dept Oncology, U of A) and John Lewis (Dept Oncology, U of A), and 16 short talks from trainees from different institutions in the province.

Agenda-APCaRI-2016-fall-symposium

Generously supported by the Bird Dogs and the Alberta Cancer Foundation

- Catalian Vasquez