New Swedish study.
"In randomised controlled trials, men with advanced, non-metastatic prostate cancer (PCa) treated with anti-androgen monotherapy (AA) had similar all-cause mortality as men treated with gonadotropin-releasing hormone (GnRH) agonists. Using real-world evidence (i.e., observational data), we aimed to further assess the difference in mortality between these two drug categories."
"The cumulative 5-year PCa mortality was lower for men treated with AA (16% ...) than men treated with GnRH agonists (22% ...). The 5-year other cause mortality was also lower for men on AA (17% ...) compared to men on GnRH agonists (27% ...). In regression analyses, the risk of PCa death was similar, GnRH agonists versus AA (reference), hazard ratio (HR) 1.08 .., but the risk of death from all causes was higher for men on GnRH agonists, HR 1.23 ..."
"Our results indicate that the use of AA as primary hormonal therapy in men with high-risk non-metastatic PCa does not increase PCa-specific mortality compared to GnRH. Using AA instead of GnRH agonists may result in shorter time on/exposure to GnRH-treatment, which may reduce the risk of adverse events associated with this treatment."
-Patrick
ncbi.nlm.nih.gov/pubmed/303...
Acta Oncol. 2018 Oct 30:1-9. doi: 10.1080/0284186X.2018.1529427. [Epub ahead of print]
Anti-androgen monotherapy versus gonadotropin-releasing hormone agonists in men with advanced, non-metastatic prostate cancer: a register-based, observational study.
Thomsen FB1, Bosco C2, Garmo H2,3, Adolfsson J4, Hammar N5,6, Stattin P7, Van Hemelrijck M2,5.
Author information
1
a Copenhagen Prostate Cancer Center, Department of Urology , Rigshospitalet, University of Copenhagen , Copenhagen , Denmark.
2
b Translational Oncology & Urology Research (TOUR), School of Cancer and Pharmaceutical Sciences , King's College London , London , UK.
3
c Regional Cancer Centre Uppsala Örebro , Uppsala University Hospital , Uppsala , Sweden.
4
d CLINTEC-department , Karolinska Institutet , Stockholm , Sweden.
5
e Unit of Epidemiology , Institute of Environmental Medicine, Karolinska Institutet , Stockholm , Sweden.
6
f Medical Evidence and Observational Research, Global Medicines Development , AstraZeneca , Stockholm , Sweden.
7
g Department of Surgical Sciences , Uppsala University Hospital , Uppsala , Sweden.
Abstract
BACKGROUND:
In randomised controlled trials, men with advanced, non-metastatic prostate cancer (PCa) treated with anti-androgen monotherapy (AA) had similar all-cause mortality as men treated with gonadotropin-releasing hormone (GnRH) agonists. Using real-world evidence (i.e., observational data), we aimed to further assess the difference in mortality between these two drug categories.
MATERIAL AND METHODS:
We emulated a trial using data from Prostate Cancer data Base Sweden 3.0. We specifically focused on men diagnosed in 2006-2012 with high-risk PCa who had no distant metastasis. They either received primary hormonal therapy with AA (n = 2078) or GnRH agonists (n = 4878) who were followed for a median time of 5 years. Risk of death from PCa and other causes was assessed using competing risk analyses and Cox proportional hazards regression analyses, including propensity score matching.
RESULTS:
The cumulative 5-year PCa mortality was lower for men treated with AA (16% [95% confidence interval, CI, 15-18%]) than men treated with GnRH agonists (22% [95% CI 21-24%]). The 5-year other cause mortality was also lower for men on AA (17% [95% CI 15-19%] compared to men on GnRH agonists (27% [95% CI 25-28%]). In regression analyses, the risk of PCa death was similar, GnRH agonists versus AA (reference), hazard ratio (HR) 1.08 (95% CI 0.95-1.23), but the risk of death from all causes was higher for men on GnRH agonists, HR 1.23 (95% CI 1.13-1.34). Consistent results were seen in the propensity score-matched cohort.
CONCLUSION:
Our results indicate that the use of AA as primary hormonal therapy in men with high-risk non-metastatic PCa does not increase PCa-specific mortality compared to GnRH. Using AA instead of GnRH agonists may result in shorter time on/exposure to GnRH-treatment, which may reduce the risk of adverse events associated with this treatment.
PMID: 30375907 DOI: 10.1080/0284186X.2018.1529427
