Incidence of invasive breast cancer in women treated with testosterone implants: Dayton prospective cohort study, 15-year update

Author:

Glaser Rebecca L.1,Dimitrakakis Constantine2,Gindri Izabelle M3,Pizzolatti André L3,Pinto Luiz Paulo S4,Glaser-Garbrick Daniel5

Affiliation:

1. Millennium Wellness Center

2. Athens University Medical School

3. bio meds Pharmaceutica LTDA, Florianópolis, SC, BR

4. Integrated Hormone Treatment Center (CITH), Curitiba, PR, BR

5. Consultant Mathematics and Computer Science, Dayton, Ohio

Abstract

Abstract Background: We previously published 10-year results (from March 2008-March 2018) from the Dayton prospective breast cancer prevention study, which showed a 40% reduction in the incidence of invasive breast cancer in women receiving testosterone or testosterone with anastrozole implant therapy compared to the age-matched Surveillance Epidemiology and End Results (SEER) expected incidence rate. We continued to follow the study subjects on therapy through March 2023. Methods: This 10-year prospective cohort study was approved in March 2008, at which time recruitment was initiated. Recruitment was closed in March 2013. Pre- and postmenopausal women who received at least two pellet insertions were eligible for analysis (n=1267). Breast cancer incidence rates are reported as an unadjusted, unweighted value of newly diagnosed cases divided by the sum of the person-time of observation for the at-risk population. The incidence rates on testosterone therapy were compared to age-specific SEER incidence rates and expected local Montgomery County incidence rates (the location of most study patients). Results: As of March 1, 2023, a total of 16 (versus 30 expected) eligible patients were diagnosed with invasive breast cancer within 240 days of their last testosterone pellet insert equating to an incidence rate of 189/100000 p-y, which is significantly less than the national SEER expected incidence rate of 355/100000, i.e., a 47% reduction. Interestingly, local incidence rates in Montgomery County are higher than US national averages. Conclusion: The 15-year follow-up data revealed a reduced incidence of invasive breast cancer with long-term testosterone or testosterone combined with anastrozole implant therapy. Because of the increased incidence of invasive breast cancer in our area, the amount of reduction (benefit) from testosterone therapy may be underestimated using national data/statistics for comparison.

Publisher

Research Square Platform LLC

Reference10 articles.

1. The androgen receptor is a tumor suppressor in estrogen receptor–positive breast cancer;Hickey TE;Nat Med,2021

2. Glaser R, Dimitrakakis C. Testosterone Implant Therapy in Women With and Without Breast Cancer: Rationale, Experience, Evidence. Androgens: Clinical Research and Therapeutics. 2021;2(1):94–110.

3. Reduced breast cancer incidence in women treated with subcutaneous testosterone, or testosterone with anastrozole: A prospective, observational study;Glaser RL;Maturitas,2013

4. Incidence of invasive breast cancer in women treated with testosterone implants: A prospective 10-year cohort study;Glaser RL;BMC Cancer,2019

5. National Program of Cancer Registries and Surveillance, Epidemiology, End Results SEER. United States Department of Health and Human Services, Centers for Disease Control and Prevention. 2022. https://www.cdc.gov/cancer/npcr/index.htm.

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