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Subcutaneous
Testosterone-Anastrozole
Therapy in
Breast Cancer Survivors
Learning Objectives
After reading and reviewing this material, the participant should be better able to: • Identify symptoms of androgen deficiency in pre and post menopausal breast cancer survivors • Recognize the potential role of subcutaneous testosterone-anastrozole implant therapy in safely treating those symptoms • Background• Methods• Results• Conclusion• Future Background
cancer survivors commonly experience symptoms of hormone deficiency that can adversely affect their health and quality of life Efficacy of Testosterone Therapy
• Continuous testosterone therapy, delivered by subcutaneous (SC) implant, effectively treats hormone/androgen deficiency symptoms as measured by the HRQOL, Menopause Rating Scale (MRS) in both pre and post menopausal patients1 Symptoms improved with SC
continuous testosterone therapy

• Hot flashes, sweating• Heart discomfort• Insomnia , sleep problems• Depressive mood, Irritability, Anxiety• Physical fatigue, Memory loss• Sexual dysfunction• Incontinence, bladder problems• Vaginal dryness• Joint and muscular pain Additional potential benefits in breast
cancer survivors

• Testosterone protects against bone loss• Testosterone stimulates bone marrow and Background
• Evidence supports that testosterone is • Testosterone can be aromatized to estradiol which may have adverse effects on breast cancer proliferation • Third generation aromatase inhibitors effectively inhibit the aromatization of testosterone to estradiol Preliminary data: 35 male patients
• 12 mg of anastrozole, a third generation aromatase inhibitor (AI), delivered subcutaneously by pellet implant, with up to 1200 mg of testosterone, effectively prevented the conversion of testosterone to estradiol in male patients with previously elevated estradiol levels Subcutaneous delivery (implants)
• Effective therapy• Avoids entero-hepatic – Bypasses liver– Does not affect clotting factors– Absence of GI side effects • Circadian release• No compliance issues• Well tolerated• Simple procedure to insert Testosterone-Anastrozole Implant
– 60 mg testosterone– 4 mg anastrozole – 120 mg testosterone– 8 mg of anastrozole Simple 2 minute Procedure
• Breast cancer survivors were referred from their oncologists or self-referred (with permission from oncologist) for symptoms of androgen deficiency including bone loss • Prior to July 2009, oral AI therapy was prescribed in conjunctions with SC testosterone in ER positive patients • Data was available on 75 testosterone- anastrozole inserts performed in 43 of 55 breast cancer survivors treated between July 2009 and May 2010 Patient Demographics
• 38/43 patients were > 5 years from diagnosis• 40/43 tumors were ER pos / non-invasive Ca• Tumor Stage – 8 DCIS, 1 LCIS– 19 Stage I– 10 Stage II– 1 Stage III– 4 Stage IV Methods: procedure, testing
• Two anastrozole-testosterone (A-T) implants (120 mg testosterone, 8 mg anastrozole) were inserted subcutaneously (SC) using local anesthesia in the upper gluteal area • Serum testosterone and estradiol levels were measured two weeks following implantation Results (Clinical)
• Subcutaneous testosterone-anastrozole therapy was effective in treating symptoms of hormone/androgen deficiency in breast cancer survivors • All patients achieved relief of symptoms – Mean: 281 ng/dl, range: 120-518 ng/dl anastrozole pellet insertions (43 patients), serum estradiol measured <30 pg/ml • A single post-menopausal patient on A-T – Subsequent level measured <30 pg/ml Results: E2 levels T alone vs. A-T
– Post menopausal females treated with – 42% (50/119) of patients treated with Testosterone alone had an E2>30 pg/ml – 6.7% (5/75) of patients treated with Anastrozole in combination with Testosterone (A-T) had an E2>30 pg/ml Estradiol Density Plot
The levels of Estradiol (E2) in the group with the aromatase inhibitor is significantly less than in the group without it (2-sample Wilcoxan rank sum test, P<0.0001). The separation of E2 in both groups is almost disjoint as illustrated by the kernel density plot. Clinical follow up
• There have been no adverse drug events in over 170 insertions in 67 breast cancer survivors (Through September 2010) • No breast cancer survivor treated with subcutaneous testosterone therapy has been diagnosed with recurrent disease in up to 4 years of therapy • There has been no progression of disease in in 2 ER pos patients and 1 ER neg patient with metastatic disease treated for up to 30 months – The 4th patient presented with active disease and has responded to chemotherapy with minimal side effects from the chemotherapy. She continues on therapy and disease is stable.
Conclusion
• The combination of testosterone with anastrozole, delivered subcutaneously as a pellet implant, provides therapeutic levels of testosterone without elevating estradiol levels Current & Future Studies
Incidence Trial (Current) Glaser, Dimitrakakis – IRB approved, 10 year prospective study looking at the incidence of breast cancer in pre and post menopausal women treated with subcutaneous testosterone therapy • ATTICA Breast* Trial (Future) Glaser, Dimitrakakis – Randomized, placebo controlled trial treating BrCa survivors on no current therapy, with SC A-T implants *Anastrozole-Testosterone Therapy in CA Breast References
1. Glaser R, Wurtzbacher, D, Dimitrakakis C. Efficacy of Testosterone Therapy Delivered by Pellet Implant. Maturitas 2009, 63(Suppl 1);283.
2. Dimitrakakis C, Bondy C. Androgens and the breast. Breast Cancer Research 2009;11(5):212.
3. Traish AM, Fetten K, Minor M, Hansen ML, Guay A. Testosterone and risk of breast cancer: appraisal of existing evidence. Hormone Molecular Biology and Clinical Investigation. 2010; 2 (1): 177 rglasermd@gmail.com
Wright State University, Boonshoft School of Medicine,

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