Background: Menopausal symptoms can be severe in breast cancer survivors in whom estrogen therapy is contraindicated. Our previous pilot trial demonstrated that testosterone (T) combined with anastrozole (A) in subcutaneous implants provided therapeutic T levels without elevating estradiol. Our current goal was to document the clinical effect of T+A combination implants (no estrogen) on menopausal symptoms. Methods: This IRB approved study was designed to prospectively follow breast cancer survivors (stage 0-4) treated with subcutaneous T+A, for breast cancer recurrence. The therapeutic effectiveness of T on the relief of psychological, somatic and urogenital symptoms was documented using the validated, self administered, 11 item Menopause Rating Scale. Patients completed the survey prior to and following therapy. Results: Over 950 T/T+A pellet insertions have been performed in breast cancer survivors since 2006. Since 4/2013, 72 patients have been enrolled in the study. T dosing is weight based. Implants are inserted at 3-month intervals on average. Therapeutic T levels were confirmed without elevation of estradiol in any postmenopausal survivor. There have been no cancer recurrences in up to 8 years of therapy. A single patient with active metastatic disease at enrollment developed ascites. There was statistically significant improvement (P < 0.0001) in psychological symptoms (depression, irritability/aggression, anxiety), somatic symptoms (hot flashes/sweating, heart discomfort, sleep problems/insomnia, physical exhaustion, impaired memory, joint/muscular pain) and urogenital symptoms (vaginal dryness, bladder problems/incontinence, sexual problems). Conclusions: Testosterone in combination with an aromatase inhibitor, delivered by subcutaneous implant, was extremely effective for the relief of hormone deficiency symptoms in breast cancer survivors. Furthermore, this supports testosterone’s therapeutic effect via the androgen receptor.
| Age at diagnosis (y) | 50.04+10.66 (31.25-90.34) |
| Age at first insertion (y) | 57.17+10.51 (31.74-90.27) |
| Treatment years | 3.93+2.41 (0.11-8.37) |
| BMI | 26.03+4.69 (18.97-40.27) |
| T dose (mg) | 168.89+32.25 |
| A dose (mg) | 8 |
| Stage 0, 1, 2, 3, 4 (n) | 15, 25, 23, 6, 3 |