Medical news_ asco breast_ implants may quell hormone deficiency - printable version

ASCO Breast: Implants May Quell Hormone Deficiency
By Charles Bankhead, Staff Writer, MedPage Today
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical
School, Boston.
October 04, 2010
MedPage Today Action Points
Note that this study was published as an abstract and presented at aconference. These data and conclusions should be considered to bepreliminary until published in a peer-reviewed journal.
Explain that subcutaneous implants of a combination of testosterone and the aromatase inhibitor anastrozole in postmenopausal breast cancer survivorsimproved menopausal symptoms without increasing estradiol levels.
Note that this proof-of-concept study has set the stage for a randomized,controlled phase III trial, according to the investigators.
NATIONAL HARBOR, Md. -- A subcutaneous testosterone implant has shown
potential to reduce hormone-deficiency symptoms without raising estradiol levels in
breast cancer survivors, data from a small clinical series showed.
Combined with the aromatase inhibitor anastrozole (Arimidex), the implantmaintained an average testosterone level of 281 ng/dL with associated estradiollevels <30 pg/mL in 43 breast cancer patients.
Implants containing testosterone alone were associated with estradiol levels >30pg/mL in 50 of 119 postmenopausal women without breast cancer. That comparedwith five of 75 (6.7%) combination implants in the breast cancer patients, Rebecca L.
Glaser, MD, of Wright State University in Dayton, Ohio, reported here at the BreastCancer Symposium.
"We believe testosterone is beneficial to breast tissue, and, in fact, most of myreferrals are from oncologists," Glaser told MedPage Today. "The downside is thattestosterone can be aromatized into estradiol, which may stimulate breast tissue.
"So, we came up with the combination of testosterone with an aromatase inhibitor,delivering it subcutaneously. It is extremely well tolerated, there are no complianceissues, and it takes care of the symptoms." Breast cancer survivors often have severe menopausal-like symptoms owing totreatment-induced hormone deficiency. Clinical and preclinical evidence suggestsandrogens inhibit mammary epithelial proliferation and breast growth, leadingresearchers to wonder if adding testosterone to hormone therapy will reduce thebreast cancer risk associated with estrogen/progestin treatment.
Glaser and colleagues have evaluated subcutaneous testosterone implants fortreatment of hormone deficiency symptoms in pre- and postmenopausal womenwithout breast cancer. In an article currently in press, they have reported that theimplants relieve a variety of symptoms, including hot flashes, sleep disturbance,depressed mood, irritability, and fatigue.
Each combination implant contains 60 mg of testosterone and 4 mg of anastrozole,and patients receive two of the implants every 90 days.
Glaser reported findings from a proof-of-concept study to evaluate the combinationpellets' effect on estradiol levels in breast cancer survivors. The study involved 43patients, 38 of whom were more than five years out from diagnosis. The studypopulation consisted of eight patients with initial diagnoses of ductal carcinoma insitu, one with lobular carcinoma in situ, 19 patients with stage I invasive cancer, 10 with stage II, one with stage III, and four with stage IV.
The 43 patients have undergone a total of 75 subcutaneous insertion procedures. In70 of 75 procedures, serum estradiol levels were ≤30 pg/mL in association withtherapeutic levels of testosterone (range 120 to 518 ng/dL). The highest estradiolmeasured was 53 pg/mL, which occurred on one occasion in a postmenopausalwoman with estrogen receptor-negative breast cancer. Subsequent measurements inthis same patient were all <30 pg/mL.
No significant adverse effects have occurred in any of the breast cancer survivorswho received the testosterone-anastrozole implants, Glaser said. The total number ofinsertions had increased to 150 by the end of August.
No breast cancer patient has had disease recurrence during treatment with theimplants for as long as three years. Additionally, three patients with metastatic breastcancer have had no evidence of disease progression since beginning treatment withthe testosterone-anastrozole pellets.
The findings have set the stage for a randomized, placebo-controlled clinical trial ofthe implants in breast cancer survivors, according to Glaser.
Glaser reported that she had no relevant disclosures.
Primary source: ASCO Breast Cancer Symposium
Source reference:
Glaser RL "Subcutaneous testosterone-anastrozole therapy in breast cancer
survivors" ASCO Breast 2010; Abstract 221.


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