Breast Tenderness and Cancer

by Leifson Ball, RPh
May 1, 2010

brought to you by Bellevue Pharmacy, a ProjectAWARE sponsor

Response to:

“New-Onset Breast Tenderness During Hormone Therapy Linked to Increased Breast Cancer Risk”, Arch Internal Med/ Vol. 169 Oct. 12, 2009

Purpose of the Study:

The purpose of the study was to evaluate the effects of conjugated equine estrogens plus medroxyprogesterone on breast tenderness and how it may be related to breast cancer.

The study was based on data from the Women’s Health Initiative (WHI) (Estrogen plus Progestin) Trial which followed 16,608 postmenopausal women between the ages of 50 and 79 years. The hypothesis was that breast cancer seen in the WHI trial was associated with preceding breast tenderness.

Breast tenderness is considered a common adverse effect of conjugated estrogen and medroxyprogesterone therapy.

Results from the study:

Breast cancer risk was significantly higher in women with new onset breast tenderness as compared with those without the estrogen plus progestin therapy.

Considerations:

These results are based on a hypothesis derived from the criteria for monitoring the patients in the WHI trial. One of the various monitoring parameters was breast tenderness. The trial assessed breast tenderness annually.

Limitations of the Study:

• Lack of annual vs. more frequent assessments of breast tenderness.

• High rates of discontinuation of therapy.

• The WHI trial ended early.

• The WHI trial did not address the long term benefits of HRT.

• The WHI trial was limited to only conjugated equine estrogens and medroxyprogesterone and does not apply to other hormone formulations.

• Exclusion of younger menopausal women with significant menopausal symptoms.

Conclusion:

The flaws initially seen with the WHI trial may be extrapolated to this study for the reason that the authors are using the same data to prove their hypothesis.

This study appears to portray that women that demonstrate new breast tenderness during conjugated estrogen/medroxyprogesterone therapy may show an indication of breast cancer. If this is true, women using this type of therapy would need to be concerned every time they exhibit any type of breast tenderness.

Breast tenderness in general, is considered a common adverse effect of conjugated estrogen and medroxyprogesterone therapy. This does not mean, however, that the person has breast cancer. It is merely a possible indication for breast cancer.

Also the study does not take into consideration the use of other hormone formulations, including bioidentical therapy, which may provide a different risk-benefit profile for breast tenderness and how it may be associated with breast cancer. Breast tenderness that lasts more than a few days should be followed up by a health care professional to determine basis for the ongoing symptom.

For questions and further information, contact Bellevue Pharmacy.