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Women's Breast Tumors

It is estimated that more than half of the women in the U.S. will see a doctor about a breast abnormality sometime during their life. Most of these physician visits are the result of a women’s self-examination in which they discover a lump in their breast. While the majority of these masses are non-cancerous or benign tumors referred to as a fibroadenomas they generally cause significant anxiety for the women. Fibroadenomas are usually solid, round, non-cancerous tumors that feel like a marble within the breast. They can range in size from microscopic to several inches across and can frequently be felt during a breast exam. Fibroadenomas may require removal if they cause pain, continue to grow or change in shape. Many women who have fibroadenomas will develop more than one.

The current treatment for fibroadenomas is both “watch and wait” or removal of the tumor. There are a number of companies that sell the surgical instruments to remove the benign tumors. Currently over 500,000 benign tumors are removed each year because of pain, the potential for continued growth and concern upon the part of the patient and/or physician regarding their future status. Fibroadenomas occur in about 10 percent of all women and account for about half of the 1.6 million breast biopsies doctors perform each year in the US. It is estimated that there are more than 5 million women with fibroadenomas throughout the world. They are common among girls in their teens and women in their twenties and thirties, but may occur at any age. According to the National Institutes of Health (NIH), fibroadenomas occur twice as often in African-American women. The current treatment for fibroadenomas is to have them surgically removed, although this procedure usually results in noticeable scarring and potential deformity of the breast that may require a second reconstructive surgery.  

An alternative to surgery is the treatment of the tumor with cryoablation. Cryoablation is the freezing of the tumor with very cold temperatures. This freezing results in the ablation of the tumor through a minimally invasive procedure that uses a long needle (probe) to ablate the tumor. This procedure results in the immediate death (necrosis) of the tumor cells which are reabsorbed over time by the body’s normal immune process. The absorption of the dead tumor cells by the body makes surgical removal unnecessary, eliminating the scarring and deformity of the breast caused by surgery.  This results in a more cosmetically appealing outcome. Since most women with fibroadenomas are between the ages of 18-40 and will more than likely produce more than one fibroadenoma over their lifetime, cosmesis is important to their emotional health, so avoiding the scars and volume reduction associated with excision is an attractive benefit.

Breast Cancer

In addition to fibroadenomas, there are projected to be over 207,000 new cases of breast cancer reported in 2010 (A Cancer Journal for Clinicians 2010).  Cryoablation can provide a superior clinical outcome for the treatment of cancerous tumors when compared to current surgical treatment. In addition none of the other ablation technologies seem to offer the benefit of a possible vaccine effect that may be found with cryoablation.  Michael Sabel MD, associate professor of surgery at the Medical School of the University of Michigan (Ann Arbor) reported in the Annals of Surgical Oncology, "Cryoablation has strong potential as a treatment for breast cancer. Not only does it appear effective in treating the primary tumor with little cosmetic concerns, but it also may stimulate an immune response capable of eradicating any cells that have traveled throughout the body, reducing both local and distant recurrence, similar to giving a breast cancer vaccine”. Researchers also learned that much of the success relies on the technique used to freeze the tumors, which can have "a significant impact on how the immune system responds," says Sabel. "The system we use today appears to be ideal for both destroying the tumor within the breast and generating an anti-cancer immune response."  This is exciting news for the estimated 192,000 women who will be diagnosed with a new case of invasive breast cancer this year in America.