Freezing Breast Cancer in Its Tracks
A new treatment for breast cancer, cryoablation, which uses extreme cold to kill cancerous cells, is currently under study at various sites across the U.S. Rache Simmons, MD, chief of breast surgery at NewYork-Presbyterian/Weill Cornell, is the lead author on the initial clinical study of cryoablation and breast cancer, and she is involved in ongoing research on cryoablation at Weill Cornell.
The Process of Cryoablation
During cryoablation, a doctor looks at an ultrasound image of the tumor while guiding a thin, hollow needle through the skin and into the tumor. Liquid nitrogen is then pumped through the needle. The nitrogen forms an ice ball that surrounds and destroys the cancerous tissue. Cryoablation requires no general anesthesia or hospitalization; the procedure can be performed in an outpatient setting with only a topical anesthetic applied to the skin.
WHAT YOU SHOULD KNOW
If you or someone you know has been diagnosed with breast cancer, you may be eligible for one of the cryoablation studies that are currently underway. Here is some basic information about the two studies; use the contact information provided to get more details.
The FROST trial is being conducted by Sanarus; visit the website at [email protected] or call 800/909-3060. Inclusion criteria: Women age 50 and older; tumor is visible on ultrasound; tumor size less than 1.5 centimeters; cancer is estrogen receptor-positive or progesterone receptor-positive and HER2-negative.
The ICE3 trial is being conducted by IceCure Medical; visit the website at http://bit.ly/2fBUxv6 or call 888/516-7389. Inclusion criteria: Women age 65 and older; tumor is visible on ultrasound; tumor size less than 1.5 centimeters; cancer is estrogen receptor-positive or progesterone receptor-positive and HER2-negative.
“Using cryoablation to treat breast cancer is a huge advance for women,” says Dr. Simmons. “The procedure takes less than 30 minutes, there’s no recovery time, and the patient goes home with a Band-Aid on the tiny incision made by the needle. When cryoablation successfully destroys all of the cancerous cells, there is no need to remove lymph nodes, to have radiation, or to take medications, such as tamoxifen and/or aromatase inhibitors (Arimidex, Aromasin, Femara), that reduce the risk of cancer recurrence.”
Study Results
In the recent clinical trial led by Dr. Simmons, cryoablation was used on 86 postmenopausal women who had estrogen receptor- or progesterone receptor-positive and HER2-negative breast cancer. The tumors treated were 2 centimeters or smaller that could be seen on ultrasound. Following cryoablation, tissue from the former tumor site was extracted and examined to see if all of the cancerous cells were destroyed. In 92 percent of the tissue, no cancerous cells were found, and among tumors that were smaller than 1 centimeter, 100 percent of the tissue was cancer-free.
“Over time, the body reabsorbs the destroyed cancer cells; once that occurs, imaging scans show no traces of the cancer,” says Dr. Simmons.
After cryoablation, patients are seen for follow-up, including mammograms, every six months for the first five years, and then have annual visits, explains Dr. Simmons.
Animal studies suggest that cryoablation may even be effective at treating more advanced breast cancers that have metastasized (spread) to other organs.
“In studies of mice with metastatic breast cancer, when the primary tumor is ablated, the cancer at other sites in the body melts away. We believe the cryotherapy causes the cancerous cells to burst and release DNA, and the body mounts an autoimmune response and kills the cancer cells in other areas of the body,” explains Dr. Simmons.
However, the effect of cryoablation on metastatic cancer will require years of study in humans before researchers can reach any definitive conclusions.
Ongoing Research
According to Dr. Simmons, there are two main ongoing cryoablation studies, the FROST trial and the ICE3 trial. “The studies last for 12 to 18 months, and then follow-up for five years is required, so it will be about seven years until final results are available.” (See What You Should Know for more information about the trials that are in progress.)
While it will be several years before the studies are concluded and the results are published, Dr. Simmons is optimistic.
“Cryoablation is not for every type of breast cancer, but it could help many patients. Hopefully, we will be able to offer many women with breast cancer an effective treatment with fewer risks than what is currently available.”
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