Lumpectomy has been the standard of care for low-risk, early-stage breast cancer, but now cryoablation — freezing cancer tumors to kill them — is emerging as a new option.
The FDA recently granted marketing authorization for ProSense® cryoablation, a minimally invasive local treatment for women aged 70 and over who have early-stage, low-risk breast cancer with biologically low-risk tumors less than 1.5 cm in size.
The ProSense® Cryoablation System, developed by IceCure Medical Ltd., is the first and only medical device that’s been granted FDA marketing authorization for the local treatment of breast cancer. Doctors call it a game-changer.
Nathalie McDowell Johnson, M.D., FACS
Senior Medical Director, Legacy Cancer Institute
“Cryoablation gives the opportunity for women to have their breast cancer treated in the office and not in a surgical suite,” said Nathalie McDowell Johnson, M.D., FACS, senior medical director of the Legacy Cancer Institute.
How it works
Breast cancer cryoablation uses liquid nitrogen to kill tumors by freezing them. The doctor uses ultrasound to guide the ProSense® System’s needle-like cryoprobe into the tumor. Next, liquid nitrogen freezes the tumor at sub-zero temperatures, resulting in an ice ball around the tumor.
Robert C. Ward, M.D.
Associate Professor of Radiology, Brown University
“The ice ball is so cold that it kills the tissue in a very targeted manner,” said Robert C. Ward, M.D., associate professor of radiology at Brown University, who specializes in breast imaging and intervention, and has been using cryoablation for 10 years.
A freeze-thaw-freeze cycle kills the targeted tissue immediately. The ice ball melts, and the body absorbs the tumor over time. No breast tissue is removed, maintaining the shape of the breast.
Patient outcomes
The goal is de-esclation of care: to do less invasive procedures while still maintaining similar outcomes. While lumpectomy has been the standard of care for decades, it’s a lengthy, surgical procedure in the hospital usually done under anesthesia, and requires cutting into and removing breast tissue. Healing can take weeks.
But ProSense® is effective, minimally invasive, and can be done in the office in about an hour. “Patients feel relaxed, some of them actually fall asleep during the procedure, and the ice has a numbing effect,” said Dr. Johnson, who has been using the tech for the past five years.
Patients can drive themselves to and from the appointment, leaving with a small bandage and resuming normal activities usually within 24 hours.
Follow-up imaging after cryotherapy ablation is the same as with a lumpectomy: a mammogram at six months, 12 months, and then annually after that.
The future
“A significant proportion of breast cancers that we diagnose nationwide would potentially benefit from this procedure instead of a lumpectomy,” said Dr. Ward, who estimates that the 150 patients who got lumpectomies at his hospital last year could have had ProSense® instead.
Now that the procedure is FDA-cleared, Dr. Johnson, a past president of the American Society of Breast Surgeons, is hopeful that more patients can utilize it and receive insurance coverage. As a breast cancer survivor, she says ProSense® gives patients more options.
“Cryoablation is wonderful, and I think it enriches patient-informed decision-making,” she said. “You explain to patients the pros and cons of different options and allow them to make choices.”
