Cryoablation has shown early indications of effectiveness in treating women with low-risk breast cancers, according to research presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSM01-01).
“If the positive preliminary findings are maintained as the patients enrolled in the study continue to be monitored, that will serve as a strong indication of the promise of cryotherapy as an alternative treatment for a specific group of [patients with] breast cancer,” said study lead author Kenneth R. Tomkovich, MD, radiologist at Princeton Radiology and Director of Breast Imaging and Interventions at CentraState Medical Center, in a statement.
Dr. Tomkovich began studying cryoablation in breast cancer more than 10 years ago, as imaging advances in mammography and ultrasound and the development of tomosynthesis enabled the detection of more low-risk cancers. These small, early-stage cancers have the potential to become invasive and life-threatening without treatment, but treatment options have not kept pace with imaging advances.
“We're finding smaller and smaller breast cancers, but we're still treating them the same way we did 30 years ago,” Dr. Tomkovich said.
Cryoablation begins with the introduction of a probe into the tumor through a small incision in the skin while the patient is under local anesthesia. The probe is guided by high-definition ultrasound in conjunction with mammography images. Once the probe is in place, liquid nitrogen is introduced into it.
During the initial, 8-minute freeze cycle, liquid nitrogen encapsulates the tumor. After a thaw cycle, another 8-minute freeze cycle is used. The procedure takes less than 1 hour, and patients are able to return to their normal activities shortly thereafter.
Ice 3 Trial
As part of the Ice 3 Trial, Dr. Tomkovich and colleagues at 18 centers across the United States have been studying cryoablation as a primary treatment for breast cancer without surgical lumpectomy. Starting in 2014, the researchers began performing cryoablation on women aged 60 years and over with biopsy-proven, low-risk breast cancer. The patients undergo the procedure and then are followed for recurrence with mammography at 6 and 12 months, and then annually for 5 years.
As of now, the researchers have 3-year follow-up data on about 20 patients and 2-year follow-up data on more than 75 patients. The procedure was successfully completed in all patients, and no serious adverse events have been reported. Only one patient experienced disease recurrence, giving the procedure a 99.4% success rate so far. Common imaging findings include fat necrosis, scarring, and a mammographic “halo” effect.
Final results of the study will be published when 5-year follow-up data are available for all the women who were treated.
Disclosure: Dr. Tomkovich is a consultant for Scion Medical Technologies, LLC, and is on the Scientific Advisory Board for IceCure Medical, Inc.
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