Image-guided cryoablation can be an effective primary treatment for small, low-risk breast tumors without lumpectomy, according to new data from the ongoing Ice 3 trial.
"The results are as good or better than I could possibly have expected," Dr. Kenneth Tomkovich, director of breast imaging and interventions at CentraState Medical Center in Freehold, New Jersey, noted in an interview with Reuters Health.
"We have a very conservative patient population, but which really encompasses the majority of patients that we are seeing today and the majority of the breast cancers that we are diagnosing because the imaging is so much better and we are finding smaller and smaller cancers," he added.
The new findings were presented today at the Radiological Society of North America (RSNA) annual meeting in Chicago.
The Ice 3 trial is limited to women aged 60 and older with a biopsy-proven primary, unifocal tumor measuring 1.5 cm or less with tumor prognostic panels that are estrogen-receptor (ER)-positive and progesterone-receptor (PR)-positive or ER-positive/PR-negative and human epidermal growth factor receptor 2 (HER2)-negative.
Ultrasound-guided cryoablation is performed using the IceSense 3 system from IceCure Medical, which is funding the study. Following local anesthesia, patients undergo a freeze-thaw-freeze cycle of cryoablation to generate a visible ice ball with at least a 10 mm margin of ice around the tumor.
The procedure takes less than an hour, and patients are able to return to their normal activities shortly thereafter.
Since enrollment began in 2014, 174 women have been treated at 20 sites throughout the United States, with 100% procedural success and no serious procedural-related adverse events, Dr. Tomkovich told attendees.
Among 107 patients followed for at least 12 months, there have been only two recurrences, "which is around a 98% success rate, which is really as good or better than surgery," he added to Reuters Health.
Final results from the Ice 3 trial will be published when five-year follow-up data are available for all patients in the trial.
"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 breast cancer patients," Dr. Tomkovich said in a news release from the conference.
He encouraged radiologists, interventional radiologists and breast surgeons to participate in this research and development of these techniques as a non-surgical option to treat breast cancer.
Dr. Tomkovich is a consultant for Scion Medical Technologies, LLC, and is on the scientific advisory board for IceCure Medical Inc.