Background: Breast cryotherapy research has shown encouraging results for benign disease but only limited success for cancers. We assessed the technical feasibility, patient acceptance, imaging and clinical outcomes of percutaneous US-guided cryotherapy for breast fibroadenomas in patients considered for surgical resection.

Methods: Using only US guidance, 63 fibroadenomas (FAs) in 50 patients and 10 cancer foci in 4 cancer (CA) patients were treated by a single 2.4-mm cryoprobe in FAs and a minimum of 3 probes in CA patients. The first 7 FA patients underwent conscious sedation but all remaining patients required only local anesthesia. Ultrasound and thermocouple monitoring of the procedure was performed to evaluate freeze protocols based on tumor size in FA patients, as well as confirm cytotoxic margins in CA patients. Saline injections interposed between the developing iceball and the skin or chest wall provided further thermal protection. Ultrasound follow-up scans were done at: 1 week; 1, 3, 6 and 12 months in FA patients. Pre- and 12 months post-cryotherapy mammograms were available for 7 patients over 30 years old. MRIs were performed in CA patients at available follow-up times.

Results: Patients reported minimal discomfort when only using local anesthesia. Average follow-up for FA patients was 4.6 years and 2.0 years for cancer patients. Ultrasound produced excellent ice visualization beyond tumor margins while thermocouples confirmed cytotoxic temperatures. No significant complications were noted and patients were very pleased with cosmetic results and resolution of palpable mass effect by ~6 months. The average pre-treatment FA volume was 4.2 + 4.7 cm3, which reduced to 0.7 + 0.8 cm3 at 12 months (73% reduction, p<0.0001). No cancer recurrence has been seen in this limited group where 2 patients underwent cryotherapy as a lumpectomy alternative and 2 received cryotherapy for local control in advanced disease patients.

Conclusions: Breast cryotherapy is a safe, effective, and virtually painless procedure that offers an office or clinic-based treatment option with good cosmesis. Cryotherapy for breast CA offers broad treatment options for both locally advanced and early disease, as long as cytotoxic margins are extended beyond CA margins >1cm by using multiple cryoprobes.