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SAN ANTONIO -- Cryoablation is an attractive alternative to surgery as primary definitive therapy for breast fibroadenomas, Sheldon Feldman, M.D., said at a breast cancer symposium sponsored by the Cancer Therapy and Research Center.
Interim results from the multicenter FibroAdenoma Cryoablation Treatment (FACT) Registry demonstrate that cryoablation is a safe, well-tolerated, minimally invasive procedure that conserves breast tissue.
Cosmesis is excellent, with little or no scarring. And unlike conventional open surgical excision of breast fibroadenomas, which typically is performed in an operating room and requires sutures, cryoablation is an office-based procedure performed through a 3-mm incision site using local anesthesia only, added Dr. Feldman, chief of the division of breast surgery at Beth Israel Medical Center, New York.
He reported on 439 FACT procedures in patients who underwent cryoablation at 55 U.S. sites. The mean baseline diameter of their fibroadenomas was 1.8 cm. A total of 79% were palpable at baseline, declining over time to 52% at 6 months after treatment and 33% at 1 year. Nearly all women who reported residual palpability described the treated area as softer and less prominent than pretreatment.
Treated fibroadenomas could be visualized using ultrasound in only 31% of cases at 6 months and 23% at 1 year.
The complication rate was low: a 0.8% infection rate and a 2.9% incidence of hematoma. Transient ecchymosis was observed in 41% of patients at short-term follow-up.
Physician ratings of cosmesis in the cryoablated area averaged 4.8 at 6 months and 4.9 at 12 months on a 5-point scale. No volume deficits occurred, unlike the case with open surgical excision, where permanent volume deficits are common, the surgeon continued.