title: Office-based cryoablation of breast fibroadenomas: 12-month followup.
abstract: BACKGROUND
  Fibroadenomas comprise between 30% and 50% of all breast biopsies. Despite their benign nature, many women have their fibroadenomas surgically removed. We previously reported on a minimally invasive therapy using cryoablation to treat fibroadenomas. We now report on 12-month followup using this technique.
  
  
  METHODS
  A prospective, nonrandomized trial was initiated in June 2000 with IRB approval. The Visica Treatment System was used to cryoablate 70 biopsy-proved fibroadenomas in 57 patients using a freeze-thaw-freeze cycle lasting 6 to 30 minutes. Each patient was serially evaluated for safety, efficacy, and satisfaction.
  
  
  RESULTS
  Fifty-seven fibroadenomas (mean 2.1 cm, range 0.8 to 4.2 cm) in 47 patients were followed for 12 months. At 1 year, with 89% median tumor volume reduction measured by ultrasonography, 75% of fibroadenomas were nonpalpable. There were no adverse events and only minor complications. Two patients (4%) had their lesions excised after 12 months; pathology revealed no viable fibroadenoma. Serial mammograms showed resorption of the fibroadenoma leaving minimal residual density without calcifications. Cosmesis was excellent with no volume deficit, as no tissue is removed. Ninety-one percent of patients were satisfied at 12 months.
  
  
  CONCLUSIONS
  Cryoablation is safe and effective in treating breast fibroadenomas. It offers a nonsurgical, office-based treatment that is well tolerated by patients and accurately monitored with ultrasonographic guidance. At 12 months we found progressive tumor volume reduction and reduced palpability, with no volume deficit, excellent cosmesis, and satisfied patients. Ultrasonography-guided cryoablation is a preferred option for treatment of breast fibroadenomas without open surgery.
authors.affiliation: Department of Surgery, University of Washington and the Bellingham Breast Center, Bellingham, WA 98225, USA.
authors.forename: Cary S
authors.initials: CS
authors.lastname: Kaufman
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Littrup
authors.forename: Laurie A
authors.initials: LA
authors.lastname: Freman-Gibb
authors.forename: Darius
authors.initials: D
authors.lastname: Francescatti
authors.forename: Lewis H
authors.initials: LH
authors.lastname: Stocks
authors.forename: J Stanley
authors.initials: JS
authors.lastname: Smith
authors.forename: C Alan
authors.initials: CA
authors.lastname: Henry
authors.forename: Lisa
authors.initials: L
authors.lastname: Bailey
authors.forename: Jay K
authors.initials: JK
authors.lastname: Harness
authors.forename: Rache
authors.initials: R
authors.lastname: Simmons
mesh_terms: D000328:Adult; D000556:Ambulatory Surgical Procedures; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000601:surgery*; D003452:Cryosurgery / Q000295:instrumentation; D005260:Female; D018226:Fibroadenoma / Q000000981:diagnostic imaging / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D017060:Patient Satisfaction; D011446:Prospective Studies; D012449:Safety; D013997:Time Factors; D014463:Ultrasonography