Prospective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors.

BACKGROUND: This study compared the surgical results of 2 localization methods-cryo-assisted localization (CAL) and needle-wire localization (NWL)-in patients undergoing breast lumpectomy for breast cancer. METHODS: A total of 310 patients were treated in an institutional review board-approved study with 18 surgeons at 17 sites. Patients were randomized 2:1 to undergo either intraoperative CAL or NWL. A cryoprobe was inserted under ultrasound guidance in the operating room and an ice ball created an 8- to 10-mm margin around the lesion. The palpable ice ball then was dissected. NWL was placed according to institutional practice and resection was performed in a standard fashion. Surgical margins, complications, re-excisions, tissue volume, procedure times, ease of localization, specimen quality, and patient satisfaction were evaluated. Positive margins were defined as any type of disease present 1 mm or less from any specimen edge. RESULTS: Positive margin status did not differ between the 2 groups (28% vs. 31%). The volume of tissue removed was significantly less in the CAL group (49 vs. 66 mL, P = .002). Re-excisions were similar in both groups. CAL was superior in ease of lumpectomy, quality of specimen, acute surgical cosmesis, short-term cosmesis, patient satisfaction, and overall procedure time for the patient. CAL had a lower invasive positive margin rate (11% vs. 20%, P = .039) but a higher observed ductal carcinoma in situ-positive margin rate (30% vs. 18%, approaching statistical significance, P = .052). CONCLUSIONS: CAL is a preferred alternative to standard wire localization because it provides a palpable template, removes less tissue and improves cosmesis, decreases overall procedure time, and is more convenient for the patient and surgeon.

Interim results from the FibroAdenoma Cryoablation Treatment Registry.

OBJECTIVE: The aim of this prospective study was to assess the intermediate- (6 months) and longer-term (12 months) follow-up of patients with breast fibroadenomas treated by cryoablation in community-based practice settings. METHODS: The FibroAdenoma Cryoablation Treatment (FACT) registry was created to systematically collect procedural and follow-up data for patients with fibroadenomas treated by cryoablation without subsequent excision. This report summarizes the experience from 55 different practice settings across the United States. Baseline and follow-up clinical data at 6 months and 12 months were tabulated for all patients. RESULTS: Data from 444 treated fibroadenomas were analyzed. The mean tumor diameter was 1.8 cm. Before cryoablation, 75% of fibroadenomas were palpable by the patient. Follow-up at 6- and 12-month intervals revealed palpability of the treated site in 46% and 35%, respectively. When fibroadenomas were grouped by size, for lesions 2 cm, residual cryoablation induce changes were visible by ultrasound in 39% of the patients at 6 months. The treatment area was palpable in 78% of the cases at the same time. Visibility by ultrasound was 32%, and palpability was 59% at 12 months follow-up. Patient satisfaction with the procedure was rated as high at 91% and 88% at 6 and 12 months follow-up, respectively. CONCLUSIONS: Before implementing this technique, patients should be apprised of the likely persistence of a palpable mass of the treated site for a prolonged period that will reabsorb over time. Palpability of the treated site persists for a substantially longer period of time for lesions greater than 2 cm in diameter. For patients with a fibroadenoma smaller than 2 cm, complete resolution can be expected in two thirds and three quarters of the patients at 6 and 12 months, respectively. We will continue to follow these patients to better define the length of time and factors influencing the resolution of the treatment induced physical and radiographic findings.

Progressive adoption of cryoablative therapy for breast fibroadenoma in community practice.

BACKGROUND: Cryoablation is a recent technological advance and has been used for the percutaneous treatment of breast fibroadenomas. Herein, we provide a retrospective summary of the early experience from a nationwide group. METHODS: We organized a national registry to document the community practice and adoption of an office-based system of cryoablation for breast fibroadenoma. Data were abstracted during the first 6 weeks after the procedure to assess acute outcome and potential complications. At 6-and 12-month follow-up intervals, additional data were collected regarding fibroadenoma resolution, cosmesis, and patient satisfaction. RESULTS: Fifty-three sites ablated 310 fibroadenomas. Early follow-up data on 256 lesions showed that the procedure was well tolerated with infrequent minor complications immediately after the procedure. At 6 and 12 months postprocedure, the remaining fibroadenoma volume progressively involuted. At both intervals, cosmesis was excellent, and patient satisfaction was rated high. CONCLUSIONS: An early community experience with office-based cryoablation of breast fibroadenomas is encouraging and comparable to the initial experience of high-volume tertiary centers. More follow-up is necessary to determine long-term results and residual mammographic changes.