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From the Department of Surgery, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (MSS); the Department of Surgery, University of Washington, Bellingham Breast Center, Bellingham, Washington (CSK); the Nashville Breast Center, Nashville, Tennessee (PW); Revlon UCLA Breast Center, Los Angeles, California (HC); Department of Surgery, Executive Surgical Center, Raleigh, North Carolina (LHS); Department of Surgery, Weill Medical College of Cornell University, New York, New York (RS); and Surgery Center of Greater Baltimore, Owings Mills, Maryland (MS).
Correspondence: Address correspondence and reprint requests to: Michael S. Sabel, MD, University of Michigan, 3304 Cancer Center, 1500 East Medical Center, Ann Arbor, MI 48109-0932; Fax: 734-647-9647; E-mail: msabel{at}umich.edu
Background: With recent improvements in breast imaging, our ability to identify small breast tumors has markedly improved, prompting significant interest in the use of ablation without surgical excision to treat early-stage breast cancer. We conducted a multi-institutional pilot safety study of cryoablation in the treatment of primary breast carcinomas.
Methods: Twenty-nine patients with ultrasound-visible primary invasive breast cancer 
2.0 cm were enrolled. Twenty-seven (93%) successfully underwent ultrasound-guided cryoablation with a tabletop argon gas-based cryoablation system with a double freeze/thaw cycle. Standard surgical resection was performed 1 to 4 weeks after cryoablation. Patients were monitored for complications, and pathology data were used to assess efficacy.
Results: Cryoablation was successfully performed in an office-based setting with only local anesthesia. There were no complications to the procedure or postprocedural pain requiring narcotic pain medications. Cryoablation successfully destroyed 100% of cancers <1.0 cm. For tumors between 1.0 and 1.5 cm, this success rate was achieved only in patients with invasive ductal carcinoma without a significant ductal carcinoma-in-situ (DCIS) component. For unselected tumors >1.5 cm, cryoablation was not reliable with this technique. Patients with noncalcified DCIS were the cause of most cryoablation failures.
Conclusions: Cryoablation is a safe and well-tolerated office-based procedure for the ablation of early-stage breast cancer. At this time, cryoablation should be limited to patients with invasive ductal carcinoma 1.5 cm and with <25% DCIS in the core biopsy. A multicenter phase II clinical trial is planned.
Key Words: Cryosurgery • Cryoablation • Breast cancer • Ablative therapies
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