title: Cryoablation of early-stage breast cancer: work-in-progress report of a multi-institutional trial.
abstract: 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.
authors.affiliation: Department of Surgery, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA. msabel@umich.edu.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Sabel
authors.forename: Cary S
authors.initials: CS
authors.lastname: Kaufman
authors.forename: Pat
authors.initials: P
authors.lastname: Whitworth
authors.forename: Helena
authors.initials: H
authors.lastname: Chang
authors.forename: Lewis H
authors.initials: LH
authors.lastname: Stocks
authors.forename: Rache
authors.initials: R
authors.lastname: Simmons
authors.forename: Michael
authors.initials: M
authors.lastname: Schultz
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000601:surgery*; D003452:Cryosurgery / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D010149:Postoperative Pain; D016896:Treatment Outcome