Cryoablation of early-stage breast cancer: work-in-progress report of a multi-institutional trial

Ann Surg Oncol. 2004 May;11(5):542-9. doi: 10.1245/ASO.2004.08.003.


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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Breast Neoplasms / pathology
  • Breast Neoplasms / surgery*
  • Carcinoma, Ductal, Breast / pathology
  • Carcinoma, Ductal, Breast / surgery*
  • Cryosurgery / adverse effects
  • Cryosurgery / methods*
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Invasiveness
  • Neoplasm Staging*
  • Pain, Postoperative*
  • Treatment Outcome