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Cryoablation of Early-Stage Breast Cancer: Work-in-Progress Report of a Multi-Institutional Trial

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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.

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Authors and Affiliations

  1. Department of Surgery, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

    Michael S. Sabel MD

  2. Department of Surgery, University of Washington, Bellingham Breast Center, Bellingham, Washington

    Cary S. Kaufman MD

  3. Nashville Breast Center, Nashville, Tennessee

    Pat Whitworth MD

  4. Revlon UCLA Breast Center, Los Angeles, California

    Helena Chang MD, PhD

  5. Department of Surgery, Executive Surgical Center, Raleigh, North Carolina

    Lewis H. Stocks MD, PhD

  6. Department of Surgery, Weill Medical College of Cornell University, New York

    Rache Simmons MD

  7. Surgery Center of Greater Baltimore, Owings Mills, Maryland

    Michael Schultz MD

  8. University of Michigan, 3304 Cancer Center, 1500 East Medical Center, Ann Arbor, MI, 48109-0932

    Michael S. Sabel MD

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  1. Michael S. Sabel MD
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  2. Cary S. Kaufman MD
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  3. Pat Whitworth MD
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  4. Helena Chang MD, PhD
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  5. Lewis H. Stocks MD, PhD
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  6. Rache Simmons MD
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  7. Michael Schultz MD
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Correspondence to Michael S. Sabel MD.

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Sabel, M.S., Kaufman, C.S., Whitworth, P. et al. Cryoablation of Early-Stage Breast Cancer: Work-in-Progress Report of a Multi-Institutional Trial. Ann Surg Oncol 11, 542–549 (2004). https://doi.org/10.1245/ASO.2004.08.003

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  • DOI: https://doi.org/10.1245/ASO.2004.08.003

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