Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial

Richard E. Fine, Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA. rfine@westclinic.com.
Richard C. Gilmore, Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA.
Jill R. Dietz, Allegheny Health Network, Pittsburgh, PA, USA.
Susan K. Boolbol, Nuvance Health System, Poughkeepsie, NY, USA.
Michael P. Berry, Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA.
Linda K. Han, Parkview Health, Indianapolis, IN, USA.
Andrew S. Kenler, Bridgeport Hospital, Bridgeport, CT, USA.
Michael Sabel, The University of Michigan Health System, Ann Arbor, MI, USA.
Kenneth R. Tomkovich, CentraState Medical Center, Freehold, NJ, USA.
Noam A. VanderWalde, Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA.
Margaret Chen, Columbia University Medical Center, New York, NY, USA.
Karen S. Columbus, Cincinnati Breast Surgeons Inc, Cincinnati, OH, USA.
Lisa D. Curcio, BreastLink, Laguna Hills, CA, USA.
Sheldon M. Feldman, Montefiore-Einstein Center for Cancer Care, New York, NY, USA.
Linsey Gold, Comprehensive Breast Care, Troy, MI, USA.
Lydia Hernandez, Cincinnati Breast Surgeons Inc, Cincinnati, OH, USA.
Eric R. Manahan, Dalton Surgical Group, Dalton, GA, USA.
Susan A. Seedman, Presbyterian Cancer Center, Rio Rancho, NM, USA.
Rashmi P. Vaidya, Ironwood Cancer and Research Centers, Glendale, AZ, USA.
Alexander B. Sevrukov, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Hussein D. Aoun, Karmanos Cancer Institute, Detroit, MI, USA.
Randy D. Hicks, Regional Medical Imaging, Flint, MI, USA.
Rache M. Simmons, Weill Cornell Weill Medical College, Cornell University, New York, NY, USA.

Document Type

Article

Publication Title

Annals of surgical oncology

Abstract

BACKGROUND: The ICE3 trial is designed to evaluate the safety and efficacy of breast cryoablation, enabling women older than 60 years with low-risk early-stage breast cancers to benefit from a nonsurgical treatment and to avoid the associated surgical risks. METHODS: The ICE3 trial is a prospective, multi-center, single-arm, non-randomized trial including women age 60 years or older with unifocal, ultrasound-visible invasive ductal carcinoma size 1.5 cm or smaller and classified as low to intermediate grade, hormone receptor (HR)-positive, and human epidermal growth factor receptor 2 (HER2)-negative. Ipsilateral breast tumor recurrence (IBTR) at 5 years was the primary outcome. A 3-year interim analysis of IBTR was performed, and the IBTR probability was estimated using the Kaplan-Meier method. RESULTS: Full eligibility for the study was met by 194 patients, who received successful cryoablation per protocol. The mean age was 75 years (range, 55-94 years). The mean tumor length was 8.1 mm (range, 8-14.9 mm), and the mean tumor width was 7.4 mm (range, 2.8-14 mm). During a mean follow-up period of 34.83 months, the IBTR rate was 2.06% (4/194 patients). Device-related adverse events were reported as mild in 18.4% and moderate in 2.4% of the patients. No severe device-related adverse events were reported. More than 95% of the patients and 98% of the physicians reported satisfaction with the cosmetic results at the clinical follow-up evaluation. CONCLUSIONS: Breast cryoablation presents a promising alternative to surgery while offering the benefits of a minimally invasive procedure with minimal risks. Further study within a clinical trial or registry is needed to confirm cryoablation as a viable alternative to surgical excision for appropriately selected low-risk patients.

First Page

5525

Last Page

5534

DOI

10.1245/s10434-021-10501-4

Publication Date

10-1-2021

Identifier

34392462 (pubmed); 10.1245/s10434-021-10501-4 (doi); 10.1245/s10434-021-10501-4 (pii)

This document is currently not available here.

Share

COinS