Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial
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
Recommended Citation
Fine, Richard E.; Gilmore, Richard C.; Dietz, Jill R.; Boolbol, Susan K.; Berry, Michael P.; Han, Linda K.; Kenler, Andrew S.; Sabel, Michael; Tomkovich, Kenneth R.; VanderWalde, Noam A.; Chen, Margaret; Columbus, Karen S.; Curcio, Lisa D.; Feldman, Sheldon M.; Gold, Linsey; Hernandez, Lydia; Manahan, Eric R.; Seedman, Susan A.; Vaidya, Rashmi P.; Sevrukov, Alexander B.; Aoun, Hussein D.; Hicks, Randy D.; and Simmons, Rache M., "Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial" (2021). Randomized Controlled Trials. 13.
https://scholar.bridgeporthospital.org/randomized_trial/13
Identifier
34392462 (pubmed); 10.1245/s10434-021-10501-4 (doi); 10.1245/s10434-021-10501-4 (pii)