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

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.

Interventional radiology in the diagnosis and treatment of diseases of the breast: a historical review and future perspective based on currently available techniques.

OBJECTIVE: The topic of imaging-guided breast interventions spans more than 30 years. Radiologists pioneered procedures such as needle or wire localization and ultrasound and stereotactic-guided biopsy. Using recently developed devices and technology, the opportunity exists to treat lesions of the breast with minimally invasive imaging-guided techniques. CONCLUSION: Breast imagers and interventional radiologists, along with our surgical and oncologic colleagues, are best qualified to participate together in the research and development of these procedures.

Breast interventions: a primer for interventional radiologists.

Breast cancer is the second leading cause of cancer related deaths in the United States. The area of breast interventions has benefited from recent advances in devices and imaging quality. Ultrasound, MRI, and stereotactic guided vacuum assisted and mechanical rotating stick freeze biopsy are the preferred methods for histologic diagnosis of breast lesions. Ablation techniques are available for the treatment of benign and malignant breast disease. The MammoSite balloon catheter can be placed percutaneously for delivering high dose short term brachytherapy. Interventional Radiologists can and should perform all of these procedures to improve the quality of women's health.