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.

The prognostic value of additional malignant lesions detected by magnetic resonance imaging versus mammography.

BACKGROUND: Nodal positivity is correlated with a poorer prognosis in breast cancer. A study was composed to compare nodal positivity in patients with single versus multiple lesions found on magnetic resonance imaging (MRI) and mammogram (MMG). METHODS: A retrospective study of breast cancer patients undergoing MRI and MMG was performed. Nodal positivity was compared in patients with additional invasive lesions found on MRI versus single invasive lesions found on MRI and MMG. RESULTS: A total of 425 patients were included. The overall nodal positivity was 23.8%. Patients with single versus multiple malignant lesions had nodal positivity of 20.9% vs 31.1% (P = .04). MRI detected multiple lesions in 120 patients, 80 of which were not detected by MMG (18.8%). Comparing single lesions with additional malignant lesions detected by MRI only, nodal positivity increased from 20.9% to 51.6% (P = .0002). CONCLUSIONS: Patients with additional invasive lesions on MRI had significantly higher nodal positivity than single invasive lesions. Hence, addition of MRI in early-stage breast cancer may have prognostic value because of detection of potential node-positive patients.

Nodal positivity in breast cancer correlated with the number of lesions detected by magnetic resonance imaging versus mammogram.

BACKGROUND: Magnetic resonance imaging (MRI) in breast cancer can detect more than 15% additional lesions than mammography. We investigated lymph node metastases rates in patients with multifocal or multicentric disease detected by MRI compared with patients with a single lesion detected by mammography and magnetic resonance imaging. METHODS: A retrospective analysis of breast cancer patients undergoing MRI and mammography was performed. The objective was to compare lymph node metastases rates in patients with additional lesions detected by MRI versus a single lesion detected by mammography or MRI. RESULTS: Of 413 patients, 318 were included for the study. The overall nodal metastases rate was 24.8%. MRI detected multiple lesions in 83 (26.1%) patients; 67 (21.1%) patient MRI findings were not detected by mammography. The lymph node metastases rate was 37.3% when ≥ 2 lesions were detected compared with 20.2% when a single malignant lesion was detected (P = .01). The evaluation of the 67 patients with additional lesions detected by MRI revealed 32 patients with invasive lesions, 29 with benign lesions, and 6 with in situ disease. Comparing patients with single malignant lesions with patients with additional malignant lesions detected by MRI, the lymph node metastases rate increased from 20.2% to 50% (P = .002). CONCLUSIONS: Our study shows a significant increase in the lymph node metastases rate in patients with additional malignant lesions detected by MRI. This finding suggests that MRI-detected malignant lesions are biologically significant and may predict more aggressive disease.