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April 7, 2026Cryoablation: A Minimally Invasive Alternative for Early-Stage Breast Cancer: 6-Year Outcomes of the FROST Clinical Trial.
| Objectives | Cryoablation is emerging as a minimally invasive alternative to lumpectomy for select women with early-stage breast cancer. The FROST trial was a prospective, phase 2 multicenter study evaluating the outcome of cryoablation in the management of stage I, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-negative invasive ductal carcinoma. |
| Authors |
Holmes DR, Manoian S, Rahman RL, Ward RC, Carp NZ, Plaza M, Kozlowski K, Abe S, Bailey L, Kruper L, Jones V, Patterson S, Tamayo J, Littrup P. |
| Journal |
Ann Surg Oncol. 2026 Jan 15. doi: 10.1245/s10434-025-18991-2
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| Methods |
Women 50 years old or older with unifocal, ultrasound-visible tumours were stratified by age:
Cryoablation was performed using a single cryoprobe under ultrasound guidance. Core biopsy 6 months after ablation was performed to confirm complete ablation. Patients were followed with clinical exams and imaging. |
| Results |
The study included 83 completed cryoablations and follow-up evaluations. The median tumor size was 9 mm. More than 85% of the subjects in each group received endocrine therapy (stratum 1 [89%, 43/48], stratum 2 [85.7%, 30/35]) and 74.3% (26/35) of the subjects in stratum 2 received recommended whole-breast radiation. Of the 83 patients, 82 received a post-ablation core biopsy 6 months after cryoablation showing no residual cancer, and 1 patient declined a core biopsy. During a median follow-up period of 6.1 years, the 5-year ipsilateral breast tumor recurrence rate (IBTR) was 3.64% overall (stratum 1, 2.08%; stratum 2, 5.80%). The invasive IBTR-free survival rate was 97.59% overall (stratum 1, 97.92%; stratum 2, 97.14%). No serious adverse events occurred. |
| Conclusions |
US-guided cryoablation is safe and effective in the long term to treat stage I, hormone receptor-positive, HER2-negative, node-negative invasive ductal carcinoma with very low recurrence rate in the long term. |
| Key points | The FROST trial adds to the growing body of literature supporting the efficacy and safety of cryoablation and supports ongoing research on cryoablation as a strategy for de-escalating breast cancer therapy.
US-guided Cryoablation emerges as a very effective minimally invasive technique to treat these types of breast cancer, not only in older patients but in patients 50-60 years-old as well. |
| Link (DOI) | https://dx.doi.org/10.1245/s10434-025-18991-2 |
| Ultrasound speciality | Breast US |
Short-Review by:
Prof. Dr. Jose Luis del Cura
Department of Radiology
Donostia University Hospital
Spain
Strengths:
Long follow-up. Prospective. Include two different age ranges. Excellent results in safety and long-term survival.
Weaknesses:
There is no control group. Limited number of cases that lead to wide confidence intervals. Only one system of cryoablation. One of the authors is a consultant of the cryoablation company. The patients were treated with the usual treatment for their breast cancer; so, it is difficult to say which part of the effect is due to the cryoablation. There is a clear selection bias, as the selection of the patients were enrolled by the physicians involved, and probably they selected cases more suitable for ablation.
Personally thinking:
This is another study that supports the use of cryoablation as an alternative to surgical lumpectomy in stage I, hormone receptor-positive, HER2-negative, node-negative invasive ductal carcinoma. This growing evidence supports the start of a clinical trial comparing both treatment strategies. Cryoablation may be another step in the progressive de-escalation to avoid surgery in the treatment of breast cancer. The most interesting issue in this article is that the study has shown that there is no significant difference between older patients and patients of 50-60 years-old, opening a path to extend this treatment to all the patients with this type of breast cancer, as a primary curative treatment and not only as an alternative for non-surgical candidates.
