Long-term data from the Phase II FROST clinical trial indicate that cryoablation can provide durable local control for carefully selected patients with Stage I breast cancer, with low recurrence rates reported at six years of follow-up.
Cryoablation, a minimally invasive technique that destroys tumors by freezing them, is being explored as an alternative to lumpectomy in early-stage disease. The prospective, multicenter FROST trial evaluated this approach in patients with hormone receptor–positive, HER2-negative, node-negative invasive ductal carcinoma, focusing on long-term outcomes to assess the durability of tumor control.
The study enrolled women aged 50 years and older with unifocal, ultrasound-visible tumors. Participants were divided into two age-based cohorts. Patients aged 70 years or older received endocrine therapy alone, while those aged 50 to 69 years received endocrine therapy combined with radiotherapy, with sentinel lymph node biopsy permitted at the physician’s discretion. Cryoablation was performed under ultrasound guidance using a single cryoprobe, and treatment success was assessed with a core biopsy six months later.
A total of 83 cryoablation procedures were completed, with a median tumor size of 9 millimeters. Most patients received endocrine therapy, including 89% of those aged 70 or older and 85.7% of those in the younger cohort. Among patients aged 50 to 69 years, nearly three-quarters underwent the recommended whole-breast radiation following cryoablation.
Six-month post-treatment biopsies were completed in 82 of the 83 patients, and no residual cancer was detected. One patient declined the biopsy. After a median follow-up of 6.1 years, the overall five-year ipsilateral breast tumor recurrence rate was 3.64%. Recurrence was lower in older patients, at 2.08%, compared with 5.80% in the younger cohort. Invasive ipsilateral breast tumor recurrence-free survival reached 97.59% overall, with consistently strong outcomes across both age groups.
Importantly, no serious adverse events related to cryoablation were reported during the study period, underscoring the procedure’s favorable safety profile.
Researchers say the findings strengthen the case for cryoablation as a potential de-escalation strategy in select patients with early-stage breast cancer. While additional studies are needed to refine patient selection and compare outcomes directly with surgery, the FROST trial’s six-year data suggest that minimally invasive cryoablation may offer durable tumor control with reduced treatment burden for some patients.
