Efficacy and safety of high-intensity focused ultrasound versus cryoablation for breast fibroadenomas: a systematic review and meta-analysis.

Methods: Up to October 2025, a systematic search was conducted in PubMed, Embase, and Web of Science. Eligible studies included patients with confirmed breast fibroadenoma treated with high-intensity focused ultrasound (HIFU) or cryoablation in prospective or retrospective observational designs, with a sample size >10 and extractable outcome data. The primary outcomes were tumor volume reduction at 6 and 12 months and treatment-related adverse events. In the absence of direct comparative studies, a random-effects meta-analysis of prospective single-arm studies was performed. Study quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS). Results: Seventeen prospective single-arm studies were included. HIFU achieved pooled tumor volume reduction rates of 54.4% at 6 months and 70.3% at 12 months, with substantial heterogeneity at 12 months (I² = 92.8%). Quantitative pooling for cryoablation was not feasible due to incomplete statistical reporting; descriptive findings suggested greater volume reduction than HIFU. The pooled adverse event rates were 23% for HIFU and 7% for cryoablation (p < 0.05), with significant heterogeneity in both groups (HIFU: I² = 95.6%; cryoablation: I² = 59.2%). No severe complications were reported. Conclusion: Both HIFU and cryoablation are effective and safe minimally invasive treatments for breast fibroadenomas. Cryoablation may provide superior tumor reduction and fewer adverse events. However, conclusions are limited by the predominance of non-randomized single-arm studies and data heterogeneity. Further high-quality comparative studies are needed.