Emerging advances in non-surgical ablation for early-stage breast cancer.

Recent advances in diagnostic imaging have led to an increase in the detection of early-stage breast cancer, prompting growing interest in minimally invasive breast surgery. These approaches include the omission of axillary lymph node dissection, use of endoscopic or robot-assisted surgery, and application of non-surgical ablation techniques. Non-surgical ablation therapy aims to eradicate tumor tissue in situ by delivering localized thermal or cryogenic energy under imaging guidance without surgical resection. Among these, radiofrequency ablation (RFA) and cryoablation have been the most extensively studied, showing promising results for small early-stage tumors. Clinical studies have reported high rates of complete tumor ablation, favorable safety profiles, and excellent cosmetic outcomes. Moreover, single-arm prospective trials have provided 5-year follow-up data, offering valuable insights into long-term efficacy. Despite these encouraging results, non-surgical ablation has not been internationally adopted as a standard treatment because of concerns regarding oncological surveillance and outcome validation. However, in Japan, RFA for early-stage breast cancer was approved for insurance coverage in December 2023. This review summarizes the current trends and clinical evidence for RFA and cryoablation, and discusses the regulatory pathways required for RFA insurance approval in Japan.