No abstract

Background: Given the increasing number of early-stage breast cancers detected by screening mammography, we aim to establish RFA as a minimally invasive, cost-efficient, and cosmetically acceptable local treatment. In our Phase 1 study, localized tumors with a maximum diameter of 2 cm, preoperatively diagnosed by imaging and histopathology, were treated with RFA. A 90% complete ablation rate was confirmed histopathologically.Subjects and Methods: From Nov. 2009 to Nov. 2012, 58 patients with early-stage breast cancer received non-surgical RFA therapy. Patients had localized solitary N0 tumors with a maximum diameter of 1 cm. They underwent RFA and SNB under general anesthesia and adjuvant therapy and breast radiation [A1]. Follow-up evaluation for residual tumor at 3, 6, and 12 months after RFA included clinical examination, diagnostic imagings and vacuum-assisted biopsy. Surgical resection was recommended for patients with suspected residual disease or incomplete ablation. The primary endpoint was the frequency of adverse events. Secondary endpoints included the complete ablation rate and ipsilateral breast relapse-free rate.Results: The follow-up period ranged from 15 to 109 months (median, 85 months). The 57 patients completed the non-surgical RFA procedure and underwent diagnostic imaging and needle biopsy after 3 months. Seven patients with suspected incomplete ablation underwent surgical resection; incomplete ablation was confirmed in 5 (8.6%, 2 with invasive and 3 with noninvasive ductal carcinoma). During subsequent follow-up, 1 patient each was diagnosed with contralateral breast cancer and ipsilateral breast tumor relapse. No distant recurrence was documented. Cosmetic results were excellent in 94% of patients.Conclusions: RFA is a promising alternative to surgery for treating localized, early-stage breast cancer.No conflict of interest.