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[Members Only] J.Jpn. Surg. Soc.. 125(5): 406-414, 2024
Feature topic
PRACTICAL APPLICATION OF RADIOFREQUENCY ABLATION FOR EARLY-STAGE BREAST CANCER
Early-stage breast cancer is increasingly detected by screening mammography, and we aim to establish radiofrequency ablation therapy (RFA) as a minimally invasive local treatment. Our RAFAELO study aims to demonstrate the noninferiority of RFA compared with standard treatment (breast-conserving surgery) in terms of local recurrence-free survival (RFS), which is the best index of local control. The inclusion criteria are lack of prior treatment for breast cancer and histologically confirmed ductal carcinoma with a single localized tumor of 1.5 cm or less in the greatest dimension on preoperative imaging. The primary endpoint is 5-year local RFS, and the secondary endpoints are residual lesion rate, overall survival, distant RFS, and adverse events of RFA. Between August 2013 and November 2017, 372 patients were enrolled from 9 institutes. Using the results of short-term reports of the RAFAELO study, RFA for early-stage breast cancer received regulatory approval and insurance reimbursement in Japan.
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