Background Excision followed by radiofrequency ablation (eRFA) is an intraoperative method that uses intracavitary hyperthermia to create an additional tumor-free zone around the lumpectomy cavity in breast cancer patients. We hypothesized that eRFA after lumpectomy for invasive breast cancer could reduce the need for re-excision for close margins as well as potentially maintain local control without the need for radiation. Study Design This prospective phase II institutional review board-approved study was conducted from March 2004 to April 2010. A standard lumpectomy was performed, then the RFA probe was deployed 1 cm circumferentially into the walls of the lumpectomy cavity and maintained at 100 C for 15 minutes. Validated Doppler sonography was used to intraoperatively determine adequacy of ablation. Results One hundred patients were accrued to the trial, with an average age of 65.02 years ± 10.0 years. The stages were Tis (n = 30); T1mic (n = 1); T1a (n = 9); T1b (n = 27); T1c (n = 22); T2 (n = 10); and T3 (n = 1). Grades were I (n = 48); II (n = 29); and III (n = 23). Seventy-eight subjects had margins >2 mm (negative), 22 patients had margins ≤ 2 mm, of which 12 were close and 3 focally positive, which, at our institution, would have required re-excision (only 1 patient in this group had re-excision). There were 6% postoperative complications, and 24 patients received radiation therapy (XRT). During the study mean follow-up period of 62 months ± 24 months (68-month median follow-up) in patients not treated with XRT, there were 2 in-site tumor recurrences treated with aromitase inhibitor, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy. Conclusions Long-term follow-up suggests that eRFA may reduce the need for re-excision for close or focally positive margins in breast cancer patients, and eRFA may be a valuable tool for treating favorable patients who desire lumpectomy and either cannot or do not want radiation. A multicenter trial has been initiated based on these results.
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