Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial.

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.

Feasibility of percutaneous excision followed by ablation for local control in breast cancer.

PURPOSE: Percutaneous ablation of breast cancer has shown promise as a treatment alternative to open lumpectomy. We hypothesized that percutaneous removal of breast cancer followed by percutaneous ablation to sterilize and widen the margins would not only provide fresh naive tissue for tumor marker and research investigation, but also better achieve negative margins after ablation. METHODS: Patients diagnosed by percutaneous biopsy (ultrasound or stereotactic-guided) with breast cancer ≤1.5 cm, >1 cm from the skin, and ≤1 cm residual disease and no multicentric disease by magnetic resonance imaging were accrued to this institutional review board-approved study. Patients were randomized to laser versus radiofrequency ablation. The ultrasound-guided ablation was performed in the operating room and followed by immediate excision, whole-mount pathology with proliferating cell nuclear antigen staining, and reconstruction. RESULTS: Twenty-one patients were enrolled onto the study. Fifteen patients received radiofrequency ablation, and all showed 100% ablation and negative margins. Magnetic resonance imaging was helpful in excluding multicentric disease but less so in predicting presence or absence of residual disease. Seven of these patients showed no residual tumor and eight showed residual dead tumor (0.5 ± 0.7 cm, range 0.1-2.5 cm) at the biopsy site with clear margins. The laser arm (3 patients) pathology demonstrated unpredictability of the ablation zone and residual live tumor. CONCLUSIONS: This pilot study demonstrates the feasibility of a novel approach to minimally invasive therapy: percutaneous excision and effective cytoreduction, followed by radiofrequency ablation of margins for the treatment of breast cancer. Laser treatment requires further improvement.

Axillary reverse mapping: mapping and preserving arm lymphatics may be important in preventing lymphedema during sentinel lymph node biopsy.

BACKGROUND: Several recent reports have shown a lymphedema rate of about 7% with sentinel lymph node biopsy (SLNB) only. We hypothesized that this higher than expected rate of lymphedema may be secondary to disruption of arm lymphatics during an SLNB procedure. STUDY DESIGN: This IRB-approved study, from May 2006 to June 2007, involved patients undergoing SLNB with or without axillary lymph node dissection. After sentinel lymph node (SLN) localization with subareolar technetium was assured, 2 to 5 mL of dermal blue dye was injected in the upper inner arm for localization of lymphatics draining the arm (axillary reverse mapping, ARM). The SLNB was then performed through an incision in the axilla. Data were collected on identification rates of hot versus blue nodes, variations in ARM lymphatic drainage that might impact SLNB, crossover between the hot and the blue lymphatics, and final pathologic nodal diagnosis. RESULTS: Median age was 57.6+/-12.5 years. Lymphatics draining the arm were near or in the SLN field in 42.7% (56 of 131) of the patients, placing the patient at risk for disruption if not identified and preserved during an SLNB or axillary lymph node dissection. ARM demonstrated that arm lymphatics do not cross over with the SLN drainage of the breast 96.1% of the time and that none of the ARM lymph nodes removed were positive, even when the SLN was (5 of 12). Seven (5.5%) blue ARM lymphatics were juxtaposed to the hot SLNBs. CONCLUSIONS: Disruption of the blue ARM node because of proximity to the hot SLN may explain the surprisingly high rate of lymphedema seen after SLNB. Identifying and preserving the ARM blue nodes may translate into a lower incidence of lymphedema with SLNB and axillary lymph node dissection.