title: Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Division of Breast Surgical Oncology, Department of Surgery, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR; Arkansas Breast Cancer Research Program (ABCRP), University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR; Department of Pathology, University of Arkansas for Medical Sciences, Little Rock, AR. Electronic address: klimbergsuzanne@uams.edu.
authors.forename: V Suzanne
authors.initials: VS
authors.lastname: Klimberg
authors.affiliation: Division of Breast Surgical Oncology, Department of Surgery, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Daniela
authors.initials: D
authors.lastname: Ochoa
authors.affiliation: Division of Breast Surgical Oncology, Department of Surgery, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Ronda
authors.initials: R
authors.lastname: Henry-Tillman
authors.affiliation: Department of Radiation Oncology, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hardee
authors.affiliation: Division of Breast Surgical Oncology, Department of Surgery, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Cristiano
authors.initials: C
authors.lastname: Boneti
authors.affiliation: Division of Breast Surgical Oncology, Department of Surgery, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Laura L
authors.initials: LL
authors.lastname: Adkins
authors.affiliation: Division of Breast Surgical Oncology, Department of Surgery, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Maureen
authors.initials: M
authors.lastname: McCarthy
authors.affiliation: Arkansas Breast Cancer Interdisciplinary Breast Fellowship, University of Arkansas for Medical Sciences, Little Rock, AR.
authors.forename: Evan
authors.initials: E
authors.lastname: Tummel
authors.affiliation: Department of Biostatistics, College of Public Health, University of Arkansas for Medical Sciences, Little Rock, AR.
authors.forename: Jeannette
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Radiology, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Sharp
authors.initials: S
authors.lastname: Malak
authors.affiliation: Department of Medicine, Division of Medical Oncology, University of Arkansas for Medical Sciences (UAMS), Winthrop P Rockefeller Cancer Institute, Little Rock, AR.
authors.forename: Issam
authors.initials: I
authors.lastname: Makhoul
authors.affiliation: Department of Pathology, University of Arkansas for Medical Sciences, Little Rock, AR.
authors.forename: Soheila
authors.initials: S
authors.lastname: Korourian
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation / Q000379:methods*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D015412:Mastectomy, Segmental / Q000379:methods*; D008875:Middle Aged; D016343:Monitoring, Intraoperative; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011300:Preoperative Care; D011446:Prospective Studies; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D016217:Ultrasonography, Mammary