27
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: not found

      A Randomized Prospective Study of Lumpectomy Margin Assessment with Use of MarginProbe in Patients with Nonpalpable Breast Malignancies

      research-article

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background

          The presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence. Twenty to 30 % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins. This study evaluated the adjunctive use of the MarginProbe device (Dune Medical Devices Ltd, Caesarea, Israel) in providing real-time intraoperative assessment of lumpectomy margins.

          Methods

          This multicenter randomized trial enrolled patients with nonpalpable breast malignancies. The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment. After specimen removal and inspection, patients were randomized to device or control arms. In the device arm, MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins. Intraoperative imaging was used in both arms; no intraoperative pathology assessment was permitted.

          Results

          In total, 596 patients were enrolled. False-negative rates were 24.8 and 66.1 % and false-positive rates were 53.6 and 16.6 % in the device and control arms, respectively. All positive margins on positive main specimens were resected in 62 % (101 of 163) of cases in the device arm, versus 22 % (33 of 147) in the control arm ( p < 0.001). A total of 19.8 % (59 of 298) of patients in the device arm underwent a reexcision procedure compared with 25.8 % (77 of 298) in the control arm (6 % absolute, 23 % relative reduction). The difference in tissue volume removed was not significant.

          Conclusions

          Adjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons’ ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment, reducing the number of patients requiring reexcision. MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system.

          Related collections

          Most cited references16

          • Record: found
          • Abstract: found
          • Article: not found

          Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial.

          After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy. Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2.5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00983684. 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1.20% (95% CI 0.53-2.71) in the targeted intraoperative radiotherapy and 0.95% (0.39-2.31) in the external beam radiotherapy group (difference between groups 0.25%, -1.04 to 1.54; p=0.41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3.3%] of 1113 vs external beam radiotherapy, 44 [3.9%] of 1119; p=0.44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0.5%]) than in the external beam radiotherapy group (23 patients [2.1%]; p=0.002). For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks. University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF). Copyright 2010 Elsevier Ltd. All rights reserved.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Effect of margin status on local recurrence after breast conservation and radiation therapy for ductal carcinoma in situ.

            There is no consensus on what constitutes an adequate surgical margin in patients receiving breast-conserving surgery (BCS) and postoperative radiation therapy (RT) for ductal carcinoma in situ (DCIS). Inadequate margins may result in high local recurrence, and excessively large resections may lead to poor cosmetic outcome without oncologic benefit. A comprehensive search for published trials that examined outcomes after adjuvant RT after BCS for DCIS was performed using MEDLINE and cross referencing available data. Reviews of each study were conducted, and data were extracted. Primary outcome was ipsilateral breast tumor recurrence (IBTR) related to surgical margins. A total of 4,660 patients were identified from trials examining BCS and RT for DCIS. Patients with negative margins were significantly less likely to experience recurrence than patients with positive margins after RT (odds ratio [OR] = 0.36; 95% CI, 0.27 to 0.47). A negative margin significantly reduced the risk of IBTR when compared with a close (OR = 0.59; 95% CI, 0.42 to 0.83) or unknown margin (OR = 0.56; 95% CI, 0.36 to 0.87). When specific margin thresholds were examined, a 2-mm margin was superior to a margin less than 2 mm (OR = 0.53; 95% CI, 0.26 to 0.96); however, we saw no significant difference in the rate of IBTR with margins between 2 mm and more than 5 mm (OR = 1.51; 95% CI, 0.51 to 5.0; P > .05). Surgical margins negative for DCIS should be obtained after BCS for DCIS. A margin threshold of 2 mm seems to be as good as a larger margin when BCS for DCIS is combined with RT.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              A systematic review of oncoplastic breast-conserving surgery: current weaknesses and future prospects.

              The primary objectives of this systematic review on oncoplastic breast surgery (OPBS) were to evaluate the oncological and cosmetic outcomes of OPBS. The secondary objectives were to assess morbidity, quality of life, and applied algorithms. Breast-conserving therapy (BCT) has become the standard of care, and survival is now excellent. Consequently, the focus of BCT has increasingly shifted to cosmetic outcome, quality of life, and patient satisfaction. Nonetheless, excision of certain tumors still presents a considerable challenge. Specialized approaches combining oncological surgery and plastic surgery techniques are collectively referred to as OPBS. A summary of OPBS outcomes would facilitate decision-making and best treatment selection by both clinicians and patients. Using specific inclusion and exclusion criteria to analyze 2090 abstracts on the topic of OPBS published between 2000 and 2011, the authors evaluated each study with respect to design and outcomes. A total of 88 articles were identified for potential inclusion and reviewed in detail by the lead authors. No randomized controlled trials were identified. Eleven prospective observational or comparative studies fulfilled inclusion criteria and were selected. In these studies, 80% to 93% of the tumors were invasive. Tumor-free resection margins were observed in 78% to 93%, resulting in a 3% to 16% mastectomy rate. Local recurrence was observed in 0% to 7% of the patients. Good cosmetic outcome was obtained in 84% to 89% of patients. However, most studies showed significant weaknesses including lack of robust design and important methodological shortcomings, negatively influencing generalizability. This systematic review reveals that current evidence supporting the efficacy of OPBS is based on poorly designed and underpowered studies. Given the increasing importance and application of OPBS, there is a pressing need for robust comparative studies, including both randomized controlled trials and well-designed, multicenter prospective longitudinal studies.
                Bookmark

                Author and article information

                Contributors
                +212-731-5367 , +212-731-6051 , freya.schnabel@nyumc.org
                Journal
                Ann Surg Oncol
                Ann. Surg. Oncol
                Annals of Surgical Oncology
                Springer US (Boston )
                1068-9265
                1534-4681
                5 March 2014
                5 March 2014
                2014
                : 21
                : 1589-1595
                Affiliations
                [ ]Department of Surgery, NYU Langone Medical Center, NYU Clinical Cancer Center, New York, NY USA
                [ ]Department of Surgery, Beth Israel Medical Center, New York, NY USA
                [ ]Department of Surgery, Breast Care Specialists, Allentown, PA USA
                [ ]Department of Surgery, Assaf Harofeh Medical Center, Zerifin, Israel
                [ ]Department of Surgery, Anne Arundel Medical Center, Annapolis, MD USA
                [ ]Department of Surgery, Columbia University Medical Center, New York, NY USA
                [ ]Department of Surgery, Pacific Breast Care, Costa Mesa, CA USA
                [ ]Department of Surgery, Mercy Medical Center, Baltimore, MD USA
                [ ]Department of Surgery, Cedars Sinai Medical Center, West Hollywood, CA USA
                [ ]Department of Surgery, University of South California, Los Angeles, CA USA
                [ ]Department of Surgery, Georgetown University Hospital, Washington, DC USA
                [ ]Department of Surgery, Shaare Zedek Medical Center, Jerusalem, Israel
                [ ]Department of Surgery, Franklin Square Hospital Center, Baltimore, MD USA
                [ ]Department of Surgery, Virginia Hospital Center, Arlington, VA USA
                [ ]Department of Surgery, St. Joseph Hospital, Orange, CA USA
                [ ]Department of Surgery, HOAG Hospital, Newport Beach, CA USA
                [ ]Department of Surgery, Bryn Mawr Hospital, Bryn Mawr, PA USA
                [ ]Department of Surgery, UC Irvine Medical Center, Orange, CA USA
                [ ]Department of Surgery, Weill Medical College of Cornell University, New York, NY USA
                [ ]Department of Surgery, St. Luke’s Roosevelt, New York, NY USA
                [ ]Department of Surgery, Hadassah Medical Organization, Jerusalem, Israel
                Article
                3602
                10.1245/s10434-014-3602-0
                3975090
                24595800
                b12f1224-d152-4977-933d-1ae59aa67eed
                © The Author(s) 2014

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

                History
                : 4 October 2013
                Categories
                Breast Oncology
                Custom metadata
                © Society of Surgical Oncology 2014

                Oncology & Radiotherapy
                Oncology & Radiotherapy

                Comments

                Comment on this article