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

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• 作者：Freya Schnabel MD (1)
  Susan K. Boolbol MD (2)
  Mark Gittleman MD (3)
  Tami Karni MD (4)
  Lorraine Tafra MD (5)
  Sheldon Feldman MD (6)
  Alice Police MD (7)
  Neil B. Friedman MD (8)
  Scott Karlan MD (9)
  Dennis Holmes MD (10)
  Shawna C. Willey MD (11)
  Moshe Carmon MD (12)
  Kristen Fernandez MD (13)
  Stephanie Akbari MD (14)
  Jay Harness MD (15)
  Lisa Guerra MD (16)
  Thomas Frazier MD (17)
  Karen Lane MD (18)
  Rache M. Simmons MD (19)
  Alison Estabrook MD (20)
  Tanir Allweis MD (21)
  
• 刊名：Annals of Surgical Oncology
• 出版年：2014
• 出版时间：May 2014
• 年：2014
• 卷：21
• 期：5
• 页码：1589-1595
• 全文大小：304 KB
• 参考文献：1. National Institutes of Health. NIH consensus statement: treatment of early-stage breast cancer 18-1 June 1990;8(6):1-9. http://consensus.nih.gov/1990/1990earlystagebreastcancer081html.htm. Accessed 1 Sept 2013.
  2. McCahill LE, Single RM, Aiello Bowes EJ, et al. Variability in re-excision following breast conservation surgery. / JAMA. 2012;307:467-5.
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  4. Houssami N, Macaskill P, Marinovich ML, et al. Meta-analysis of the impact of surgical margins on local recurrence in women with early-stage invasive breast cancer treated with breast conserving therapy. / Eur J Cancer. 2010;46:3219-2. CrossRef
  5. Dunne C, Burke JP, Morrow M, Kell MR. Effect of margin status on local recurrence after breast conservation and radiation therapy for ductal carcinoma in situ. / J Clin Oncol. 2009;27:1615-0. CrossRef
  6. Lupe K, Truong PT, Alexander C, et al. Subsets of women with close or positive margins after breast-conserving surgery with high local recurrence risk despite breast plus boost radiotherapy. / Int J Radiat Oncol Biol Phys. 2011;81:e561-. CrossRef
  7. Tartter PI, Kaplan J, Bleiweiss I, et al. Lumpectomy margins, re-excision, and local recurrence of breast cancer. / Am J Surg. 2000;179:81-. CrossRef
  8. Mulleniz PS, Cuadrado DG, Steele SR, et al. Secondary operations are frequently required to complete the surgical phase of therapy in the era of breast conservation and sentinel lymph node biopsy. / Am J Surg. 2004;187:643-. CrossRef
  9. Thill M. MarginProbe: intraoperative margin assessment during breast conserving surgery by using radiofrequency spectroscopy. / Expert Rev Med Devices. 2013;10:301-5. CrossRef
  10. Pappo I, Spector R, Schindel A, et al. Diagnostic performance of a novel device for real-time margin assessment in lumpectomy specimens. / J Surg Res. 2010;160:277-1. CrossRef
  11. Allweiss TM, Kaufman Z, Lelcuk S, et al. A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. / Am J Surg. 2008;196:483-. CrossRef
  12. Blair SL, Thompson K, Rococco J, et al. Attaining negative margins in breast-conservation operations: is there a consensus among breast surgeons? / J Am Coll Surg. 2009;209:608-3. CrossRef
  13. Taghian A, Jagsi R, Makris A, et al. Results of a survey regarding irradiation of internal mammary chain in patients with breast cancer: practiceis culture driven rather than evidence based. / Int J Radiat Oncol Biol Phys. 2004;60:706-4. CrossRef
  14. Balch GC, Mithani SK, Simpson JF, Kelley MC. Accuracy of intraoperative gross examination of surgical margin status in women undergoing partial mastectomy for breast malignancy. / Am Surg. 2005;71:22-.
  15. Jeevan R, Cromwell DA, Trivella M, et al. Reoperation rates after breast conserving surgery for breast cancer among women in England: retrospective study of hospital episode statistics. / BMJ. 2012;345:e4505. CrossRef
  16. Aziz D, Rawlinson E, Narod SA, et al. The role of re-excision for positive margins in optimizing local disease control after breast-conserving surgery for cancer. / Breast J. 2006;12:331-. CrossRef
  17. Heil J, Breitkreuz K, Golatta M, et al. Do reexcisions impair aesthetic outcome in breast conservation surgery? Exploratory analysis of a prospective cohort study. / Ann Surg Oncol. 2012;19:541-. CrossRef
  18. Jacobson AF, Asad J, Boolbol SK, et al. Do additional shaved margins at the time of lumpectomy eliminate the need for re-excision? / Am J Surg. 2008;196:556-. CrossRef
  19. Mook J, Klein R, Kobbermann A, et al. Volume of excision and cosmesis with routine cavity shave margins technique. / Ann Surg Oncol. 2012;19:886-1. CrossRef
  20. Coopey SB, Buckley JM, Smith BL, et al. Lumpectomy cavity shaved margins do not impact re-excision rates in breast cancer patients. / Ann Surg Oncol. 2011;18:3036-0. CrossRef
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  22. Haloua MH, Krekel NM, Winters HA. A systematic review of oncoplastic breast-conserving surgery: current weaknesses and future prospects. / Ann Surg. 2013;257:609-0. CrossRef
  
• 作者单位：Freya Schnabel MD (1)
  Susan K. Boolbol MD (2)
  Mark Gittleman MD (3)
  Tami Karni MD (4)
  Lorraine Tafra MD (5)
  Sheldon Feldman MD (6)
  Alice Police MD (7)
  Neil B. Friedman MD (8)
  Scott Karlan MD (9)
  Dennis Holmes MD (10)
  Shawna C. Willey MD (11)
  Moshe Carmon MD (12)
  Kristen Fernandez MD (13)
  Stephanie Akbari MD (14)
  Jay Harness MD (15)
  Lisa Guerra MD (16)
  Thomas Frazier MD (17)
  Karen Lane MD (18)
  Rache M. Simmons MD (19)
  Alison Estabrook MD (20)
  Tanir Allweis MD (21)
  
  1. Department of Surgery, NYU Langone Medical Center, NYU Clinical Cancer Center, New York, NY, USA
  2. Department of Surgery, Beth Israel Medical Center, New York, NY, USA
  3. Department of Surgery, Breast Care Specialists, Allentown, PA, USA
  4. Department of Surgery, Assaf Harofeh Medical Center, Zerifin, Israel
  5. Department of Surgery, Anne Arundel Medical Center, Annapolis, MD, USA
  6. Department of Surgery, Columbia University Medical Center, New York, NY, USA
  7. Department of Surgery, Pacific Breast Care, Costa Mesa, CA, USA
  8. Department of Surgery, Mercy Medical Center, Baltimore, MD, USA
  9. Department of Surgery, Cedars Sinai Medical Center, West Hollywood, CA, USA
  10. Department of Surgery, University of South California, Los Angeles, CA, USA
  11. Department of Surgery, Georgetown University Hospital, Washington, DC, USA
  12. Department of Surgery, Shaare Zedek Medical Center, Jerusalem, Israel
  13. Department of Surgery, Franklin Square Hospital Center, Baltimore, MD, USA
  14. Department of Surgery, Virginia Hospital Center, Arlington, VA, USA
  15. Department of Surgery, St. Joseph Hospital, Orange, CA, USA
  16. Department of Surgery, HOAG Hospital, Newport Beach, CA, USA
  17. Department of Surgery, Bryn Mawr Hospital, Bryn Mawr, PA, USA
  18. Department of Surgery, UC Irvine Medical Center, Orange, CA, USA
  19. Department of Surgery, Weill Medical College of Cornell University, New York, NY, USA
  20. Department of Surgery, St. Luke’s Roosevelt, New York, NY, USA
  21. Department of Surgery, Hadassah Medical Organization, Jerusalem, Israel
  
• ISSN：1534-4681

文摘

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.