MarginProbe© reduces the rate of re-excision following breast conserving surgery for breast cancer
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A positive margin status after breast conserving surgery (BCS) is one of the strongest predictors for local recurrence of intraductal (DCIS) and invasive carcinoma. As much as 20–50 % of patients with BCS need to undergo a second operation to receive free margins. In this study we tested the clinical performance of MarginProbe© (Dune Medical Devices, Paoli, PA, USA), a device for the intraoperative evaluation of surgical margins.
A prospective clinical study was performed: The device was utilized in BCS of 150 patients treated at a single facility from November 2012 to June 2013. The re-excision rate was compared to the re-excision rate of a historical group of 172 patients treated with BCS at the same hospital without the application of the device. We analyzed whether the results of MarginProbe© are affected by the morphology, grading, size of the tumor, breast density, age, BMI or the use of marker-wires.
The application of MarginProbe© resulted in an overall decreased re-excision rate of 14.6 %. In the subgroup of DCIS the re-excision rate was reduced from 61.7 to 23.1 %. In the subgroup of invasive lobular carcinomas the re-excision rate decreased from 37.0 to 19.0 %. MarginProbe© results were not affected by grading, tumor size, breast density, age, BMI or marker-wire application.
MarginProbe© detects positive margins in invasive carcinoma, DCIS as well as in invasive lobular carcinoma. The device decreases the re-excision rate after BCS significantly. It does not interfere with any of the factors we examined.
KeywordsRe-excision rate breast cancer Free-margins breast cancer Breast conserving therapy MarginProbe©
Unrestricted grant from Dunne Medical Corp. for scientific work. Prof. Blohmer got honoraria for presentations from Dunne Medical Corp.
Compliance with ethical standards
Conflict of interest
The author declares that there is no actual or potential conflict of interest in relation to this article exists apart from what is mentioned under acknowledgements.
This prospective study was approved by our institution’s ethical committee. Authors had full control of all primary data and agree to allow the Journal to review the data if requested.
- 1.German guideline: www.ago-online.de
- 2.German guideline: S3-Leitlinie zur Diagnostik, Therapie und Nachsorge des Mammakarzinoms, herausgegeben von der Deutschen Krebsgesellschaft 2012Google Scholar
- 3.Jackisch C, Harbeck N, Huober J, von Minckwitz G, Gerber B, Kreipe HH, Liedtke C, Marschner N, Möbus V, Scheithauer H, Schneeweiss A, Thomssen C, Loibl S, Beckmann M, Blohmer JU, Costa SD, Decker T, Diel I, Fasching PA, Fehm T, Janni W, Lück HJ, Maass N, Scharl A, Untch M (2015) Primary Therapy of Early Breast Cancer Evidence, Controversies, Consensus. Opinions of German Specialists to the 14th St. Gallen International Breast Cancer Conference 2015 (Vienna 2015). Geburtshilfe Frauenheilkd 75(6):556–565. doi: 10.1055/s-0035-1546120 CrossRefPubMedPubMedCentralGoogle Scholar
- 4.Krekel NM, Haloua MH, Lopes Cardozo AM, de Wit RH, Bosch AM, de Widt-Levert LM, Muller S, van der Veen H, Bergers E, de Lange de Klerk ES, Meijer S, van den Tol MP (2013) Intraoperative ultrasound guidance for palpable breast cancer excision (COBALT trial): a multicentre, randomised controlled trial. Lancet Oncol 14:48–54Google Scholar
- 5.Pan H, Wu N, Ding H, Ding Q, Dai J, Ling L, Chen L, Zha X, Liu X, Zhou W, Wang S (2013) Intraoperative ultrasound guidance is associated with clear lumpectomy margins for breast cancer: a systematic review and meta-analysis. PLoS One 8(9):e74028. doi: 10.1371/journal.pone.0074028 CrossRefPubMedPubMedCentralGoogle Scholar
- 10.Blohmer JU, Tanko J, Groß J, Völker R (2014) MarginProbe device is able to reduce re-excision rate of breast conserving surgery in invasive and pre-invasive breast cancer independent from any patient or tumor related factors. SABCS, P1-16-06Google Scholar
- 11.Allweis TM, Kaufman Z, Leicuk S, Pappo I, Karni T, Schneebaum S, Spector R, Schindel A, Hershko D, Zilberman M, Sayfan J, Berlin Y, Hadary A, Olsha O, Paran H, Gutman M, Carmon M (2008) A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. Am J Surg 196:483–489CrossRefPubMedGoogle Scholar
- 15.Houssami N, Macaskill P, Luke Marinovich M, Morrow M (2014) The association of surgical margins and local recurrence in women with early-stage invasive breast cancer treated with breast-conserving therapy: a meta-analysis. Ann Surg Oncol 21:717–730Google Scholar
- 16.Jeevan R, Cromwell DA, Trivella M, Lawrence G, Kearins O, Pereira J, Sheppard C, Caddy CM, van der Meulen JH (2012) Reoperation rates after breast conserving surgery for breast cancer among women in England: retrospective study of hospital episode statistics. BMJ 345:e4505. doi: 10.1136/bmj.e4505 CrossRefPubMedPubMedCentralGoogle Scholar
- 17.Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chave-Macgregor M, Freedman G, Houssami N, Johnson PL, Morrow M (2014) Society of Surgical Oncology-American Society for Radiation Oncology Consensus guideline on margins for breast-conserving surgery with whole breast irradiation in stages I and II invasive breast cancer. J Clin Oncol 32(14):1507-1515. doi: 10.1200/JCO.2013.53.3935 CrossRefPubMedGoogle Scholar
- 18.Gruber IV, Rueckert M, Kagan KO, Staebler A, Siegmann KC, Hartkopf A, Wallwiener D, Hahn M (2013) Measurement of tumour size with mammography, sonography and magnetic resonance imaging as compared to histological tumour size in primary breast cancer. BMC Cancer 5(13):328. doi: 10.1186/1471-2407-13-328 CrossRefGoogle Scholar
- 20.Dunne C, Burke JP, Morrow M, Kell MR (2009) Effect of margin status on local recurrence after breast conservation and radiation therapy for ductal carcinoma in situ. J Clin Oncol 27(1615–1620):19Google Scholar
- 23.Chagpar A, Yen T, Sahin A, Hunt KK, Whitman GJ, Ames FC, Ross MI, Meric-Bernstam F, Babiera GV, Singletary SE, Kuerer HM. Intraoperative margin assessment reduces reexcision rates in patients with ductal carcinoma in situ treated with breast-conserving surgery. Am J Surg 186 (2003):371–377Google Scholar