Top

Breast Cancer Research and Treatment

Published in:

01-08-2020 | Breast Cancer | Clinical trial

Use of MarginProbe as an adjunct to standard operating procedure does not significantly reduce re-excision rates in breast conserving surgery

Authors: Elyse LeeVan, Be Thi Ho, Sadie Seto, Jeannie Shen

Published in: Breast Cancer Research and Treatment | Issue 1/2020

Abstract

Purpose

A positive margin after breast conserving surgery has consistently been shown to be a significant predictor for ipsilateral breast tumor recurrence. Currently, there is no standard for intraoperative margin assessment during lumpectomy, and up to 20% of cases result in positive margins. MarginProbe is a device that provides real-time evaluation of lumpectomy margins during surgery. The aim of this study was to evaluate the impact of MarginProbe as an adjunct to standard operating procedure (SOP).

Methods

Patients diagnosed with breast cancer scheduled for breast conserving surgery were consented for intraoperative use of MarginProbe. Shaved margins were excised based on margin assessment using the surgeon’s SOP which included specimen radiography and gross pathologic examination, and feedback from the device. The primary endpoint was re-excision rate. Secondary endpoints included sensitivity, specificity, false-positive and negative rates.

Results

Of the 60 breast cancers, initial histologically close/positive margins were identified in 18 patients (30%). The re-excision rate in the overall cohort was 6.6%, compared to a historical re-excision rate of 8.6% (p < 0.01). Based on 360 measurement sites, MarginProbe demonstrated a sensitivity of 67% and specificity of 60%, with a positive predictive value of 16%, and of negative predictive value of 94%, which was similar to the accuracy of SOP.

Conclusions

MarginProbe performs equally as well as specimen radiography and gross pathologic examination. In this setting where the baseline re-excision rate was low, the use of MarginProbe as an adjunct to SOP resulted in a small 2% absolute reduction in re-excision rate.

NIH (1992) Early stage breast cancer: consensus statement. NIH consensus development conference, June 18–21, 1990. Cancer Treat Res 60:383–393

Lautner M, Lin H, Shen Y, Parker C, Kuerer H, Shaitelman S, Babiera G, Bedrosian I (2015) Disparities in the use of breast-conserving therapy among patients with early-stage breast cancer. JAMA Surg 150:778–786CrossRef

Chen K, Li S, Li Q, Zhu L, Liu Y, Song E, Su F (2016) Breast-conserving surgery rates in breast cancer patients with different molecular subtypes: an observational study based on Surveillance, Epidemiology, and End Results (SEER) database. Medicine (Baltimore) 95:e2593CrossRef

Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N (2002) Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for treatment of invasive breast cancer. N Engl J Med 347:1233–1241CrossRef

Braunstein LZ, Taghian AG, Miemierko A, Salama L, Capuco A, Bellon JR, Wong JS, Punglia RS, MacDonald SM, Harris JR (2017) Breast-cancer subtype, age, and lymph node status as predictors of local recurrence following breast-conserving therapy. Breast Cancer Res Treat 161:173–179CrossRef

Arvold ND, Taghian AG, Niemierko A, Abi Raad RF, Sreedhara M, Mguyen PL, Bellon JR, Wong JS, Smith BL, Harris JR (2011) Age, breast cancer subtype approximation, and local recurrence after breast-conserving therapy. J Clin Oncol 29:3885–3891CrossRef

Vos EL, Gaal J, Verhoef C, Brouwer K, van Deurzen CHM, Koppert LB (2017) Focally positive margins in breast conserving surgery: predictors, residual disease, and local recurrence. Eur J Surg Oncol 43:1846–1854CrossRef

Marinovich ML, Azizi L, Macaskill P, Irwig L, Morrow M, Solin LF, Houssami N (2016) The association of surgical margins and local recurrence in women with ductal carcinoma in situ treated with breast-conserving therapy: a meta-analysis. Ann Surg Oncol 23:3811–3821CrossRef

Mechera R, Viehl CT, Oertli D (2009) Factors predicting in-breast tumor recurrence after breast-conserving surgery. Breast Cancer Res Treat 116:171–177CrossRef

10.

Houssami N, Macaskill P, Marinovich ML, 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 21:717–730CrossRef

11.

Lupe K, Truong PT, Alexander C, Lesperance M, Speers C, Tyldesley S (2011) 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 81:3561–3568

12.

Early breast Cancer Trialists’ Collaborative Group (EBCTCG), Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R (2011) Lancet 378:1707–1716CrossRef

13.

Gray RJ, Pockaj BA, Garvey E, Blair S (2018) Intraoperative margin management in breast-conserving surgery: a systematic review of the literature. Ann Surg Oncol 24:18–27CrossRef

14.

Allweis TM, Kaufman Z, Lelcuk 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 196:483–489CrossRef

15.

Rivera RJ, Holmes DR, Tafra L (2012) Analysis of the impact of intraoperative margin assessment with adjunctive use of MarginProbe versus standard of care on tissue volume removed. Int J Surg Oncol. https://doi.org/10.1155/2012/868623 CrossRefPubMedPubMedCentral

16.

Thill M, Dittmer C, Baumann K, Friedrichs K, Blohmer JU (2014) MarginProbe-final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ. Breast 23:94–96CrossRef

17.

Sebastian M, Akbari S, Anglin B, Lin EH, Police AM (2015) The impact of use of an intraoperative margin assessment device on re-excision rates. Springerplus. https://doi.org/10.1186/s40064-015-0801-5 CrossRefPubMedPubMedCentral

18.

Coble J, Reid V (2017) Achieving clear margins. Directed shaving using MarginProbe, as compared to a full cavity shave approach. Am Surg J 213:627–630CrossRef

19.

Kupstas A, Ibrar W, Hayward RD, Ockner D, Wesen C, Falk J (2018) A novel modality for intraoperative margin assessment and its impact on re-excision rates in breast conserving surgery. Am J Surg 215:400–403CrossRef

20.

McCahill LE, Single RM, Aiello Bowels EJ, Feigelson HS, James TA, Barney T, Engel JM, Initilo AA (2012) Variability in reexcision following breast conservation surgery. JAMA 307:467–475CrossRef

21.

Morrow M, Abrahamse P, Hofer TP, Ward KC, Hamilton AS, Kurian AW, Katz SJ, Jagsi R (2017) Trends in reoperation after initial lumpectomy for breast cancer: addressing overtreatment in surgical management. JAMA Oncol 3:1352–1357CrossRef

22.

Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR (2015) A randomized, controlled trial of cavity shave margins in breast cancer. N Engl J Med 373:503–510CrossRef

23.

Blohmer JU, Tanko J, Kueper J, Grob J, Volker R, Machleidt A (2016) MarginProbe reduces the rate of re-excision following breast conserving surgery for breast cancer. Arch Gynecol Obstet 294:361–367CrossRef

24.

Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T (2014) A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol 21:1589–1595CrossRef

25.

Van Deurzen CH (2016) Predictors of surgical margins following breast-conserving surgery: a large population-based cohort study. Ann Surg Oncol 23(Suppl 5):627–633CrossRef

26.

Pappo I, Spector R, Schindel A, Morgenstern S, Sandbank J, Leider LT, Schneebaum S, Lelcuk S, Karni T (2010) Diagnostic performance of a novel device for real-time margin assessment in lumpectomy specimens. J Surg Res 160:277–281CrossRef

27.

Lai HW, Huang TH, Wu YT, Chen CJ, Chen ST, Lin YJ, Chen DR, Lee CW, Wu HK, Lin HY, Kuo SJ (2018) Clinicopathologic factors related to surgical margin involvement, reoperation, and residual cancer in primary operable breast cancer: an analysis of 2050 patients. Eur J Surg Oncol 44:1725–1735CrossRef

28.

Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M; Society of Surgical Oncology; American Society of Radiation Oncology (2014) Society of Surgical Oncology-American Society for Radiaton Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. J Clin Oncol 32:1507–1515CrossRef

29.

Morrow M, Van Zee KJ, Solin LJ, Houssami N, Chavez-MacGregor M, Harris JR, Horton J, Hwang S, Johnson PL, Marinovich ML, Schnitt SJ, Wapnir I, Moran MS (2016) Society of Surgical Oncology-American Society for Radiation Oncology-American Society of Clinical Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in Ductal Carcinoma In Situ. J Clin Oncol 23:4040–4046CrossRef

30.

Schulman AM, Mirrielees JA, Leverson G, Landercasper J, Greenberg C, Wilke LG (2017) Reexcision surgery for breast cancer: an analysis of the American Society of Breast Surgeons (ASBrS) Mastery Breast Surgery Database following the SSO-ASTRO “No Ink on Tumor” guidelines. Ann Surg Oncol 24:52–58CrossRef

31.

DeSnyder SM, Hunt KK, Dong W, Smith BD, Moran MS, Chavez-MacGregor M, Shen Y, Kuerer HM, Lucci A (2018) American Society of Breast Surgeons’ Practice Patterns after publication of the SSO-ASTRO-ASCO DCIS consensus guidelines on margins for breast-conserving surgery with whole-breast irradiation. Ann Surg Oncol 25:2965–2974CrossRef

Title: Use of MarginProbe as an adjunct to standard operating procedure does not significantly reduce re-excision rates in breast conserving surgery
Authors: Elyse LeeVan
Be Thi Ho
Sadie Seto
Jeannie Shen
Publication date: 01-08-2020
Publisher: Springer US
Keywords: Breast Cancer
Breast Cancer
Published in: Breast Cancer Research and Treatment / Issue 1/2020
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-020-05773-5

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 1/2020

Estrogen, progesterone, and human epidermal growth factor receptor 2 discordance between primary and metastatic breast cancer

Prognostic potential of automated Ki67 evaluation in breast cancer: different hot spot definitions versus true global score

Factors influencing adherence to adjuvant endocrine therapy in breast cancer-treated women: using real-world data to inform a switch from acute to chronic disease management

High FOXA1 protein expression might predict late recurrence in patients with estrogen-positive and HER2-negative breast cancer

CELF6 modulates triple-negative breast cancer progression by regulating the stability of FBP1 mRNA

Identification of a prognostic LncRNA signature for ER-positive, ER-negative and triple-negative breast cancers

Keynote webinar | Spotlight on antibody–drug conjugates in cancer