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Ultraschall Med 2019; 40(03): 326-332
DOI: 10.1055/a-0637-1725
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Ultrasound-Assisted Tumor Surgery in Breast Cancer – A Prospective, Randomized, Single-Center Study (MAC 001)

Ultraschall-assistierte Tumorchirurgie beim Mammakarzinom – eine prospektive, randomisierte, monozentrische Studie (MAC 001)
Jürgen Hoffmann   *
1   Department of Gynecology and Obstetrics, University Hospital of Duesseldorf, Germany
,
Mario Marx   *
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Andreas Hengstmann
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Harald Seeger
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Ernst Oberlechner
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Gisela Helms
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Carmen Röhm
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Claudia Ott
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Diethelm Wallwiener
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Annette Stäbler
3   Department for Pathology and Neuropathology, University Hospital Tuebingen, Germany
,
Benjamin Wiesinger
4   Department of Radiology, University Hospital Tuebingen, Germany
,
Andreas D. Hartkopf
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Sara Y. Brucker   **
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
,
Markus Hahn   **
2   Department for Women’s Health, University Hospital of Tuebingen, Germany
› Author Affiliations
Further Information

Publication History

19 June 2017

16 May 2018

Publication Date:
05 July 2018 (online)

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Abstract

Purpose Breast-conserving therapy is associated with a risk of tumor-involved margins. For intraoperative orientation, non- palpable or indistinctly palpable lesions are wire-marked prior to surgery. Ultrasound-guided surgery has the potential to reduce the number of tumor-involved margins. In the MAC 001 trial we evaluated ultrasound-guided breast-conserving surgery compared to wire-guided surgery with regard to free tumor margins, duration of surgery and resection volume.

Materials and Methods In this randomized, prospective, single-center controlled trial, patients with ductal invasive breast cancer were recruited for either ultrasound-guided or wire localization surgery. Primary outcomes were tumor-free resection margins, the reoperation rate and the resection volume in each group. The results were analyzed by intention to treat. The trial was registered under ClinicalTrials.gov NCT02222675.

Results 56 patients were assessed, and 47 patients were evaluated in the trial. 93 % (25/27) of the patients in the ultrasound arm had an R0 reoperation compared to 65 % (13/20) in the wire localization control arm. This result was statistically significant (p = 0.026). No statistical difference was found for the resection volume or the duration of surgery between the two arms. No major complication was seen in either arm.

Conclusion Ultrasound-assisted breast surgery significantly increases the possibility of tumor-free margins and therefore reduces the risk of reoperations. Breast surgeons should be trained in ultrasound and ultrasound should be available in every breast surgery operating room.

Zusammenfassung

Ziel Die brusterhaltende Therapie des Mammakarzinoms unterliegt dem Risiko der R1-Resektion. Zur intraoperativen Orientierung werden nicht oder unsicher palpable Tumoren vor der Operation mittels Draht markiert. Mittels der ultraschall-assistierten Tumorchirurgie kann die Rate an R1 Resektionen reduziert werden. Die MAC 001 Studie verglich die ultraschall-assistierte Tumorchirurgie mit der konventionellen drahtmarkierten Chirurgie und untersuchte dabei die R0-Resektionsrate, Operationszeit und das Resektionsvolumen.

Material und Methode Patientinnen mit einem invasiv duktalen Mammakarzinom wurden in die prospektiv, randomisierte, unizentrische Studie eingeschlossen und entweder in den ultraschall-assistierten oder Draht markierten Arm randomisiert und ausgewertet. Die Studie war unter ClinicalTrial.gov NCT02222675 registriert worden.

Ergebnisse 56 Patientinnen erfüllten die Einschlusskriterien von dehnen 47 ausgewertet werden konnten. 93 % (25/27) der Patientinnen im ultraschall-assistierten Arm hatten im Vergleich zu 65 % (13/20) im Draht markierten Kontrollarm eine R0 Resektion. Das Ergebnis war statistisch signifikant (p = 0.026). In Bezug auf das entnommene Resektionsvolumen und die Operationsdauer wurde kein signifikanter Unterschied beobachtet. Revisionspflichtige Komplikationen traten nicht auf.

Schlussfolgerung Die ultraschall-assistierte Tumorchirurgie kann im Vergleich zur konventionellen Draht markierten Tumorchirurgie die R0-Rate bei brusterhaltender Operation signifikant erhöhen. Aus unserer Sicht sollten Brustchirurgen im Ultraschall ausgebildet sein. Ein Ultraschallgerät sollte Bestandteil jedes Brustoperationssaales sein.

Key words

breast cancer - ultrasound-guided surgery - breast-conserving surgery

* both authors contributed equally first


** both authors contributed equally last


 

  • References

  • 1 Gruber IV, Rueckert M, Kagan KO. et al. Measurement of tumour size with mammography, sonography and magnetic resonance imaging as compared to histological tumour size in primary breast cancer. BMC cancer 2013; 13: 328
    CrossrefPubMedGoogle Scholar
  • 2 Hahn M, Roessner L, Krainick-Strobel U. et al. Sonographic criteria for the differentiation of benign and malignant breast lesions using real-time spatial compound imaging in combination with XRES adaptive image processing. Ultraschall in der Medizin 2012; 33: 270-274
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Dunne C, Burke JP, Morrow M. et al. Effect of margin status on local recurrence after breast conservation and radiation therapy for ductal carcinoma in situ. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2009; 27: 1615-1620
    CrossrefPubMedGoogle Scholar
  • 4 Fisher B, Anderson S, Bryant J. et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. The New England journal of medicine 2002; 347: 1233-1241
    CrossrefPubMedGoogle Scholar
  • 5 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. European journal of cancer 2010; 46: 3219-3232
    CrossrefPubMedGoogle Scholar
  • 6 Veronesi U, Cascinelli N, Mariani L. et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. The New England journal of medicine 2002; 347: 1227-1232
    CrossrefPubMedGoogle Scholar
  • 7 Wang SY, Chu H, Shamliyan T. et al. Network meta-analysis of margin threshold for women with ductal carcinoma in situ. Journal of the National Cancer Institute 2012; 104: 507-516
    CrossrefPubMedGoogle Scholar
  • 8 Morrow M, Harris JR, Schnitt SJ. Surgical margins in lumpectomy for breast cancer--bigger is not better. The New England journal of medicine 2012; 367: 79-82
    CrossrefPubMedGoogle Scholar
  • 9 Singletary SE. Surgical margins in patients with early-stage breast cancer treated with breast conservation therapy. American journal of surgery 2002; 184: 383-393
    CrossrefPubMedGoogle Scholar
  • 10 Moore MM, Whitney LA, Cerilli L. et al. Intraoperative ultrasound is associated with clear lumpectomy margins for palpable infiltrating ductal breast cancer. Annals of surgery 2001; 233: 761-768
    CrossrefPubMedGoogle Scholar
  • 11 Haloua MH, Volders JH, Krekel NM. et al. Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT). Ann Surg Oncol 2016; 23: 30-37
    CrossrefPubMedGoogle Scholar
  • 12 Haid A, Knauer M, Dunzinger S. et al. Intra-operative sonography: a valuable aid during breast-conserving surgery for occult breast cancer. Annals of surgical oncology 2007; 14: 3090-3101
    CrossrefPubMedGoogle Scholar
  • 13 Harlow SP, Krag DN, Ames SE. et al. Intraoperative ultrasound localization to guide surgical excision of nonpalpable breast carcinoma. Journal of the American College of Surgeons 1999; 189: 241-246
    CrossrefPubMedGoogle Scholar
  • 14 Rahusen FD, Taets van Amerongen AH, van Diest PJ. et al. Ultrasound-guided lumpectomy of nonpalpable breast cancers: A feasibility study looking at the accuracy of obtained margins. Journal of surgical oncology 1999; 72: 72-76
    CrossrefPubMedGoogle Scholar
  • 15 Schwartz GF, Goldberg BB, Rifkin MD. et al. Ultrasonography: an alternative to x-ray-guided needle localization of nonpalpable breast masses. Surgery 1988; 104: 870-873
    PubMedGoogle Scholar
  • 16 Schwartz GF, Goldberg BB, Rifkin MD. et al. Ultrasonographic localization of non-palpable breast masses. Ultrasound in medicine & biology 1988; 14: 23-25
    CrossrefPubMedGoogle Scholar
  • 17 Krekel NM, Haloua MH, Lopes CardozoAM. et al. Intraoperative ultrasound guidance for palpable breast cancer excision (COBALT trial): a multicentre, randomised controlled trial. The Lancet Oncology 2013; 14: 48-54
    CrossrefPubMedGoogle Scholar
  • 18 Krekel NM, Lopes CardozoAM, Muller S. et al. Optimising surgical accuracy in palpable breast cancer with intra-operative breast ultrasound--feasibility and surgeons’ learning curve. European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology 2011; 37: 1044-1050
    PubMedGoogle Scholar
  • 19 James TA, Harlow S, Sheehey-Jones J. et al. Intraoperative ultrasound versus mammographic needle localization for ductal carcinoma in situ. Annals of surgical oncology 2009; 16: 1164-1169
    CrossrefPubMedGoogle Scholar
  • 20 Yu CC, Chiang KC, Kuo WL. et al. Low re-excision rate for positive margins in patients treated with ultrasound-guided breast-conserving surgery. Breast 2013; 22: 698-702
    CrossrefPubMedGoogle Scholar
  • 21 Davis KM, Hsu CH, Bouton ME. et al. Intraoperative ultrasound can decrease the re-excision lumpectomy rate in patients with palpable breast cancers. The American surgeon 2011; 77: 720-725
    CrossrefPubMedGoogle Scholar
  • 22 Olsha O, Shemesh D, Carmon M. et al. Resection margins in ultrasound-guided breast-conserving surgery. Annals of surgical oncology 2011; 18: 447-452
    CrossrefPubMedGoogle Scholar
  • 23 Eggemann H, Ignatov T, Costa SD. et al. Accuracy of ultrasound-guided breast-conserving surgery in the determination of adequate surgical margins. Breast cancer research and treatment 2014; 145: 129-136
    CrossrefPubMedGoogle Scholar
  • 24 Stachs A, Pandjaitan A, Martin A. et al. Accuracy of Tumor Sizing in Breast Cancer: A Comparison of Strain Elastography, 3-D Ultrasound and Conventional B-Mode Ultrasound with and without Compound Imaging. Ultrasound in medicine & biology 2016; 42: 2758-2765
    CrossrefPubMedGoogle Scholar