Subscribe to RSS
DOI: 10.1055/a-2290-1543
Ultrasound-guided breast-conserving surgery compared to conventional breast-conserving surgery
Ultraschallassistierte versus konventionelle Tumorchirurgie bei brusterhaltender Therapie des Mammakarzinoms Supported by: Deutsche Gesellschaft für Ultraschall in der Medizin FoFö 2015-10-14Clinical Trial: Registration number (trial ID): NCT02840864, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: monocentric, prospective, randomized, and non-blinded parallel-group study
Abstract
Purpose The goal of breast-conserving surgery is to achieve negative tumor margins, since insufficient marginal distance is associated with more local and distant recurrences. This study investigates whether IOUS (intraoperative ultrasound) can reduce the re-resection rate compared to standard breast surgery, regardless of tumor biology and focality.
Materials and Methods The present study is a monocentric, prospective, randomized, and non-blinded parallel group study conducted between 7/2015 and 2/2018. Patients with sonographically visible breast cancer were randomized into two study arms: 1) breast-conserving surgery with IOUS; 2) conventional arm.
Results 364 patients were included in the study and underwent surgery. Tumor biology, size, and focality were equally distributed in both groups (p = 0.497). The study arms did not differ significantly in the proportion of preoperative wire markings (p= 0.084), specimen weight (p = 0.225), surgery duration (p = 0.849), and the proportion of shavings taken intraoperatively (p = 0.903). Positive margins were present in 16.6% of the cases in the IOUS arm and in 20.8% in the conventional arm (p = 0.347). Re-operation was necessary after intraoperative shavings in 14.4% of cases in the US arm and in 21.3% in the conventional arm (p = 0.100).
Conclusion Although the present study showed a clear difference in the rate of positive tumor margins with IOUS compared to conventional breast surgery without IOUS, this was not statistically significant in contrast to the current literature. This could be due to the high expertise of the breast surgeons, the precise wire marking, or the fact that the IOUS technique was not standardized.
Zusammenfassung
Ziel Das Ziel einer brusterhaltenden Operation stellen negative Tumorränder dar. In dieser Studie wird untersucht, ob intraoperativer Ultraschall (IOUS), unabhängig von der Tumorbiologie und -fokalität, die Zweitoperationsrate im Vergleich zur Standardoperation senken kann.
Material und Methoden Die vorliegende monozentrische, prospektive, randomisierte und unverblindete Parallelgruppenstudie wurde zwischen 7/2015 und 2/2018 durchgeführt. Patientinnen mit sonografisch sichtbarem Mammakarzinom wurden in zwei Studienarme randomisiert: 1) brusterhaltende Operation mit IOUS; 2) konventioneller Arm.
Ergebnisse 364 Patientinnen wurden eingeschlossen und brusterhaltend operiert. Tumorbiologie, -größe und Fokalität waren in beiden Gruppen ähnlich (p = 0,497). Es gab keinen signifikanten Unterschied hinsichtlich der präoperativen Drahtmarkierungen (p = 0,084), des Resektatgewichts (p = 0,225), der Operationsdauer (p = 0,849) oder der intraoperativ entnommenen Shavings (p = 0,903). Positive Ränder waren in 16,6% der Fälle im US-Arm und in 20,8% der Fälle im konventionellen Arm vorhanden (p = 0,347). Eine Zweitoperation war nach intraoperativ entnommenen Shavings in 14,4% der Fälle im US-Arm und in 21,3% der Fälle im konventionellen Arm erforderlich (p = 0,100).
Schlussfolgerung Obwohl die vorliegende Studie einen deutlichen Benefit durch Hinzunahme des IOUS im Vergleich zur konventionellen Brustchirurgie zeigte, war dieser im Gegensatz zur aktuellen Literatur statistisch nicht signifikant. Ursächlich könnten die hohe Expertise der Brustchirurgen, die präzise präoperative Drahtmarkierung und die nicht standardisierte IOUS-Technik sein – es wurde nur „freier Rand“ im Ultraschall verwendet.
Publication History
Received: 12 December 2023
Accepted after revision: 15 March 2024
Article published online:
20 June 2024
© 2024. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
Literature
- 1 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. N Engl J Med 2002; 347: 1233-1241
- 2 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. N Engl J Med 2002; 347: 1227-1232
- 3 Pusic AL, Klassen AF, Scott AM. et al. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg 2009; 124: 345-353
- 4 Fisher S, Yasui Y, Dabbs K. et al. Re-excision and survival following breast conserving surgery in early stage breast cancer patients: a population-based study. BMC Health Serv Res 2018; 18: 94
- 5 Langhans L, Jensen MB, Talman MM. et al. Reoperation Rates in Ductal Carcinoma In Situ vs Invasive Breast Cancer After Wire-Guided Breast-Conserving Surgery. JAMA Surg 2017; 152: 378-384
- 6 Buchholz TA, Somerfield MR, Griggs JJ. et al. Margins for breast-conserving surgery with whole-breast irradiation in stage I and II invasive breast cancer: American Society of Clinical Oncology endorsement of the Society of Surgical Oncology/American Society for Radiation Oncology consensus guideline. J Clin Oncol 2014; 32: 1502-1506
- 7 Hahn M, Gerber B. Wohin entwickelt sich die operative Senologie?. Der Gynäkologe 2020; 53: 300-308
- 8 Newman LA, Kuerer HM. Advances in breast conservation therapy. J Clin Oncol 2005; 23: 1685-1697
- 9 Bundred JR, Michael S, Stuart B. et al. Margin status and survival outcomes after breast cancer conservation surgery: prospectively registered systematic review and meta-analysis. BMJ 2022; 378: e070346
- 10 Hennigs A, Fuchs V, Sinn HP. et al. Do Patients After Reexcision Due to Involved or Close Margins Have the Same Risk of Local Recurrence as Those After One-Step Breast-Conserving Surgery?. Ann Surg Oncol 2016; 23: 1831-1837
- 11 Katalinic A, Eisemann N, Kraywinkel K. et al. Breast cancer incidence and mortality before and after implementation of the German mammography screening program. Int J Cancer 2020; 147: 709-718
- 12 Chan BK, Wiseberg-Firtell JA, Jois RH. et al. Localization techniques for guided surgical excision of non-palpable breast lesions. Cochrane Database Syst Rev 2015; CD009206
- 13 Kasem I, Mokbel K. Savi Scout(R) Radar Localisation of Non-palpable Breast Lesions: Systematic Review and Pooled Analysis of 842 Cases. Anticancer Res 2020; 40: 3633-3643
- 14 Layeequr Rahman R, Puckett Y, Habrawi Z. et al. A decade of intraoperative ultrasound guided breast conservation for margin negative resection – Radioactive, and magnetic, and Infrared Oh My. Am J Surg 2020; 220: 1410-1416
- 15 Lowes S, Bell A, Milligan R. et al. Use of Hologic LOCalizer radiofrequency identification (RFID) tags to localise impalpable breast lesions and axillary nodes: experience of the first 150 cases in a UK breast unit. Clin Radiol 2020; 75: 942-949
- 16 di Giorgio A, Arnone P, Canavese A. Ultrasound guided excisional biopsy of non-palpable breast lesions: technique and preliminary results. Eur J Surg 1998; 164: 819-824
- 17 Harlow SP, Krag DN, Ames SE. et al. Intraoperative ultrasound localization to guide surgical excision of nonpalpable breast carcinoma. J Am Coll Surg 1999; 189: 241-246
- 18 Hoffmann J, Marx M, Hengstmann A. et al. Ultrasound-Assisted Tumor Surgery in Breast Cancer – A Prospective, Randomized, Single-Center Study (MAC 001). Ultraschall in Med 2019; 40: 326-332
- 19 Krekel NM, Haloua MH, Lopes Cardozo AM. et al. Intraoperative ultrasound guidance for palpable breast cancer excision (COBALT trial): a multicentre, randomised controlled trial. Lancet Oncol 2013; 14: 48-54
- 20 Moore MM, Whitney LA, Cerilli L. et al. Intraoperative ultrasound is associated with clear lumpectomy margins for palpable infiltrating ductal breast cancer. Ann Surg 2001; 233: 761-768
- 21 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. J Surg Oncol 1999; 72: 72-76
- 22 Wilson M, Boggis CR, Mansel RE. et al. Non-invasive ultrasound localization of impalpable breast lesions. Clin Radiol 1993; 47: 337-338
- 23 Banys-Paluchowski M, Rubio IT, Karadeniz Cakmak G. et al. Intraoperative Ultrasound-Guided Excision of Non-Palpable and Palpable Breast Cancer: Systematic Review and Meta-Analysis. Ultraschall in Med 2022; 43: 367-379
- 24 Hu X, Li S, Jiang Y. et al. Intraoperative ultrasound-guided lumpectomy versus wire-guided excision for nonpalpable breast cancer. J Int Med Res 2020; 48: 300060519896707
- 25 Rahusen FD, Bremers AJ, Fabry HF. et al. Ultrasound-guided lumpectomy of nonpalpable breast cancer versus wire-guided resection: a randomized clinical trial. Ann Surg Oncol 2002; 9: 994-998
- 26 Eggemann H, Costa SD, Ignatov A. Ultrasound-Guided Versus Wire-Guided Breast-Conserving Surgery for Nonpalpable Breast Cancer. Clin Breast Cancer 2016; 16: e1-6
- 27 Kaufman CS, Jacobson L, Bachman B. et al. Intraoperative ultrasound facilitates surgery for early breast cancer. Ann Surg Oncol 2002; 9: 988-993
- 28 Chang S, Brooke M, Cureton E. et al. Rapid Implementation of Intraoperative Ultrasonography to Reduce Wire Localization in The Permanente Medical Group. Perm J 2019; 23
- 29 Rubio IT, Esgueva-Colmenarejo A, Espinosa-Bravo M. et al. Intraoperative Ultrasound-Guided Lumpectomy Versus Mammographic Wire Localization for Breast Cancer Patients After Neoadjuvant Treatment. Ann Surg Oncol 2016; 23: 38-43