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Efficacy of ‘radioguided occult lesion localisation’ (ROLL) versus ‘wire-guided localisation’ (WGL) in breast conserving surgery for non-palpable breast cancer: a randomised controlled multicentre trial

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Abstract

For the management of non-palpable breast cancer, accurate pre-operative localisation is essential to achieve complete resection with optimal cosmetic results. Radioguided occult lesions localisation (ROLL) uses the radiotracer, injected intra-tumourally for sentinel lymph node identification to guide surgical excision of the primary tumour. In a multicentre randomised controlled trial, we determined if ROLL is superior to the standard of care (i.e. wire-guided localisation, WGL) for preoperative tumour localisation. Women (>18 years.) with histologically proven non-palpable breast cancer and eligible for breast conserving treatment with sentinel node procedure were randomised to ROLL or WGL. Patients allocated to ROLL received an intra-tumoural dose of 120 Mbq technetium-99 m nanocolloid. The tumour was surgically removed, guided by gamma probe detection. In the WGL group, ultrasound- or mammography-guided insertion of a hooked wire provided surgical guidance for excision of the primary tumour. Primary outcome measures were the proportion of complete tumour excisions (i.e. with negative margins), the proportion of patients requiring re-excision and the volume of tissue removed. Data were analysed according to intention-to-treat principle. This study is registered at ClinincalTrials.gov, number NCT00539474. In total, 314 patients with 316 invasive breast cancers were enrolled. Complete tumour removal with negative margins was achieved in 140/162 (86 %) patients in the ROLL group versus 134/152 (88 %) patients in the WGL group (P = 0.644). Re-excision was required in 19/162 (12 %) patients in the ROLL group versus 15/152 (10 %) (P = 0.587) in the WGL group. Specimen volumes in the ROLL arm were significantly larger than those in the WGL arm (71 vs. 64 cm3, P = 0.017). No significant differences were seen in the duration and difficulty of the radiological and surgical procedures, the success rate of the sentinel node procedure, and cosmetic outcomes. In this first multicentre randomised controlled comparison of ROLL versus WGL in patients with histologically proven breast cancer, ROLL is comparable to WGL in terms of complete tumour excision and re-excision rates. ROLL, however, leads to excision of larger tissue volumes. Therefore, ROLL cannot replace WGL as the standard of care.

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References

  1. Dodd GD, Fry K, Delany W (1965) Pre-operative localization of occult carcinoma of the breast. In: Nealon TF (ed) Management of the Patient with Breast Cancer. WB Saunders, Philadelphia, pp 88–113

  2. Verkooijen HM, Peeters PH, Buskens E et al (2000) Diagnostic accuracy of large-core needle biopsy for nonpalpable breast disease: a meta-analysis. Br J Cancer 82:1017–1021. doi:10.1054/bjoc.1999.1036

    Article  PubMed  CAS  Google Scholar 

  3. Fleming FJ, Hill AD, Mc Dermott EW et al (2004) Intraoperative margin assessment and re-excision rate in breast conserving surgery. Eur J Surg Oncol 30:233–237. doi:10.1016/j.ejso.2003.11.008

    Article  PubMed  CAS  Google Scholar 

  4. Burkholder HC, Witherspoon LE, Burns RP et al (2007) Breast surgery techniques: preoperative bracketing wire localization by surgeons. Am Surg 73:574–578 discussion 578–9

    PubMed  Google Scholar 

  5. Lovrics PJ, Cornacchi SD, Farrokhyar F et al (2009) The relationship between surgical factors and margin status after breast-conservation surgery for early stage breast cancer. Am J Surg 197:740–746. doi:10.1016/j.amjsurg.2008.03.007

    Article  PubMed  Google Scholar 

  6. Postma EL, Witkamp AJ, van den Bosch MA et al (2011) Localization of nonpalpable breast lesions. Expert Rev Anticancer Ther 11:1295–1302. doi:10.1586/era.11.116

    Article  PubMed  Google Scholar 

  7. Klimberg VS, Kepple J, Shafirstein G et al (2006) eRFA: excision followed by RFA-a new technique to improve local control in breast cancer. Ann Surg Oncol 13:1422–1433. doi:10.1245/s10434-006-9151-4

    Article  PubMed  Google Scholar 

  8. Helvie MA, Ikeda DM, Adler DD (1991) Localization and needle aspiration of breast lesions: complications in 370 cases. Am J Roentgenol 157:711–714

    CAS  Google Scholar 

  9. Azoury F, Sayad P, Rizk A (2009) Thoracoscopic management of a pericardial migration of a breast biopsy localization wire. Ann Thorac Surg 87:1937–1939. doi:10.1016/j.athoracsur.2008.10.069

    Article  PubMed  Google Scholar 

  10. Chadwick DR, Shorthouse AJ (1997) Wire-directed localization biopsy of the breast: an audit of results and analysis of factors influencing therapeutic value in the treatment of breast cancer. Eur J Surg Oncol 23:128–133

    Article  PubMed  CAS  Google Scholar 

  11. Seifi A, Axelrod H, Nascimento T et al (2009) Migration of guidewire after surgical breast biopsy: an unusual case report. Cardiovasc Intervent Radiol 32:1087–1090. doi:10.1007/s00270-009-9620-9

    Article  PubMed  Google Scholar 

  12. Luini A, Zurrida S, Galimberti V et al (1998) Radioguided surgery of occult breast lesions. Eur J Cancer 34:204–205

    Article  PubMed  CAS  Google Scholar 

  13. van der Ploeg IM, Hobbelink M, van den Bosch MA et al (2008) ‘Radioguided occult lesion localisation’ (ROLL) for non-palpable breast lesions: a review of the relevant literature. Eur J Surg Oncol 34:1–5. doi:10.1016/j.ejso.2007.03.002

    Article  PubMed  Google Scholar 

  14. Lovrics P, Cornacchi S, Vora R et al (2010) Systematic review of radio-guided surgery for nonpalpable breast cancer. Ann Surg Oncol 17:S181

    Google Scholar 

  15. van Esser S, Hobbelink MG, Peeters PH et al (2008) The efficacy of ‘radio guided occult lesion localization’ (ROLL) versus ‘wire-guided localization’ (WGL) in breast conserving surgery for non-palpable breast cancer: a randomized clinical trial–ROLL study. BMC Surg 8:9. doi:10.1186/1471-2482-8-9

    Article  PubMed  Google Scholar 

  16. Wapnir IL, Wartenberg DE, Greco RS (1996) Three dimensional staging of breast cancer. Breast Cancer Res Treat 41:15–19

    Article  PubMed  CAS  Google Scholar 

  17. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213

    Article  PubMed  Google Scholar 

  18. Farrokhyar F, Karanicolas PJ, Thoma A et al (2010) Randomized controlled trials of surgical interventions. Ann Surg 251:409–416. doi:10.1097/SLA.0b013e3181cf863d

    Article  PubMed  Google Scholar 

  19. Zelman DC, Dukes E, Brandenburg N et al (2005) Identification of cut-points for mild, moderate and severe pain due to diabetic peripheral neuropathy. Pain 115:29–36. doi:10.1016/j.pain.2005.01.028

    Article  PubMed  Google Scholar 

  20. Van Esser S, Hobbelink M, Van der Ploeg IM et al (2008) Radio guided occult lesion localization (ROLL) for non-palpable invasive breast cancer. J Surg Oncol 98:526–529. doi:10.1002/jso.21143

    Article  PubMed  Google Scholar 

  21. Mariscal Martinez A, Sola M, Perez De Tudela A et al (2009) Radioguided localization of nonpalpable breast cancer lesions: randomized comparison with wire localization in patients undergoing conservative surgery and sentinel node biopsy. Am J Roentgenol 193:1001–1009

    Article  Google Scholar 

  22. Medina-Franco H, Abarca-Perez L, Garcia-Alvarez MN et al (2008) Radioguided occult lesion localization (ROLL) versus wire-guided lumpectomy for non-palpable breast lesions: a randomized prospective evaluation. J Surg Oncol 97:108–111. doi:10.1002/jso.20880

    Article  PubMed  Google Scholar 

  23. Moreno M, Wiltgen JE, Bodanese B et al (2008) Radioguided breast surgery for occult lesion localization—correlation between two methods. J Exp Clin Cancer Res 27:29. doi:10.1186/1756-9966-27-29

    Article  PubMed  Google Scholar 

  24. Ocal K, Dag A, Turkmenoglu O et al (2011) Radioguided occult lesion localization versus wire-guided localization for non-palpable breast lesions: randomized controlled trial. Clinics (Sao Paulo) 66:1003–1007

    Article  Google Scholar 

  25. Graham RA, Homer MJ, Katz J et al (2002) The pancake phenomenon contributes to the inaccuracy of margin assessment in patients with breast cancer. Am J Surg 184:89–93

    Article  PubMed  Google Scholar 

  26. Yeap BH, Muniandy S, Lee SK et al (2007) Specimen shrinkage and its influence on margin assessment in breast cancer. Asian J Surg 30:183–187. doi:10.1016/S1015-9584(08)60020-2

    Article  PubMed  Google Scholar 

  27. Krekel NM, van Slooten HJ, Barbe E et al (2012) Is breast specimen shrinkage really a problem in breast-conserving surgery? J Clin Pathol 65:224–227. doi:10.1136/jclinpath-2011-200392

    Article  PubMed  Google Scholar 

  28. Jakub JW, Gray RJ, Degnim AC et al (2010) Current status of radioactive seed for localization of non palpable breast lesions. Am J Surg 199:522–528. doi:10.1016/j.amjsurg.2009.05.019

    Article  PubMed  Google Scholar 

  29. Lovrics PJ, Goldsmith CH, Hodgson N et al (2011) A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas. Ann Surg Oncol 18:3407–3414. doi:10.1245/s10434-011-1699-y

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

This trial was funded by ZonMw (Dutch organisation for health care research and innovation of care), project number 170882101. The authors thank Lilian Glaap for the data collection and expertise.

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Correspondence to R. van Hillegersberg.

Additional information

This study is conducted on behalf of the ROLL study group.

The members of this ROLL study group are listed in the appendix.

Appendix

Appendix

ROLL study group:

Amphia Hospital, Breda: G. Van der Schelling; A. Rijken; J. Nuytinck; E. Luiten; E. Tetteroo; H. Dijkstra; P. Raaymakers; P. Van Noorden; J. Baas; D. Vos; J. Wijsman.

St. Antonius Hospital, Nieuwegein: R. Koelemij; E. Theunissen; S. van Esser; A. van Wieringen; P. Go; J. Lavalaye; T. Bollen; M. Appelman.

UMC Utrecht, Utrecht: E.L. Postma; L. Glaap; A.J. Witkamp; I.H.M. Borel Rinkes; R. van Hillegersberg; M. Hobbelink; A. Fernandez; G. Stapper; M. van den Bosch; W. Mali; H. Verkooijen; S.M. Willems; P.J. van Diest.

Maasstad ziekenhuis, Rotterdam: C. Contant.

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Postma, E.L., Verkooijen, H.M., van Esser, S. et al. Efficacy of ‘radioguided occult lesion localisation’ (ROLL) versus ‘wire-guided localisation’ (WGL) in breast conserving surgery for non-palpable breast cancer: a randomised controlled multicentre trial. Breast Cancer Res Treat 136, 469–478 (2012). https://doi.org/10.1007/s10549-012-2225-z

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  • DOI: https://doi.org/10.1007/s10549-012-2225-z

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