Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2015 Dec 31;2015(12):CD009206.
doi: 10.1002/14651858.CD009206.pub2.

Localization techniques for guided surgical excision of non-palpable breast lesions

Benjamin K Y Chan  1 , Jill A Wiseberg-Firtell, Ramesh H S Jois, Katrin Jensen, Riccardo A Audisio
Affiliations
Meta-Analysis

Localization techniques for guided surgical excision of non-palpable breast lesions

Benjamin K Y Chan et al. Cochrane Database Syst Rev. .

Abstract

Background: Breast cancer is the most common form of cancer and the second leading cause of death amongst women in Europe. Amongst five invasive cancers per 1000 women detected in screening, 2.7 were < 15 mm in diameter; and others reported that over one third of excised breast lesions were clinically occult. The challenge is to accurately locate small non-palpable lesions intraoperatively for optimal therapeutic outcome. A secondary important goal is to remove the smallest amount possible of healthy glandular tissue for optimal cosmesis. Currently the most widely adopted approach (80% in one survey) in guided breast-conserving surgery for excising non-palpable breast lesions is wire-guided localization (WGL). With the clinical setting shifting towards earlier non-palpable breast lesions being detected through screening, we investigated whether the current standard in assisting surgical excision of these lesions, WGL, yields the best therapeutic outcome for women with breast cancer.

Objectives: To assess the therapeutic outcomes of any new form of guided surgical intervention for non-palpable breast lesions against wire-guided localization, the current gold standard.

Search methods: We searched the Cochrane Breast Cancer Group's (CBCG) Specialized Register, MEDLINE (via PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal from the earliest available date up to 30 March 2015. We also handsearched recent conference proceedings and sought information from experts in the field.

Selection criteria: Two review authors, BC and RJ, independently screened by title and abstract the studies we had identified through the search strategy; when this was inconclusive, they examined the full-text article for inclusion. We resolved any discrepancies regarding eligibility by discussion with a third review author, RA.

Data collection and analysis: Three review authors, BC, JW, and RJ, independently extracted data using a standardized data sheet. We performed all analyses using Review Manager (RevMan) or the R meta package, and in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. We reported results via a graphical assessment using forest plots showing the study estimates. We considered and discussed additional subgroup and sensitivity analyses.

Main results: We identified 11 randomized controlled trials (RCTs) that met the inclusion criteria of this Cochrane review and included eight trials in the meta-analyses. Six RCTs compared radioguided occult lesion localization (ROLL) versus WGL, and two RCTs compared radioactive iodine ((125)I) seed localization (RSL) versus WGL. Of the three remaining trials, one RCT compared cryo-assisted techniques (CAL) versus WGL, one compared intraoperative ultrasound-guided lumpectomy (IOUS) versus WGL, and one compared modified ROLL technique in combination with methylene dye (RCML) versus WGL. Of the trials we included in the meta-analysis, there were a total of 1273 participants with non-palpable breast lesions (627 participants (WGL); 443 participants (ROLL); and 203 participants (RSL)). The participant population varied considerably between included trials, which included participants with both non-palpable benign and malignant lesions, and varied in defining clear margins. The included trials did not report any long-term outcomes.In general, the outcomes of WGL, ROLL and RSL were comparable.ROLL demonstrated favourable results in successful localization (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.16 to 2.28; 869 participants; six trials), positive excision margins (RR 0.74, 95% CI 0.42 to 1.29; 517 participants; five trials), and re-operation rates (RR 0.51, 95% CI 0.21 to 1.23; 583 participants; four trials) versus WGL, but none were statistically significant. WGL was significantly superior to RSL in successfully localizing non-palpable lesions (RR 3.85, 95% CI 1.21 to 12.19; 402 participants; two trials). However, for successful excision, ROLL and RSL have comparable outcomes versus WGL (ROLL versus WGL: RR 1.00, 95% CI 0.99 to 1.01; 871 participants; six trials; RSL versus WGL: RR 1.00, 95% CI 0.99 to 1.01; 402 participants; two trials). These findings were similar in that RSL demonstrated favourable results over WGL in positive tumour margins (RR 0.67, 95% CI 0.43 to 1.06; 366 participants; two trials), and re-operation rates (RR 0.80, 95% CI 0.48 to 1.32; 305 participants; one trial) but neither reached statistical significance. In contrast, WGL had fewer postoperative complications to both ROLL (RR 1.18, 95% CI 0.71 to 1.98; 642 participants; four trials) and RSL (RR 1.51, 95% CI 0.75 to 3.03; 305 participants; one trial), although this was also not statistically significant.The overall quality of evidence was good. The main risk of bias amongst included studies consisted of incomplete data sets, selective reporting, and allocation concealment. Interpretation and applicability of this meta-analysis was hindered by the mixed indication of diagnostic versus therapeutic purposes when undertaking WGL, ROLL, or RSL, leading to a high level of mixed pathology in numerous trials. Other limitations include underpowered studies, lack of data in standardized format for meta-analysis, lack of complete data amongst the trials, and absence of long-term data.

Authors' conclusions: Owing to a lack of trials in certain localization techniques, we could only draw conclusions about ROLL and RSL versus WGL. There is no clear evidence to support one guided technique for surgically excising a non-palpable breast lesion over another. Results from this Cochrane review support the continued use of WGL as a safe and tested technique that allows for flexibility in selected cases when faced with extensive microcalcification. ROLL and RSL could be offered to patients as a comparable replacement for WGL as they are equally reliable. Other techniques such as IOUS, RCML, and CAL are of academic interest, but recommendation for routine use in the clinical environment and oncological outcomes require further validation. The results of this Cochrane review also stress the need for more fully powered RCTs to evaluate the best technique according to the comprehensive criteria described, with a more consistent and standardized approach in outcome reporting.

PubMed Disclaimer

Conflict of interest statement

BC: None known. JW: None known. RJ: None known. KJ: None known. RA: None known.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included trial.
3
3
Forest plot of comparison: 1 Localization complication, outcome: 1.1 ROLL versus WGL.
4
4
Forest plot of comparison: 1 RSL versus WGL, outcome: 1.2 Localization complications.
5
5
Forest plot of comparison: 3 Positive margins, outcome: 3.2 RSL versus WGL.
6
6
Forest plot of comparison: 4 Re‐operation rate, outcome: 4.1 ROLL versus WGL.
1.1
1.1. Analysis
Comparison 1 Localization complication, Outcome 1 ROLL versus WGL.
2.1
2.1. Analysis
Comparison 2 Successful excision, Outcome 1 ROLL versus WGL.
2.2
2.2. Analysis
Comparison 2 Successful excision, Outcome 2 RSL versus WGL.
3.1
3.1. Analysis
Comparison 3 Positive margins, Outcome 1 ROLL versus WGL.
3.2
3.2. Analysis
Comparison 3 Positive margins, Outcome 2 RSL versus WGL.
4.1
4.1. Analysis
Comparison 4 Re‐operation rate, Outcome 1 ROLL versus WGL.
4.2
4.2. Analysis
Comparison 4 Re‐operation rate, Outcome 2 RSL versus WGL.
5.1
5.1. Analysis
Comparison 5 Postoperative complications, Outcome 1 ROLL versus WGL.
5.2
5.2. Analysis
Comparison 5 Postoperative complications, Outcome 2 RSL versus WGL.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD009206

References

References to studies included in this review

Gray 2001 {published data only}
    1. Gray RJ, Salud C, Nguyen K, Dauway E, Friedland J, Berman C, et al. Randomized prospective evaluation of a novel technique for biopsy or lumpectomy of nonpalpable breast lesions: radioactive seed versus wire localization. Annals of Surgical Oncology 2001;8(9):711‐5. - PubMed
Lovrics 2011a {published data only}
    1. Lovrics PJ, Goldsmith CH, Hodgson N, McCready D, Gohla G, Boylan C, et al. A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas. Annals of Surgical Oncology 2011;18(12):3407‐14. - PubMed
Mariscal Martinez 2009 {published data only}
    1. Mariscal Martínez A, Solà M, Tudela AP, Julián JF, Fraile M, Vizcaya S, et al. Radioguided localization of nonpalpable breast cancer lesions: randomized comparison with wire localization in patients undergoing conservative surgery and sentinel node biopsy. American Journal of Roentgenology 2009;193(4):1001‐9. - PubMed
Medina‐Franco 2008 {published data only}
    1. Medina‐Franco H, Abarca‐Pérez L, García‐Alvarez MN, Ulloa‐Gómez JL, Romero‐Trejo C, Sepúlveda‐Méndez J. Radioguided occult lesion localization (ROLL) versus wire‐guided lumpectomy for non‐palpable breast lesions: a randomized prospective evaluation. Journal of Surgical Oncology 2008;97(2):108‐11. - PubMed
Moreno 2008 {published data only}
    1. Moreno M, Wiltgen JE, Bodanese B, Schmitt RL, Gutfilen B, Fonseca LM. Radioguided breast surgery for occult lesion localization ‐ correlation between two methods. Journal of Experimental & Clinical Cancer Research 2008;27:29. - PMC - PubMed
Ocal 2011 {published data only}
    1. Ocal K, Dag A, Turkmenoglu O, Gunay EC, Yucel E, Duce MN. Radioguided occult lesion localization versus wire‐guided localization for non‐palpable breast lesions: randomized controlled trial. Clinics (São Paulo) 2011;66(6):1003‐7. - PMC - PubMed
Postma 2012 {published data only}
    1. Postma EL, Verkooijen HM, Esser S, Hobbelink MG, Schelling GP, Koelemij R, 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 Research and Treatment 2012;136(2):469‐78. - PubMed
Rampaul 2004 {published data only}
    1. Rampaul RS, Bagnall M, Burrell H, Pinder SE, Evans AJ, Macmillan RD. Randomized clinical trial comparing radioisotope occult lesion localization and wire‐guided excision for biopsy of occult breast lesions. The British Journal of Surgery 2004;91(12):1575‐7. - PubMed

References to studies excluded from this review

Rahusen 2002 {published data only}
    1. Rahusen FD, Bremers AJ, Fabry HF, Amerongen AH, Boom RP, Meijer S. Ultrasound‐guided lumpectomy of nonpalpable breast cancer versus wire‐guided resection: a randomized clinical trial. Annals of Surgical Oncology 2002;9(10):994‐8. - PubMed
Tafra 2006 {published data only}
    1. Tafra L, Fine R, Whitworth P, Berry M, Woods J, Ekbom G, et al. Prospective randomized study comparing cryo‐assisted and needle‐wire localization of ultrasound‐visible breast tumors. American Journal of Surgery 2006;192(4):462‐70. - PubMed
Tang 2011 {published data only}
    1. Tang J, Xie XM, Wang X, Xie ZM, He JH, Wu YP, et al. Radiocolloid in combination with methylene dye localization, rather than wire localization, is a preferred procedure for excisional biopsy of nonpalpable breast lesions. Annals of Surgical Oncology 2011;18(1):109‐13. - PubMed

References to studies awaiting assessment

References to ongoing studies

Langhans 2017 {unpublished data only}
    1. A Randomized Study of Localization of Nonpalpable Breast Lesions ‐ RSL vs WGL. Ongoing study January 2014.

Additional references

Ahmed 2013
    1. Ahmed M, Hemelrijck M, Douek M. Systematic review of radioguided versus wire‐guided localization in the treatment of non‐palpable breast cancers. Breast Cancer Research Treatment 2013;140(2):241‐52. - PubMed
Audisio 2005
    1. Audisio RA, Nadeem R, Harris O, Desmond S, Thind R, Chagla LS. Radioguided occult lesion localisation (ROLL) is available in the UK for impalpable breast lesions. Annals of the Royal College of Surgeons of England 2005;87(2):92‐5. - PMC - PubMed
Bruce 2008
    1. Bruce N, Pope D, Stanistreet D. Quantitative Methods for Health Research: a Practical Guide to Epidemiology and Statistics. 1st Edition. Chichester: Wiley‐Interscience, 2008.
Cochrane Breast Cancer Group
    1. Wilcken N, Ghersi D, Brunswick C, Clarke M, Dinh P, Ganz P, et al. Cochrane Breast Cancer Group. In: the Cochrane Library, 2009, Issue 3. Chichester: Wiley‐Blackwell. Updated quarterly. http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/BREASTCA... (accessed 16 December 2015).
De Cicco 2002
    1. Cicco C, Pizzamiglio M, Trifirò G, Luini A, Ferrari M, Prisco G, et al. Radioguided occult lesion localisation (ROLL) and surgical biopsy in breast cancer. Technical aspects. The Quarterly Journal of Nuclear Medicine 2002;46(2):145‐51. - PubMed
Egger 1997
    1. Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta‐analysis detected by a simple, graphical test. BMJ 1997;315(7109):629‐34. - PMC - PubMed
Ernst 2002
    1. Ernst MF, Roukema JA. Diagnosis of non‐palpable breast cancer: a review. The Breast 2002;11(1):13‐22. - PubMed
Ferlay 2007
    1. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology 2007;18(3):581‐92. - PubMed
Fisher 2002
    1. Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, 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(16):1233‐41. - PubMed
Higgins 2011
    1. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
Hirsch 1989
    1. Hirsch JI, Banks WL Jr, Sullivan JS, Horsley JS 3rd. Effect of methylene blue on estrogen‐receptor activity. Radiology 1989;171(1):105‐7. - PubMed
Hughes 2008
    1. Hughes JH, Mason MC, Gray RJ, McLaughlin SA, Degnim AC, Fulmer JT, et al. A multi‐site validation trial of radioactive seed localization as an alternative to wire localization. The Breast Journal 2008;14(2):153‐7. - PubMed
Jakub 2010
    1. Jakub JW, Gray RJ, Degnim AC, Boughey JC, Gardner M, Cox CE. Current status of radioactive seed for localization of non palpable breast lesions. American Journal of Surgery 2010;199(4):522‐8. - PubMed
Lovrics 2011b
    1. Lovrics PJ, Cornacchi SD, Vora R, Goldsmith CH, Kahnamoui K. Systematic review of radioguided surgery for non‐palpable breast cancer. European Journal of Surgical Oncology 2011;37(5):388‐97. - PubMed
Luini 1998
    1. Luini A, Zurrida S, Galimberti V, Paganelli G. Radioguided surgery of occult breast lesions. European Journal of Cancer 1998;34(1):204‐5. - PubMed
Nadeem 2005
    1. Nadeem R, Chagla LS, Harris O, Desmond S, Thind R, Titterrell C, et al. Occult breast lesions: A comparison between radioguided occult lesion localisation (ROLL) vs. wire‐guided lumpectomy (WGL). The Breast 2005;14(4):283‐9. - PubMed
Oxman 1992
    1. Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Annals of Internal Medicine 1992;116(1):78‐84. - PubMed
Philips 2008
    1. Philips N, Coldman A. Comparison of nonbreast cancer incidence, survival and mortality between breast screening program participants and nonparticipants. International Journal of Cancer 2008;122(1):197‐201. - PubMed
Pleijhuis 2009
    1. Pleijhuis RG, Graafland M, Vries J, Bart J, Jong JS, Dam GM. Obtaining adequate surgical margins in breast‐conserving therapy for patients with early‐stage breast cancer: current modalities and future directions. Annals of Surgical Oncology 2009;16(10):2717‐30. - PMC - PubMed
R [Computer program]
    1. R Core Team. R: A Language and Environment for Statistical Computing. Version Version 3.2.2. Vienna: R Foundation for Statistical Computing, 14 August 2015.
R package 'meta' [Computer program]
    1. Schwarzer G. R: Package 'meta'. Version Version 4.3‐0 (02 July 2015). Vienna: R Foundation for Statistical Computing, 2015.
RevMan 5.3 [Computer program]
    1. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Rose 2003
    1. Rose A, Collins JP, Neerhut P, Bishop CV, Mann GB. Carbon localisation of impalpable breast lesions. The Breast 2003;12(4):264‐9. - PubMed
Rovera 2008
    1. Rovera F, Frattini F, Marelli M, Corben AD, Vanoli C, Dionigi G, et al. Radio‐guided occult lesion localization versus wire‐guided localization in non‐palpable breast lesions. International Journal of Surgery 2008;6 Suppl 1:S101‐3. - PubMed
Sajid 2012
    1. Sajid MS, Parampalli U, Haider Z, Bonomi R. Comparison of radioguided occult lesion localization (ROLL) and wire localization for non‐palpable breast cancers: a meta‐analysis. Journal of Surgical Oncology 2012;105(8):852‐8. - PubMed
Schulz 1995
    1. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408‐12. - PubMed
Schwartz 2006
    1. Schwartz GF, Veronesi U, Clough KB, Dixon JM, Fentiman IS, Heywang‐Köbrunner SH, et al. Consensus conference on breast conservation. Journal of the American College of Surgeons 2006;203(2):198‐207. - PubMed
Schünemann 2011
    1. Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glaziou P, et al. Chapter 12: Interpretingresults and drawing conclusions. In: Higgins JPT, Green S (editors). Cochrane Handbook of Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
Tromberg 2008
    1. Tromberg BJ, Pogue BW, Paulsen KD, Yodh AG, Boas DA, Cerussi AE. Assessing the future of diffuse optical imaging technologies for breast cancer management. Medical Physics 2008;35(6):2443‐51. - PMC - PubMed
UK NSC Breast Cancer Screening Recommendation 2012
    1. The Independent UK Panel on Breast Cancer Screening. The Benefits and Harms of Breast Cancer Screening: An Independent Review. http://legacy.screening.nhs.uk/breastcancer (accessed 16 December 2015).
Van der Ploeg 2008
    1. Ploeg IM, Hobbelink M, Bosch MA, Mali WP, Borel Rinkes IH, Hillegersberg R. 'Radioguided occult lesion localisation' (ROLL) for non‐palpable breast lesions: a review of the relevant literature. European Journal of Surgical Oncology 2008;34(1):1‐5. - PubMed
Van Esser 2008
    1. Esser S, Hobbelink M, Ploeg IM, Mali WP, Diest PJ, Borel Rinkes IH, et al. Radio guided occult lesion localization (ROLL) for non‐palpable invasive breast cancer. Journal of Surgical Oncology 2008;98(7):526‐9. - PubMed
Wilson 1993
    1. Wilson M, Boggis CR, Mansel RE, Harland RN. Non‐invasive ultrasound localization of impalpable breast lesions. Clinical Radiology 1993;47(5):337‐8. - PubMed

References to other published versions of this review

Chan 2011
    1. Chan BKY, Jois RHS, Wiseberg JA, Audisio RA. Localization techniques for guided surgical excision of non‐palpable breast lesions. Cochrane Database of Systematic Reviews 2011, Issue 7. [DOI: 10.1002/14651858.CD009206] - DOI - PMC - PubMed

Publication types

Substances