Breast Cancer Research and Treatment

, Volume 139, Issue 1, pp 87–93 | Cite as

Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients

  • Vicente Peg
  • Martín Espinosa-Bravo
  • Begoña Vieites
  • Felip Vilardell
  • José R. Antúnez
  • Magdalena Sancho de Salas
  • Julio J. Delgado-Sánchez
  • Willy Pinto
  • Francisco Gozalbo
  • Anna Petit
  • Irene Sansano
  • María del Mar Téllez
  • Isabel T. Rubio
Clinical Trial


Objective To assess the intraoperative positive sentinel lymph node (SLN) total tumor load (TTL, defined as the amount of CK19 mRNA copies [copies/μL] in all positive SLNs) obtained by one-step nucleic acid amplification (OSNA) and to determine whether it is predictive of non-SLNs involvement. Summary background data The OSNA assay (Sysmex Corporation, Kobe, Japan) is a new diagnostic technique that uses molecular biological techniques to analyze SLN that has been validated as an accurate method for detection of positive SLN. Although the American College of Surgeons Oncology Group Z0011 trial has defined a select cohort of patients in whom a completion axillary lymph node dissection (cALND) may be safely omitted, there are a still a number of patients where prediction of non-SLN metastasis may be helpful for cALND decision making. Multiple studies suggest that specific pathologic characteristics of the primary tumor and the SLN metastases are associated with an increased likelihood of additional positive non-SLN. Methods This is a retrospective multicentric cohort study of 697 patients with cT1-3N0 breast cancer, who had had intraoperative SLN evaluation by OSNA assay with a cALND. TTL is defined as the amount of CK19 mRNA copies number in all positives SLN (copies/μL). Results Univariate logistic regression showed that, in addition to TTL (p < 0.001), the number of affected SLNs (p < 0.001), tumor size (p < 0.001), HER2 status (p = 0.007), and lymphovascular invasion (LVI, p < 0.001) were predictive of ALND status. The multivariate logistic regression analysis showed that TTL is an independent predictor of metastatic non-SLNs, after adjusting for the tumor size, HER2 status, LVI and, in particular, the number of affected SLNs. Conclusions TTL by OSNA is a newly standardized and automated tool that predicts axillary node status better and independently of the number of affected SLNs and the type of surgery. This value can then help clinicians to personalize surgical treatment. Prospective studies will be carried out to determine the clinical impact of this variable in the management of patients.


Breast sentinel lymph node OSNA Total tumor load 



This study was supported by a Grant from the Sysmex España S.L. The sponsor had no role in the study design, analysis, or interpretation of the data.

Conflict of interest

All authors declare no conflict of interest.

Supplementary material

10549_2013_2524_MOESM1_ESM.docx (86 kb)
Supplementary material 1 (DOCX 86 kb)


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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Vicente Peg
    • 1
    • 11
  • Martín Espinosa-Bravo
    • 12
  • Begoña Vieites
    • 2
  • Felip Vilardell
    • 3
  • José R. Antúnez
    • 4
  • Magdalena Sancho de Salas
    • 5
  • Julio J. Delgado-Sánchez
    • 6
  • Willy Pinto
    • 7
  • Francisco Gozalbo
    • 8
  • Anna Petit
    • 9
  • Irene Sansano
    • 1
    • 11
  • María del Mar Téllez
    • 10
  • Isabel T. Rubio
    • 12
  1. 1.Department of PathologyVall d’Hebron University HospitalBarcelonaSpain
  2. 2.Department of PathologyHospital Virgen del RocíoSevilleSpain
  3. 3.Department of PathologyHospital Arnau de VilanovaLéridaSpain
  4. 4.Department of PathologyComplejo Hospitalario Universitario de Santiago de CompostelaSantiago de CompostelaSpain
  5. 5.Department of PathologyHospital Clínico de SalamancaSalamancaSpain
  6. 6.Department of PathologyHospital 12 de OctubreMadridSpain
  7. 7.Department of PathologyHospital Dr. NegrínGran CanarySpain
  8. 8.Instituto Valenciano de OncologíaValenciaSpain
  9. 9.Department of PathologyHospital de BellvitgeBarcelonaSpain
  10. 10.SOLTI Breast Cancer Research GroupBarcelonaSpain
  11. 11.Department of Morphological SciencesUniversitat Autònoma de BarcelonaBarcelonaSpain
  12. 12.Breast Cancer CenterVall d’Hebron University HospitalBarcelonaSpain

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