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OSNA in routine use – clinical studies

The efficacy of the OSNA® test procedure has been confirmed in several clinical studies worldwide, where the method was compared with a highly differentiated histopathological processing of alternating lymph node tissue samples.
For the OSNA® test these multicentre studies demonstrated concordance, sensitivity and specificity of over 95% compared to the histological findings.

There have been a host of publications by routine users, who describe the comparability of the method and the avoidance of second operations, along with other benefits of OSNA®.
The evaluation of the available patient results shows that there is a correlation between the OSNA® result and the axillary lymph node status. The CK19 mRNA copy number has been shown to be a statistically significant parameter in predicting the risks of further positive axillary lymph nodes. Users have already started to develop statistical calculation models (nomograms) to predict the nodal status from the CK19 copy number in combination with other prognostic factors.

This aspect is of particular importance in relation to more recent study results, which are having a key impact on the therapeutic measures undertaken in patients with positive sentinel nodes. Thus women in the very early stage of breast cancer whose lymph node involvement is very low (only micrometastases, max. 2 positive sentinel nodes) do not need to undergo an axillary lymph node dissection (ALND).

The OSNA® result is a convincing parameter in determining the best therapeutic decision and selecting this group of patients.

Performance evaluations

  • Tsujimoto M, Nakabayashi K, Yoshidome K et al. One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients. Clin Can Res 2007 13: 4807-16.
  • Visser M, Jiwa M, Horstman A et al. Intra-operative diagnostic method based on CK19 mRNA expression for the detection of lymph node metastases in breast cancer. Int J Cancer 2008 122: 2562-67.
  • Schem C, Maass N, Bauerschlag D et al. One-step nucleic acid amplification – a molecular method of lymph node metastases in breast cancer patients; results of the German study group. Virchows Arch 2009 454: 203-10.
  • Snook KL, Layer GT, Jackson P et al. Multicentre evaluation of intraoperative molecular analysis of sentinel lymph nodes in breast carcinoma. Br J Surg. 2010 Dec 23. [Epub ahead of print].
  • Khaddage A, Berremila SA, Forest F, Clemenson A, Bouteille C, Seffert P, Peoc'h M.Implementation of Molecular Intra-operative Assessment of Sentinel Lymph Node in Breast Cancer. Anticancer Res. 2011 Feb;31(2):585-90.

Prediction of the axillary status

  • 26. Osako T, Iwase T, Kimura K, Horii R, Akiyama F. Sentinel node tumour burden quantified based on cytokeratin 19 mRNA copy number predicts non-sentinel node metastases in breast cancer: Molecular whole-node analysis of all removed nodes. Eur J Cancer. 2012 Dec 19. pii: S0959-8049(12)00918-5. doi: 10.1016/j.ejca.2012.11.022.
  • Ohi Y, Umekita Y, Sagara Y, Rai Y, Yotsumoto D, Matsukata A, Baba S, Tamada S, Matsuyama Y, Ando M, Sagara Y, Sasaki M, Tsuchimochi S, Tanimoto A, Sagara Y. Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer. Br J Cancer. 2012 Aug 28. doi: 10.1038/bjc.2012.387.
  • Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JR, de Salas MS, Delgado-Sánchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Téllez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 Apr 11. [Epub ahead of print]
  • Deambrogio C, Castellano I, Paganotti A, Zorini EO, Corsi F, Bussone R, Franchini R, Antona J, Miglio U, Sapino A, Antonacci C, Boldorini R. A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies patients eligible for axillary lymph node dissection in breast cancer. J Clin Pathol. 2014 Jun 6. pii: jclinpath-2014-202384. doi: 10.1136/jclinpath-2014-202384
  • Rubio IT, Espinosa-Bravo M, Rodrigo M, Diaz MA, Hardisson D, Sagasta A, Dueñas B, Peg V. Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients. Breast Cancer Res Treat. 2014 Sep;147(2):371-380. Epub 2014 Aug 28.
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