Evaluation of the histological size of the sentinel lymph node metastases using RT-PCR assay: a rapid tool to estimate the risk of non-sentinel lymph node invasion in patients with breast cancer

A RT-PCR assay (GeneSearch™, Veridex, LLC), FDA approved and CE marked to detect metastases >0.2 mm in sentinel lymph nodes (SLNs) is used intra-operatively for the management of patients with breast cancer. The assay provides qualitative results by applying cut-off values to cycle times (Ct) for...

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Bibliographic Details
Published in:	Breast cancer research and treatment Vol. 124; no. 3; pp. 599 - 605
Main Authors:	Veys, I, Majjaj, S, Salgado, R, Noterman, D, Schobbens, J. C, Manouach, F, Bourgeois, P, Nogaret, J. M, Larsimont, D, Durbecq, V
Format:	Journal Article
Language:	English
Published:	Boston Boston : Springer US 01-12-2010 Springer US Springer Springer Nature B.V Springer Verlag
Subjects:	Belgium Biological and medical sciences Breast cancer breast neoplasms Breast Neoplasms - genetics Breast Neoplasms - pathology Breast Neoplasms - surgery Cancer patients Cancer research Cancer therapies Drug approval Female Gene Expression Regulation, Neoplastic Gynecology. Andrology. Obstetrics Health risk assessment Hematologic and hematopoietic diseases Humans Intraoperative Care Keratin Keratin-19 - genetics Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis Lymph Nodes - pathology Lymph Nodes - surgery Lymphatic Metastasis Lymphatic system Mammary gland diseases Mastectomy, Segmental Medical research Medical sciences Medicine Medicine & Public Health Medicine, Experimental Metastasis Molecular assay Neoplasm Invasiveness Nodal metastases size Oncology Polymerase chain reaction Preclinical Study Predictive Value of Tests Reoperation Retrospective Studies Reverse Transcriptase Polymerase Chain Reaction Risk Assessment Risk Factors Sensitivity and Specificity Sentinel lymph node Sentinel Lymph Node Biopsy Size Treatment Outcome Tumors Uteroglobin - genetics Belgium Nodal metastases size Breast cancer Sentinel lymph node Molecular assay Breast disease RNA-directed DNA polymerase Size Malignant lymphadenopathy Reverse transcription polymerase chain reaction Human Evaluation Lymph node Enzyme Transferases Patient Malignant hemopathy Histology Malignant tumor Gene expression Invasion Lymph node metastasis Mammary gland diseases Nucleotidyltransferases Risk factor Molecular biology Cancer
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Summary:	A RT-PCR assay (GeneSearch™, Veridex, LLC), FDA approved and CE marked to detect metastases >0.2 mm in sentinel lymph nodes (SLNs) is used intra-operatively for the management of patients with breast cancer. The assay provides qualitative results by applying cut-off values to cycle times (Ct) for mammaglobin (MG) and cytokeratin-19 (CK19) genes. Aims of this study were to evaluate the performance of the quantitative Ct values to estimate the size of nodal metastases and the risk of additional disease in non-SLNs. SLNs from 367 patients were clinically processed using both BLN assay and post-operative histology. Complementary axillary lymph node dissection (ALND) was performed concurrently in case of BLN assay positivity or tumour size >2 cm. BLN positivity was reported in 19.6% of the patients for a sensitivity of 89%. BLN specificity (94.5%) and negative predictive value (97.5%) clearly demonstrated its reliability to guide ALND decision. All, except one, residual axillary metastases were found in BLN-positive patients. Considering the 78 patients with SLN positivity or discordant status according to both criteria, the metastases histological size was significantly correlated to the expression level of MG (ρ = 0.62) and CK19 (ρ = 0.64) genes (P < 10E-6). Moreover, ALND status positivity was significantly associated to Ct value of MG (z = 2.4; P = 0.018) and CK19 (z = 3.2; P = 0.001). The high intra-operative quality performance of the BLN assay minimizes the need for second surgeries for ALND. Results from this investigational study suggest that markers Ct value may provide, intra-operatively, valuable metastases size data and a risk prediction of additional disease in non-SLNs.
Bibliography:	http://dx.doi.org/10.1007/s10549-009-0555-2 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0167-6806 1573-7217
DOI:	10.1007/s10549-009-0555-2