Detection of breast cancer metastasis in sentinel lymph nodes using intra-operative real time GeneSearch™ BLN Assay in the operating room

Results of the Cardiff study

Robert E. Mansel, Amit Goyal, Anthony Douglas-Jones, Victoria Woods, Sumit Goyal, Ian Monypenny, Helen Sweetland, Robert G. Newcombe, Bharat Jasani

Research output: Contribution to journalArticle

46 Citations (Scopus)

Abstract

Background Intra-operative assessment is not routinely performed in the UK due to poor sensitivity of available methods and overburdened pathology resources. We conducted a prospective clinical feasibility study of the GeneSearch™ Breast Lymph Node (BLN) Assay (Veridex, LLC, Warren, NJ) to confirm its potential usefulness within the UK healthcare system. Methods In the assay 50% of the lymph node was processed to detect the presence of cytokeratin-19 and mammaglobin mRNA. The assay was calibrated to detect metastases >0.2 mm. Assay results were compared to H&E performed on each face of ∼2 mm alternating node slabs and 3 additional sections cut at ∼150 μm interval from each face of the node slab. Results 124 sentinel lymph nodes were removed from 82 breast cancer patients. The assay correctly identified all 6 patients with sentinel node macrometastases (>2.0 mm), and 2 of 3 patients with sentinel node micrometastases (0.2-2.0 mm). Sentinel lymph nodes in 4 patients were assay positive but histology negative. Two of these four patients had isolated tumor cells seen by histology. The overall concordance with histology was 93.9% (77/82), with sensitivity of 88.9% (8/9, 95% CI 56.5-98%), specificity of 94.6% (69/73, 95% CI 86.7-97.8%), positive predictive value of 66.7% (8/12, 95% CI 39.1-86.2%) and negative predictive value of 98.6% (69/70, 95% CI 92.3-99.7%). The assay was performed in a median time of 32 min (range 26-69 min). Conclusion Intra-operative assessment of sentinel lymph node can be performed rapidly and accurately using the GeneSearch™ BLN Assay.

Original languageEnglish
Pages (from-to)595-600
Number of pages6
JournalBreast Cancer Research and Treatment
Volume115
Issue number3
DOIs
Publication statusPublished - Jun 2009
Externally publishedYes

Fingerprint

Operating Rooms
Operative Time
Breast
Lymph Nodes
Breast Neoplasms
Neoplasm Metastasis
Histology
Keratin-19
Neoplasm Micrometastasis
Feasibility Studies
Sentinel Lymph Node
Pathology
Delivery of Health Care
Messenger RNA
Neoplasms
cyhalothrin

Keywords

  • Axillary lymph node dissection
  • Breast cancer
  • Intra-operative PCR
  • Sentinel lymph node biopsy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Detection of breast cancer metastasis in sentinel lymph nodes using intra-operative real time GeneSearch™ BLN Assay in the operating room : Results of the Cardiff study. / Mansel, Robert E.; Goyal, Amit; Douglas-Jones, Anthony; Woods, Victoria; Goyal, Sumit; Monypenny, Ian; Sweetland, Helen; Newcombe, Robert G.; Jasani, Bharat.

In: Breast Cancer Research and Treatment, Vol. 115, No. 3, 06.2009, p. 595-600.

Research output: Contribution to journalArticle

Mansel, Robert E. ; Goyal, Amit ; Douglas-Jones, Anthony ; Woods, Victoria ; Goyal, Sumit ; Monypenny, Ian ; Sweetland, Helen ; Newcombe, Robert G. ; Jasani, Bharat. / Detection of breast cancer metastasis in sentinel lymph nodes using intra-operative real time GeneSearch™ BLN Assay in the operating room : Results of the Cardiff study. In: Breast Cancer Research and Treatment. 2009 ; Vol. 115, No. 3. pp. 595-600.
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abstract = "Background Intra-operative assessment is not routinely performed in the UK due to poor sensitivity of available methods and overburdened pathology resources. We conducted a prospective clinical feasibility study of the GeneSearch™ Breast Lymph Node (BLN) Assay (Veridex, LLC, Warren, NJ) to confirm its potential usefulness within the UK healthcare system. Methods In the assay 50{\%} of the lymph node was processed to detect the presence of cytokeratin-19 and mammaglobin mRNA. The assay was calibrated to detect metastases >0.2 mm. Assay results were compared to H&E performed on each face of ∼2 mm alternating node slabs and 3 additional sections cut at ∼150 μm interval from each face of the node slab. Results 124 sentinel lymph nodes were removed from 82 breast cancer patients. The assay correctly identified all 6 patients with sentinel node macrometastases (>2.0 mm), and 2 of 3 patients with sentinel node micrometastases (0.2-2.0 mm). Sentinel lymph nodes in 4 patients were assay positive but histology negative. Two of these four patients had isolated tumor cells seen by histology. The overall concordance with histology was 93.9{\%} (77/82), with sensitivity of 88.9{\%} (8/9, 95{\%} CI 56.5-98{\%}), specificity of 94.6{\%} (69/73, 95{\%} CI 86.7-97.8{\%}), positive predictive value of 66.7{\%} (8/12, 95{\%} CI 39.1-86.2{\%}) and negative predictive value of 98.6{\%} (69/70, 95{\%} CI 92.3-99.7{\%}). The assay was performed in a median time of 32 min (range 26-69 min). Conclusion Intra-operative assessment of sentinel lymph node can be performed rapidly and accurately using the GeneSearch™ BLN Assay.",
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T1 - Detection of breast cancer metastasis in sentinel lymph nodes using intra-operative real time GeneSearch™ BLN Assay in the operating room

T2 - Results of the Cardiff study

AU - Mansel, Robert E.

AU - Goyal, Amit

AU - Douglas-Jones, Anthony

AU - Woods, Victoria

AU - Goyal, Sumit

AU - Monypenny, Ian

AU - Sweetland, Helen

AU - Newcombe, Robert G.

AU - Jasani, Bharat

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N2 - Background Intra-operative assessment is not routinely performed in the UK due to poor sensitivity of available methods and overburdened pathology resources. We conducted a prospective clinical feasibility study of the GeneSearch™ Breast Lymph Node (BLN) Assay (Veridex, LLC, Warren, NJ) to confirm its potential usefulness within the UK healthcare system. Methods In the assay 50% of the lymph node was processed to detect the presence of cytokeratin-19 and mammaglobin mRNA. The assay was calibrated to detect metastases >0.2 mm. Assay results were compared to H&E performed on each face of ∼2 mm alternating node slabs and 3 additional sections cut at ∼150 μm interval from each face of the node slab. Results 124 sentinel lymph nodes were removed from 82 breast cancer patients. The assay correctly identified all 6 patients with sentinel node macrometastases (>2.0 mm), and 2 of 3 patients with sentinel node micrometastases (0.2-2.0 mm). Sentinel lymph nodes in 4 patients were assay positive but histology negative. Two of these four patients had isolated tumor cells seen by histology. The overall concordance with histology was 93.9% (77/82), with sensitivity of 88.9% (8/9, 95% CI 56.5-98%), specificity of 94.6% (69/73, 95% CI 86.7-97.8%), positive predictive value of 66.7% (8/12, 95% CI 39.1-86.2%) and negative predictive value of 98.6% (69/70, 95% CI 92.3-99.7%). The assay was performed in a median time of 32 min (range 26-69 min). Conclusion Intra-operative assessment of sentinel lymph node can be performed rapidly and accurately using the GeneSearch™ BLN Assay.

AB - Background Intra-operative assessment is not routinely performed in the UK due to poor sensitivity of available methods and overburdened pathology resources. We conducted a prospective clinical feasibility study of the GeneSearch™ Breast Lymph Node (BLN) Assay (Veridex, LLC, Warren, NJ) to confirm its potential usefulness within the UK healthcare system. Methods In the assay 50% of the lymph node was processed to detect the presence of cytokeratin-19 and mammaglobin mRNA. The assay was calibrated to detect metastases >0.2 mm. Assay results were compared to H&E performed on each face of ∼2 mm alternating node slabs and 3 additional sections cut at ∼150 μm interval from each face of the node slab. Results 124 sentinel lymph nodes were removed from 82 breast cancer patients. The assay correctly identified all 6 patients with sentinel node macrometastases (>2.0 mm), and 2 of 3 patients with sentinel node micrometastases (0.2-2.0 mm). Sentinel lymph nodes in 4 patients were assay positive but histology negative. Two of these four patients had isolated tumor cells seen by histology. The overall concordance with histology was 93.9% (77/82), with sensitivity of 88.9% (8/9, 95% CI 56.5-98%), specificity of 94.6% (69/73, 95% CI 86.7-97.8%), positive predictive value of 66.7% (8/12, 95% CI 39.1-86.2%) and negative predictive value of 98.6% (69/70, 95% CI 92.3-99.7%). The assay was performed in a median time of 32 min (range 26-69 min). Conclusion Intra-operative assessment of sentinel lymph node can be performed rapidly and accurately using the GeneSearch™ BLN Assay.

KW - Axillary lymph node dissection

KW - Breast cancer

KW - Intra-operative PCR

KW - Sentinel lymph node biopsy

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