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 language | English |
|---|---|
| Pages (from-to) | 595-600 |
| Number of pages | 6 |
| Journal | Breast Cancer Research and Treatment |
| Volume | 115 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Jun 2009 |
| Externally published | Yes |
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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 journal › Article
}
TY - JOUR
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
PY - 2009/6
Y1 - 2009/6
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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U2 - 10.1007/s10549-008-0155-6
DO - 10.1007/s10549-008-0155-6
M3 - Article
VL - 115
SP - 595
EP - 600
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
SN - 0167-6806
IS - 3
ER -