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Observational and cost analysis of the implementation of breast cancer sentinel node intraoperative molecular diagnosis

Observational and cost analysis of the implementation of breast cancer sentinel node intraoperative molecular diagnosis
Observational and cost analysis of the implementation of breast cancer sentinel node intraoperative molecular diagnosis

BACKGROUND: Accurate intraoperative sentinel lymph node (SLN) assessment enables axillary clearance to be completed immediately in node-positive breast cancer patients. This article reports a study of the introduction of intraoperative molecular SLN analysis in routine clinical practice in the Portsmouth Breast Care Centre.

DESIGN: There was prospective analysis of 254 consecutive patients who underwent SLN biopsy in a single centre. Nodes were sectioned at 2 mm intervals and alternate slices were analysed using a CE-marked assay for mammaglobin (MG) and cytokeratin 19 (CK19). Remaining slices of node were sent for histological analysis, which included CK19 immunohistochemistry. While the assay was being carried out, the surgeon performed the breast tumour resection. The cost per patient was estimated retrospectively and the cost effects on the hospital and primary care trust for a typical service were also estimated.

RESULTS: A total of 491 SLNs from 254 patients were evaluated. The intraoperative assay showed positivity of SLNs for metastatic cells in 78 patients. There was 100% detection of macrometastases within sentinel nodes analysed by GeneSearch. Overall concordance between histological status, including micrometastases and GeneSearch analysis, was 95% (sensitivity 96%, specificity 95%). The cost per procedure was increased for wide local excision with SLN biopsy and intraoperative assessment compared with other models, but fewer procedures were carried out.

CONCLUSION: Intraoperative assessment of SLNs in breast cancer using a molecular assay is a safe, acceptable and accurate technique that allows a reduction in the frequency of delayed axillary clearance surgery. Take-up of this method may be hampered by perverse incentives operating within healthcare funding.

Adult, Aged, Aged, 80 and over, Breast Neoplasms/economics, Costs and Cost Analysis, England, Epidemiologic Methods, Female, Health Care Costs/statistics & numerical data, Humans, Intraoperative Care/economics, Lymph Node Excision/economics, Lymphatic Metastasis/diagnosis, Mastectomy/economics, Middle Aged, Polymerase Chain Reaction/economics, Sentinel Lymph Node Biopsy/economics
0021-9746
522-9
Cutress, R I
68ae4f86-e8cf-411f-a335-cdba51797406
McDowell, A
48032983-8665-4b73-beda-4e07dc0c8988
Gabriel, F G
609b14ad-ce02-4ed9-9f21-5ec6d5e17903
Gill, J
1e31eb24-f833-462e-b610-23b5b28e7285
Jeffrey, M J
9d4d4611-5ad4-4669-9e10-172174aaa0f6
Agrawal, A
6f9fe130-fc73-4d92-8052-967879ae7810
Wise, M
81c04d83-a0fb-4418-b4ea-b8b52844f78f
Raftery, J
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Cree, I A
c1c5f52c-365f-4768-8b03-b62e249cefaa
Yiangou, C
e58f7811-c036-4085-b3b2-25a5ce0a6f09
Cutress, R I
68ae4f86-e8cf-411f-a335-cdba51797406
McDowell, A
48032983-8665-4b73-beda-4e07dc0c8988
Gabriel, F G
609b14ad-ce02-4ed9-9f21-5ec6d5e17903
Gill, J
1e31eb24-f833-462e-b610-23b5b28e7285
Jeffrey, M J
9d4d4611-5ad4-4669-9e10-172174aaa0f6
Agrawal, A
6f9fe130-fc73-4d92-8052-967879ae7810
Wise, M
81c04d83-a0fb-4418-b4ea-b8b52844f78f
Raftery, J
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Cree, I A
c1c5f52c-365f-4768-8b03-b62e249cefaa
Yiangou, C
e58f7811-c036-4085-b3b2-25a5ce0a6f09

Cutress, R I, McDowell, A, Gabriel, F G, Gill, J, Jeffrey, M J, Agrawal, A, Wise, M, Raftery, J, Cree, I A and Yiangou, C (2010) Observational and cost analysis of the implementation of breast cancer sentinel node intraoperative molecular diagnosis. Journal of Clinical Pathology, 63 (6), 522-9. (doi:10.1136/jcp.2009.072942).

Record type: Article

Abstract

BACKGROUND: Accurate intraoperative sentinel lymph node (SLN) assessment enables axillary clearance to be completed immediately in node-positive breast cancer patients. This article reports a study of the introduction of intraoperative molecular SLN analysis in routine clinical practice in the Portsmouth Breast Care Centre.

DESIGN: There was prospective analysis of 254 consecutive patients who underwent SLN biopsy in a single centre. Nodes were sectioned at 2 mm intervals and alternate slices were analysed using a CE-marked assay for mammaglobin (MG) and cytokeratin 19 (CK19). Remaining slices of node were sent for histological analysis, which included CK19 immunohistochemistry. While the assay was being carried out, the surgeon performed the breast tumour resection. The cost per patient was estimated retrospectively and the cost effects on the hospital and primary care trust for a typical service were also estimated.

RESULTS: A total of 491 SLNs from 254 patients were evaluated. The intraoperative assay showed positivity of SLNs for metastatic cells in 78 patients. There was 100% detection of macrometastases within sentinel nodes analysed by GeneSearch. Overall concordance between histological status, including micrometastases and GeneSearch analysis, was 95% (sensitivity 96%, specificity 95%). The cost per procedure was increased for wide local excision with SLN biopsy and intraoperative assessment compared with other models, but fewer procedures were carried out.

CONCLUSION: Intraoperative assessment of SLNs in breast cancer using a molecular assay is a safe, acceptable and accurate technique that allows a reduction in the frequency of delayed axillary clearance surgery. Take-up of this method may be hampered by perverse incentives operating within healthcare funding.

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More information

Published date: June 2010
Keywords: Adult, Aged, Aged, 80 and over, Breast Neoplasms/economics, Costs and Cost Analysis, England, Epidemiologic Methods, Female, Health Care Costs/statistics & numerical data, Humans, Intraoperative Care/economics, Lymph Node Excision/economics, Lymphatic Metastasis/diagnosis, Mastectomy/economics, Middle Aged, Polymerase Chain Reaction/economics, Sentinel Lymph Node Biopsy/economics

Identifiers

Local EPrints ID: 73102
URI: http://eprints.soton.ac.uk/id/eprint/73102
ISSN: 0021-9746
PURE UUID: 4871af48-48f8-45d6-b4be-41e5bc7a7e92

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Date deposited: 02 Mar 2010
Last modified: 13 Mar 2024 21:52

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Contributors

Author: R I Cutress
Author: A McDowell
Author: F G Gabriel
Author: J Gill
Author: M J Jeffrey
Author: A Agrawal
Author: M Wise
Author: J Raftery
Author: I A Cree
Author: C Yiangou

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