A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer.
Identifieur interne : 001088 ( PubMed/Corpus ); précédent : 001087; suivant : 001089A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer.
Auteurs : Nicola Huxley ; Tracey Jones-Hughes ; Helen Coelho ; Tristan Snowsill ; Chris Cooper ; Yang Meng ; Chris Hyde ; Rubén Mújica-MotaSource :
- Health technology assessment (Winchester, England) [ 2046-4924 ] ; 2015.
English descriptors
- KwdEn :
- Axilla, Breast Neoplasms (pathology), Cost-Benefit Analysis, England, Humans, Intraoperative Period, Lymph Nodes (pathology), Lymphatic Metastasis, Nucleic Acid Amplification Techniques (methods), Quality of Life, Quality-Adjusted Life Years, Sensitivity and Specificity, Sentinel Lymph Node Biopsy, State Medicine.
- MESH :
- geographic : England.
- methods : Nucleic Acid Amplification Techniques.
- pathology : Breast Neoplasms, Lymph Nodes.
- Axilla, Cost-Benefit Analysis, Humans, Intraoperative Period, Lymphatic Metastasis, Quality of Life, Quality-Adjusted Life Years, Sensitivity and Specificity, Sentinel Lymph Node Biopsy, State Medicine.
Abstract
In breast cancer patients, sentinel lymph node biopsy is carried out at the same time as the removal of the primary tumour to postoperatively test with histopathology for regional metastases in the sentinel lymph node. Those patients with positive test results are then operated on 2-4 weeks after primary surgery to remove the lymph nodes from the axilla (axillary lymph node dissection, ALND). New molecular tests RD-100i [one-step nucleic acid amplification (OSNA); based on messenger RNA amplification to identify the cytokeratin-19 (CK19) gene marker] (Sysmex, Norderstedt, Germany) and Metasin (using the CK19 and mammaglobin gene markers) (Cellular Pathology, Princess Alexandra Hospital NHS Trust, Harlow, UK) are intended to provide an intraoperative diagnosis, thereby avoiding the need for postoperative histopathology and, in positive cases, a second operation for ALND.
DOI: 10.3310/hta19020
PubMed: 25586547
Links to Exploration step
pubmed:25586547Le document en format XML
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last="Coelho">Helen Coelho</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Snowsill, Tristan" sort="Snowsill, Tristan" uniqKey="Snowsill T" first="Tristan" last="Snowsill">Tristan Snowsill</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cooper, Chris" sort="Cooper, Chris" uniqKey="Cooper C" first="Chris" last="Cooper">Chris Cooper</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Meng, Yang" sort="Meng, Yang" uniqKey="Meng Y" first="Yang" last="Meng">Yang Meng</name><affiliation><nlm:affiliation>School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Hyde, Chris" sort="Hyde, Chris" uniqKey="Hyde C" first="Chris" last="Hyde">Chris Hyde</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mujica Mota, Ruben" sort="Mujica Mota, Ruben" uniqKey="Mujica Mota R" first="Rubén" last="Mújica-Mota">Rubén Mújica-Mota</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25586547</idno><idno type="pmid">25586547</idno><idno type="doi">10.3310/hta19020</idno><idno type="wicri:Area/PubMed/Corpus">001088</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001088</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer.</title><author><name sortKey="Huxley, Nicola" sort="Huxley, Nicola" uniqKey="Huxley N" first="Nicola" last="Huxley">Nicola Huxley</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Jones Hughes, Tracey" sort="Jones Hughes, Tracey" uniqKey="Jones Hughes T" first="Tracey" last="Jones-Hughes">Tracey Jones-Hughes</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Coelho, Helen" sort="Coelho, Helen" uniqKey="Coelho H" first="Helen" last="Coelho">Helen Coelho</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Snowsill, Tristan" sort="Snowsill, Tristan" uniqKey="Snowsill T" first="Tristan" last="Snowsill">Tristan Snowsill</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cooper, Chris" sort="Cooper, Chris" uniqKey="Cooper C" first="Chris" last="Cooper">Chris Cooper</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Meng, Yang" sort="Meng, Yang" uniqKey="Meng Y" first="Yang" last="Meng">Yang Meng</name><affiliation><nlm:affiliation>School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Hyde, Chris" sort="Hyde, Chris" uniqKey="Hyde C" first="Chris" last="Hyde">Chris Hyde</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mujica Mota, Ruben" sort="Mujica Mota, Ruben" uniqKey="Mujica Mota R" first="Rubén" last="Mújica-Mota">Rubén Mújica-Mota</name><affiliation><nlm:affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Health technology assessment (Winchester, England)</title><idno type="eISSN">2046-4924</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Axilla</term><term>Breast Neoplasms (pathology)</term><term>Cost-Benefit Analysis</term><term>England</term><term>Humans</term><term>Intraoperative Period</term><term>Lymph Nodes (pathology)</term><term>Lymphatic Metastasis</term><term>Nucleic Acid Amplification Techniques (methods)</term><term>Quality of Life</term><term>Quality-Adjusted Life Years</term><term>Sensitivity and Specificity</term><term>Sentinel Lymph Node Biopsy</term><term>State Medicine</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>England</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Nucleic Acid Amplification Techniques</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term><term>Lymph Nodes</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Axilla</term><term>Cost-Benefit Analysis</term><term>Humans</term><term>Intraoperative Period</term><term>Lymphatic Metastasis</term><term>Quality of Life</term><term>Quality-Adjusted Life Years</term><term>Sensitivity and Specificity</term><term>Sentinel Lymph Node Biopsy</term><term>State Medicine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In breast cancer patients, sentinel lymph node biopsy is carried out at the same time as the removal of the primary tumour to postoperatively test with histopathology for regional metastases in the sentinel lymph node. Those patients with positive test results are then operated on 2-4 weeks after primary surgery to remove the lymph nodes from the axilla (axillary lymph node dissection, ALND). New molecular tests RD-100i [one-step nucleic acid amplification (OSNA); based on messenger RNA amplification to identify the cytokeratin-19 (CK19) gene marker] (Sysmex, Norderstedt, Germany) and Metasin (using the CK19 and mammaglobin gene markers) (Cellular Pathology, Princess Alexandra Hospital NHS Trust, Harlow, UK) are intended to provide an intraoperative diagnosis, thereby avoiding the need for postoperative histopathology and, in positive cases, a second operation for ALND.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25586547</PMID><DateCreated><Year>2015</Year><Month>01</Month><Day>14</Day></DateCreated><DateCompleted><Year>2015</Year><Month>09</Month><Day>15</Day></DateCompleted><DateRevised><Year>2016</Year><Month>03</Month><Day>23</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2046-4924</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>2</Issue><PubDate><Year>2015</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Health technology assessment (Winchester, England)</Title><ISOAbbreviation>Health Technol Assess</ISOAbbreviation></Journal><ArticleTitle>A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer.</ArticleTitle><Pagination><MedlinePgn>v-xxv, 1-215</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3310/hta19020</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In breast cancer patients, sentinel lymph node biopsy is carried out at the same time as the removal of the primary tumour to postoperatively test with histopathology for regional metastases in the sentinel lymph node. Those patients with positive test results are then operated on 2-4 weeks after primary surgery to remove the lymph nodes from the axilla (axillary lymph node dissection, ALND). New molecular tests RD-100i [one-step nucleic acid amplification (OSNA); based on messenger RNA amplification to identify the cytokeratin-19 (CK19) gene marker] (Sysmex, Norderstedt, Germany) and Metasin (using the CK19 and mammaglobin gene markers) (Cellular Pathology, Princess Alexandra Hospital NHS Trust, Harlow, UK) are intended to provide an intraoperative diagnosis, thereby avoiding the need for postoperative histopathology and, in positive cases, a second operation for ALND.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the clinical effectiveness and cost-effectiveness of using OSNA and Metasin in the NHS in England for the intraoperative diagnosis of sentinel lymph nodes metastases, compared with postoperative histopathology, the current standard.</AbstractText><AbstractText Label="DATA SOURCES" NlmCategory="METHODS">Electronic databases including MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library and the Health Economic Evaluations Database as well as clinical trial registries, grey literature and conference proceedings were searched up to July 2012.</AbstractText><AbstractText Label="REVIEW METHODS" NlmCategory="METHODS">A systematic review of the evidence was carried out using standard methods. Single-gate studies were used to estimate the accuracy of OSNA with histopathology as the reference standard. The cost-effectiveness analysis adapted an existing simulation model of the long-term costs and health implications of early breast cancer diagnostic outcomes. The model accounted for the costs of an extended first operation with intraoperative testing, the loss of health-related quality of life (disutility) from waiting for postoperative test results, disutility and costs of a second operation, and long-term costs and disutility from lymphoedema related to ALND, adjuvant therapy, locoregional recurrence and metastatic recurrence.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 724 references were identified in the searches, of which 17 studies assessing test accuracy were included in the review, 15 on OSNA and two on Metasin. Both Metasin studies were unpublished. OSNA sensitivity of 84.5% [95% confidence interval (CI) 74.7% to 91.0%] and specificity of 91.8% (95% CI 87.8% to 94.6%) for patient nodal status were estimated in a meta-analysis of five studies [unadjusted for tissue allocation bias (TAB)]. At these values and a 20% node-positive rate, OSNA resulted in lifetime discounted cost-savings of £498 and a quality-adjusted life-year (QALY) loss of 0.048 relative to histopathology, that is, £4324 saved per QALY lost. The most favourable plausible scenario for OSNA in terms of the node-positive rate (range 10-40%), diagnostic accuracy values (91.3% sensitivity and 94.2% specificity, from three reports that adjusted for TAB), the costs of histopathology, OSNA and second surgery, and long-term costs and utilities resulted in a maximum saving per QALY lost of £10,500; OSNA sensitivity and specificity would need to be ≥ 95% for this figure to be ≥ £20,000.</AbstractText><AbstractText Label="LIMITATIONS" NlmCategory="CONCLUSIONS">There is limited evidence on the diagnostic test accuracy of intraoperative tests. The quality of information on costs of resource utilisation during the diagnostic pathway is low and no evidence exists on the disutility of waiting for a second surgery. No comparative studies exist that report clinical outcomes of intraoperative diagnostic tests. These knowledge gaps have more influence on the decision than current uncertainty in the performance of postoperative histopathology in standard practice.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">One-step nucleic acid amplification is not cost-effective for the intraoperative diagnosis of sentinel lymph node metastases. OSNA is less accurate than histopathology and the consequent loss of health benefits in this patient group is not compensated for by health gains elsewhere in the health system that may be obtained with the cost-savings made. The evidence on Metasin is insufficient to evaluate its cost-effectiveness.</AbstractText><AbstractText Label="STUDY REGISTRATION" NlmCategory="BACKGROUND">This study is registered as PROSPERO CRD42012002889.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">The National Institute for Health Research Health Technology Assessment programme.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Huxley</LastName><ForeName>Nicola</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jones-Hughes</LastName><ForeName>Tracey</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coelho</LastName><ForeName>Helen</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Snowsill</LastName><ForeName>Tristan</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cooper</LastName><ForeName>Chris</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Meng</LastName><ForeName>Yang</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hyde</LastName><ForeName>Chris</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mújica-Mota</LastName><ForeName>Rubén</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Health Technol Assess</MedlineTA><NlmUniqueID>9706284</NlmUniqueID><ISSNLinking>1366-5278</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D001365" MajorTopicYN="N">Axilla</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001943" MajorTopicYN="N">Breast Neoplasms</DescriptorName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003362" MajorTopicYN="N">Cost-Benefit Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004739" MajorTopicYN="N" Type="Geographic">England</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007432" MajorTopicYN="N">Intraoperative Period</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008198" MajorTopicYN="N">Lymph Nodes</DescriptorName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008207" MajorTopicYN="N">Lymphatic Metastasis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D021141" MajorTopicYN="N">Nucleic Acid Amplification Techniques</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011788" MajorTopicYN="N">Quality of Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019057" MajorTopicYN="N">Quality-Adjusted Life Years</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012680" MajorTopicYN="N">Sensitivity and Specificity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D021701" MajorTopicYN="N">Sentinel Lymph Node Biopsy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013222" MajorTopicYN="N">State Medicine</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4781263</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>1</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>1</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>9</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25586547</ArticleId><ArticleId IdType="doi">10.3310/hta19020</ArticleId><ArticleId IdType="pmc">PMC4781263</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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