Clinical Validity/Utility, Change in Practice Patterns, and Economic Implications of Risk Stratifiers to Predict Outcomes for Early-Stage Breast Cancer: A Systematic Review
At least 14 stratifiers exist to assess recurrence risk, chemotherapy response, and overall survival (OS) in women with early-stage breast cancer (ESBC). These stratifiers have not been compared using a recently developed rigorous framework. We performed a systematic review of the literature on clin...
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| Veröffentlicht in: | JNCI : Journal of the National Cancer Institute 2012-07, Vol.104 (14), p.1068-1079 |
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| creator | HORNBERGER, John ALVARADO, Michael D CHIEN, Rebecca GUTIERREZ, Hialy R YU, Tiffany M GRADISHAR, William J |
| description | At least 14 stratifiers exist to assess recurrence risk, chemotherapy response, and overall survival (OS) in women with early-stage breast cancer (ESBC). These stratifiers have not been compared using a recently developed rigorous framework. We performed a systematic review of the literature on clinical validity/utility, change in clinical practice, and economic implications of ESBC stratifiers.
A systematic literature search was performed using PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews, and bibliographies of relevant studies. Data were extracted by two investigators and graded using a previously published framework. The Level-of-Evidence determination for each study was summarized, and the studies that provide evidence on change in clinical practice and economic implications are reported.
Fifty-six articles published original evidence addressing the 21-gene recurrence score (n = 31), 70-gene signature (n = 14), Adjuvant! Online (n = 12), 5-antibody immunohistochemistry panel (n = 3), 5-gene expression index (n = 1), and 14-gene signature (n = 1). The 21-gene recurrence score satisfied Level I evidence (the highest level of evidence among five levels) for estimating distant recurrence risk (DRR), OS, and response to adjuvant chemotherapy, and Level II for estimating local recurrence risk. The 5-antibody immunohistochemistry panel and 70-gene signature satisfied Level II evidence for estimating DRR and OS. Adjuvant! Online satisfied Level II evidence for estimating DRR, OS, and chemotherapy response. The 5-gene expression index satisfied Level III evidence for predicting DRR. The 14-gene signature satisfied Level III evidence for predicting DRR and OS. Ten studies reported changes in clinical practice patterns; seven studies reported economic implications.
The available evidence on the ability of stratifiers to predict risks of recurrence and response to chemotherapy in ESBC is growing. Level-of-Evidence determinations using the newer framework provide a solid scientific foundation for clinical recommendations. |
| doi_str_mv | 10.1093/jnci/djs261 |
| format | Article |
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A systematic literature search was performed using PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews, and bibliographies of relevant studies. Data were extracted by two investigators and graded using a previously published framework. The Level-of-Evidence determination for each study was summarized, and the studies that provide evidence on change in clinical practice and economic implications are reported.
Fifty-six articles published original evidence addressing the 21-gene recurrence score (n = 31), 70-gene signature (n = 14), Adjuvant! Online (n = 12), 5-antibody immunohistochemistry panel (n = 3), 5-gene expression index (n = 1), and 14-gene signature (n = 1). The 21-gene recurrence score satisfied Level I evidence (the highest level of evidence among five levels) for estimating distant recurrence risk (DRR), OS, and response to adjuvant chemotherapy, and Level II for estimating local recurrence risk. The 5-antibody immunohistochemistry panel and 70-gene signature satisfied Level II evidence for estimating DRR and OS. Adjuvant! Online satisfied Level II evidence for estimating DRR, OS, and chemotherapy response. The 5-gene expression index satisfied Level III evidence for predicting DRR. The 14-gene signature satisfied Level III evidence for predicting DRR and OS. Ten studies reported changes in clinical practice patterns; seven studies reported economic implications.
The available evidence on the ability of stratifiers to predict risks of recurrence and response to chemotherapy in ESBC is growing. Level-of-Evidence determinations using the newer framework provide a solid scientific foundation for clinical recommendations.</description><identifier>ISSN: 0027-8874</identifier><identifier>EISSN: 1460-2105</identifier><identifier>DOI: 10.1093/jnci/djs261</identifier><identifier>PMID: 22767204</identifier><identifier>CODEN: JNCIEQ</identifier><language>eng</language><publisher>Cary, NC: Oxford University Press</publisher><subject>Antibodies, Neoplasm - analysis ; Antineoplastic Combined Chemotherapy Protocols - economics ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Biomarkers, Tumor - analysis ; Breast cancer ; Breast Neoplasms - chemistry ; Breast Neoplasms - drug therapy ; Breast Neoplasms - economics ; Breast Neoplasms - pathology ; Chemotherapy ; Chemotherapy, Adjuvant ; Cost-Benefit Analysis ; Evidence-Based Medicine ; Female ; Gene Expression Profiling ; Gynecology. Andrology. Obstetrics ; Health Care Costs ; Humans ; Immunohistochemistry ; Mammary gland diseases ; Medical sciences ; Neoplasm Staging ; Practice Patterns, Physicians' - economics ; Practice Patterns, Physicians' - trends ; Predictive Value of Tests ; Prognosis ; Reproducibility of Results ; Risk Assessment ; Risk Factors ; Systematic review ; Tumors ; Women</subject><ispartof>JNCI : Journal of the National Cancer Institute, 2012-07, Vol.104 (14), p.1068-1079</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright Oxford Publishing Limited(England) Jul 18, 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c483t-c291b278c6376a9ce04af222c16c4d635c43b2ad807c30eff3e104e7cda7e1cd3</citedby><cites>FETCH-LOGICAL-c483t-c291b278c6376a9ce04af222c16c4d635c43b2ad807c30eff3e104e7cda7e1cd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26219657$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22767204$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>HORNBERGER, John</creatorcontrib><creatorcontrib>ALVARADO, Michael D</creatorcontrib><creatorcontrib>CHIEN, Rebecca</creatorcontrib><creatorcontrib>GUTIERREZ, Hialy R</creatorcontrib><creatorcontrib>YU, Tiffany M</creatorcontrib><creatorcontrib>GRADISHAR, William J</creatorcontrib><title>Clinical Validity/Utility, Change in Practice Patterns, and Economic Implications of Risk Stratifiers to Predict Outcomes for Early-Stage Breast Cancer: A Systematic Review</title><title>JNCI : Journal of the National Cancer Institute</title><addtitle>J Natl Cancer Inst</addtitle><description>At least 14 stratifiers exist to assess recurrence risk, chemotherapy response, and overall survival (OS) in women with early-stage breast cancer (ESBC). These stratifiers have not been compared using a recently developed rigorous framework. We performed a systematic review of the literature on clinical validity/utility, change in clinical practice, and economic implications of ESBC stratifiers.
A systematic literature search was performed using PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews, and bibliographies of relevant studies. Data were extracted by two investigators and graded using a previously published framework. The Level-of-Evidence determination for each study was summarized, and the studies that provide evidence on change in clinical practice and economic implications are reported.
Fifty-six articles published original evidence addressing the 21-gene recurrence score (n = 31), 70-gene signature (n = 14), Adjuvant! Online (n = 12), 5-antibody immunohistochemistry panel (n = 3), 5-gene expression index (n = 1), and 14-gene signature (n = 1). The 21-gene recurrence score satisfied Level I evidence (the highest level of evidence among five levels) for estimating distant recurrence risk (DRR), OS, and response to adjuvant chemotherapy, and Level II for estimating local recurrence risk. The 5-antibody immunohistochemistry panel and 70-gene signature satisfied Level II evidence for estimating DRR and OS. Adjuvant! Online satisfied Level II evidence for estimating DRR, OS, and chemotherapy response. The 5-gene expression index satisfied Level III evidence for predicting DRR. The 14-gene signature satisfied Level III evidence for predicting DRR and OS. Ten studies reported changes in clinical practice patterns; seven studies reported economic implications.
The available evidence on the ability of stratifiers to predict risks of recurrence and response to chemotherapy in ESBC is growing. Level-of-Evidence determinations using the newer framework provide a solid scientific foundation for clinical recommendations.</description><subject>Antibodies, Neoplasm - analysis</subject><subject>Antineoplastic Combined Chemotherapy Protocols - economics</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Biomarkers, Tumor - analysis</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - chemistry</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - economics</subject><subject>Breast Neoplasms - pathology</subject><subject>Chemotherapy</subject><subject>Chemotherapy, Adjuvant</subject><subject>Cost-Benefit Analysis</subject><subject>Evidence-Based Medicine</subject><subject>Female</subject><subject>Gene Expression Profiling</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Health Care Costs</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>Mammary gland diseases</subject><subject>Medical sciences</subject><subject>Neoplasm Staging</subject><subject>Practice Patterns, Physicians' - economics</subject><subject>Practice Patterns, Physicians' - trends</subject><subject>Predictive Value of Tests</subject><subject>Prognosis</subject><subject>Reproducibility of Results</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Systematic review</subject><subject>Tumors</subject><subject>Women</subject><issn>0027-8874</issn><issn>1460-2105</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU2LFDEQhoMo7rh68i4BEQS3nXxNp9vb2oy6sLDLjuu1yVRXa8buZEzSu8x_8keaYUYFT9aloHh4qpKXkOecveWslvONAzvvNlGU_AGZcVWyQnC2eEhmjAldVJVWJ-RJjBuWqxbqMTkRQpdaMDUjP5vBOgtmoF_MYDubdvPbZIfcz2jzzbivSK2j18FAsoD02qSEwcUzalxHl-CdHy3Qi3E7ZEmy3kXqe3pj43e6SiFPeosh0uSzAzsLiV5NCfyIkfY-0KUJw65YJZP3vA9oYqKNcYDhHT2nq11MOGYH0Bu8s3j_lDzqzRDx2bGfktsPy8_Np-Ly6uNFc35ZgKpkKkDUfC10BaXUpakBmTK9EAJ4Caor5QKUXAvTVUyDZNj3EjlTqKEzGjl08pS8Pni3wf-YMKZ2tBFwGIxDP8WWM1mVTCmt_wPNh0iZt2f05T_oxk_B5YfshTKfrtQiU28OFAQfY8C-3QY7mrDLULvPu93n3R7yzvSLo3Naj9j9YX8HnIFXR8DEnHIf8u_a-JcrBa_LhZa_AIMatVw</recordid><startdate>20120718</startdate><enddate>20120718</enddate><creator>HORNBERGER, John</creator><creator>ALVARADO, Michael D</creator><creator>CHIEN, Rebecca</creator><creator>GUTIERREZ, Hialy R</creator><creator>YU, Tiffany M</creator><creator>GRADISHAR, William J</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>7U1</scope><scope>7U2</scope></search><sort><creationdate>20120718</creationdate><title>Clinical Validity/Utility, Change in Practice Patterns, and Economic Implications of Risk Stratifiers to Predict Outcomes for Early-Stage Breast Cancer: A Systematic Review</title><author>HORNBERGER, John ; ALVARADO, Michael D ; CHIEN, Rebecca ; GUTIERREZ, Hialy R ; YU, Tiffany M ; GRADISHAR, William J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c483t-c291b278c6376a9ce04af222c16c4d635c43b2ad807c30eff3e104e7cda7e1cd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Antibodies, Neoplasm - analysis</topic><topic>Antineoplastic Combined Chemotherapy Protocols - economics</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Biomarkers, Tumor - analysis</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - chemistry</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - economics</topic><topic>Breast Neoplasms - pathology</topic><topic>Chemotherapy</topic><topic>Chemotherapy, Adjuvant</topic><topic>Cost-Benefit Analysis</topic><topic>Evidence-Based Medicine</topic><topic>Female</topic><topic>Gene Expression Profiling</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Health Care Costs</topic><topic>Humans</topic><topic>Immunohistochemistry</topic><topic>Mammary gland diseases</topic><topic>Medical sciences</topic><topic>Neoplasm Staging</topic><topic>Practice Patterns, Physicians' - economics</topic><topic>Practice Patterns, Physicians' - trends</topic><topic>Predictive Value of Tests</topic><topic>Prognosis</topic><topic>Reproducibility of Results</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Systematic review</topic><topic>Tumors</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>HORNBERGER, John</creatorcontrib><creatorcontrib>ALVARADO, Michael D</creatorcontrib><creatorcontrib>CHIEN, Rebecca</creatorcontrib><creatorcontrib>GUTIERREZ, Hialy R</creatorcontrib><creatorcontrib>YU, Tiffany M</creatorcontrib><creatorcontrib>GRADISHAR, William J</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>Risk Abstracts</collection><collection>Safety Science and Risk</collection><jtitle>JNCI : Journal of the National Cancer Institute</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>HORNBERGER, John</au><au>ALVARADO, Michael D</au><au>CHIEN, Rebecca</au><au>GUTIERREZ, Hialy R</au><au>YU, Tiffany M</au><au>GRADISHAR, William J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical Validity/Utility, Change in Practice Patterns, and Economic Implications of Risk Stratifiers to Predict Outcomes for Early-Stage Breast Cancer: A Systematic Review</atitle><jtitle>JNCI : Journal of the National Cancer Institute</jtitle><addtitle>J Natl Cancer Inst</addtitle><date>2012-07-18</date><risdate>2012</risdate><volume>104</volume><issue>14</issue><spage>1068</spage><epage>1079</epage><pages>1068-1079</pages><issn>0027-8874</issn><eissn>1460-2105</eissn><coden>JNCIEQ</coden><abstract>At least 14 stratifiers exist to assess recurrence risk, chemotherapy response, and overall survival (OS) in women with early-stage breast cancer (ESBC). These stratifiers have not been compared using a recently developed rigorous framework. We performed a systematic review of the literature on clinical validity/utility, change in clinical practice, and economic implications of ESBC stratifiers.
A systematic literature search was performed using PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews, and bibliographies of relevant studies. Data were extracted by two investigators and graded using a previously published framework. The Level-of-Evidence determination for each study was summarized, and the studies that provide evidence on change in clinical practice and economic implications are reported.
Fifty-six articles published original evidence addressing the 21-gene recurrence score (n = 31), 70-gene signature (n = 14), Adjuvant! Online (n = 12), 5-antibody immunohistochemistry panel (n = 3), 5-gene expression index (n = 1), and 14-gene signature (n = 1). The 21-gene recurrence score satisfied Level I evidence (the highest level of evidence among five levels) for estimating distant recurrence risk (DRR), OS, and response to adjuvant chemotherapy, and Level II for estimating local recurrence risk. The 5-antibody immunohistochemistry panel and 70-gene signature satisfied Level II evidence for estimating DRR and OS. Adjuvant! Online satisfied Level II evidence for estimating DRR, OS, and chemotherapy response. The 5-gene expression index satisfied Level III evidence for predicting DRR. The 14-gene signature satisfied Level III evidence for predicting DRR and OS. Ten studies reported changes in clinical practice patterns; seven studies reported economic implications.
The available evidence on the ability of stratifiers to predict risks of recurrence and response to chemotherapy in ESBC is growing. Level-of-Evidence determinations using the newer framework provide a solid scientific foundation for clinical recommendations.</abstract><cop>Cary, NC</cop><pub>Oxford University Press</pub><pmid>22767204</pmid><doi>10.1093/jnci/djs261</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Antibodies, Neoplasm - analysis Antineoplastic Combined Chemotherapy Protocols - economics Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Biomarkers, Tumor - analysis Breast cancer Breast Neoplasms - chemistry Breast Neoplasms - drug therapy Breast Neoplasms - economics Breast Neoplasms - pathology Chemotherapy Chemotherapy, Adjuvant Cost-Benefit Analysis Evidence-Based Medicine Female Gene Expression Profiling Gynecology. Andrology. Obstetrics Health Care Costs Humans Immunohistochemistry Mammary gland diseases Medical sciences Neoplasm Staging Practice Patterns, Physicians' - economics Practice Patterns, Physicians' - trends Predictive Value of Tests Prognosis Reproducibility of Results Risk Assessment Risk Factors Systematic review Tumors Women |
| title | Clinical Validity/Utility, Change in Practice Patterns, and Economic Implications of Risk Stratifiers to Predict Outcomes for Early-Stage Breast Cancer: A Systematic Review |
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