Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory
Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain r...
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| Veröffentlicht in: | Journal of clinical oncology 2008-05, Vol.26 (15), p.2473-2481 |
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| creator | BADVE, Sunil S BAEHNER, Frederick L MARTINO, Silvana DAVIDSON, Nancy E SLEDGE, George W GOLDSTEIN, Lori J SPARANO, Joseph A GRAY, Robert P CHILDS, Barrett H MADDALA, Tara LIU, Mei-Lan ROWLEY, Steve C SHAK, Steven PEREZ, Edith D SHULMAN, Lawrence J |
| description | Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay.
A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay.
For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P < .0001).
There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence. |
| doi_str_mv | 10.1200/JCO.2007.13.6424 |
| format | Article |
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A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay.
For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P < .0001).
There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.2007.13.6424</identifier><identifier>PMID: 18487567</identifier><language>eng</language><publisher>Baltimore, MD: American Society of Clinical Oncology</publisher><subject>Adult ; Biological and medical sciences ; Breast Neoplasms - genetics ; Breast Neoplasms - metabolism ; Breast Neoplasms - pathology ; Carcinoma, Ductal, Breast - genetics ; Carcinoma, Ductal, Breast - metabolism ; Carcinoma, Ductal, Breast - secondary ; Carcinoma, Lobular - genetics ; Carcinoma, Lobular - metabolism ; Carcinoma, Lobular - secondary ; Female ; Humans ; Immunoenzyme Techniques ; Medical sciences ; Middle Aged ; Neoplasm Recurrence, Local - diagnosis ; Neoplasm Staging ; Neoplasms, Hormone-Dependent - genetics ; Neoplasms, Hormone-Dependent - metabolism ; Neoplasms, Hormone-Dependent - secondary ; Prognosis ; Prospective Studies ; Receptors, Estrogen - genetics ; Receptors, Estrogen - metabolism ; Receptors, Progesterone - genetics ; Receptors, Progesterone - metabolism ; Reverse Transcriptase Polymerase Chain Reaction ; Tumors</subject><ispartof>Journal of clinical oncology, 2008-05, Vol.26 (15), p.2473-2481</ispartof><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c467t-ee5ae6b82978654c801b1e466a6f8c300b82a82d9a8ad740fdd4f4b5a1f0cc493</citedby><cites>FETCH-LOGICAL-c467t-ee5ae6b82978654c801b1e466a6f8c300b82a82d9a8ad740fdd4f4b5a1f0cc493</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3716,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20373098$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18487567$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>BADVE, Sunil S</creatorcontrib><creatorcontrib>BAEHNER, Frederick L</creatorcontrib><creatorcontrib>MARTINO, Silvana</creatorcontrib><creatorcontrib>DAVIDSON, Nancy E</creatorcontrib><creatorcontrib>SLEDGE, George W</creatorcontrib><creatorcontrib>GOLDSTEIN, Lori J</creatorcontrib><creatorcontrib>SPARANO, Joseph A</creatorcontrib><creatorcontrib>GRAY, Robert P</creatorcontrib><creatorcontrib>CHILDS, Barrett H</creatorcontrib><creatorcontrib>MADDALA, Tara</creatorcontrib><creatorcontrib>LIU, Mei-Lan</creatorcontrib><creatorcontrib>ROWLEY, Steve C</creatorcontrib><creatorcontrib>SHAK, Steven</creatorcontrib><creatorcontrib>PEREZ, Edith D</creatorcontrib><creatorcontrib>SHULMAN, Lawrence J</creatorcontrib><title>Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory</title><title>Journal of clinical oncology</title><addtitle>J Clin Oncol</addtitle><description>Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay.
A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay.
For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P < .0001).
There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Breast Neoplasms - genetics</subject><subject>Breast Neoplasms - metabolism</subject><subject>Breast Neoplasms - pathology</subject><subject>Carcinoma, Ductal, Breast - genetics</subject><subject>Carcinoma, Ductal, Breast - metabolism</subject><subject>Carcinoma, Ductal, Breast - secondary</subject><subject>Carcinoma, Lobular - genetics</subject><subject>Carcinoma, Lobular - metabolism</subject><subject>Carcinoma, Lobular - secondary</subject><subject>Female</subject><subject>Humans</subject><subject>Immunoenzyme Techniques</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local - diagnosis</subject><subject>Neoplasm Staging</subject><subject>Neoplasms, Hormone-Dependent - genetics</subject><subject>Neoplasms, Hormone-Dependent - metabolism</subject><subject>Neoplasms, Hormone-Dependent - secondary</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Receptors, Estrogen - genetics</subject><subject>Receptors, Estrogen - metabolism</subject><subject>Receptors, Progesterone - genetics</subject><subject>Receptors, Progesterone - metabolism</subject><subject>Reverse Transcriptase Polymerase Chain Reaction</subject><subject>Tumors</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNplkU1v1DAQhiMEokvhzgn5Apyy-Ctxwg1FSylaactSJG7WxJl0XSXx1k6K8j_5QXg_BAdOM9L7zDv2vEnymtEl45R--FptlrGqJRPLXHL5JFmwjKtUqSx7miyoEjxlhfh5kbwI4Z5SJguRPU8uWCELleVqkfxehdG7OxxSAkNDbg59GNG7AdMtGtyPzpPvI4xTIHYgq2pzRTgr1UdSuX4P3gY3ENeS676fBrezYXRmh32sfib1TNbOQHe0rnAYfezXUDsP0dZiOArfJhhGG1fYRyRbfEQfkNx6GILxdj_auODGdXOPHqJQ7SC-Y4tgjkpc8Z_x_DJ51kIX8NW5XiY_Pq9uqy_penN1XX1ap0bmakwRM8C8LnipijyTpqCsZijzHPK2MILSKEHBmxIKaJSkbdPIVtYZsJYaI0txmbw7-e69e5ji3XT8uMGugwHdFLSKAZQiP4D0BBrvQvDY6r23PfhZM6oPSeqYpD4kqZnQhyTjyJuz91T32PwbOEcXgbdnAEK8cRsPZmz4y3EqlKBlEbn3J25n73a_rEcdeui6aMv1vXE81yzTXCoh_gCWc7ik</recordid><startdate>20080520</startdate><enddate>20080520</enddate><creator>BADVE, Sunil S</creator><creator>BAEHNER, Frederick L</creator><creator>MARTINO, Silvana</creator><creator>DAVIDSON, Nancy E</creator><creator>SLEDGE, George W</creator><creator>GOLDSTEIN, Lori J</creator><creator>SPARANO, Joseph A</creator><creator>GRAY, Robert P</creator><creator>CHILDS, Barrett H</creator><creator>MADDALA, Tara</creator><creator>LIU, Mei-Lan</creator><creator>ROWLEY, Steve C</creator><creator>SHAK, Steven</creator><creator>PEREZ, Edith D</creator><creator>SHULMAN, Lawrence J</creator><general>American Society of Clinical Oncology</general><general>Lippincott Williams & Wilkins</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>7X8</scope></search><sort><creationdate>20080520</creationdate><title>Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory</title><author>BADVE, Sunil S ; BAEHNER, Frederick L ; MARTINO, Silvana ; DAVIDSON, Nancy E ; SLEDGE, George W ; GOLDSTEIN, Lori J ; SPARANO, Joseph A ; GRAY, Robert P ; CHILDS, Barrett H ; MADDALA, Tara ; LIU, Mei-Lan ; ROWLEY, Steve C ; SHAK, Steven ; PEREZ, Edith D ; SHULMAN, Lawrence J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c467t-ee5ae6b82978654c801b1e466a6f8c300b82a82d9a8ad740fdd4f4b5a1f0cc493</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Breast Neoplasms - genetics</topic><topic>Breast Neoplasms - metabolism</topic><topic>Breast Neoplasms - pathology</topic><topic>Carcinoma, Ductal, Breast - genetics</topic><topic>Carcinoma, Ductal, Breast - metabolism</topic><topic>Carcinoma, Ductal, Breast - secondary</topic><topic>Carcinoma, Lobular - genetics</topic><topic>Carcinoma, Lobular - metabolism</topic><topic>Carcinoma, Lobular - secondary</topic><topic>Female</topic><topic>Humans</topic><topic>Immunoenzyme Techniques</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Recurrence, Local - diagnosis</topic><topic>Neoplasm Staging</topic><topic>Neoplasms, Hormone-Dependent - genetics</topic><topic>Neoplasms, Hormone-Dependent - metabolism</topic><topic>Neoplasms, Hormone-Dependent - secondary</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Receptors, Estrogen - genetics</topic><topic>Receptors, Estrogen - metabolism</topic><topic>Receptors, Progesterone - genetics</topic><topic>Receptors, Progesterone - metabolism</topic><topic>Reverse Transcriptase Polymerase Chain Reaction</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>BADVE, Sunil S</creatorcontrib><creatorcontrib>BAEHNER, Frederick L</creatorcontrib><creatorcontrib>MARTINO, Silvana</creatorcontrib><creatorcontrib>DAVIDSON, Nancy E</creatorcontrib><creatorcontrib>SLEDGE, George W</creatorcontrib><creatorcontrib>GOLDSTEIN, Lori J</creatorcontrib><creatorcontrib>SPARANO, Joseph A</creatorcontrib><creatorcontrib>GRAY, Robert P</creatorcontrib><creatorcontrib>CHILDS, Barrett H</creatorcontrib><creatorcontrib>MADDALA, Tara</creatorcontrib><creatorcontrib>LIU, Mei-Lan</creatorcontrib><creatorcontrib>ROWLEY, Steve C</creatorcontrib><creatorcontrib>SHAK, Steven</creatorcontrib><creatorcontrib>PEREZ, Edith D</creatorcontrib><creatorcontrib>SHULMAN, Lawrence 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>MEDLINE - Academic</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>BADVE, Sunil S</au><au>BAEHNER, Frederick L</au><au>MARTINO, Silvana</au><au>DAVIDSON, Nancy E</au><au>SLEDGE, George W</au><au>GOLDSTEIN, Lori J</au><au>SPARANO, Joseph A</au><au>GRAY, Robert P</au><au>CHILDS, Barrett H</au><au>MADDALA, Tara</au><au>LIU, Mei-Lan</au><au>ROWLEY, Steve C</au><au>SHAK, Steven</au><au>PEREZ, Edith D</au><au>SHULMAN, Lawrence J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory</atitle><jtitle>Journal of clinical oncology</jtitle><addtitle>J Clin Oncol</addtitle><date>2008-05-20</date><risdate>2008</risdate><volume>26</volume><issue>15</issue><spage>2473</spage><epage>2481</epage><pages>2473-2481</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay.
A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay.
For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P < .0001).
There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.</abstract><cop>Baltimore, MD</cop><pub>American Society of Clinical Oncology</pub><pmid>18487567</pmid><doi>10.1200/JCO.2007.13.6424</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical oncology, 2008-05, Vol.26 (15), p.2473-2481 |
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| source | MEDLINE; American Society of Clinical Oncology Online Journals; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adult Biological and medical sciences Breast Neoplasms - genetics Breast Neoplasms - metabolism Breast Neoplasms - pathology Carcinoma, Ductal, Breast - genetics Carcinoma, Ductal, Breast - metabolism Carcinoma, Ductal, Breast - secondary Carcinoma, Lobular - genetics Carcinoma, Lobular - metabolism Carcinoma, Lobular - secondary Female Humans Immunoenzyme Techniques Medical sciences Middle Aged Neoplasm Recurrence, Local - diagnosis Neoplasm Staging Neoplasms, Hormone-Dependent - genetics Neoplasms, Hormone-Dependent - metabolism Neoplasms, Hormone-Dependent - secondary Prognosis Prospective Studies Receptors, Estrogen - genetics Receptors, Estrogen - metabolism Receptors, Progesterone - genetics Receptors, Progesterone - metabolism Reverse Transcriptase Polymerase Chain Reaction Tumors |
| title | Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory |
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