{"id":"https://openalex.org/W3126322756","doi":"https://doi.org/10.1158/1557-3265.endomet20-po020","title":"Abstract PO020: Approval for the proliferative marker Ki-67 as an integrated biomarker for endometrial cancer in NRG study GY011","display_name":"Abstract PO020: Approval for the proliferative marker Ki-67 as an integrated biomarker for endometrial cancer in NRG study GY011","publication_year":2021,"publication_date":"2021-02-01","ids":{"openalex":"https://openalex.org/W3126322756","doi":"https://doi.org/10.1158/1557-3265.endomet20-po020","mag":"3126322756"},"language":"en","primary_location":{"id":"doi:10.1158/1557-3265.endomet20-po020","doi":"https://doi.org/10.1158/1557-3265.endomet20-po020","is_oa":false,"landing_page_url":"https://doi.org/10.1158/1557-3265.endomet20-po020","pdf_url":null,"source":{"id":"https://openalex.org/S183149254","display_name":"Clinical Cancer Research","issn_l":"1078-0432","issn":["1078-0432","1557-3265"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320273","host_organization_name":"American Association for Cancer Research","host_organization_lineage":["https://openalex.org/P4310320273"],"host_organization_lineage_names":["American Association for Cancer Research"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Cancer Research","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5034340864","display_name":"Megan I. Samuelson","orcid":"https://orcid.org/0000-0003-2582-1078","observed_orcids":["https://orcid.org/0000-0003-2582-1078"]},"institutions":[{"id":"https://openalex.org/I126307644","display_name":"University of Iowa","ror":"https://ror.org/036jqmy94","country_code":"US","type":"education","lineage":["https://openalex.org/I126307644"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Megan I. Samuelson","raw_affiliation_strings":["1University of Iowa, Iowa City, IA,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"1University of Iowa, Iowa City, IA,","institution_ids":["https://openalex.org/I126307644"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014849163","display_name":"Virginia L. Filiaci","orcid":"https://orcid.org/0000-0002-0623-9667","observed_orcids":["https://orcid.org/0000-0002-0623-9667"]},"institutions":[{"id":"https://openalex.org/I4210162619","display_name":"NRG Oncology","ror":"https://ror.org/050draa26","country_code":"US","type":"nonprofit","lineage":["https://openalex.org/I4210162619"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Virginia Filiaci","raw_affiliation_strings":["2NRG Oncology, Buffalo, NY,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"2NRG Oncology, Buffalo, NY,","institution_ids":["https://openalex.org/I4210162619"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012807831","display_name":"Kelley S. Carrick","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I867280407","display_name":"The University of Texas Southwestern Medical Center","ror":"https://ror.org/05byvp690","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I867280407"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kelley Carrick","raw_affiliation_strings":["3UT Southwestern, Dallas, TX,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"3UT Southwestern, Dallas, TX,","institution_ids":["https://openalex.org/I867280407"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5043049490","display_name":"Anand Rajan","orcid":"https://orcid.org/0000-0002-6368-5217","observed_orcids":["https://orcid.org/0000-0002-6368-5217"]},"institutions":[{"id":"https://openalex.org/I126307644","display_name":"University of Iowa","ror":"https://ror.org/036jqmy94","country_code":"US","type":"education","lineage":["https://openalex.org/I126307644"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Anand Rajan KD","raw_affiliation_strings":["1University of Iowa, Iowa City, IA,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"1University of Iowa, Iowa City, IA,","institution_ids":["https://openalex.org/I126307644"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5048305253","display_name":"William Harry Rodgers","orcid":"https://orcid.org/0000-0003-3946-3136","observed_orcids":["https://orcid.org/0000-0003-3946-3136","https://orcid.org/0009-0002-1247-3107"]},"institutions":[{"id":"https://openalex.org/I4387153466","display_name":"Weill Cornell Medicine","ror":"https://ror.org/02r109517","country_code":"US","type":"education","lineage":["https://openalex.org/I205783295","https://openalex.org/I4387153466"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"William H. Rodgers","raw_affiliation_strings":["4Weill Cornell Medical College, New York, NY,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"4Weill Cornell Medical College, New York, NY,","institution_ids":["https://openalex.org/I4387153466"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5043390661","display_name":"Kristina W. Thiel","orcid":"https://orcid.org/0000-0001-8295-864X","observed_orcids":["https://orcid.org/0000-0001-8295-864X"]},"institutions":[{"id":"https://openalex.org/I126307644","display_name":"University of Iowa","ror":"https://ror.org/036jqmy94","country_code":"US","type":"education","lineage":["https://openalex.org/I126307644"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kristina W. Thiel","raw_affiliation_strings":["1University of Iowa, Iowa City, IA,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"1University of Iowa, Iowa City, IA,","institution_ids":["https://openalex.org/I126307644"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5054372225","display_name":"Linda Duska","orcid":"https://orcid.org/0000-0002-8878-4123","observed_orcids":["https://orcid.org/0000-0002-8878-4123"]},"institutions":[{"id":"https://openalex.org/I51556381","display_name":"University of Virginia","ror":"https://ror.org/0153tk833","country_code":"US","type":"education","lineage":["https://openalex.org/I51556381"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Linda R. Duska","raw_affiliation_strings":["5University of Virginia, Charlottesville, VA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"5University of Virginia, Charlottesville, VA","institution_ids":["https://openalex.org/I51556381"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5011828487","display_name":"Kimberly Kay Leslie","orcid":"https://orcid.org/0000-0002-2704-8990","observed_orcids":["https://orcid.org/0000-0002-2704-8990"]},"institutions":[{"id":"https://openalex.org/I126307644","display_name":"University of Iowa","ror":"https://ror.org/036jqmy94","country_code":"US","type":"education","lineage":["https://openalex.org/I126307644"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kimberly K. Leslie","raw_affiliation_strings":["1University of Iowa, Iowa City, IA,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"1University of Iowa, Iowa City, IA,","institution_ids":["https://openalex.org/I126307644"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":5,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"27","issue":"3_Supplement","first_page":"PO020","last_page":"PO020"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10668","display_name":"Endometrial and Cervical Cancer Treatments","score":0.9775000214576721,"subfield":{"id":"https://openalex.org/subfields/2729","display_name":"Obstetrics and Gynecology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10668","display_name":"Endometrial and Cervical Cancer Treatments","score":0.9775000214576721,"subfield":{"id":"https://openalex.org/subfields/2729","display_name":"Obstetrics and Gynecology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10183","display_name":"Breast Cancer Treatment Studies","score":0.01600000075995922,"subfield":{"id":"https://openalex.org/subfields/1306","display_name":"Cancer Research"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10550","display_name":"Ovarian cancer diagnosis and treatment","score":0.00039999998989515007,"subfield":{"id":"https://openalex.org/subfields/2743","display_name":"Reproductive Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/ki-67","display_name":"Ki-67","score":0.9750000238418579},{"id":"https://openalex.org/keywords/endometrial-cancer","display_name":"endometrial cancer","score":0.9890000224113464},{"id":"https://openalex.org/keywords/medroxyprogesterone-acetate","display_name":"medroxyprogesterone acetate","score":0.9070000052452087},{"id":"https://openalex.org/keywords/entinostat","display_name":"entinostat","score":0.9990000128746033},{"id":"https://openalex.org/keywords/histone-deacetylase-inhibitors","display_name":"histone deacetylase inhibitors","score":0.8740000128746033},{"id":"https://openalex.org/keywords/progesterone-receptor","display_name":"progesterone receptor","score":0.9660000205039978},{"id":"https://openalex.org/keywords/interobserver-concordance","display_name":"interobserver concordance","score":0.6600000262260437},{"id":"https://openalex.org/keywords/immunohistochemistry","display_name":"immunohistochemistry","score":0.6439999938011169},{"id":"https://openalex.org/keywords/epigenetic-modifications","display_name":"epigenetic modifications","score":0.7210000157356262}],"concepts":[{"id":"https://openalex.org/C2781197716","wikidata":"https://www.wikidata.org/wiki/Q864574","display_name":"Biomarker","level":2,"score":0.776813268661499},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7522537708282471},{"id":"https://openalex.org/C160798450","wikidata":"https://www.wikidata.org/wiki/Q4230870","display_name":"Concordance","level":2,"score":0.6796329617500305},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.587804913520813},{"id":"https://openalex.org/C2777088508","wikidata":"https://www.wikidata.org/wiki/Q944777","display_name":"Endometrial cancer","level":3,"score":0.5741180181503296},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.5562800168991089},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.5422561764717102},{"id":"https://openalex.org/C2775934546","wikidata":"https://www.wikidata.org/wiki/Q179991","display_name":"Biopsy","level":2,"score":0.45887982845306396},{"id":"https://openalex.org/C2779494336","wikidata":"https://www.wikidata.org/wiki/Q550675","display_name":"Hysterectomy","level":2,"score":0.4351653456687927},{"id":"https://openalex.org/C141341695","wikidata":"https://www.wikidata.org/wiki/Q2368661","display_name":"Surrogate endpoint","level":2,"score":0.4269601106643677},{"id":"https://openalex.org/C29456083","wikidata":"https://www.wikidata.org/wiki/Q1221899","display_name":"Gynecology","level":1,"score":0.35957539081573486},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.289813756942749},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.10666957497596741},{"id":"https://openalex.org/C55493867","wikidata":"https://www.wikidata.org/wiki/Q7094","display_name":"Biochemistry","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1158/1557-3265.endomet20-po020","doi":"https://doi.org/10.1158/1557-3265.endomet20-po020","is_oa":false,"landing_page_url":"https://doi.org/10.1158/1557-3265.endomet20-po020","pdf_url":null,"source":{"id":"https://openalex.org/S183149254","display_name":"Clinical Cancer Research","issn_l":"1078-0432","issn":["1078-0432","1557-3265"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320273","host_organization_name":"American Association for Cancer Research","host_organization_lineage":["https://openalex.org/P4310320273"],"host_organization_lineage_names":["American Association for Cancer Research"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Cancer Research","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.9537000060081482}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2558156847","https://openalex.org/W3194949122","https://openalex.org/W2168197820","https://openalex.org/W3136128457","https://openalex.org/W4393861755","https://openalex.org/W2338409671","https://openalex.org/W6981050428","https://openalex.org/W2411682551","https://openalex.org/W4322769985","https://openalex.org/W4295907281"],"abstract_inverted_index":{"Abstract":[0],"Introduction:":[1],"NRG":[2,390],"Study":[3],"GY011":[4,392],"is":[5],"a":[6,17,60,174],"surgical":[7],"window":[8],"trial":[9,34],"of":[10,32,40,50,132,207,234,248,257,275,297,344,396],"medroxy-progesterone":[11],"acetate":[12],"(MPA)":[13],"+/-":[14],"entinostat":[15],"(E),":[16],"histone":[18],"deacetylase":[19],"inhibitor":[20],"hypothesized":[21],"to":[22,36,89,121,178,250,282],"upregulate":[23],"PR":[24,64],"levels":[25],"through":[26],"epigenetic":[27],"modifications.":[28],"The":[29,198,284],"principal":[30],"goal":[31],"this":[33],"was":[35,66,73,116,163,202,238],"determine":[37],"the":[38,43,48,69,81,95,101,130,133,205,245,272,302,316,321,335,378,397],"impact":[39],"treatment":[41,179],"on":[42,111,157],"level":[44,274],"as":[45,47,83,193,204,209,299,328,340,382],"well":[46],"activity":[49,65],"progesterone":[51],"receptors":[52],"(PR)":[53],"in":[54,80,347,389],"women":[55],"with":[56,98,141,152,254,301],"endometrial":[57,349,387],"cancer.":[58],"However,":[59],"reliable":[61],"marker":[62,380],"for":[63,78,143,185,212,231,332,337,377,386],"needed,":[67],"and":[68,113,125,145,148,159,171,182,191,217,224,259,265,269,310,408],"most":[70],"promising":[71],"choice":[72],"Ki-67.":[74],"To":[75],"be":[76],"approved":[77,326,342],"inclusion":[79],"study":[82,123,391],"an":[84,329,341,383],"integrated":[85,330,384],"biomarker,":[86],"Ki-67":[87,154,252,327,381],"had":[88,271],"first":[90],"undergo":[91],"rigorous":[92],"evaluation":[93],"by":[94,100,118,126,165],"participating":[96],"pathologists":[97],"oversight":[99],"NIH":[102,322],"Biomarker":[103,323],"Review":[104,324],"Committee.":[105],"Methods:":[106],"Fifty":[107],"patients":[108],"were":[109,136,189,229,289],"enrolled":[110],"GY011,":[112,333],"specimen":[114],"collection":[115],"planned":[117],"biopsy":[119],"prior":[120],"receiving":[122],"drugs":[124],"tissue":[127],"sample":[128],"at":[129],"time":[131],"hysterectomy.":[134],"There":[135,237],"42":[137],"pre-drug":[138,251],"administration":[139],"specimens":[140,151,162],"tumor":[142],"analysis":[144],"1":[146,268],"without":[147],"43":[149],"hysterectomy":[150],"tumor.":[153],"immunohistochemistry":[155],"performed":[156],"pre":[158],"post":[160,249],"drug":[161],"evaluated":[164],"three":[166],"experienced":[167],"reviewers":[168,216,243],"(MS,":[169],"KC":[170],"AR)":[172],"using":[173,244],"qualitative":[175,246],"approach,":[176],"blinded":[177],"arm.":[180],"Pre":[181],"post-drug":[183],"samples":[184],"each":[186],"individual":[187,232],"patient":[188],"compared":[190],"scored":[192,293],"increased,":[194],"decreased,":[195],"or":[196],"unchanged.":[197],"Fleiss":[199],"kappa":[200,227],"statistic":[201],"chosen":[203],"measure":[206],"concordance":[208,241,318],"it":[210],"allows":[211],"more":[213,218],"than":[214,219],"two":[215,220],"categories.":[221],"Percent":[222],"agreement":[223,278],"standard":[225],"weighted":[226,260],"statistics":[228],"calculated":[230],"pairs":[233,298],"reviewers.":[235],"Results:":[236],"very":[239],"good":[240],"between":[242,263,306,319],"comparison":[247],"staining":[253],"Fleiss\u2019":[255],"Kappa":[256],"0.91":[258],"Kappa\u2019s":[261],"ranging":[262],"0.85":[264],"0.95.":[266],"Reviewers":[267],"2":[270],"highest":[273],"concordance.":[276],"Reviewer":[277],"ranged":[279],"from":[280],"0.92":[281],"0.98.":[283],"reviewer-specific":[285],"(marginal)":[286],"score":[287],"distributions":[288],"similar.":[290],"Each":[291],"reviewer":[292],"about":[294],"80%":[295],"(79.5%-82.5%)":[296],"decreasing,":[300],"remainder":[303],"split":[304],"similarly":[305],"no":[307],"change":[308],"(7.5%-10%)":[309],"increasing":[311],"(10%-12.8%).":[312],"Conclusion:":[313],"Based":[314],"upon":[315],"high":[317],"reviewers,":[320],"Committee":[325],"biomarker":[331,343,385],"setting":[334],"stage":[336],"its":[338],"use":[339],"therapeutic":[345],"effectiveness":[346],"future":[348],"cancer":[350,388],"trials.":[351],"Citation":[352],"Format:":[353],"Megan":[354],"I.":[355],"Samuelson,":[356],"Virginia":[357],"Filiaci,":[358],"Kelley":[359],"Carrick,":[360],"Anand":[361],"Rajan":[362],"KD,":[363],"William":[364],"H.":[365],"Rodgers,":[366],"Kristina":[367],"W.":[368],"Thiel,":[369],"Linda":[370],"R.":[371],"Duska,":[372],"Kimberly":[373],"K.":[374],"Leslie.":[375],"Approval":[376],"proliferative":[379],"[abstract].":[393],"In:":[394],"Proceedings":[395],"AACR":[398],"Virtual":[399],"Special":[400],"Conference:":[401],"Endometrial":[402],"Cancer:":[403],"New":[404],"Biology":[405],"Driving":[406],"Research":[407],"Treatment;":[409],"2020":[410],"Nov":[411],"9-10.":[412],"Philadelphia":[413],"(PA):":[414],"AACR;":[415],"Clin":[416],"Cancer":[417],"Res":[418],"2021;27(3_Suppl):Abstract":[419],"nr":[420],"PO020.":[421]},"counts_by_year":[{"year":2024,"cited_by_count":1}],"updated_date":"2026-10-01T08:54:57.152042","created_date":"2021-02-15T00:00:00"}