{"id":"https://openalex.org/W3170098415","doi":"https://doi.org/10.1200/jco.2021.39.15_suppl.533","title":"Clinical trial testing superiority of combination plinabulin (Plin) and pegfilgrastim (Peg) versus peg alone in breast cancer treated with high-risk febrile neutropenia risk chemotherapy (chemo): Final results of the phase 3 protective-2 in chemo-induced neutropenia (CIN) prevention.","display_name":"Clinical trial testing superiority of combination plinabulin (Plin) and pegfilgrastim (Peg) versus peg alone in breast cancer treated with high-risk febrile neutropenia risk chemotherapy (chemo): Final results of the phase 3 protective-2 in chemo-induced neutropenia (CIN) prevention.","publication_year":2021,"publication_date":"2021-05-20","ids":{"openalex":"https://openalex.org/W3170098415","doi":"https://doi.org/10.1200/jco.2021.39.15_suppl.533","mag":"3170098415"},"language":"en","primary_location":{"id":"doi:10.1200/jco.2021.39.15_suppl.533","doi":"https://doi.org/10.1200/jco.2021.39.15_suppl.533","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2021.39.15_suppl.533","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","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/A5061736755","display_name":"Douglas W. Blayney","orcid":"https://orcid.org/0000-0002-7931-4533","observed_orcids":["https://orcid.org/0000-0002-7931-4533"]},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Douglas W. Blayney","raw_affiliation_strings":["Stanford University, Stanford, CA;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Stanford University, Stanford, CA;","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100709250","display_name":"Yuankai Shi","orcid":"https://orcid.org/0000-0002-3342-4964","observed_orcids":["https://orcid.org/0000-0002-3342-4964"]},"institutions":[{"id":"https://openalex.org/I200296433","display_name":"Chinese Academy of Medical Sciences & Peking Union Medical College","ror":"https://ror.org/02drdmm93","country_code":"CN","type":"education","lineage":["https://openalex.org/I200296433"]},{"id":"https://openalex.org/I4210141458","display_name":"Cancer Hospital of Chinese Academy of Medical Sciences","ror":"https://ror.org/03x937183","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210141458"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Yuankai Shi","raw_affiliation_strings":["National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China;","institution_ids":["https://openalex.org/I200296433","https://openalex.org/I4210141458"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083650834","display_name":"Hryhorii Adamchuk","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Hryhorii Adamchuk","raw_affiliation_strings":["Kryvyi Rig Oncology Dispensary, Krivoy Rog, Ukraine;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Kryvyi Rig Oncology Dispensary, Krivoy Rog, Ukraine;","institution_ids":[]}]},{"author_position":"middle","author":{"id":null,"display_name":"David Feng","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"David Feng","raw_affiliation_strings":["TCM Groups, Inc., Berkeley Heights, NJ;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"TCM Groups, Inc., Berkeley Heights, NJ;","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100741380","display_name":"Qingyuan Zhang","orcid":"https://orcid.org/0000-0001-8116-5293","observed_orcids":["https://orcid.org/0000-0001-8116-5293","https://orcid.org/0000-0001-7618-4393","https://orcid.org/0000-0002-1763-9412","https://orcid.org/0000-0002-5003-8897"]},"institutions":[{"id":"https://openalex.org/I4210103956","display_name":"Third Affiliated Hospital of Harbin Medical University","ror":"https://ror.org/01f77gp95","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210103956"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Qingyuan Zhang","raw_affiliation_strings":["Harbin Medical University Cancer Hospital, Harbin, China;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Harbin Medical University Cancer Hospital, Harbin, China;","institution_ids":["https://openalex.org/I4210103956"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5112455305","display_name":"Lihua Du","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Lihua Du","raw_affiliation_strings":["BeyondSpring Pharmaceuticals, Inc., New York, NY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BeyondSpring Pharmaceuticals, Inc., New York, NY;","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5070754234","display_name":"Lan Huang","orcid":"https://orcid.org/0000-0002-3140-4687","observed_orcids":["https://orcid.org/0000-0002-3140-4687"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Lan Huang","raw_affiliation_strings":["BeyondSpring Pharmaceuticals, Inc., New York, NY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BeyondSpring Pharmaceuticals, Inc., New York, NY;","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5015687794","display_name":"Ramon W. Mohanlal","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ramon Mohanlal","raw_affiliation_strings":["BeyondSpring Pharmaceuticals, Inc., New York, NY;"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BeyondSpring Pharmaceuticals, Inc., New York, NY;","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":7,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"39","issue":"15_suppl","first_page":"533","last_page":"533"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12172","display_name":"Neutropenia and Cancer Infections","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/T12172","display_name":"Neutropenia and Cancer Infections","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/T12919","display_name":"Blood disorders and treatments","score":0.0,"subfield":{"id":"https://openalex.org/subfields/1311","display_name":"Genetics"},"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/T11752","display_name":"Cancer Treatment and Pharmacology","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/plinabulin","display_name":"plinabulin","score":0.9990000128746033},{"id":"https://openalex.org/keywords/pegfilgrastim","display_name":"pegfilgrastim","score":0.9990000128746033},{"id":"https://openalex.org/keywords/chemotherapy-induced-neutropenia","display_name":"chemotherapy-induced neutropenia","score":0.859000027179718},{"id":"https://openalex.org/keywords/febrile-neutropenia","display_name":"febrile neutropenia","score":0.8970000147819519},{"id":"https://openalex.org/keywords/breast-cancer","display_name":"breast cancer","score":0.921999990940094},{"id":"https://openalex.org/keywords/combination-therapy","display_name":"combination therapy","score":0.5270000100135803},{"id":"https://openalex.org/keywords/neutropenia-prevention","display_name":"neutropenia prevention","score":0.7620000243186951},{"id":"https://openalex.org/keywords/early-breast-cancer","display_name":"early breast cancer","score":0.6449999809265137},{"id":"https://openalex.org/keywords/absolute-neutrophil-count","display_name":"absolute neutrophil count","score":0.7429999709129333}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.942244291305542},{"id":"https://openalex.org/C2778658803","wikidata":"https://www.wikidata.org/wiki/Q1592932","display_name":"Pegfilgrastim","level":5,"score":0.8116114139556885},{"id":"https://openalex.org/C54400483","wikidata":"https://www.wikidata.org/wiki/Q1793202","display_name":"PEG ratio","level":2,"score":0.5867603421211243},{"id":"https://openalex.org/C2777063308","wikidata":"https://www.wikidata.org/wiki/Q1435822","display_name":"Neutropenia","level":3,"score":0.543384850025177},{"id":"https://openalex.org/C2778850193","wikidata":"https://www.wikidata.org/wiki/Q3775974","display_name":"Febrile neutropenia","level":4,"score":0.5050893425941467},{"id":"https://openalex.org/C530470458","wikidata":"https://www.wikidata.org/wiki/Q128581","display_name":"Breast cancer","level":3,"score":0.4747657775878906},{"id":"https://openalex.org/C2781190966","wikidata":"https://www.wikidata.org/wiki/Q420436","display_name":"Docetaxel","level":3,"score":0.47341758012771606},{"id":"https://openalex.org/C2775930923","wikidata":"https://www.wikidata.org/wiki/Q12859063","display_name":"Metastatic breast cancer","level":4,"score":0.45044273138046265},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.4438770115375519},{"id":"https://openalex.org/C2777767877","wikidata":"https://www.wikidata.org/wiki/Q419327","display_name":"Granulocyte colony-stimulating factor","level":3,"score":0.41185545921325684},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.3370726704597473},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.3360673785209656},{"id":"https://openalex.org/C2776694085","wikidata":"https://www.wikidata.org/wiki/Q974135","display_name":"Chemotherapy","level":2,"score":0.3239870071411133},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.2803765833377838},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0},{"id":"https://openalex.org/C10138342","wikidata":"https://www.wikidata.org/wiki/Q43015","display_name":"Finance","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1200/jco.2021.39.15_suppl.533","doi":"https://doi.org/10.1200/jco.2021.39.15_suppl.533","is_oa":false,"landing_page_url":"https://doi.org/10.1200/jco.2021.39.15_suppl.533","pdf_url":null,"source":{"id":"https://openalex.org/S15137598","display_name":"Journal of Clinical Oncology","issn_l":"0732-183X","issn":["0732-183X","1527-7755"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Oncology","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":1.0}],"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/W2947292239","https://openalex.org/W3095561524","https://openalex.org/W3129386684","https://openalex.org/W3171922292","https://openalex.org/W3171295247","https://openalex.org/W3203266297","https://openalex.org/W2947778483","https://openalex.org/W2984749858","https://openalex.org/W3131553692","https://openalex.org/W4206195540"],"abstract_inverted_index":{"533":[0],"Background:":[1],"Peg":[2,90,99,163,175,193,198,347,354],"is":[3,42,109,142,179,309,381],"standard":[4],"of":[5,11,15,25,87,168,229,296,301,305,311,367,374],"care":[6],"(SoC)":[7],"for":[8,171,254],"the":[9,26,30,85,95,169,293,375,379],"prevention":[10,173],"CIN.":[12,56],"Peg\u2019s":[13],"mechanism":[14],"action":[16],"leaves":[17],"patients":[18],"vulnerable":[19],"to":[20,162,187,291,346,353,384,390],"FN":[21,387],"in":[22,55,64,74,139,147,150,205,217,269,320,322,333,378],"week":[23,39,75],"1":[24,76,239,271],"chemo":[27,68],"cycle(C),":[28],"as":[29,133,211],"absolute":[31],"neutrophil":[32],"count":[33],"(ANC)":[34],"does":[35],"not":[36],"normalize":[37],"until":[38],"2.":[40],"Plin":[41,88,108,132,159,189,345],"a":[43,117,180,226,299,359],"first-in-class,":[44],"non-G-CSF":[45],"small":[46],"molecule":[47],"agent,":[48],"which":[49],"received":[50,240],"breakthrough":[51],"designation":[52],"from":[53,67],"FDA":[54],"It":[57],"prevents":[58],"CIN":[59,92,172,350,376],"by":[60,363],"protecting":[61],"progenitor":[62],"cells":[63,214],"bone":[65],"marrow":[66],"assault":[69],"and":[70,89,121,247,259,286,330,341,356],"has":[71,116,123,358],"normal":[72],"ANC":[73,212,264,331],"(Blayney":[77],"JAMA":[78],"Onc":[79],"2020).":[80],"Phase":[81],"2":[82],"testing":[83,166],"showed":[84],"combination":[86,170,380],"achieved":[91],"protection":[93,351,377],"throughout":[94],"entire":[96],"cycle":[97],"vs":[98,174],"alone":[100,355],"(Blayney:":[101],"St":[102],"Gallen":[103],"2019,":[104],"ASCO":[105],"2019).":[106],"Methods:":[107],"given":[110],"on":[111,252,273],"Day":[112],"(D)1":[113],"after":[114],"Chemo,":[115],"favorable":[118],"safety":[119,338,361],"profile,":[120],"also":[122,336,357,382],"anticancer":[124,135],"activity.":[125],"A":[126],"separate":[127],"phase":[128],"3":[129],"study":[130,186,260],"evaluating":[131],"an":[134],"agent":[136],"(DUBLIN-3;":[137],"NCT02504489)":[138],"NSCLC":[140],"pts":[141,233,297,312],"underway,":[143],"with":[144,225,234,298,313],"anti-cancer":[145],"results":[146],"OS":[148],"expected":[149],"2021.":[151],"In":[152],"PROTECTIVE-2":[153],"(Study":[154],"106;":[155],"NCT0329457),":[156],"we":[157],"added":[158],"(on":[160,164],"D1)":[161],"D2),":[165],"superiority":[167],"alone.":[176,392],"Study":[177],"106,":[178],"global":[181],"multicenter":[182],"randomized":[183],"(1:1)":[184],"double-blind":[185],"evaluate":[188],"40":[190],"mg":[191],"+":[192,200],"6mg":[194,199],"(Arm":[195,203],"1)":[196],"versus":[197],"Placebo":[201],"(Plac)":[202],"2)":[204],"preventing":[206],"Severe":[207,302],"Neutropenia":[208,303],"(N),":[209],"(defined":[210],"<0.5":[213],"\u00d7":[215],"10E9/L)":[216],"early-stage":[218],"BC":[219],"(node":[220],"positive":[221],"or":[222,238],"node":[223],"negative":[224],"high":[227],"risk":[228],"recurrence)":[230],"pts.":[231],"221":[232],"ECOG":[235],"status":[236],"0":[237,306],"Docetaxel":[241],"(75":[242],"mg/m2),":[243,246],"Doxorubicin":[244],"(50":[245],"Cyclophosphamide":[248],"(500":[249],"mg/m2)":[250],"(TAC)":[251],"D1":[253],"four":[255],"21":[256],"D":[257,274],"cycles":[258],"treatment.":[261],"Central":[262],"laboratory":[263],"was":[265,290],"assessed":[266],"at":[267],"Covance":[268],"Cycle":[270],"(C1)":[272],"1,":[275],"2,":[276],"3,":[277],"6,":[278],"7,":[279],"8,":[280],"9,":[281],"10,":[282],"11,":[283],"12,":[284],"13,":[285],"15.":[287],"Primary":[288],"objective":[289],"compare":[292],"percentage":[294],"(%)":[295],"Duration":[300],"(DSN)":[304],"days":[307],"[that":[308],"%":[310],"no":[314],"Grade":[315],"(Gr)":[316],"4":[317,369],"neutropenia":[318],"(N)]":[319],"C1":[321],"each":[323],"arm.":[324],"Key":[325],"secondary":[326],"endpoints":[327],"were":[328],"DSN":[329],"Nadir":[332],"C1.":[334],"We":[335],"evaluated":[337],"(AE":[339],"frequency":[340],"Grade).":[342],"Conclusions:":[343],"Adding":[344],"offers":[348],"superior":[349,360],"compared":[352,389],"profile":[362],"lowering":[364],"over":[365],"20%":[366],"grade":[368],"AE.":[370],"The":[371],"effect":[372],"size":[373],"correlated":[383],"clinical":[385],"meaningful":[386],"reduction":[388],"peg":[391],"Clinical":[393],"trial":[394],"information:":[395],"NCT03531099.":[396],"[Table:":[397],"see":[398],"text]":[399]},"counts_by_year":[{"year":2024,"cited_by_count":1},{"year":2023,"cited_by_count":3},{"year":2022,"cited_by_count":2},{"year":2021,"cited_by_count":1}],"updated_date":"2026-11-05T12:25:35.769452","created_date":"2021-06-22T00:00:00"}