Phase II, multicenter, open-label, randomized study of YM155 plus docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer.
Identifieur interne : 000288 ( PubMed/Curation ); précédent : 000287; suivant : 000289Phase II, multicenter, open-label, randomized study of YM155 plus docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer.
Auteurs : Michael R. Clemens [Allemagne] ; Oleg A. Gladkov ; Elaina Gartner ; Vladimir Vladimirov ; John Crown ; Joyce Steinberg ; Fei Jie ; Anne KeatingSource :
- Breast cancer research and treatment [ 1573-7217 ] ; 2015.
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Breast Neoplasms (drug therapy), Breast Neoplasms (pathology), Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions (pathology), Female, Humans, Imidazoles (administration & dosage), Imidazoles (adverse effects), Lymphatic Metastasis, Middle Aged, Naphthoquinones (administration & dosage), Naphthoquinones (adverse effects), Receptor, ErbB-2 (genetics), Taxoids (administration & dosage), Taxoids (adverse effects), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Imidazoles, Naphthoquinones, Taxoids.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- chemical , adverse effects : Imidazoles, Naphthoquinones, Taxoids.
- drug therapy : Breast Neoplasms.
- chemical , genetics : Receptor, ErbB-2.
- pathology : Breast Neoplasms, Drug-Related Side Effects and Adverse Reactions.
- Adult, Aged, Disease-Free Survival, Female, Humans, Lymphatic Metastasis, Middle Aged, Treatment Outcome.
Abstract
The objective of this study was to assess the efficacy and tolerability of YM155, a survivin suppressor, in combination with docetaxel, compared with docetaxel alone in patients with HER2-negative metastatic breast cancer. This phase II, multicenter, open-label, 2-arm study randomized patients (≥18 years) with histologically or cytologically confirmed stage IV HER2-negative metastatic breast cancer and ≥1 measurable lesion, to receive docetaxel alone or docetaxel plus YM155. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), time to response (TTR), biomarker assessment, and analysis of circulating tumor cells. Patients were women diagnosed with HER2-negative breast cancer; most had received prior drug therapies. The median PFS was 8.4 months with YM155 plus docetaxel (n = 50) and 10.5 months with docetaxel alone (n = 51; HR 1.53; 95 % CI 0.83, 2.83; P = 0.176). No statistically significant differences were observed for secondary endpoints, although slightly greater OS (630 vs 601 days; P = 0.768), CBR (84.3 vs 82.0 %; P = 0.855), DOR, and TTR were observed with docetaxel alone compared with YM155 plus docetaxel, whereas ORR was similar (25.5 vs 26.0). The most common TEAEs observed with YM155 plus docetaxel compared with docetaxel alone were neutropenia (83.3 vs 84.3 %), alopecia (62.5 vs 52.9 %), fatigue (50 vs 41.2 %), and nausea (37.5 vs 41.2 %). Although YM155 is a novel drug that suppresses survivin, YM155 plus docetaxel exhibited no statistically significant differences in endpoints compared with docetaxel alone. The combination regimen was well tolerated.
DOI: 10.1007/s10549-014-3238-6
PubMed: 25547219
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Gladkov</name></author><author><name sortKey="Gartner, Elaina" sort="Gartner, Elaina" uniqKey="Gartner E" first="Elaina" last="Gartner">Elaina Gartner</name></author><author><name sortKey="Vladimirov, Vladimir" sort="Vladimirov, Vladimir" uniqKey="Vladimirov V" first="Vladimir" last="Vladimirov">Vladimir Vladimirov</name></author><author><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name></author><author><name sortKey="Steinberg, Joyce" sort="Steinberg, Joyce" uniqKey="Steinberg J" first="Joyce" last="Steinberg">Joyce Steinberg</name></author><author><name sortKey="Jie, Fei" sort="Jie, Fei" uniqKey="Jie F" first="Fei" last="Jie">Fei Jie</name></author><author><name sortKey="Keating, Anne" sort="Keating, Anne" uniqKey="Keating A" first="Anne" last="Keating">Anne Keating</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25547219</idno><idno type="pmid">25547219</idno><idno type="doi">10.1007/s10549-014-3238-6</idno><idno type="wicri:Area/PubMed/Corpus">000288</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000288</idno><idno type="wicri:Area/PubMed/Curation">000288</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000288</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Phase II, multicenter, open-label, randomized study of YM155 plus docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer.</title><author><name sortKey="Clemens, Michael R" sort="Clemens, Michael R" uniqKey="Clemens M" first="Michael R" last="Clemens">Michael R. Clemens</name><affiliation wicri:level="1"><nlm:affiliation>Innere Medizin I, Klinikum Mutterhaus de Borromaerinnen GmbH, Trier, Germany, Clemens@mutterhaus.de.</nlm:affiliation><country wicri:rule="url">Allemagne</country><wicri:regionArea>Innere Medizin I, Klinikum Mutterhaus de Borromaerinnen GmbH, Trier, Germany</wicri:regionArea></affiliation></author><author><name sortKey="Gladkov, Oleg A" sort="Gladkov, Oleg A" uniqKey="Gladkov O" first="Oleg A" last="Gladkov">Oleg A. Gladkov</name></author><author><name sortKey="Gartner, Elaina" sort="Gartner, Elaina" uniqKey="Gartner E" first="Elaina" last="Gartner">Elaina Gartner</name></author><author><name sortKey="Vladimirov, Vladimir" sort="Vladimirov, Vladimir" uniqKey="Vladimirov V" first="Vladimir" last="Vladimirov">Vladimir Vladimirov</name></author><author><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name></author><author><name sortKey="Steinberg, Joyce" sort="Steinberg, Joyce" uniqKey="Steinberg J" first="Joyce" last="Steinberg">Joyce Steinberg</name></author><author><name sortKey="Jie, Fei" sort="Jie, Fei" uniqKey="Jie F" first="Fei" last="Jie">Fei Jie</name></author><author><name sortKey="Keating, Anne" sort="Keating, Anne" uniqKey="Keating A" first="Anne" last="Keating">Anne Keating</name></author></analytic><series><title level="j">Breast cancer research and treatment</title><idno type="eISSN">1573-7217</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antineoplastic Combined Chemotherapy Protocols (administration & dosage)</term><term>Breast Neoplasms (drug therapy)</term><term>Breast Neoplasms (pathology)</term><term>Disease-Free Survival</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Female</term><term>Humans</term><term>Imidazoles (administration & dosage)</term><term>Imidazoles (adverse effects)</term><term>Lymphatic Metastasis</term><term>Middle Aged</term><term>Naphthoquinones (administration & dosage)</term><term>Naphthoquinones (adverse effects)</term><term>Receptor, ErbB-2 (genetics)</term><term>Taxoids (administration & dosage)</term><term>Taxoids (adverse effects)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Imidazoles</term><term>Naphthoquinones</term><term>Taxoids</term></keywords><keywords scheme="MESH" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Imidazoles</term><term>Naphthoquinones</term><term>Taxoids</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Receptor, ErbB-2</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Lymphatic Metastasis</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to assess the efficacy and tolerability of YM155, a survivin suppressor, in combination with docetaxel, compared with docetaxel alone in patients with HER2-negative metastatic breast cancer. This phase II, multicenter, open-label, 2-arm study randomized patients (≥18 years) with histologically or cytologically confirmed stage IV HER2-negative metastatic breast cancer and ≥1 measurable lesion, to receive docetaxel alone or docetaxel plus YM155. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), time to response (TTR), biomarker assessment, and analysis of circulating tumor cells. Patients were women diagnosed with HER2-negative breast cancer; most had received prior drug therapies. The median PFS was 8.4 months with YM155 plus docetaxel (n = 50) and 10.5 months with docetaxel alone (n = 51; HR 1.53; 95 % CI 0.83, 2.83; P = 0.176). No statistically significant differences were observed for secondary endpoints, although slightly greater OS (630 vs 601 days; P = 0.768), CBR (84.3 vs 82.0 %; P = 0.855), DOR, and TTR were observed with docetaxel alone compared with YM155 plus docetaxel, whereas ORR was similar (25.5 vs 26.0). The most common TEAEs observed with YM155 plus docetaxel compared with docetaxel alone were neutropenia (83.3 vs 84.3 %), alopecia (62.5 vs 52.9 %), fatigue (50 vs 41.2 %), and nausea (37.5 vs 41.2 %). Although YM155 is a novel drug that suppresses survivin, YM155 plus docetaxel exhibited no statistically significant differences in endpoints compared with docetaxel alone. The combination regimen was well tolerated.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25547219</PMID><DateCreated><Year>2015</Year><Month>01</Month><Day>20</Day></DateCreated><DateCompleted><Year>2015</Year><Month>09</Month><Day>28</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1573-7217</ISSN><JournalIssue CitedMedium="Internet"><Volume>149</Volume><Issue>1</Issue><PubDate><Year>2015</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Breast cancer research and treatment</Title><ISOAbbreviation>Breast Cancer Res. Treat.</ISOAbbreviation></Journal><ArticleTitle>Phase II, multicenter, open-label, randomized study of YM155 plus docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer.</ArticleTitle><Pagination><MedlinePgn>171-9</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s10549-014-3238-6</ELocationID><Abstract><AbstractText>The objective of this study was to assess the efficacy and tolerability of YM155, a survivin suppressor, in combination with docetaxel, compared with docetaxel alone in patients with HER2-negative metastatic breast cancer. This phase II, multicenter, open-label, 2-arm study randomized patients (≥18 years) with histologically or cytologically confirmed stage IV HER2-negative metastatic breast cancer and ≥1 measurable lesion, to receive docetaxel alone or docetaxel plus YM155. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), time to response (TTR), biomarker assessment, and analysis of circulating tumor cells. Patients were women diagnosed with HER2-negative breast cancer; most had received prior drug therapies. The median PFS was 8.4 months with YM155 plus docetaxel (n = 50) and 10.5 months with docetaxel alone (n = 51; HR 1.53; 95 % CI 0.83, 2.83; P = 0.176). No statistically significant differences were observed for secondary endpoints, although slightly greater OS (630 vs 601 days; P = 0.768), CBR (84.3 vs 82.0 %; P = 0.855), DOR, and TTR were observed with docetaxel alone compared with YM155 plus docetaxel, whereas ORR was similar (25.5 vs 26.0). The most common TEAEs observed with YM155 plus docetaxel compared with docetaxel alone were neutropenia (83.3 vs 84.3 %), alopecia (62.5 vs 52.9 %), fatigue (50 vs 41.2 %), and nausea (37.5 vs 41.2 %). Although YM155 is a novel drug that suppresses survivin, YM155 plus docetaxel exhibited no statistically significant differences in endpoints compared with docetaxel alone. The combination regimen was well tolerated.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Clemens</LastName><ForeName>Michael R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Innere Medizin I, Klinikum Mutterhaus de Borromaerinnen GmbH, Trier, Germany, Clemens@mutterhaus.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gladkov</LastName><ForeName>Oleg A</ForeName><Initials>OA</Initials></Author><Author ValidYN="Y"><LastName>Gartner</LastName><ForeName>Elaina</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Vladimirov</LastName><ForeName>Vladimir</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Crown</LastName><ForeName>John</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Steinberg</LastName><ForeName>Joyce</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Jie</LastName><ForeName>Fei</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Keating</LastName><ForeName>Anne</ForeName><Initials>A</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>12</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Breast Cancer Res Treat</MedlineTA><NlmUniqueID>8111104</NlmUniqueID><ISSNLinking>0167-6806</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007093">Imidazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D009285">Naphthoquinones</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D043823">Taxoids</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C523798">YM 155</NameOfSubstance></Chemical><Chemical><RegistryNumber>15H5577CQD</RegistryNumber><NameOfSubstance UI="C067311">docetaxel</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance UI="D018719">Receptor, ErbB-2</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Ann Oncol. 2001;12 Suppl 1:S57-62</RefSource><PMID Version="1">11521723</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29</RefSource><PMID Version="1">24399786</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Nature. 1998 Dec 10;396(6711):580-4</RefSource><PMID Version="1">9859993</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Oncologist. 2004;9(6):606-16</RefSource><PMID Version="1">15561805</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Br J Cancer. 2005 Jan 17;92(1):120-4</RefSource><PMID Version="1">15611790</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Oncologist. 2005;10 Suppl 3:20-9</RefSource><PMID Version="1">16368868</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Cancer Res. 2007 Apr 15;13(8):2329-34</RefSource><PMID Version="1">17438091</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ann Oncol. 2007 Jul;18(7):1133-44</RefSource><PMID Version="1">17675394</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cancer 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Version="1">21674125</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Tumour Biol. 2013 Aug;34(4):2053-62</RefSource><PMID Version="1">23690235</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Biol Pharm Bull. 2013;36(12):1921-7</RefSource><PMID Version="1">24432379</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2002 Jan 24;346(4):235-42</RefSource><PMID Version="1">11807147</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001943" 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effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008207" MajorTopicYN="N">Lymphatic Metastasis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009285" MajorTopicYN="N">Naphthoquinones</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018719" MajorTopicYN="N">Receptor, ErbB-2</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D043823" MajorTopicYN="N">Taxoids</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" 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