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 : 000348 ( Main/Exploration ); précédent : 000347; suivant : 000349Phase 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 [Russie] ; Elaina Gartner [États-Unis] ; Vladimir Vladimirov [Russie] ; John Crown [Irlande (pays)] ; Joyce Steinberg [États-Unis] ; Fei Jie [États-Unis] ; Anne Keating [États-Unis]Source :
- Breast Cancer Research and Treatment [ 0167-6806 ] ; 2014.
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 (
Url:
DOI: 10.1007/s10549-014-3238-6
PubMed: 25547219
PubMed Central: 4298663
Affiliations:
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Le document en format XML
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Clemens</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Innere Medizin I, Klinikum Mutterhaus de Borromaerinnen GmbH, Trier, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Innere Medizin I, Klinikum Mutterhaus de Borromaerinnen GmbH, Trier</wicri:regionArea><wicri:noRegion>Trier</wicri:noRegion><wicri:noRegion>Trier</wicri:noRegion><wicri:noRegion>Trier</wicri:noRegion></affiliation></author><author><name sortKey="Gladkov, Oleg A" sort="Gladkov, Oleg A" uniqKey="Gladkov O" first="Oleg A." last="Gladkov">Oleg A. Gladkov</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, Russia</nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea>Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk</wicri:regionArea><wicri:noRegion>Chelyabinsk</wicri:noRegion></affiliation></author><author><name sortKey="Gartner, Elaina" sort="Gartner, Elaina" uniqKey="Gartner E" first="Elaina" last="Gartner">Elaina Gartner</name><affiliation wicri:level="2"><nlm:aff id="Aff3">Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Vladimirov, Vladimir" sort="Vladimirov, Vladimir" uniqKey="Vladimirov V" first="Vladimir" last="Vladimirov">Vladimir Vladimirov</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Pyatigorsk Oncology Dispensary, Pyatigorsk, Russia</nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea>Pyatigorsk Oncology Dispensary, Pyatigorsk</wicri:regionArea><wicri:noRegion>Pyatigorsk</wicri:noRegion></affiliation></author><author><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Ireland Cooperative Oncology Research Group, Dublin, Ireland</nlm:aff><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Ireland Cooperative Oncology Research Group, Dublin</wicri:regionArea><wicri:noRegion>Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Steinberg, Joyce" sort="Steinberg, Joyce" uniqKey="Steinberg J" first="Joyce" last="Steinberg">Joyce Steinberg</name><affiliation wicri:level="2"><nlm:aff id="Aff6">Astellas Pharma Global Development, Northbrook, IL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Astellas Pharma Global Development, Northbrook</wicri:cityArea></affiliation></author><author><name sortKey="Jie, Fei" sort="Jie, Fei" uniqKey="Jie F" first="Fei" last="Jie">Fei Jie</name><affiliation wicri:level="2"><nlm:aff id="Aff6">Astellas Pharma Global Development, Northbrook, IL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Astellas Pharma Global Development, Northbrook</wicri:cityArea></affiliation></author><author><name sortKey="Keating, Anne" sort="Keating, Anne" uniqKey="Keating A" first="Anne" last="Keating">Anne Keating</name><affiliation wicri:level="2"><nlm:aff id="Aff6">Astellas Pharma Global Development, Northbrook, IL USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Astellas Pharma Global Development, Northbrook</wicri:cityArea></affiliation></author></analytic><series><title level="j">Breast Cancer Research and Treatment</title><idno type="ISSN">0167-6806</idno><idno type="eISSN">1573-7217</idno><imprint><date when="2014">2014</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"><p>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 (<italic>n</italic> = 50) and 10.5 months with docetaxel alone (<italic>n</italic> = 51; HR 1.53; 95 % CI 0.83, 2.83; <italic>P</italic> = 0.176). No statistically significant differences were observed for secondary endpoints, although slightly greater OS (630 vs 601 days; <italic>P</italic> = 0.768), CBR (84.3 vs 82.0 %; <italic>P</italic> = 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.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Siegel, R" uniqKey="Siegel R">R Siegel</name></author><author><name sortKey="Ma, J" uniqKey="Ma J">J Ma</name></author><author><name sortKey="Zou, Z" uniqKey="Zou Z">Z Zou</name></author><author><name sortKey="Jemal, A" uniqKey="Jemal A">A Jemal</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cianfrocca, M" uniqKey="Cianfrocca M">M Cianfrocca</name></author><author><name sortKey="Goldstein, Lj" uniqKey="Goldstein L">LJ Goldstein</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="O Haughnessy, J" uniqKey="O Haughnessy J">J O’Shaughnessy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Coiffier, B" uniqKey="Coiffier B">B Coiffier</name></author><author><name 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Papadopoulos</name></author><author><name sortKey="Takimoto, C" uniqKey="Takimoto C">C Takimoto</name></author><author><name sortKey="Bartels, P" uniqKey="Bartels P">P Bartels</name></author><author><name sortKey="Keating, A" uniqKey="Keating A">A Keating</name></author><author><name sortKey="Antonia, S" uniqKey="Antonia S">S Antonia</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Lewis, Kd" uniqKey="Lewis K">KD Lewis</name></author><author><name sortKey="Samlowski, W" uniqKey="Samlowski W">W Samlowski</name></author><author><name sortKey="Ward, J" uniqKey="Ward J">J Ward</name></author><author><name sortKey="Catlett, J" uniqKey="Catlett J">J Catlett</name></author><author><name sortKey="Cranmer, L" uniqKey="Cranmer L">L Cranmer</name></author><author><name sortKey="Kirkwood, J" uniqKey="Kirkwood J">J Kirkwood</name></author><author><name sortKey="Lawson, D" uniqKey="Lawson D">D 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sortKey="Kinoyama, I" uniqKey="Kinoyama I">I Kinoyama</name></author><author><name sortKey="Matsuhisa, A" uniqKey="Matsuhisa A">A Matsuhisa</name></author><author><name sortKey="Kudoh, M" uniqKey="Kudoh M">M Kudoh</name></author><author><name sortKey="Sasamata, M" uniqKey="Sasamata M">M Sasamata</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ryan, B" uniqKey="Ryan B">B Ryan</name></author><author><name sortKey="O Onovan, N" uniqKey="O Onovan N">N O’Donovan</name></author><author><name sortKey="Browne, B" uniqKey="Browne B">B Browne</name></author><author><name sortKey="O Hea, C" uniqKey="O Hea C">C O’Shea</name></author><author><name sortKey="Crown, J" uniqKey="Crown J">J Crown</name></author><author><name sortKey="Hill, Ad" uniqKey="Hill A">AD Hill</name></author><author><name sortKey="Mcdermott, E" uniqKey="Mcdermott E">E McDermott</name></author><author><name sortKey="O Iggins, N" uniqKey="O Iggins N">N O’Higgins</name></author><author><name sortKey="Duffy, Mj" uniqKey="Duffy M">MJ Duffy</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Irlande (pays)</li><li>Russie</li><li>États-Unis</li></country><region><li>Illinois</li><li>Michigan</li></region></list><tree><country name="Allemagne"><noRegion><name sortKey="Clemens, Michael R" sort="Clemens, Michael R" uniqKey="Clemens M" first="Michael R." last="Clemens">Michael R. Clemens</name></noRegion></country><country name="Russie"><noRegion><name sortKey="Gladkov, Oleg A" sort="Gladkov, Oleg A" uniqKey="Gladkov O" first="Oleg A." last="Gladkov">Oleg A. Gladkov</name></noRegion><name sortKey="Vladimirov, Vladimir" sort="Vladimirov, Vladimir" uniqKey="Vladimirov V" first="Vladimir" last="Vladimirov">Vladimir Vladimirov</name></country><country name="États-Unis"><region name="Michigan"><name sortKey="Gartner, Elaina" sort="Gartner, Elaina" uniqKey="Gartner E" first="Elaina" last="Gartner">Elaina Gartner</name></region><name sortKey="Jie, Fei" sort="Jie, Fei" uniqKey="Jie F" first="Fei" last="Jie">Fei Jie</name><name sortKey="Keating, Anne" sort="Keating, Anne" uniqKey="Keating A" first="Anne" last="Keating">Anne Keating</name><name sortKey="Steinberg, Joyce" sort="Steinberg, Joyce" uniqKey="Steinberg J" first="Joyce" last="Steinberg">Joyce Steinberg</name></country><country name="Irlande (pays)"><noRegion><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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