Veliparib With Temozolomide or Carboplatin/Paclitaxel Versus Placebo With Carboplatin/Paclitaxel in Patients With BRCA1/2 Locally Recurrent/Metastatic Breast Cancer: Randomized Phase II Study.
Identifieur interne : 000449 ( PubMed/Curation ); précédent : 000448; suivant : 000450Veliparib With Temozolomide or Carboplatin/Paclitaxel Versus Placebo With Carboplatin/Paclitaxel in Patients With BRCA1/2 Locally Recurrent/Metastatic Breast Cancer: Randomized Phase II Study.
Auteurs : H S Han [États-Unis] ; V. Diéras [France] ; M. Robson [États-Unis] ; M. Palácová [République tchèque] ; P K Marcom [États-Unis] ; A. Jager [Pays-Bas] ; I. Bondarenko [Ukraine] ; D. Citrin [États-Unis] ; M. Campone [France] ; M L Telli [États-Unis] ; S M Domchek [États-Unis] ; M. Friedlander [Australie] ; B. Kaufman [Israël] ; J E Garber [États-Unis] ; Y. Shparyk [Ukraine] ; E. Chmielowska [Pologne] ; E H Jakobsen [Danemark] ; V. Kaklamani [États-Unis] ; W. Gradishar [États-Unis] ; C K Ratajczak [États-Unis] ; C. Nickner [États-Unis] ; Q. Qin [États-Unis] ; J. Qian [États-Unis] ; S P Shepherd [États-Unis] ; S J Isakoff [États-Unis] ; S. Puhalla [États-Unis]Source :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2017.
Abstract
Homologous recombination defects in BRCA1/2-mutated tumors result in sensitivity to poly(ADP-ribose) polymerase (PARP) inhibitors, which interfere with DNA damage repair. Veliparib, a potent PARP inhibitor, enhanced the antitumor activity of platinum agents and temozolomide in early phase clinical trials. This phase II study examined the safety and efficacy of intermittent veliparib with carboplatin/paclitaxel (VCP) or temozolomide (VT) in patients with BRCA1/2-mutated breast cancer.
DOI: 10.1093/annonc/mdx505
PubMed: 29045554
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Diéras</name><affiliation wicri:level="1"><nlm:affiliation>Institut Curie, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut Curie, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Robson, M" sort="Robson, M" uniqKey="Robson M" first="M" last="Robson">M. Robson</name><affiliation wicri:level="2"><nlm:affiliation>Weill Cornell Medical College, New York, NY.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Weill Cornell Medical College, New York</wicri:cityArea></affiliation></author><author><name sortKey="Palacova, M" sort="Palacova, M" uniqKey="Palacova M" first="M" last="Palácová">M. 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Citrin</name><affiliation wicri:level="2"><nlm:affiliation>Midwestern Regional Medical Center, Zion, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Midwestern Regional Medical Center, Zion</wicri:cityArea></affiliation></author><author><name sortKey="Campone, M" sort="Campone, M" uniqKey="Campone M" first="M" last="Campone">M. Campone</name><affiliation wicri:level="1"><nlm:affiliation>Institut de Cancérologie de l'Ouest, Saint Herblain, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut de Cancérologie de l'Ouest, Saint Herblain</wicri:regionArea></affiliation></author><author><name sortKey="Telli, M L" sort="Telli, M L" uniqKey="Telli M" first="M L" last="Telli">M L Telli</name><affiliation wicri:level="2"><nlm:affiliation>Stanford University School of Medicine, Stanford, CA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Stanford University School of Medicine, Stanford</wicri:cityArea></affiliation></author><author><name sortKey="Domchek, S M" sort="Domchek, S M" uniqKey="Domchek S" first="S M" last="Domchek">S M Domchek</name><affiliation wicri:level="2"><nlm:affiliation>University of Pennsylvania, Philadelphia, PA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>University of Pennsylvania, Philadelphia</wicri:cityArea></affiliation></author><author><name sortKey="Friedlander, M" sort="Friedlander, M" uniqKey="Friedlander M" first="M" last="Friedlander">M. Friedlander</name><affiliation wicri:level="1"><nlm:affiliation>Prince of Wales Hospital, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Prince of Wales Hospital, Sydney, NSW</wicri:regionArea></affiliation></author><author><name sortKey="Kaufman, B" sort="Kaufman, B" uniqKey="Kaufman B" first="B" last="Kaufman">B. Kaufman</name><affiliation wicri:level="1"><nlm:affiliation>Sheba Medical Center, Tel Hashomer, Israel.</nlm:affiliation><country xml:lang="fr">Israël</country><wicri:regionArea>Sheba Medical Center, Tel Hashomer</wicri:regionArea></affiliation></author><author><name sortKey="Garber, J E" sort="Garber, J E" uniqKey="Garber J" first="J E" last="Garber">J E Garber</name><affiliation wicri:level="2"><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Dana-Farber Cancer Institute, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Shparyk, Y" sort="Shparyk, Y" uniqKey="Shparyk Y" first="Y" last="Shparyk">Y. Shparyk</name><affiliation wicri:level="1"><nlm:affiliation>Chemotherapy Department, Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv, Ukraine.</nlm:affiliation><country xml:lang="fr">Ukraine</country><wicri:regionArea>Chemotherapy Department, Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv</wicri:regionArea></affiliation></author><author><name sortKey="Chmielowska, E" sort="Chmielowska, E" uniqKey="Chmielowska E" first="E" last="Chmielowska">E. Chmielowska</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK, Torun, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK, Torun</wicri:regionArea></affiliation></author><author><name sortKey="Jakobsen, E H" sort="Jakobsen, E H" uniqKey="Jakobsen E" first="E H" last="Jakobsen">E H Jakobsen</name><affiliation wicri:level="1"><nlm:affiliation>Department of Oncology, Vejle Hospital/Lillebaelt Hospital, Vejle, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Oncology, Vejle Hospital/Lillebaelt Hospital, Vejle</wicri:regionArea></affiliation></author><author><name sortKey="Kaklamani, V" sort="Kaklamani, V" uniqKey="Kaklamani V" first="V" last="Kaklamani">V. Kaklamani</name><affiliation wicri:level="2"><nlm:affiliation>Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio</wicri:cityArea></affiliation></author><author><name sortKey="Gradishar, W" sort="Gradishar, W" uniqKey="Gradishar W" first="W" last="Gradishar">W. Gradishar</name><affiliation wicri:level="2"><nlm:affiliation>Division of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Division of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Ratajczak, C K" sort="Ratajczak, C K" uniqKey="Ratajczak C" first="C K" last="Ratajczak">C K Ratajczak</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Nickner, C" sort="Nickner, C" uniqKey="Nickner C" first="C" last="Nickner">C. Nickner</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Qin, Q" sort="Qin, Q" uniqKey="Qin Q" first="Q" last="Qin">Q. Qin</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Qian, J" sort="Qian, J" uniqKey="Qian J" first="J" last="Qian">J. Qian</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Shepherd, S P" sort="Shepherd, S P" uniqKey="Shepherd S" first="S P" last="Shepherd">S P Shepherd</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Isakoff, S J" sort="Isakoff, S J" uniqKey="Isakoff S" first="S J" last="Isakoff">S J Isakoff</name><affiliation wicri:level="2"><nlm:affiliation>Massachusetts General Hospital, Boston, MA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Massachusetts General Hospital, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Puhalla, S" sort="Puhalla, S" uniqKey="Puhalla S" first="S" last="Puhalla">S. Puhalla</name><affiliation wicri:level="2"><nlm:affiliation>University of Pittsburgh Cancer Institute, Pittsburgh, PA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>University of Pittsburgh Cancer Institute, Pittsburgh</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:29045554</idno><idno type="pmid">29045554</idno><idno type="doi">10.1093/annonc/mdx505</idno><idno type="wicri:Area/PubMed/Corpus">000451</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000451</idno><idno type="wicri:Area/PubMed/Curation">000449</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000449</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Veliparib With Temozolomide or Carboplatin/Paclitaxel Versus Placebo With Carboplatin/Paclitaxel in Patients With BRCA1/2 Locally Recurrent/Metastatic Breast Cancer: Randomized Phase II Study.</title><author><name sortKey="Han, H S" sort="Han, H S" uniqKey="Han H" first="H S" last="Han">H S Han</name><affiliation wicri:level="2"><nlm:affiliation>Moffitt Cancer Center, Tampa, FL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Moffitt Cancer Center, Tampa</wicri:cityArea></affiliation></author><author><name sortKey="Dieras, V" sort="Dieras, V" uniqKey="Dieras V" first="V" last="Diéras">V. Diéras</name><affiliation wicri:level="1"><nlm:affiliation>Institut Curie, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut Curie, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Robson, M" sort="Robson, M" uniqKey="Robson M" first="M" last="Robson">M. Robson</name><affiliation wicri:level="2"><nlm:affiliation>Weill Cornell Medical College, New York, NY.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Weill Cornell Medical College, New York</wicri:cityArea></affiliation></author><author><name sortKey="Palacova, M" sort="Palacova, M" uniqKey="Palacova M" first="M" last="Palácová">M. Palácová</name><affiliation wicri:level="1"><nlm:affiliation>Masarykuv onkologický ústav, Brno, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Masarykuv onkologický ústav, Brno</wicri:regionArea></affiliation></author><author><name sortKey="Marcom, P K" sort="Marcom, P K" uniqKey="Marcom P" first="P K" last="Marcom">P K Marcom</name><affiliation wicri:level="2"><nlm:affiliation>Duke University; Durham, NC.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Duke University; Durham</wicri:cityArea></affiliation></author><author><name sortKey="Jager, A" sort="Jager, A" uniqKey="Jager A" first="A" last="Jager">A. Jager</name><affiliation wicri:level="1"><nlm:affiliation>Erasmus MC Cancer Institute, Rotterdam, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Erasmus MC Cancer Institute, Rotterdam</wicri:regionArea></affiliation></author><author><name sortKey="Bondarenko, I" sort="Bondarenko, I" uniqKey="Bondarenko I" first="I" last="Bondarenko">I. Bondarenko</name><affiliation wicri:level="1"><nlm:affiliation>Dnepropetrovsk Medical Academy, City Hospital #4, Dnipro, Ukraine.</nlm:affiliation><country xml:lang="fr">Ukraine</country><wicri:regionArea>Dnepropetrovsk Medical Academy, City Hospital #4, Dnipro</wicri:regionArea></affiliation></author><author><name sortKey="Citrin, D" sort="Citrin, D" uniqKey="Citrin D" first="D" last="Citrin">D. Citrin</name><affiliation wicri:level="2"><nlm:affiliation>Midwestern Regional Medical Center, Zion, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Midwestern Regional Medical Center, Zion</wicri:cityArea></affiliation></author><author><name sortKey="Campone, M" sort="Campone, M" uniqKey="Campone M" first="M" last="Campone">M. Campone</name><affiliation wicri:level="1"><nlm:affiliation>Institut de Cancérologie de l'Ouest, Saint Herblain, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut de Cancérologie de l'Ouest, Saint Herblain</wicri:regionArea></affiliation></author><author><name sortKey="Telli, M L" sort="Telli, M L" uniqKey="Telli M" first="M L" last="Telli">M L Telli</name><affiliation wicri:level="2"><nlm:affiliation>Stanford University School of Medicine, Stanford, CA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Stanford University School of Medicine, Stanford</wicri:cityArea></affiliation></author><author><name sortKey="Domchek, S M" sort="Domchek, S M" uniqKey="Domchek S" first="S M" last="Domchek">S M Domchek</name><affiliation wicri:level="2"><nlm:affiliation>University of Pennsylvania, Philadelphia, PA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>University of Pennsylvania, Philadelphia</wicri:cityArea></affiliation></author><author><name sortKey="Friedlander, M" sort="Friedlander, M" uniqKey="Friedlander M" first="M" last="Friedlander">M. Friedlander</name><affiliation wicri:level="1"><nlm:affiliation>Prince of Wales Hospital, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Prince of Wales Hospital, Sydney, NSW</wicri:regionArea></affiliation></author><author><name sortKey="Kaufman, B" sort="Kaufman, B" uniqKey="Kaufman B" first="B" last="Kaufman">B. Kaufman</name><affiliation wicri:level="1"><nlm:affiliation>Sheba Medical Center, Tel Hashomer, Israel.</nlm:affiliation><country xml:lang="fr">Israël</country><wicri:regionArea>Sheba Medical Center, Tel Hashomer</wicri:regionArea></affiliation></author><author><name sortKey="Garber, J E" sort="Garber, J E" uniqKey="Garber J" first="J E" last="Garber">J E Garber</name><affiliation wicri:level="2"><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Dana-Farber Cancer Institute, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Shparyk, Y" sort="Shparyk, Y" uniqKey="Shparyk Y" first="Y" last="Shparyk">Y. Shparyk</name><affiliation wicri:level="1"><nlm:affiliation>Chemotherapy Department, Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv, Ukraine.</nlm:affiliation><country xml:lang="fr">Ukraine</country><wicri:regionArea>Chemotherapy Department, Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv</wicri:regionArea></affiliation></author><author><name sortKey="Chmielowska, E" sort="Chmielowska, E" uniqKey="Chmielowska E" first="E" last="Chmielowska">E. Chmielowska</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK, Torun, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK, Torun</wicri:regionArea></affiliation></author><author><name sortKey="Jakobsen, E H" sort="Jakobsen, E H" uniqKey="Jakobsen E" first="E H" last="Jakobsen">E H Jakobsen</name><affiliation wicri:level="1"><nlm:affiliation>Department of Oncology, Vejle Hospital/Lillebaelt Hospital, Vejle, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Oncology, Vejle Hospital/Lillebaelt Hospital, Vejle</wicri:regionArea></affiliation></author><author><name sortKey="Kaklamani, V" sort="Kaklamani, V" uniqKey="Kaklamani V" first="V" last="Kaklamani">V. Kaklamani</name><affiliation wicri:level="2"><nlm:affiliation>Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio</wicri:cityArea></affiliation></author><author><name sortKey="Gradishar, W" sort="Gradishar, W" uniqKey="Gradishar W" first="W" last="Gradishar">W. Gradishar</name><affiliation wicri:level="2"><nlm:affiliation>Division of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>Division of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Ratajczak, C K" sort="Ratajczak, C K" uniqKey="Ratajczak C" first="C K" last="Ratajczak">C K Ratajczak</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Nickner, C" sort="Nickner, C" uniqKey="Nickner C" first="C" last="Nickner">C. Nickner</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Qin, Q" sort="Qin, Q" uniqKey="Qin Q" first="Q" last="Qin">Q. Qin</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Qian, J" sort="Qian, J" uniqKey="Qian J" first="J" last="Qian">J. Qian</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Shepherd, S P" sort="Shepherd, S P" uniqKey="Shepherd S" first="S P" last="Shepherd">S P Shepherd</name><affiliation wicri:level="2"><nlm:affiliation>AbbVie Inc., North Chicago, IL.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Illinois</region></placeName><wicri:cityArea>AbbVie Inc., North Chicago</wicri:cityArea></affiliation></author><author><name sortKey="Isakoff, S J" sort="Isakoff, S J" uniqKey="Isakoff S" first="S J" last="Isakoff">S J Isakoff</name><affiliation wicri:level="2"><nlm:affiliation>Massachusetts General Hospital, Boston, MA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Massachusetts General Hospital, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Puhalla, S" sort="Puhalla, S" uniqKey="Puhalla S" first="S" last="Puhalla">S. Puhalla</name><affiliation wicri:level="2"><nlm:affiliation>University of Pittsburgh Cancer Institute, Pittsburgh, PA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>University of Pittsburgh Cancer Institute, Pittsburgh</wicri:cityArea></affiliation></author></analytic><series><title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title><idno type="eISSN">1569-8041</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Homologous recombination defects in BRCA1/2-mutated tumors result in sensitivity to poly(ADP-ribose) polymerase (PARP) inhibitors, which interfere with DNA damage repair. Veliparib, a potent PARP inhibitor, enhanced the antitumor activity of platinum agents and temozolomide in early phase clinical trials. This phase II study examined the safety and efficacy of intermittent veliparib with carboplatin/paclitaxel (VCP) or temozolomide (VT) in patients with BRCA1/2-mutated breast cancer.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">29045554</PMID><DateCreated><Year>2017</Year><Month>10</Month><Day>18</Day></DateCreated><DateRevised><Year>2017</Year><Month>10</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1569-8041</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year><Month>Sep</Month><Day>29</Day></PubDate></JournalIssue><Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title><ISOAbbreviation>Ann. Oncol.</ISOAbbreviation></Journal><ArticleTitle>Veliparib With Temozolomide or Carboplatin/Paclitaxel Versus Placebo With Carboplatin/Paclitaxel in Patients With BRCA1/2 Locally Recurrent/Metastatic Breast Cancer: Randomized Phase II Study.</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdx505</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">Homologous recombination defects in BRCA1/2-mutated tumors result in sensitivity to poly(ADP-ribose) polymerase (PARP) inhibitors, which interfere with DNA damage repair. Veliparib, a potent PARP inhibitor, enhanced the antitumor activity of platinum agents and temozolomide in early phase clinical trials. This phase II study examined the safety and efficacy of intermittent veliparib with carboplatin/paclitaxel (VCP) or temozolomide (VT) in patients with BRCA1/2-mutated breast cancer.</AbstractText><AbstractText Label="Patients and methods" NlmCategory="UNASSIGNED">Eligible patients ≥18 years with locally recurrent or metastatic breast cancer and a deleterious BRCA1/2 germline mutation were randomized 1:1:1 to VCP, VT, or placebo plus carboplatin/paclitaxel (PCP). Primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS) and overall response rate (ORR).</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">Of 290 randomized patients, 284 were BRCA+, confirmed by central laboratory. For VCP versus PCP, median PFS was 14.1 and 12.3 months, respectively (hazard ratio [HR], 0.789; 95% CI, 0.536-1.162; P=0.227), interim median OS 28.3 and 25.9 months (HR, 0.750; 95% CI, 0.503-1.117; P = 0.156), and ORR 77.8% and 61.3% (P = 0.027). For VT (versus PCP), median PFS was 7.4 months (HR, 1.858; 95% CI, 1.278-2.702; P=0.001), interim median OS 19.1 months (HR, 1.483; 95% CI, 1.032-2.131; P=0.032), and ORR 28.6% (P<0.001). Safety profile was comparable between carboplatin/paclitaxel arms. Adverse events (all grades) of neutropenia, anemia, alopecia, and neuropathy were less frequent with VT versus PCP.</AbstractText><AbstractText Label="Conclusion" NlmCategory="UNASSIGNED">Numerical but not statistically significant increases in both PFS and OS were observed in patients with BRCA1/2-mutated recurrent/metastatic breast cancer receiving VCP compared to PCP. The addition of veliparib to carboplatin/paclitaxel significantly improved ORR. There was no clinically meaningful increase in toxicity with VCP versus PCP. VT was inferior to PCP. An ongoing phase III trial is evaluating VCP versus PCP, with optional continuation single-agent therapy with veliparib/placebo if chemotherapy is discontinued without progression, in this patient population. Clinical trial information: NCT01506609.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Han</LastName><ForeName>H S</ForeName><Initials>HS</Initials><AffiliationInfo><Affiliation>Moffitt Cancer Center, Tampa, FL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Diéras</LastName><ForeName>V</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Institut Curie, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robson</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Weill Cornell Medical College, New York, NY.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Palácová</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Masarykuv onkologický ústav, Brno, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marcom</LastName><ForeName>P K</ForeName><Initials>PK</Initials><AffiliationInfo><Affiliation>Duke University; Durham, NC.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jager</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Erasmus MC Cancer Institute, Rotterdam, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bondarenko</LastName><ForeName>I</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Dnepropetrovsk Medical Academy, City Hospital #4, Dnipro, Ukraine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Citrin</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Midwestern Regional Medical Center, Zion, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campone</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Institut de Cancérologie de l'Ouest, Saint Herblain, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Telli</LastName><ForeName>M L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Stanford University School of Medicine, Stanford, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Domchek</LastName><ForeName>S M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>University of Pennsylvania, Philadelphia, PA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Friedlander</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Prince of Wales Hospital, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaufman</LastName><ForeName>B</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Sheba Medical Center, Tel Hashomer, Israel.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garber</LastName><ForeName>J E</ForeName><Initials>JE</Initials><AffiliationInfo><Affiliation>Dana-Farber Cancer Institute, Boston, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shparyk</LastName><ForeName>Y</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Chemotherapy Department, Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv, Ukraine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chmielowska</LastName><ForeName>E</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK, Torun, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jakobsen</LastName><ForeName>E H</ForeName><Initials>EH</Initials><AffiliationInfo><Affiliation>Department of Oncology, Vejle Hospital/Lillebaelt Hospital, Vejle, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaklamani</LastName><ForeName>V</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gradishar</LastName><ForeName>W</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Division of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ratajczak</LastName><ForeName>C K</ForeName><Initials>CK</Initials><AffiliationInfo><Affiliation>AbbVie Inc., North Chicago, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nickner</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>AbbVie Inc., North Chicago, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Qin</LastName><ForeName>Q</ForeName><Initials>Q</Initials><AffiliationInfo><Affiliation>AbbVie Inc., North Chicago, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Qian</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>AbbVie Inc., North Chicago, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shepherd</LastName><ForeName>S P</ForeName><Initials>SP</Initials><AffiliationInfo><Affiliation>AbbVie Inc., North Chicago, IL.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Isakoff</LastName><ForeName>S J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>Massachusetts General Hospital, Boston, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Puhalla</LastName><ForeName>S</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>University of Pittsburgh Cancer Institute, Pittsburgh, PA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>09</Month><Day>29</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Ann Oncol</MedlineTA><NlmUniqueID>9007735</NlmUniqueID><ISSNLinking>0923-7534</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">PARP inhibitors</Keyword><Keyword MajorTopicYN="N">metastatic breast cancer</Keyword><Keyword MajorTopicYN="N">platinum</Keyword><Keyword MajorTopicYN="N">temozolomide</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>10</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>10</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>10</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">29045554</ArticleId><ArticleId IdType="pii">4282670</ArticleId><ArticleId IdType="doi">10.1093/annonc/mdx505</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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