Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial.
Identifieur interne : 004518 ( Ncbi/Merge ); précédent : 004517; suivant : 004519Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial.
Auteurs : Ruben A. Mesa [États-Unis] ; Alessandro M. Vannucchi [Italie] ; Adam Mead [Royaume-Uni] ; Miklos Egyed [Hongrie] ; Anita Szoke [Hongrie] ; Aleksandr Suvorov [Russie] ; Janos Jakucs [Hongrie] ; Andrew Perkins [Australie] ; Ritam Prasad [Australie] ; Jiri Mayer [République tchèque] ; Judit Demeter [Hongrie] ; Peter Ganly [Nouvelle-Zélande] ; Jack W. Singer [États-Unis] ; Huafeng Zhou [États-Unis] ; James P. Dean [États-Unis] ; Peter A. Te Boekhorst [Pays-Bas] ; Jyoti Nangalia [Royaume-Uni] ; Jean-Jacques Kiladjian [France] ; Claire N. Harrison [Royaume-Uni]Source :
- The Lancet. Haematology [ 2352-3026 ] ; 2017.
Abstract
Available therapies for myelofibrosis can exacerbate cytopenias and are not indicated for patients with severe thrombocytopenia. Pacritinib, which inhibits both JAK2 and FLT3, induced spleen responses with limited myelosuppression in phase 1/2 trials. We aimed to assess the efficacy and safety of pacritinib versus best available therapy in patients with myelofibrosis irrespective of baseline cytopenias.
DOI: 10.1016/S2352-3026(17)30027-3
PubMed: 28336242
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial.</title><author><name sortKey="Mesa, Ruben A" sort="Mesa, Ruben A" uniqKey="Mesa R" first="Ruben A" last="Mesa">Ruben A. Mesa</name><affiliation wicri:level="2"><nlm:affiliation>Division of Hematology and Medical Oncology, Mayo Clinic, Scottsdale, AZ, USA. Electronic address: mesa.ruben@mayo.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Hematology and Medical Oncology, Mayo Clinic, Scottsdale, AZ</wicri:regionArea><placeName><region type="state">Arizona</region></placeName></affiliation></author><author><name sortKey="Vannucchi, Alessandro M" sort="Vannucchi, Alessandro M" uniqKey="Vannucchi A" first="Alessandro M" last="Vannucchi">Alessandro M. Vannucchi</name><affiliation wicri:level="1"><nlm:affiliation>Center of Research and Innovation of Myeloproliferative Neoplasms, Department of Experimental and Clinical Medicine, AOU Careggi and University of Florence, Florence, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Center of Research and Innovation of Myeloproliferative Neoplasms, Department of Experimental and Clinical Medicine, AOU Careggi and University of Florence, Florence</wicri:regionArea><wicri:noRegion>Florence</wicri:noRegion></affiliation></author><author><name sortKey="Mead, Adam" sort="Mead, Adam" uniqKey="Mead A" first="Adam" last="Mead">Adam Mead</name><affiliation wicri:level="3"><nlm:affiliation>Clinical Haematology, NIHR Biomedical Research Centre, Churchill Hospital, Oxford, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Haematology, NIHR Biomedical Research Centre, Churchill Hospital, Oxford</wicri:regionArea><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region></placeName></affiliation></author><author><name sortKey="Egyed, Miklos" sort="Egyed, Miklos" uniqKey="Egyed M" first="Miklos" last="Egyed">Miklos Egyed</name><affiliation wicri:level="1"><nlm:affiliation>Department of Hematology, Somogy County Kaposi Mor Hospital, Kaposvar, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Department of Hematology, Somogy County Kaposi Mor Hospital, Kaposvar</wicri:regionArea><wicri:noRegion>Kaposvar</wicri:noRegion></affiliation></author><author><name sortKey="Szoke, Anita" sort="Szoke, Anita" uniqKey="Szoke A" first="Anita" last="Szoke">Anita Szoke</name><affiliation wicri:level="1"><nlm:affiliation>Second Department of Internal Medicine and Cardiology Center, Albert Szent-Györgyi Clinical Center, University of Szeged, Szeged, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Second Department of Internal Medicine and Cardiology Center, Albert Szent-Györgyi Clinical Center, University of Szeged, Szeged</wicri:regionArea><wicri:noRegion>Szeged</wicri:noRegion></affiliation></author><author><name sortKey="Suvorov, Aleksandr" sort="Suvorov, Aleksandr" uniqKey="Suvorov A" first="Aleksandr" last="Suvorov">Aleksandr Suvorov</name><affiliation wicri:level="1"><nlm:affiliation>First Republican Clinical Hospital of Udmurtia, Izhevsk, Russia.</nlm:affiliation><country xml:lang="fr">Russie</country><wicri:regionArea>First Republican Clinical Hospital of Udmurtia, Izhevsk</wicri:regionArea><wicri:noRegion>Izhevsk</wicri:noRegion></affiliation></author><author><name sortKey="Jakucs, Janos" sort="Jakucs, Janos" uniqKey="Jakucs J" first="Janos" last="Jakucs">Janos Jakucs</name><affiliation wicri:level="1"><nlm:affiliation>Békés Megyei Pándy Kálmán Kórház, Gyula, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Békés Megyei Pándy Kálmán Kórház, Gyula</wicri:regionArea><wicri:noRegion>Gyula</wicri:noRegion></affiliation></author><author><name sortKey="Perkins, Andrew" sort="Perkins, Andrew" uniqKey="Perkins A" first="Andrew" last="Perkins">Andrew Perkins</name><affiliation wicri:level="1"><nlm:affiliation>ICON Cancer Care, South Brisbane, QLD, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>ICON Cancer Care, South Brisbane, QLD</wicri:regionArea><wicri:noRegion>QLD</wicri:noRegion></affiliation></author><author><name sortKey="Prasad, Ritam" sort="Prasad, Ritam" uniqKey="Prasad R" first="Ritam" last="Prasad">Ritam Prasad</name><affiliation wicri:level="1"><nlm:affiliation>Royal Hobart Hospital, Hobart, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Royal Hobart Hospital, Hobart</wicri:regionArea><wicri:noRegion>Hobart</wicri:noRegion></affiliation></author><author><name sortKey="Mayer, Jiri" sort="Mayer, Jiri" uniqKey="Mayer J" first="Jiri" last="Mayer">Jiri Mayer</name><affiliation wicri:level="3"><nlm:affiliation>Department of Internal Medicine, University Hospital Brno, Brno, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Internal Medicine, University Hospital Brno, Brno</wicri:regionArea><placeName><settlement type="city">Brno</settlement><region>Moravie</region></placeName></affiliation></author><author><name sortKey="Demeter, Judit" sort="Demeter, Judit" uniqKey="Demeter J" first="Judit" last="Demeter">Judit Demeter</name><affiliation wicri:level="3"><nlm:affiliation>First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>First Department of Internal Medicine, Semmelweis University, Budapest</wicri:regionArea><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></affiliation></author><author><name sortKey="Ganly, Peter" sort="Ganly, Peter" uniqKey="Ganly P" first="Peter" last="Ganly">Peter Ganly</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Christchurch Hospital, Christchurch, New Zealand.</nlm:affiliation><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>Department of Haematology, Christchurch Hospital, Christchurch</wicri:regionArea><wicri:noRegion>Christchurch</wicri:noRegion></affiliation></author><author><name sortKey="Singer, Jack W" sort="Singer, Jack W" uniqKey="Singer J" first="Jack W" last="Singer">Jack W. Singer</name><affiliation wicri:level="2"><nlm:affiliation>CTI BioPharma Corp, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CTI BioPharma Corp, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Zhou, Huafeng" sort="Zhou, Huafeng" uniqKey="Zhou H" first="Huafeng" last="Zhou">Huafeng Zhou</name><affiliation wicri:level="2"><nlm:affiliation>CTI BioPharma Corp, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CTI BioPharma Corp, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Dean, James P" sort="Dean, James P" uniqKey="Dean J" first="James P" last="Dean">James P. Dean</name><affiliation wicri:level="2"><nlm:affiliation>CTI BioPharma Corp, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CTI BioPharma Corp, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Te Boekhorst, Peter A" sort="Te Boekhorst, Peter A" uniqKey="Te Boekhorst P" first="Peter A" last="Te Boekhorst">Peter A. Te Boekhorst</name><affiliation wicri:level="3"><nlm:affiliation>Erasmus Medical Center, Rotterdam, Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Erasmus Medical Center, Rotterdam</wicri:regionArea><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Nangalia, Jyoti" sort="Nangalia, Jyoti" uniqKey="Nangalia J" first="Jyoti" last="Nangalia">Jyoti Nangalia</name><affiliation wicri:level="1"><nlm:affiliation>Wellcome Trust Sanger Instutite, Hinxton, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Wellcome Trust Sanger Instutite, Hinxton</wicri:regionArea><wicri:noRegion>Hinxton</wicri:noRegion></affiliation></author><author><name sortKey="Kiladjian, Jean Jacques" sort="Kiladjian, Jean Jacques" uniqKey="Kiladjian J" first="Jean-Jacques" last="Kiladjian">Jean-Jacques Kiladjian</name><affiliation wicri:level="3"><nlm:affiliation>Centre d'Investigations Cliniques, APHP, Hôpital Saint-Louis, INSERM CIC 1427, Paris, France; Paris Diderot University, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigations Cliniques, APHP, Hôpital Saint-Louis, INSERM CIC 1427, Paris, France; Paris Diderot University, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Harrison, Claire N" sort="Harrison, Claire N" uniqKey="Harrison C" first="Claire N" last="Harrison">Claire N. Harrison</name><affiliation wicri:level="3"><nlm:affiliation>Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28336242</idno><idno type="pmid">28336242</idno><idno type="doi">10.1016/S2352-3026(17)30027-3</idno><idno type="wicri:Area/PubMed/Corpus">000C32</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000C32</idno><idno type="wicri:Area/PubMed/Curation">000C29</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000C29</idno><idno type="wicri:Area/PubMed/Checkpoint">000C29</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000C29</idno><idno type="wicri:Area/Ncbi/Merge">004518</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial.</title><author><name sortKey="Mesa, Ruben A" sort="Mesa, Ruben A" uniqKey="Mesa R" first="Ruben A" last="Mesa">Ruben A. Mesa</name><affiliation wicri:level="2"><nlm:affiliation>Division of Hematology and Medical Oncology, Mayo Clinic, Scottsdale, AZ, USA. Electronic address: mesa.ruben@mayo.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Hematology and Medical Oncology, Mayo Clinic, Scottsdale, AZ</wicri:regionArea><placeName><region type="state">Arizona</region></placeName></affiliation></author><author><name sortKey="Vannucchi, Alessandro M" sort="Vannucchi, Alessandro M" uniqKey="Vannucchi A" first="Alessandro M" last="Vannucchi">Alessandro M. Vannucchi</name><affiliation wicri:level="1"><nlm:affiliation>Center of Research and Innovation of Myeloproliferative Neoplasms, Department of Experimental and Clinical Medicine, AOU Careggi and University of Florence, Florence, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Center of Research and Innovation of Myeloproliferative Neoplasms, Department of Experimental and Clinical Medicine, AOU Careggi and University of Florence, Florence</wicri:regionArea><wicri:noRegion>Florence</wicri:noRegion></affiliation></author><author><name sortKey="Mead, Adam" sort="Mead, Adam" uniqKey="Mead A" first="Adam" last="Mead">Adam Mead</name><affiliation wicri:level="3"><nlm:affiliation>Clinical Haematology, NIHR Biomedical Research Centre, Churchill Hospital, Oxford, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Haematology, NIHR Biomedical Research Centre, Churchill Hospital, Oxford</wicri:regionArea><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region></placeName></affiliation></author><author><name sortKey="Egyed, Miklos" sort="Egyed, Miklos" uniqKey="Egyed M" first="Miklos" last="Egyed">Miklos Egyed</name><affiliation wicri:level="1"><nlm:affiliation>Department of Hematology, Somogy County Kaposi Mor Hospital, Kaposvar, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Department of Hematology, Somogy County Kaposi Mor Hospital, Kaposvar</wicri:regionArea><wicri:noRegion>Kaposvar</wicri:noRegion></affiliation></author><author><name sortKey="Szoke, Anita" sort="Szoke, Anita" uniqKey="Szoke A" first="Anita" last="Szoke">Anita Szoke</name><affiliation wicri:level="1"><nlm:affiliation>Second Department of Internal Medicine and Cardiology Center, Albert Szent-Györgyi Clinical Center, University of Szeged, Szeged, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Second Department of Internal Medicine and Cardiology Center, Albert Szent-Györgyi Clinical Center, University of Szeged, Szeged</wicri:regionArea><wicri:noRegion>Szeged</wicri:noRegion></affiliation></author><author><name sortKey="Suvorov, Aleksandr" sort="Suvorov, Aleksandr" uniqKey="Suvorov A" first="Aleksandr" last="Suvorov">Aleksandr Suvorov</name><affiliation wicri:level="1"><nlm:affiliation>First Republican Clinical Hospital of Udmurtia, Izhevsk, Russia.</nlm:affiliation><country xml:lang="fr">Russie</country><wicri:regionArea>First Republican Clinical Hospital of Udmurtia, Izhevsk</wicri:regionArea><wicri:noRegion>Izhevsk</wicri:noRegion></affiliation></author><author><name sortKey="Jakucs, Janos" sort="Jakucs, Janos" uniqKey="Jakucs J" first="Janos" last="Jakucs">Janos Jakucs</name><affiliation wicri:level="1"><nlm:affiliation>Békés Megyei Pándy Kálmán Kórház, Gyula, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>Békés Megyei Pándy Kálmán Kórház, Gyula</wicri:regionArea><wicri:noRegion>Gyula</wicri:noRegion></affiliation></author><author><name sortKey="Perkins, Andrew" sort="Perkins, Andrew" uniqKey="Perkins A" first="Andrew" last="Perkins">Andrew Perkins</name><affiliation wicri:level="1"><nlm:affiliation>ICON Cancer Care, South Brisbane, QLD, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>ICON Cancer Care, South Brisbane, QLD</wicri:regionArea><wicri:noRegion>QLD</wicri:noRegion></affiliation></author><author><name sortKey="Prasad, Ritam" sort="Prasad, Ritam" uniqKey="Prasad R" first="Ritam" last="Prasad">Ritam Prasad</name><affiliation wicri:level="1"><nlm:affiliation>Royal Hobart Hospital, Hobart, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Royal Hobart Hospital, Hobart</wicri:regionArea><wicri:noRegion>Hobart</wicri:noRegion></affiliation></author><author><name sortKey="Mayer, Jiri" sort="Mayer, Jiri" uniqKey="Mayer J" first="Jiri" last="Mayer">Jiri Mayer</name><affiliation wicri:level="3"><nlm:affiliation>Department of Internal Medicine, University Hospital Brno, Brno, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Department of Internal Medicine, University Hospital Brno, Brno</wicri:regionArea><placeName><settlement type="city">Brno</settlement><region>Moravie</region></placeName></affiliation></author><author><name sortKey="Demeter, Judit" sort="Demeter, Judit" uniqKey="Demeter J" first="Judit" last="Demeter">Judit Demeter</name><affiliation wicri:level="3"><nlm:affiliation>First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.</nlm:affiliation><country xml:lang="fr">Hongrie</country><wicri:regionArea>First Department of Internal Medicine, Semmelweis University, Budapest</wicri:regionArea><placeName><settlement type="city">Budapest</settlement><region nuts="2">Hongrie centrale</region></placeName></affiliation></author><author><name sortKey="Ganly, Peter" sort="Ganly, Peter" uniqKey="Ganly P" first="Peter" last="Ganly">Peter Ganly</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, Christchurch Hospital, Christchurch, New Zealand.</nlm:affiliation><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea>Department of Haematology, Christchurch Hospital, Christchurch</wicri:regionArea><wicri:noRegion>Christchurch</wicri:noRegion></affiliation></author><author><name sortKey="Singer, Jack W" sort="Singer, Jack W" uniqKey="Singer J" first="Jack W" last="Singer">Jack W. Singer</name><affiliation wicri:level="2"><nlm:affiliation>CTI BioPharma Corp, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CTI BioPharma Corp, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Zhou, Huafeng" sort="Zhou, Huafeng" uniqKey="Zhou H" first="Huafeng" last="Zhou">Huafeng Zhou</name><affiliation wicri:level="2"><nlm:affiliation>CTI BioPharma Corp, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CTI BioPharma Corp, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Dean, James P" sort="Dean, James P" uniqKey="Dean J" first="James P" last="Dean">James P. Dean</name><affiliation wicri:level="2"><nlm:affiliation>CTI BioPharma Corp, Seattle, WA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CTI BioPharma Corp, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Te Boekhorst, Peter A" sort="Te Boekhorst, Peter A" uniqKey="Te Boekhorst P" first="Peter A" last="Te Boekhorst">Peter A. Te Boekhorst</name><affiliation wicri:level="3"><nlm:affiliation>Erasmus Medical Center, Rotterdam, Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Erasmus Medical Center, Rotterdam</wicri:regionArea><placeName><settlement type="city">Rotterdam</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Nangalia, Jyoti" sort="Nangalia, Jyoti" uniqKey="Nangalia J" first="Jyoti" last="Nangalia">Jyoti Nangalia</name><affiliation wicri:level="1"><nlm:affiliation>Wellcome Trust Sanger Instutite, Hinxton, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Wellcome Trust Sanger Instutite, Hinxton</wicri:regionArea><wicri:noRegion>Hinxton</wicri:noRegion></affiliation></author><author><name sortKey="Kiladjian, Jean Jacques" sort="Kiladjian, Jean Jacques" uniqKey="Kiladjian J" first="Jean-Jacques" last="Kiladjian">Jean-Jacques Kiladjian</name><affiliation wicri:level="3"><nlm:affiliation>Centre d'Investigations Cliniques, APHP, Hôpital Saint-Louis, INSERM CIC 1427, Paris, France; Paris Diderot University, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigations Cliniques, APHP, Hôpital Saint-Louis, INSERM CIC 1427, Paris, France; Paris Diderot University, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Harrison, Claire N" sort="Harrison, Claire N" uniqKey="Harrison C" first="Claire N" last="Harrison">Claire N. Harrison</name><affiliation wicri:level="3"><nlm:affiliation>Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></analytic><series><title level="j">The Lancet. Haematology</title><idno type="eISSN">2352-3026</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">Available therapies for myelofibrosis can exacerbate cytopenias and are not indicated for patients with severe thrombocytopenia. Pacritinib, which inhibits both JAK2 and FLT3, induced spleen responses with limited myelosuppression in phase 1/2 trials. We aimed to assess the efficacy and safety of pacritinib versus best available therapy in patients with myelofibrosis irrespective of baseline cytopenias.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28336242</PMID><DateCreated><Year>2017</Year><Month>03</Month><Day>24</Day></DateCreated><DateRevised><Year>2017</Year><Month>05</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2352-3026</ISSN><JournalIssue CitedMedium="Internet"><Volume>4</Volume><Issue>5</Issue><PubDate><Year>2017</Year><Month>May</Month></PubDate></JournalIssue><Title>The Lancet. Haematology</Title><ISOAbbreviation>Lancet Haematol</ISOAbbreviation></Journal><ArticleTitle>Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial.</ArticleTitle><Pagination><MedlinePgn>e225-e236</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S2352-3026(17)30027-3</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S2352-3026(17)30027-3</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Available therapies for myelofibrosis can exacerbate cytopenias and are not indicated for patients with severe thrombocytopenia. Pacritinib, which inhibits both JAK2 and FLT3, induced spleen responses with limited myelosuppression in phase 1/2 trials. We aimed to assess the efficacy and safety of pacritinib versus best available therapy in patients with myelofibrosis irrespective of baseline cytopenias.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This international, multicentre, randomised, phase 3 trial (PERSIST-1) was done at 67 sites in 12 countries. Patients with higher-risk myelofibrosis (with no exclusions for baseline anaemia or thrombocytopenia) were randomly assigned (2:1) to receive oral pacritinib 400 mg once daily or best available therapy (BAT) excluding JAK2 inhibitors until disease progression or unacceptable toxicity. Randomisation was stratified by risk category, platelet count, and region. Treatment assignments were known to investigators, site personnel, patients, clinical monitors, and pharmacovigilance personnel. The primary endpoint was spleen volume reduction (SVR) of 35% or more from baseline to week 24 in the intention-to-treat population as assessed by blinded, centrally reviewed MRI or CT. We did safety analyses in all randomised patients who received either treatment. Here we present the final data. This trial is registered with ClinicalTrials.gov, number NCT01773187.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Jan 8, 2013, and Aug 1, 2014, 327 patients were randomly assigned to pacritinib (n=220) or BAT (n=107). Median follow-up was 23·2 months (IQR 14·8-28·7). At week 24, the primary endpoint of SVR of 35% or more was achieved by 42 (19%) patients in the pacritinib group versus five (5%) patients in the BAT group (p=0·0003). 90 patients in the BAT group crossed over to receive pacritinib at a median of 6·3 months (IQR 5·8-6·7). The most common grade 3-4 adverse events through week 24 were anaemia (n=37 [17%]), thrombocytopenia (n=26 [12%]), and diarrhoea (n=11 [5%]) in the pacritinib group, and anaemia (n=16 [15%]), thrombocytopenia (n=12 [11%]), dyspnoea (n=3 [3%]), and hypotension (n=3 [3%]) in the BAT group. The most common serious adverse events that occurred through week 24 were anaemia (10 [5%]), cardiac failure (5 [2%]), pyrexia (4 [2%]), and pneumonia (4 [2%]) with pacritinib, and anaemia (5 [5%]), sepsis (2 [2%]), and dyspnoea (2 [2%]) with BAT. Deaths due to adverse events were observed in 27 (12%) patients in the pacritinib group and 14 (13%) patients in the BAT group throughout the duration of the study.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Pacritinib therapy was well tolerated and induced significant and sustained SVR and symptom reduction, even in patients with severe baseline cytopenias. Pacritinib could be a treatment option for patients with myelofibrosis, including those with baseline cytopenias for whom options are particularly limited.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">CTI BioPharma Corp.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mesa</LastName><ForeName>Ruben A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>Division of Hematology and Medical Oncology, Mayo Clinic, Scottsdale, AZ, USA. Electronic address: mesa.ruben@mayo.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vannucchi</LastName><ForeName>Alessandro M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Center of Research and Innovation of Myeloproliferative Neoplasms, Department of Experimental and Clinical Medicine, AOU Careggi and University of Florence, Florence, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mead</LastName><ForeName>Adam</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Clinical Haematology, NIHR Biomedical Research Centre, Churchill Hospital, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Egyed</LastName><ForeName>Miklos</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Hematology, Somogy County Kaposi Mor Hospital, Kaposvar, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Szoke</LastName><ForeName>Anita</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Second Department of Internal Medicine and Cardiology Center, Albert Szent-Györgyi Clinical Center, University of Szeged, Szeged, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Suvorov</LastName><ForeName>Aleksandr</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>First Republican Clinical Hospital of Udmurtia, Izhevsk, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jakucs</LastName><ForeName>Janos</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Békés Megyei Pándy Kálmán Kórház, Gyula, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Perkins</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>ICON Cancer Care, South Brisbane, QLD, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Prasad</LastName><ForeName>Ritam</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Royal Hobart Hospital, Hobart, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mayer</LastName><ForeName>Jiri</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, University Hospital Brno, Brno, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Demeter</LastName><ForeName>Judit</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ganly</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Haematology, Christchurch Hospital, Christchurch, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Singer</LastName><ForeName>Jack W</ForeName><Initials>JW</Initials><AffiliationInfo><Affiliation>CTI BioPharma Corp, Seattle, WA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhou</LastName><ForeName>Huafeng</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>CTI BioPharma Corp, Seattle, WA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dean</LastName><ForeName>James P</ForeName><Initials>JP</Initials><AffiliationInfo><Affiliation>CTI BioPharma Corp, Seattle, WA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Te Boekhorst</LastName><ForeName>Peter A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Erasmus Medical Center, Rotterdam, Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nangalia</LastName><ForeName>Jyoti</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Wellcome Trust Sanger Instutite, Hinxton, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kiladjian</LastName><ForeName>Jean-Jacques</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Centre d'Investigations Cliniques, APHP, Hôpital Saint-Louis, INSERM CIC 1427, Paris, France; Paris Diderot University, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Harrison</LastName><ForeName>Claire N</ForeName><Initials>CN</Initials><AffiliationInfo><Affiliation>Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>03</Month><Day>20</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Haematol</MedlineTA><NlmUniqueID>101643584</NlmUniqueID><ISSNLinking>2352-3026</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>10</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>02</Month><Day>07</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>02</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>3</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>3</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>3</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28336242</ArticleId><ArticleId IdType="pii">S2352-3026(17)30027-3</ArticleId><ArticleId IdType="doi">10.1016/S2352-3026(17)30027-3</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>France</li><li>Hongrie</li><li>Italie</li><li>Nouvelle-Zélande</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>Russie</li><li>République tchèque</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Arizona</li><li>Grand Londres</li><li>Hollande-Méridionale</li><li>Hongrie centrale</li><li>Moravie</li><li>Oxfordshire</li><li>Washington (État)</li><li>Île-de-France</li></region><settlement><li>Brno</li><li>Budapest</li><li>Londres</li><li>Oxford</li><li>Paris</li><li>Rotterdam</li></settlement></list><tree><country name="États-Unis"><region name="Arizona"><name sortKey="Mesa, Ruben A" sort="Mesa, Ruben A" uniqKey="Mesa R" first="Ruben A" last="Mesa">Ruben A. Mesa</name></region><name sortKey="Dean, James P" sort="Dean, James P" uniqKey="Dean J" first="James P" last="Dean">James P. Dean</name><name sortKey="Singer, Jack W" sort="Singer, Jack W" uniqKey="Singer J" first="Jack W" last="Singer">Jack W. Singer</name><name sortKey="Zhou, Huafeng" sort="Zhou, Huafeng" uniqKey="Zhou H" first="Huafeng" last="Zhou">Huafeng Zhou</name></country><country name="Italie"><noRegion><name sortKey="Vannucchi, Alessandro M" sort="Vannucchi, Alessandro M" uniqKey="Vannucchi A" first="Alessandro M" last="Vannucchi">Alessandro M. Vannucchi</name></noRegion></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Mead, Adam" sort="Mead, Adam" uniqKey="Mead A" first="Adam" last="Mead">Adam Mead</name></region><name sortKey="Harrison, Claire N" sort="Harrison, Claire N" uniqKey="Harrison C" first="Claire N" last="Harrison">Claire N. Harrison</name><name sortKey="Nangalia, Jyoti" sort="Nangalia, Jyoti" uniqKey="Nangalia J" first="Jyoti" last="Nangalia">Jyoti Nangalia</name></country><country name="Hongrie"><noRegion><name sortKey="Egyed, Miklos" sort="Egyed, Miklos" uniqKey="Egyed M" first="Miklos" last="Egyed">Miklos Egyed</name></noRegion><name sortKey="Demeter, Judit" sort="Demeter, Judit" uniqKey="Demeter J" first="Judit" last="Demeter">Judit Demeter</name><name sortKey="Jakucs, Janos" sort="Jakucs, Janos" uniqKey="Jakucs J" first="Janos" last="Jakucs">Janos Jakucs</name><name sortKey="Szoke, Anita" sort="Szoke, Anita" uniqKey="Szoke A" first="Anita" last="Szoke">Anita Szoke</name></country><country name="Russie"><noRegion><name sortKey="Suvorov, Aleksandr" sort="Suvorov, Aleksandr" uniqKey="Suvorov A" first="Aleksandr" last="Suvorov">Aleksandr Suvorov</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Perkins, Andrew" sort="Perkins, Andrew" uniqKey="Perkins A" first="Andrew" last="Perkins">Andrew Perkins</name></noRegion><name sortKey="Prasad, Ritam" sort="Prasad, Ritam" uniqKey="Prasad R" first="Ritam" last="Prasad">Ritam Prasad</name></country><country name="République tchèque"><region name="Moravie"><name sortKey="Mayer, Jiri" sort="Mayer, Jiri" uniqKey="Mayer J" first="Jiri" last="Mayer">Jiri Mayer</name></region></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Ganly, Peter" sort="Ganly, Peter" uniqKey="Ganly P" first="Peter" last="Ganly">Peter Ganly</name></noRegion></country><country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Te Boekhorst, Peter A" sort="Te Boekhorst, Peter A" uniqKey="Te Boekhorst P" first="Peter A" last="Te Boekhorst">Peter A. Te Boekhorst</name></region></country><country name="France"><region name="Île-de-France"><name sortKey="Kiladjian, Jean Jacques" sort="Kiladjian, Jean Jacques" uniqKey="Kiladjian J" first="Jean-Jacques" last="Kiladjian">Jean-Jacques Kiladjian</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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