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Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial.

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Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial.

Auteurs : Srdan Verstovsek ; Alessandro M. Vannucchi [Italie] ; Martin Griesshammer [Allemagne] ; Tamas Masszi [Hongrie] ; Simon Durrant [Australie] ; Francesco Passamonti [Italie] ; Claire N. Harrison [Royaume-Uni] ; Fabrizio Pane [Italie] ; Pierre Zachee [Belgique] ; Keita Kirito [Japon] ; Carlos Besses [Espagne] ; Masayuki Hino [Japon] ; Beatriz Moiraghi [Argentine] ; Carole B. Miller [États-Unis] ; Mario Cazzola [Italie] ; Vittorio Rosti [Italie] ; Igor Blau [Allemagne] ; Ruben Mesa [États-Unis] ; Mark M. Jones [États-Unis] ; Huiling Zhen [États-Unis] ; Jingjin Li [États-Unis] ; Nathalie Francillard [France] ; Dany Habr [États-Unis] ; Jean-Jacques Kiladjian [France]

Source :

Haematologica [ 1592-8721 ] ; 2016.

RBID : pubmed:27102499

Descripteurs français

KwdFr :
- Adulte, Adulte d'âge moyen, Allèles, Association thérapeutique, Femelle, Fréquence d'allèle, Humains, Hématocrite, Inhibiteurs de protéines kinases (administration et posologie), Inhibiteurs de protéines kinases (effets indésirables), Inhibiteurs de protéines kinases (usage thérapeutique), Janus kinases (antagonistes et inhibiteurs), Janus kinases (génétique), Mutation, Mâle, Polyglobulie primitive essentielle (diagnostic), Polyglobulie primitive essentielle (génétique), Polyglobulie primitive essentielle (traitement médicamenteux), Pyrazoles (administration et posologie), Pyrazoles (effets indésirables), Pyrazoles (usage thérapeutique), Résultat thérapeutique, Sujet âgé, Thérapie moléculaire ciblée, Études de suivi.
MESH :
- administration et posologie : Inhibiteurs de protéines kinases, Pyrazoles.
- antagonistes et inhibiteurs : Janus kinases.
- diagnostic : Polyglobulie primitive essentielle.
- effets indésirables : Inhibiteurs de protéines kinases, Pyrazoles.
- génétique : Janus kinases, Polyglobulie primitive essentielle.
- traitement médicamenteux : Polyglobulie primitive essentielle.
- usage thérapeutique : Inhibiteurs de protéines kinases, Pyrazoles.
- Adulte, Adulte d'âge moyen, Allèles, Association thérapeutique, Femelle, Fréquence d'allèle, Humains, Hématocrite, Mutation, Mâle, Résultat thérapeutique, Sujet âgé, Thérapie moléculaire ciblée, Études de suivi.

English descriptors

KwdEn :
- Adult, Aged, Alleles, Combined Modality Therapy, Female, Follow-Up Studies, Gene Frequency, Hematocrit, Humans, Janus Kinases (antagonists & inhibitors), Janus Kinases (genetics), Male, Middle Aged, Molecular Targeted Therapy, Mutation, Polycythemia Vera (diagnosis), Polycythemia Vera (drug therapy), Polycythemia Vera (genetics), Protein Kinase Inhibitors (administration & dosage), Protein Kinase Inhibitors (adverse effects), Protein Kinase Inhibitors (therapeutic use), Pyrazoles (administration & dosage), Pyrazoles (adverse effects), Pyrazoles (therapeutic use), Treatment Outcome.
MESH :
- chemical , administration & dosage : Protein Kinase Inhibitors, Pyrazoles.
- chemical , adverse effects : Protein Kinase Inhibitors, Pyrazoles.
- chemical , antagonists & inhibitors : Janus Kinases.
- chemical , genetics : Janus Kinases.
- diagnosis : Polycythemia Vera.
- drug therapy : Polycythemia Vera.
- genetics : Polycythemia Vera.
- chemical , therapeutic use : Protein Kinase Inhibitors, Pyrazoles.
- Adult, Aged, Alleles, Combined Modality Therapy, Female, Follow-Up Studies, Gene Frequency, Hematocrit, Humans, Male, Middle Aged, Molecular Targeted Therapy, Mutation, Treatment Outcome.

Abstract

RESPONSE is an open-label phase 3 study evaluating the Janus kinase 1/Janus kinase 2 inhibitor ruxolitinib versus best available therapy for efficacy/safety in hydroxyurea-resistant or intolerant patients with polycythemia vera. This preplanned analysis occurred when all patients completed the Week 80 visit or discontinued. Objectives included evaluating the durability of the primary response (Week 32 phlebotomy-independent hematocrit control plus ≥35% spleen volume reduction), its components, and that of complete hematologic remission; and long-term safety. Median exposure was 111 weeks; 91/110 (82.7%) patients randomized to ruxolitinib remained on treatment. No patients continued best available therapy (98/112 [87.5%] crossed over to ruxolitinib, most at/soon after Week 32). At Week 32, primary response was achieved by 22.7% vs. 0.9% of patients randomized to ruxolitinib and best available therapy, respectively (hematocrit control, 60.0% vs. 18.8%; spleen response, 40.0% vs. 0.9%). The probability of maintaining primary and hematocrit responses for ≥80 weeks was 92% and 89%, respectively; 43/44 spleen responses were maintained until Week 80. Complete hematologic remission at Week 32 was achieved in 23.6% of ruxolitinib-randomized patients; the probability of maintaining complete hematologic remission for ≥80 weeks was 69%. Among ruxolitinib crossover patients, 79.2% were not phlebotomized, and 18.8% achieved a ≥35% reduction from baseline in spleen volume after 32 weeks of treatment. New or worsening hematologic laboratory abnormalities in ruxolitinib-treated patients were primarily grade 1/2 decreases in hemoglobin, lymphocytes, and platelets. The thromboembolic event rate per 100 patient-years was 1.8 with randomized ruxolitinib treatment vs. 8.2 with best available therapy. These data support ruxolitinib as an effective long-term treatment option for hydroxyurea-resistant or intolerant patients with polycythemia vera. This trial was registered at clinicaltrials.gov identifier: 01243944.

DOI: 10.3324/haematol.2016.143644
PubMed: 27102499

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Srdan Verstovsek

<affiliation><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA sverstov@mdanderson.org.</nlm:affiliation>
<wicri:noCountry code="subField">USA sverstov@mdanderson.org.</wicri:noCountry>
</affiliation>

Le document en format XML

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<author><name sortKey="Zhen, Huiling" sort="Zhen, Huiling" uniqKey="Zhen H" first="Huiling" last="Zhen">Huiling Zhen</name>
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<author><name sortKey="Li, Jingjin" sort="Li, Jingjin" uniqKey="Li J" first="Jingjin" last="Li">Jingjin Li</name>
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<author><name sortKey="Cazzola, Mario" sort="Cazzola, Mario" uniqKey="Cazzola M" first="Mario" last="Cazzola">Mario Cazzola</name>
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<series><title level="j">Haematologica</title>
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<front><div type="abstract" xml:lang="en">RESPONSE is an open-label phase 3 study evaluating the Janus kinase 1/Janus kinase 2 inhibitor ruxolitinib versus best available therapy for efficacy/safety in hydroxyurea-resistant or intolerant patients with polycythemia vera. This preplanned analysis occurred when all patients completed the Week 80 visit or discontinued. Objectives included evaluating the durability of the primary response (Week 32 phlebotomy-independent hematocrit control plus ≥35% spleen volume reduction), its components, and that of complete hematologic remission; and long-term safety. Median exposure was 111 weeks; 91/110 (82.7%) patients randomized to ruxolitinib remained on treatment. No patients continued best available therapy (98/112 [87.5%] crossed over to ruxolitinib, most at/soon after Week 32). At Week 32, primary response was achieved by 22.7% vs. 0.9% of patients randomized to ruxolitinib and best available therapy, respectively (hematocrit control, 60.0% vs. 18.8%; spleen response, 40.0% vs. 0.9%). The probability of maintaining primary and hematocrit responses for ≥80 weeks was 92% and 89%, respectively; 43/44 spleen responses were maintained until Week 80. Complete hematologic remission at Week 32 was achieved in 23.6% of ruxolitinib-randomized patients; the probability of maintaining complete hematologic remission for ≥80 weeks was 69%. Among ruxolitinib crossover patients, 79.2% were not phlebotomized, and 18.8% achieved a ≥35% reduction from baseline in spleen volume after 32 weeks of treatment. New or worsening hematologic laboratory abnormalities in ruxolitinib-treated patients were primarily grade 1/2 decreases in hemoglobin, lymphocytes, and platelets. The thromboembolic event rate per 100 patient-years was 1.8 with randomized ruxolitinib treatment vs. 8.2 with best available therapy. These data support ruxolitinib as an effective long-term treatment option for hydroxyurea-resistant or intolerant patients with polycythemia vera. This trial was registered at clinicaltrials.gov identifier: 01243944.</div>
</front>
</TEI>
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<DateCreated><Year>2016</Year>
<Month>07</Month>
<Day>01</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>07</Month>
<Day>07</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>09</Month>
<Day>30</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1592-8721</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>101</Volume>
<Issue>7</Issue>
<PubDate><Year>2016</Year>
<Month>Jul</Month>
</PubDate>
</JournalIssue>
<Title>Haematologica</Title>
<ISOAbbreviation>Haematologica</ISOAbbreviation>
</Journal>
<ArticleTitle>Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial.</ArticleTitle>
<Pagination><MedlinePgn>821-9</MedlinePgn>
</Pagination>
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<Abstract><AbstractText>RESPONSE is an open-label phase 3 study evaluating the Janus kinase 1/Janus kinase 2 inhibitor ruxolitinib versus best available therapy for efficacy/safety in hydroxyurea-resistant or intolerant patients with polycythemia vera. This preplanned analysis occurred when all patients completed the Week 80 visit or discontinued. Objectives included evaluating the durability of the primary response (Week 32 phlebotomy-independent hematocrit control plus ≥35% spleen volume reduction), its components, and that of complete hematologic remission; and long-term safety. Median exposure was 111 weeks; 91/110 (82.7%) patients randomized to ruxolitinib remained on treatment. No patients continued best available therapy (98/112 [87.5%] crossed over to ruxolitinib, most at/soon after Week 32). At Week 32, primary response was achieved by 22.7% vs. 0.9% of patients randomized to ruxolitinib and best available therapy, respectively (hematocrit control, 60.0% vs. 18.8%; spleen response, 40.0% vs. 0.9%). The probability of maintaining primary and hematocrit responses for ≥80 weeks was 92% and 89%, respectively; 43/44 spleen responses were maintained until Week 80. Complete hematologic remission at Week 32 was achieved in 23.6% of ruxolitinib-randomized patients; the probability of maintaining complete hematologic remission for ≥80 weeks was 69%. Among ruxolitinib crossover patients, 79.2% were not phlebotomized, and 18.8% achieved a ≥35% reduction from baseline in spleen volume after 32 weeks of treatment. New or worsening hematologic laboratory abnormalities in ruxolitinib-treated patients were primarily grade 1/2 decreases in hemoglobin, lymphocytes, and platelets. The thromboembolic event rate per 100 patient-years was 1.8 with randomized ruxolitinib treatment vs. 8.2 with best available therapy. These data support ruxolitinib as an effective long-term treatment option for hydroxyurea-resistant or intolerant patients with polycythemia vera. This trial was registered at clinicaltrials.gov identifier: 01243944.</AbstractText>
<CopyrightInformation>Copyright© Ferrata Storti Foundation.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Verstovsek</LastName>
<ForeName>Srdan</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA sverstov@mdanderson.org.</Affiliation>
</AffiliationInfo>
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<ForeName>Alessandro M</ForeName>
<Initials>AM</Initials>
<AffiliationInfo><Affiliation>Center for Research and Innovation of Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Italy.</Affiliation>
</AffiliationInfo>
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<ForeName>Martin</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Johannes Wesling Clinic, Minden, Germany.</Affiliation>
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<AffiliationInfo><Affiliation>Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.</Affiliation>
</AffiliationInfo>
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<ForeName>Claire N</ForeName>
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<AffiliationInfo><Affiliation>Guy's and St. Thomas' NHS Foundation Trust, London, UK.</Affiliation>
</AffiliationInfo>
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<ForeName>Fabrizio</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>University of Naples Federico II, Italy.</Affiliation>
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</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Besses</LastName>
<ForeName>Carlos</ForeName>
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<ForeName>Masayuki</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Clinical Hematology and Diagnostics, Osaka City University Graduate School of Medicine, Japan.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Beatriz</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Miller</LastName>
<ForeName>Carole B</ForeName>
<Initials>CB</Initials>
<AffiliationInfo><Affiliation>Saint Agnes Cancer Institute, Baltimore, MD, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cazzola</LastName>
<ForeName>Mario</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Hematology, University of Pavia, Italy.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Rosti</LastName>
<ForeName>Vittorio</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Center for the Study of Myelofibrosis, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.</Affiliation>
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<ForeName>Jean-Jacques</ForeName>
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   |texte=   Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial.
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	Serveur d'exploration sur les relations entre la France et l'Australie
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Serveur d'exploration sur les relations entre la France et l'Australie

Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial.

Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial.

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