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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies</title><author><name sortKey="Mesa, Ruben A" sort="Mesa, Ruben A" uniqKey="Mesa R" first="Ruben A." last="Mesa">Ruben A. Mesa</name><affiliation><nlm:aff id="af1-0990292">Mayo Clinic, Scottsdale, AZ, USA</nlm:aff></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><nlm:aff id="af2-0990292">Hôpital Saint-Louis et Université Paris Diderot, Paris, France</nlm:aff></affiliation></author><author><name sortKey="Verstovsek, Srdan" sort="Verstovsek, Srdan" uniqKey="Verstovsek S" first="Srdan" last="Verstovsek">Srdan Verstovsek</name><affiliation><nlm:aff id="af3-0990292">The University of Texas, MD Anderson Cancer Center, Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Al Ali, Haifa Kathrin" sort="Al Ali, Haifa Kathrin" uniqKey="Al Ali H" first="Haifa Kathrin" last="Al-Ali">Haifa Kathrin Al-Ali</name><affiliation><nlm:aff id="af4-0990292">University of Leipzig, Germany</nlm:aff></affiliation></author><author><name sortKey="Gotlib, Jason" sort="Gotlib, Jason" uniqKey="Gotlib J" first="Jason" last="Gotlib">Jason Gotlib</name><affiliation><nlm:aff id="af5-0990292">Stanford Cancer Institute, Stanford, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Gisslinger, Heinz" sort="Gisslinger, Heinz" uniqKey="Gisslinger H" first="Heinz" last="Gisslinger">Heinz Gisslinger</name><affiliation><nlm:aff id="af6-0990292">Medical University of Vienna, Austria</nlm:aff></affiliation></author><author><name sortKey="Levy, Richard" sort="Levy, Richard" uniqKey="Levy R" first="Richard" last="Levy">Richard Levy</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Siulnik, Andres" sort="Siulnik, Andres" uniqKey="Siulnik A" first="Andres" last="Siulnik">Andres Siulnik</name><affiliation><nlm:aff id="af8-0990292">Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Gupta, Vikas" sort="Gupta, Vikas" uniqKey="Gupta V" first="Vikas" last="Gupta">Vikas Gupta</name><affiliation><nlm:aff id="af9-0990292">Princess Margaret Cancer Centre, University of Toronto, Ontario, Canada</nlm:aff></affiliation></author><author><name sortKey="Khan, Mahmudul" sort="Khan, Mahmudul" uniqKey="Khan M" first="Mahmudul" last="Khan">Mahmudul Khan</name><affiliation><nlm:aff id="af8-0990292">Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Dipersio, John F" sort="Dipersio, John F" uniqKey="Dipersio J" first="John F." last="Dipersio">John F. Dipersio</name><affiliation><nlm:aff id="af10-0990292">Washington University School of Medicine, St. Louis, MO, USA</nlm:aff></affiliation></author><author><name sortKey="Mcquitty, Mari" sort="Mcquitty, Mari" uniqKey="Mcquitty M" first="Mari" last="Mcquitty">Mari Mcquitty</name><affiliation><nlm:aff id="af11-0990292">Novartis Pharma, Basel, Switzerland</nlm:aff></affiliation></author><author><name sortKey="Catalano, John V" sort="Catalano, John V" uniqKey="Catalano J" first="John V." last="Catalano">John V. Catalano</name><affiliation><nlm:aff id="af12-0990292">Frankston Hospital and Monash University, Frankston, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Hunter, Deborah S" sort="Hunter, Deborah S" uniqKey="Hunter D" first="Deborah S." last="Hunter">Deborah S. Hunter</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Knoops, Laurent" sort="Knoops, Laurent" uniqKey="Knoops L" first="Laurent" last="Knoops">Laurent Knoops</name><affiliation><nlm:aff id="af13-0990292">Cliniques Universitaires Saint-Luc, Université Catholique de Louvain and Ludwig Institute for Cancer Research, Brussels, Belgium</nlm:aff></affiliation></author><author><name sortKey="Deininger, Michael" sort="Deininger, Michael" uniqKey="Deininger M" first="Michael" last="Deininger">Michael Deininger</name><affiliation><nlm:aff id="af14-0990292">Oregon Health and Science University, Portland, OR, USA</nlm:aff></affiliation></author><author><name sortKey="Cervantes, Francisco" sort="Cervantes, Francisco" uniqKey="Cervantes F" first="Francisco" last="Cervantes">Francisco Cervantes</name><affiliation><nlm:aff id="af15-0990292">Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain</nlm:aff></affiliation></author><author><name sortKey="Miller, Carole" sort="Miller, Carole" uniqKey="Miller C" first="Carole" last="Miller">Carole Miller</name><affiliation><nlm:aff id="af16-0990292">Saint Agnes Cancer Institute, Baltimore, MD, USA</nlm:aff></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><nlm:aff id="af17-0990292">University of Florence, Florence, Italy</nlm:aff></affiliation></author><author><name sortKey="Silver, Richard T" sort="Silver, Richard T" uniqKey="Silver R" first="Richard T." last="Silver">Richard T. Silver</name><affiliation><nlm:aff id="af18-0990292">Weill Cornell Medical College, New York, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Barbui, Tiziano" sort="Barbui, Tiziano" uniqKey="Barbui T" first="Tiziano" last="Barbui">Tiziano Barbui</name><affiliation><nlm:aff id="af19-0990292">A.O. Ospedali Riuniti di Bergamo, Italy</nlm:aff></affiliation></author><author><name sortKey="Talpaz, Moshe" sort="Talpaz, Moshe" uniqKey="Talpaz M" first="Moshe" last="Talpaz">Moshe Talpaz</name><affiliation><nlm:aff id="af20-0990292">University of Michigan, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Barosi, Giovanni" sort="Barosi, Giovanni" uniqKey="Barosi G" first="Giovanni" last="Barosi">Giovanni Barosi</name><affiliation><nlm:aff id="af21-0990292">IRCCS Policlinico San Matteo Foundation, Pavia, Italy</nlm:aff></affiliation></author><author><name sortKey="Winton, Elliott F" sort="Winton, Elliott F" uniqKey="Winton E" first="Elliott F." last="Winton">Elliott F. Winton</name><affiliation><nlm:aff id="af22-0990292">Emory University School of Medicine, Atlanta, GA, USA</nlm:aff></affiliation></author><author><name sortKey="Mendeson, Estella" sort="Mendeson, Estella" uniqKey="Mendeson E" first="Estella" last="Mendeson">Estella Mendeson</name><affiliation><nlm:aff id="af8-0990292">Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Harvey, Jimmie H" sort="Harvey, Jimmie H" uniqKey="Harvey J" first="Jimmie H." last="Harvey">Jimmie H. Harvey</name><affiliation><nlm:aff id="af23-0990292">Birmingham Hematology and Oncology, Birmingham, AL, USA</nlm:aff></affiliation></author><author><name sortKey="Arcasoy, Murat O" sort="Arcasoy, Murat O" uniqKey="Arcasoy M" first="Murat O." last="Arcasoy">Murat O. Arcasoy</name><affiliation><nlm:aff id="af24-0990292">Duke University Health System, Durham, NC, USA</nlm:aff></affiliation></author><author><name sortKey="Hexner, Elizabeth" sort="Hexner, Elizabeth" uniqKey="Hexner E" first="Elizabeth" last="Hexner">Elizabeth Hexner</name><affiliation><nlm:aff id="af25-0990292">Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Lyons, Roger M" sort="Lyons, Roger M" uniqKey="Lyons R" first="Roger M." last="Lyons">Roger M. Lyons</name><affiliation><nlm:aff id="af26-0990292">Cancer Care Centers of South Texas and US Oncology, San Antonio, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Paquette, Ronald" sort="Paquette, Ronald" uniqKey="Paquette R" first="Ronald" last="Paquette">Ronald Paquette</name><affiliation><nlm:aff id="af27-0990292">UCLA Division of Hematology and Oncology, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Raza, Azra" sort="Raza, Azra" uniqKey="Raza A" first="Azra" last="Raza">Azra Raza</name><affiliation><nlm:aff id="af28-0990292">Columbia Presbyterian Medical Center, New York, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Sun, William" sort="Sun, William" uniqKey="Sun W" first="William" last="Sun">William Sun</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Sandor, Victor" sort="Sandor, Victor" uniqKey="Sandor V" first="Victor" last="Sandor">Victor Sandor</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:aff id="af3-0990292">The University of Texas, MD Anderson Cancer Center, Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Harrison, Claire" sort="Harrison, Claire" uniqKey="Harrison C" first="Claire" last="Harrison">Claire Harrison</name><affiliation><nlm:aff id="af29-0990292">Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, UK</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23911705</idno><idno type="pmc">3912959</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3912959</idno><idno type="RBID">PMC:3912959</idno><idno type="doi">10.3324/haematol.2013.087650</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">001856</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001856</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies</title><author><name sortKey="Mesa, Ruben A" sort="Mesa, Ruben A" uniqKey="Mesa R" first="Ruben A." last="Mesa">Ruben A. Mesa</name><affiliation><nlm:aff id="af1-0990292">Mayo Clinic, Scottsdale, AZ, USA</nlm:aff></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><nlm:aff id="af2-0990292">Hôpital Saint-Louis et Université Paris Diderot, Paris, France</nlm:aff></affiliation></author><author><name sortKey="Verstovsek, Srdan" sort="Verstovsek, Srdan" uniqKey="Verstovsek S" first="Srdan" last="Verstovsek">Srdan Verstovsek</name><affiliation><nlm:aff id="af3-0990292">The University of Texas, MD Anderson Cancer Center, Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Al Ali, Haifa Kathrin" sort="Al Ali, Haifa Kathrin" uniqKey="Al Ali H" first="Haifa Kathrin" last="Al-Ali">Haifa Kathrin Al-Ali</name><affiliation><nlm:aff id="af4-0990292">University of Leipzig, Germany</nlm:aff></affiliation></author><author><name sortKey="Gotlib, Jason" sort="Gotlib, Jason" uniqKey="Gotlib J" first="Jason" last="Gotlib">Jason Gotlib</name><affiliation><nlm:aff id="af5-0990292">Stanford Cancer Institute, Stanford, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Gisslinger, Heinz" sort="Gisslinger, Heinz" uniqKey="Gisslinger H" first="Heinz" last="Gisslinger">Heinz Gisslinger</name><affiliation><nlm:aff id="af6-0990292">Medical University of Vienna, Austria</nlm:aff></affiliation></author><author><name sortKey="Levy, Richard" sort="Levy, Richard" uniqKey="Levy R" first="Richard" last="Levy">Richard Levy</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Siulnik, Andres" sort="Siulnik, Andres" uniqKey="Siulnik A" first="Andres" last="Siulnik">Andres Siulnik</name><affiliation><nlm:aff id="af8-0990292">Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Gupta, Vikas" sort="Gupta, Vikas" uniqKey="Gupta V" first="Vikas" last="Gupta">Vikas Gupta</name><affiliation><nlm:aff id="af9-0990292">Princess Margaret Cancer Centre, University of Toronto, Ontario, Canada</nlm:aff></affiliation></author><author><name sortKey="Khan, Mahmudul" sort="Khan, Mahmudul" uniqKey="Khan M" first="Mahmudul" last="Khan">Mahmudul Khan</name><affiliation><nlm:aff id="af8-0990292">Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Dipersio, John F" sort="Dipersio, John F" uniqKey="Dipersio J" first="John F." last="Dipersio">John F. Dipersio</name><affiliation><nlm:aff id="af10-0990292">Washington University School of Medicine, St. Louis, MO, USA</nlm:aff></affiliation></author><author><name sortKey="Mcquitty, Mari" sort="Mcquitty, Mari" uniqKey="Mcquitty M" first="Mari" last="Mcquitty">Mari Mcquitty</name><affiliation><nlm:aff id="af11-0990292">Novartis Pharma, Basel, Switzerland</nlm:aff></affiliation></author><author><name sortKey="Catalano, John V" sort="Catalano, John V" uniqKey="Catalano J" first="John V." last="Catalano">John V. Catalano</name><affiliation><nlm:aff id="af12-0990292">Frankston Hospital and Monash University, Frankston, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Hunter, Deborah S" sort="Hunter, Deborah S" uniqKey="Hunter D" first="Deborah S." last="Hunter">Deborah S. Hunter</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Knoops, Laurent" sort="Knoops, Laurent" uniqKey="Knoops L" first="Laurent" last="Knoops">Laurent Knoops</name><affiliation><nlm:aff id="af13-0990292">Cliniques Universitaires Saint-Luc, Université Catholique de Louvain and Ludwig Institute for Cancer Research, Brussels, Belgium</nlm:aff></affiliation></author><author><name sortKey="Deininger, Michael" sort="Deininger, Michael" uniqKey="Deininger M" first="Michael" last="Deininger">Michael Deininger</name><affiliation><nlm:aff id="af14-0990292">Oregon Health and Science University, Portland, OR, USA</nlm:aff></affiliation></author><author><name sortKey="Cervantes, Francisco" sort="Cervantes, Francisco" uniqKey="Cervantes F" first="Francisco" last="Cervantes">Francisco Cervantes</name><affiliation><nlm:aff id="af15-0990292">Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain</nlm:aff></affiliation></author><author><name sortKey="Miller, Carole" sort="Miller, Carole" uniqKey="Miller C" first="Carole" last="Miller">Carole Miller</name><affiliation><nlm:aff id="af16-0990292">Saint Agnes Cancer Institute, Baltimore, MD, USA</nlm:aff></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><nlm:aff id="af17-0990292">University of Florence, Florence, Italy</nlm:aff></affiliation></author><author><name sortKey="Silver, Richard T" sort="Silver, Richard T" uniqKey="Silver R" first="Richard T." last="Silver">Richard T. Silver</name><affiliation><nlm:aff id="af18-0990292">Weill Cornell Medical College, New York, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Barbui, Tiziano" sort="Barbui, Tiziano" uniqKey="Barbui T" first="Tiziano" last="Barbui">Tiziano Barbui</name><affiliation><nlm:aff id="af19-0990292">A.O. Ospedali Riuniti di Bergamo, Italy</nlm:aff></affiliation></author><author><name sortKey="Talpaz, Moshe" sort="Talpaz, Moshe" uniqKey="Talpaz M" first="Moshe" last="Talpaz">Moshe Talpaz</name><affiliation><nlm:aff id="af20-0990292">University of Michigan, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Barosi, Giovanni" sort="Barosi, Giovanni" uniqKey="Barosi G" first="Giovanni" last="Barosi">Giovanni Barosi</name><affiliation><nlm:aff id="af21-0990292">IRCCS Policlinico San Matteo Foundation, Pavia, Italy</nlm:aff></affiliation></author><author><name sortKey="Winton, Elliott F" sort="Winton, Elliott F" uniqKey="Winton E" first="Elliott F." last="Winton">Elliott F. Winton</name><affiliation><nlm:aff id="af22-0990292">Emory University School of Medicine, Atlanta, GA, USA</nlm:aff></affiliation></author><author><name sortKey="Mendeson, Estella" sort="Mendeson, Estella" uniqKey="Mendeson E" first="Estella" last="Mendeson">Estella Mendeson</name><affiliation><nlm:aff id="af8-0990292">Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA</nlm:aff></affiliation></author><author><name sortKey="Harvey, Jimmie H" sort="Harvey, Jimmie H" uniqKey="Harvey J" first="Jimmie H." last="Harvey">Jimmie H. Harvey</name><affiliation><nlm:aff id="af23-0990292">Birmingham Hematology and Oncology, Birmingham, AL, USA</nlm:aff></affiliation></author><author><name sortKey="Arcasoy, Murat O" sort="Arcasoy, Murat O" uniqKey="Arcasoy M" first="Murat O." last="Arcasoy">Murat O. Arcasoy</name><affiliation><nlm:aff id="af24-0990292">Duke University Health System, Durham, NC, USA</nlm:aff></affiliation></author><author><name sortKey="Hexner, Elizabeth" sort="Hexner, Elizabeth" uniqKey="Hexner E" first="Elizabeth" last="Hexner">Elizabeth Hexner</name><affiliation><nlm:aff id="af25-0990292">Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Lyons, Roger M" sort="Lyons, Roger M" uniqKey="Lyons R" first="Roger M." last="Lyons">Roger M. Lyons</name><affiliation><nlm:aff id="af26-0990292">Cancer Care Centers of South Texas and US Oncology, San Antonio, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Paquette, Ronald" sort="Paquette, Ronald" uniqKey="Paquette R" first="Ronald" last="Paquette">Ronald Paquette</name><affiliation><nlm:aff id="af27-0990292">UCLA Division of Hematology and Oncology, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Raza, Azra" sort="Raza, Azra" uniqKey="Raza A" first="Azra" last="Raza">Azra Raza</name><affiliation><nlm:aff id="af28-0990292">Columbia Presbyterian Medical Center, New York, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Sun, William" sort="Sun, William" uniqKey="Sun W" first="William" last="Sun">William Sun</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Sandor, Victor" sort="Sandor, Victor" uniqKey="Sandor V" first="Victor" last="Sandor">Victor Sandor</name><affiliation><nlm:aff id="af7-0990292">Incyte Corporation, Wilmington, DE, USA</nlm:aff></affiliation></author><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M." last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:aff id="af3-0990292">The University of Texas, MD Anderson Cancer Center, Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Harrison, Claire" sort="Harrison, Claire" uniqKey="Harrison C" first="Claire" last="Harrison">Claire Harrison</name><affiliation><nlm:aff id="af29-0990292">Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, UK</nlm:aff></affiliation></author></analytic><series><title level="j">Haematologica</title><idno type="ISSN">0390-6078</idno><idno type="eISSN">1592-8721</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Prior to Janus kinase inhibitors, available therapies for myelofibrosis were generally supportive and did not improve survival. This analysis compares efficacy outcomes of patients with myelofibrosis in the control arms (placebo [n=154] and best available therapy [n=73]) from the two phase 3 COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (COMFORT) studies. Spleen volume was assessed by magnetic resonance imaging/computed tomography at baseline and every 12 weeks through week 72; spleen length was assessed by palpation at each study visit. Health-related quality of life and symptoms were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items at baseline and in weeks 4, 8, 12, 16 and 24 in COMFORT-I and in weeks 8, 16, 24 and 48 in COMFORT-II. The demographic and baseline characteristics were similar between the control arms of the two studies. One patient who received placebo and no patients who received best available therapy had a ≥35% reduction in spleen volume from baseline at week 24. At 24 weeks, neither placebo nor best available therapy had produced clinically meaningful changes in global quality of life or symptom scales. Non-hematologic adverse events were mostly grade 1/2; the most frequently reported adverse events in each group were abdominal pain, fatigue, peripheral edema and diarrhea. These data suggest that non–Janus kinase inhibitor therapies provide little improvement in splenomegaly, symptoms or quality of life as compared with placebo. Both COMFORT-I (NCT00952289) and COMFORT-II (NCT00934544) studies have been appropriately registered with <ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link>.</p></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Haematologica</journal-id><journal-id journal-id-type="iso-abbrev">Haematologica</journal-id><journal-id journal-id-type="hwp">haematol</journal-id><journal-id journal-id-type="publisher-id">Haematologica</journal-id><journal-title-group><journal-title>Haematologica</journal-title></journal-title-group><issn pub-type="ppub">0390-6078</issn><issn pub-type="epub">1592-8721</issn><publisher><publisher-name>Ferrata Storti Foundation</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">23911705</article-id><article-id pub-id-type="pmc">3912959</article-id><article-id pub-id-type="doi">10.3324/haematol.2013.087650</article-id><article-id pub-id-type="publisher-id">0990292</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject><subj-group><subject>Chronic Myeloproliferative Syndromes</subject></subj-group></subj-group></article-categories><title-group><article-title>Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Mesa</surname><given-names>Ruben A.</given-names></name><xref ref-type="aff" rid="af1-0990292">1</xref></contrib><contrib contrib-type="author"><name><surname>Kiladjian</surname><given-names>Jean-Jacques</given-names></name><xref ref-type="aff" rid="af2-0990292">2</xref></contrib><contrib contrib-type="author"><name><surname>Verstovsek</surname><given-names>Srdan</given-names></name><xref ref-type="aff" rid="af3-0990292">3</xref></contrib><contrib contrib-type="author"><name><surname>Al-Ali</surname><given-names>Haifa Kathrin</given-names></name><xref ref-type="aff" rid="af4-0990292">4</xref></contrib><contrib contrib-type="author"><name><surname>Gotlib</surname><given-names>Jason</given-names></name><xref ref-type="aff" rid="af5-0990292">5</xref></contrib><contrib contrib-type="author"><name><surname>Gisslinger</surname><given-names>Heinz</given-names></name><xref ref-type="aff" rid="af6-0990292">6</xref></contrib><contrib contrib-type="author"><name><surname>Levy</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="af7-0990292">7</xref></contrib><contrib contrib-type="author"><name><surname>Siulnik</surname><given-names>Andres</given-names></name><xref ref-type="aff" rid="af8-0990292">8</xref></contrib><contrib contrib-type="author"><name><surname>Gupta</surname><given-names>Vikas</given-names></name><xref ref-type="aff" rid="af9-0990292">9</xref></contrib><contrib contrib-type="author"><name><surname>Khan</surname><given-names>Mahmudul</given-names></name><xref ref-type="aff" rid="af8-0990292">8</xref></contrib><contrib contrib-type="author"><name><surname>DiPersio</surname><given-names>John F.</given-names></name><xref ref-type="aff" rid="af10-0990292">10</xref></contrib><contrib contrib-type="author"><name><surname>McQuitty</surname><given-names>Mari</given-names></name><xref ref-type="aff" rid="af11-0990292">11</xref></contrib><contrib contrib-type="author"><name><surname>Catalano</surname><given-names>John V.</given-names></name><xref ref-type="aff" rid="af12-0990292">12</xref></contrib><contrib contrib-type="author"><name><surname>Hunter</surname><given-names>Deborah S.</given-names></name><xref ref-type="aff" rid="af7-0990292">7</xref></contrib><contrib contrib-type="author"><name><surname>Knoops</surname><given-names>Laurent</given-names></name><xref ref-type="aff" rid="af13-0990292">13</xref></contrib><contrib contrib-type="author"><name><surname>Deininger</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="af14-0990292">14</xref></contrib><contrib contrib-type="author"><name><surname>Cervantes</surname><given-names>Francisco</given-names></name><xref ref-type="aff" rid="af15-0990292">15</xref></contrib><contrib contrib-type="author"><name><surname>Miller</surname><given-names>Carole</given-names></name><xref ref-type="aff" rid="af16-0990292">16</xref></contrib><contrib contrib-type="author"><name><surname>Vannucchi</surname><given-names>Alessandro M.</given-names></name><xref ref-type="aff" rid="af17-0990292">17</xref></contrib><contrib contrib-type="author"><name><surname>Silver</surname><given-names>Richard T.</given-names></name><xref ref-type="aff" rid="af18-0990292">18</xref></contrib><contrib contrib-type="author"><name><surname>Barbui</surname><given-names>Tiziano</given-names></name><xref ref-type="aff" rid="af19-0990292">19</xref></contrib><contrib contrib-type="author"><name><surname>Talpaz</surname><given-names>Moshe</given-names></name><xref ref-type="aff" rid="af20-0990292">20</xref></contrib><contrib contrib-type="author"><name><surname>Barosi</surname><given-names>Giovanni</given-names></name><xref ref-type="aff" rid="af21-0990292">21</xref></contrib><contrib contrib-type="author"><name><surname>Winton</surname><given-names>Elliott F.</given-names></name><xref ref-type="aff" rid="af22-0990292">22</xref></contrib><contrib contrib-type="author"><name><surname>Mendeson</surname><given-names>Estella</given-names></name><xref ref-type="aff" rid="af8-0990292">8</xref></contrib><contrib contrib-type="author"><name><surname>Harvey</surname><given-names>Jimmie H.</given-names><suffix>Jr</suffix></name><xref ref-type="aff" rid="af23-0990292">23</xref></contrib><contrib contrib-type="author"><name><surname>Arcasoy</surname><given-names>Murat O.</given-names></name><xref ref-type="aff" rid="af24-0990292">24</xref></contrib><contrib contrib-type="author"><name><surname>Hexner</surname><given-names>Elizabeth</given-names></name><xref ref-type="aff" rid="af25-0990292">25</xref></contrib><contrib contrib-type="author"><name><surname>Lyons</surname><given-names>Roger M.</given-names></name><xref ref-type="aff" rid="af26-0990292">26</xref></contrib><contrib contrib-type="author"><name><surname>Paquette</surname><given-names>Ronald</given-names></name><xref ref-type="aff" rid="af27-0990292">27</xref></contrib><contrib contrib-type="author"><name><surname>Raza</surname><given-names>Azra</given-names></name><xref ref-type="aff" rid="af28-0990292">28</xref></contrib><contrib contrib-type="author"><name><surname>Sun</surname><given-names>William</given-names></name><xref ref-type="aff" rid="af7-0990292">7</xref></contrib><contrib contrib-type="author"><name><surname>Sandor</surname><given-names>Victor</given-names></name><xref ref-type="aff" rid="af7-0990292">7</xref></contrib><contrib contrib-type="author"><name><surname>Kantarjian</surname><given-names>Hagop M.</given-names></name><xref ref-type="aff" rid="af3-0990292">3</xref></contrib><contrib contrib-type="author"><name><surname>Harrison</surname><given-names>Claire</given-names></name><xref ref-type="aff" rid="af29-0990292">29</xref><xref ref-type="corresp" rid="c1-0990292"></xref></contrib></contrib-group><aff id="af1-0990292"><label>1</label>Mayo Clinic, Scottsdale, AZ, USA</aff><aff id="af2-0990292"><label>2</label>Hôpital Saint-Louis et Université Paris Diderot, Paris, France</aff><aff id="af3-0990292"><label>3</label>The University of Texas, MD Anderson Cancer Center, Houston, TX, USA</aff><aff id="af4-0990292"><label>4</label>University of Leipzig, Germany</aff><aff id="af5-0990292"><label>5</label>Stanford Cancer Institute, Stanford, CA, USA</aff><aff id="af6-0990292"><label>6</label>Medical University of Vienna, Austria</aff><aff id="af7-0990292"><label>7</label>Incyte Corporation, Wilmington, DE, USA</aff><aff id="af8-0990292"><label>8</label>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA</aff><aff id="af9-0990292"><label>9</label>Princess Margaret Cancer Centre, University of Toronto, Ontario, Canada</aff><aff id="af10-0990292"><label>10</label>Washington University School of Medicine, St. Louis, MO, USA</aff><aff id="af11-0990292"><label>11</label>Novartis Pharma, Basel, Switzerland</aff><aff id="af12-0990292"><label>12</label>Frankston Hospital and Monash University, Frankston, Victoria, Australia</aff><aff id="af13-0990292"><label>13</label>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain and Ludwig Institute for Cancer Research, Brussels, Belgium</aff><aff id="af14-0990292"><label>14</label>Oregon Health and Science University, Portland, OR, USA</aff><aff id="af15-0990292"><label>15</label>Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain</aff><aff id="af16-0990292"><label>16</label>Saint Agnes Cancer Institute, Baltimore, MD, USA</aff><aff id="af17-0990292"><label>17</label>University of Florence, Florence, Italy</aff><aff id="af18-0990292"><label>18</label>Weill Cornell Medical College, New York, NY, USA</aff><aff id="af19-0990292"><label>19</label>A.O. Ospedali Riuniti di Bergamo, Italy</aff><aff id="af20-0990292"><label>20</label>University of Michigan, Ann Arbor, MI, USA</aff><aff id="af21-0990292"><label>21</label>IRCCS Policlinico San Matteo Foundation, Pavia, Italy</aff><aff id="af22-0990292"><label>22</label>Emory University School of Medicine, Atlanta, GA, USA</aff><aff id="af23-0990292"><label>23</label>Birmingham Hematology and Oncology, Birmingham, AL, USA</aff><aff id="af24-0990292"><label>24</label>Duke University Health System, Durham, NC, USA</aff><aff id="af25-0990292"><label>25</label>Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA, USA</aff><aff id="af26-0990292"><label>26</label>Cancer Care Centers of South Texas and US Oncology, San Antonio, TX, USA</aff><aff id="af27-0990292"><label>27</label>UCLA Division of Hematology and Oncology, Los Angeles, CA, USA</aff><aff id="af28-0990292"><label>28</label>Columbia Presbyterian Medical Center, New York, NY, USA</aff><aff id="af29-0990292"><label>29</label>Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, UK</aff><author-notes><corresp id="c1-0990292">Correspondence: <email>claire.harrison@gstt.nhs.uk</email></corresp></author-notes><pub-date pub-type="ppub"><month>2</month><year>2014</year></pub-date><volume>99</volume><issue>2</issue><fpage>292</fpage><lpage>298</lpage><history><date date-type="received"><day>15</day><month>3</month><year>2013</year></date><date date-type="accepted"><day>02</day><month>8</month><year>2013</year></date></history><permissions><copyright-statement>Copyright© Ferrata Storti Foundation</copyright-statement><copyright-year>2014</copyright-year></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="99292.pdf"></self-uri><abstract><p>Prior to Janus kinase inhibitors, available therapies for myelofibrosis were generally supportive and did not improve survival. This analysis compares efficacy outcomes of patients with myelofibrosis in the control arms (placebo [n=154] and best available therapy [n=73]) from the two phase 3 COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (COMFORT) studies. Spleen volume was assessed by magnetic resonance imaging/computed tomography at baseline and every 12 weeks through week 72; spleen length was assessed by palpation at each study visit. Health-related quality of life and symptoms were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items at baseline and in weeks 4, 8, 12, 16 and 24 in COMFORT-I and in weeks 8, 16, 24 and 48 in COMFORT-II. The demographic and baseline characteristics were similar between the control arms of the two studies. One patient who received placebo and no patients who received best available therapy had a ≥35% reduction in spleen volume from baseline at week 24. At 24 weeks, neither placebo nor best available therapy had produced clinically meaningful changes in global quality of life or symptom scales. Non-hematologic adverse events were mostly grade 1/2; the most frequently reported adverse events in each group were abdominal pain, fatigue, peripheral edema and diarrhea. These data suggest that non–Janus kinase inhibitor therapies provide little improvement in splenomegaly, symptoms or quality of life as compared with placebo. Both COMFORT-I (NCT00952289) and COMFORT-II (NCT00934544) studies have been appropriately registered with <ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link>.</p></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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