{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T01:59:51Z","timestamp":1793411991910,"version":"4.5.0"},"reference-count":17,"publisher":"American Society of Hematology","issue":"19","license":[{"start":{"date-parts":[[2022,1,10]],"date-time":"2022-01-10T00:00:00Z","timestamp":1641772800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/legalcode"}],"content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,5,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>The goal of therapy for patients with essential thrombocythemia (ET) and polycythemia vera (PV) is to reduce thrombotic events by normalizing blood counts. Hydroxyurea (HU) and interferon-\u03b1 (IFN-\u03b1) are the most frequently used cytoreductive options for patients with ET and PV at high risk for vascular complications. Myeloproliferative Disorders Research Consortium 112 was an investigator-initiated, phase 3 trial comparing HU to pegylated IFN-\u03b1 (PEG) in treatment-na\u00efve, high-risk patients with ET\/PV. The primary endpoint was complete response (CR) rate at 12 months. A total of 168 patients were treated for a median of 81.0 weeks. CR for HU was 37% and 35% for PEG (P = .80) at 12 months. At 24 to 36 months, CR was 20% to 17% for HU and 29% to 33% for PEG. PEG led to a greater reduction in JAK2V617F at 24 months, but histopathologic responses were more frequent with HU. Thrombotic events and disease progression were infrequent in both arms, whereas grade 3\/4 adverse events were more frequent with PEG (46% vs 28%). At 12 months of treatment, there was no significant difference in CR rates between HU and PEG. This study indicates that PEG and HU are both effective treatments for PV and ET. With longer treatment, PEG was more effective in normalizing blood counts and reducing driver mutation burden, whereas HU produced more histopathologic responses. Despite these differences, both agents did not differ in limiting thrombotic events and disease progression in high-risk patients with ET\/PV. This trial was registered at www.clinicaltrials.gov as #NCT01259856.<\/jats:p>","DOI":"10.1182\/blood.2021012743","type":"journal-article","created":{"date-parts":[[2022,1,10]],"date-time":"2022-01-10T18:54:37Z","timestamp":1641840877000},"page":"2931-2941","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":141,"title":["A randomized phase 3 trial of interferon-\u03b1 vs hydroxyurea in polycythemia vera and essential thrombocythemia"],"prefix":"10.1182","volume":"139","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8400-0483","authenticated-orcid":false,"given":"John","family":"Mascarenhas","sequence":"first","affiliation":[{"name":"The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heidi E.","family":"Kosiorek","sequence":"additional","affiliation":[{"name":"Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8019-2940","authenticated-orcid":false,"given":"Josef T.","family":"Prchal","sequence":"additional","affiliation":[{"name":"Division of Hematology and Hematologic Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Rambaldi","sequence":"additional","affiliation":[{"name":"Hematology and Bone Marrow Transplantation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitriy","family":"Berenzon","sequence":"additional","affiliation":[{"name":"Comprehensive Cancer Center, Wake Forest Baptist Health, Comprehensive Cancer Center, Winston-Salem, NC;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5293-4620","authenticated-orcid":false,"given":"Abdulraheem","family":"Yacoub","sequence":"additional","affiliation":[{"name":"Kansas University Cancer Center, Leawood, KS;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire N.","family":"Harrison","sequence":"additional","affiliation":[{"name":"Department of Haematology, Guy\u2019s Hospital, London, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0773-0204","authenticated-orcid":false,"given":"Mary Frances","family":"McMullin","sequence":"additional","affiliation":[{"name":"Queen\u2019s University Belfast, Belfast, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5755-0730","authenticated-orcid":false,"given":"Alessandro M.","family":"Vannucchi","sequence":"additional","affiliation":[{"name":"University of Florence, Azienda Ospedaliero Universitaria Careggi, Florence, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanne","family":"Ewing","sequence":"additional","affiliation":[{"name":"Heart of England NHS Foundation Trust, UHB, Birmingham, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Casey L.","family":"O'Connell","sequence":"additional","affiliation":[{"name":"Keck School of Medicine, University of Southern California, Los Angeles, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8121-438X","authenticated-orcid":false,"given":"Jean-Jacques","family":"Kiladjian","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris, Assistance Publique\u2013H\u00f4pitaux de Paris (AP-HP), H\u00f4pital Saint-Louis, Centre d\u2019Investigations Cliniques, INSERM, Paris, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8522-1002","authenticated-orcid":false,"given":"Adam J.","family":"Mead","sequence":"additional","affiliation":[{"name":"Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elliott F.","family":"Winton","sequence":"additional","affiliation":[{"name":"Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5254-9829","authenticated-orcid":false,"given":"David S.","family":"Leibowitz","sequence":"additional","affiliation":[{"name":"Oncology Department, Palo Alto Medical Foundation Sutter Health, Cupertino, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5178-5827","authenticated-orcid":false,"given":"Valerio","family":"De Stefano","sequence":"additional","affiliation":[{"name":"Section of Hematology, Department of Radiological and Hematological Sciences, Catholic University, Fondazione Policlinico Universitario A. 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