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A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia.
Mascarenhas, John; Kosiorek, Heidi E; Prchal, Josef T; Rambaldi, Alessandro; Berenzon, Dmitriy; Yacoub, Abdulraheem; Harrison, Claire N; McMullin, Mary Frances; Vannucchi, Alessandro M; Ewing, Joanne; O'Connell, Casey L; Kiladjian, Jean-Jacques; Mead, Adam J; Winton, Elliott F; Leibowitz, David S; De Stefano, Valerio; Arcasoy, Murat O; Kessler, Craig M; Catchatourian, Rosalind; Rondelli, Damiano; Silver, Richard T; Bacigalupo, Andrea; Nagler, Arnon; Kremyanskaya, Marina; Levine, Max F; Arango Ossa, Juan E; McGovern, Erin; Sandy, Lonette; Salama, Mohamad E; Najfeld, Vesna; Tripodi, Joseph; Farnoud, Noushin; Penson, Alexander V; Weinberg, Rona Singer; Price, Leah; Goldberg, Judith D; Barbui, Tiziano; Marchioli, Roberto; Tognoni, Gianni; Rampal, Raajit K; Mesa, Ruben A; Dueck, Amylou C; Hoffman, Ronald.
Afiliación
  • Mascarenhas J; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
  • Kosiorek HE; Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ.
  • Prchal JT; Division of Hematology and Hematologic Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.
  • Rambaldi A; Hematology and Bone Marrow Transplantation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
  • Berenzon D; Comprehensive Cancer Center, Wake Forest Baptist Health, Comprehensive Cancer Center, Winston-Salem, NC.
  • Yacoub A; Kansas University Cancer Center, Leawood, KS.
  • Harrison CN; Department of Haematology, Guy's Hospital, London, United Kingdom.
  • McMullin MF; Queen's University Belfast, Belfast, United Kingdom.
  • Vannucchi AM; University of Florence, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.
  • Ewing J; Heart of England NHS Foundation Trust, UHB, Birmingham, United Kingdom.
  • O'Connell CL; Keck School of Medicine, University of Southern California, Los Angeles, CA.
  • Kiladjian JJ; Université de Paris, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint-Louis, Centre d'Investigations Cliniques, INSERM, Paris, France.
  • Mead AJ; Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
  • Winton EF; Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA.
  • Leibowitz DS; Oncology Department, Palo Alto Medical Foundation Sutter Health, Cupertino, CA.
  • De Stefano V; Section of Hematology, Department of Radiological and Hematological Sciences, Catholic University, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
  • Arcasoy MO; Duke University School of Medicine, Durham, NC.
  • Kessler CM; Georgetown University Medical Center, Washington, DC.
  • Catchatourian R; Oncology Department, John H. Stroger Jr Hospital of Cook County, Chicago, IL.
  • Rondelli D; Division of Hematology/Oncology, University of Illinois at Chicago, Chicago, IL.
  • Silver RT; Richard T. Silver Myeloproliferative Neoplasms Center, New York Presbyterian Weill Cornell Medical Center, New York, NY.
  • Bacigalupo A; Section of Hematology, Department of Radiological and Hematological Sciences, Catholic University, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
  • Nagler A; Hematology Department, Chaim Sheba Medical Center, Tel Hashomer, Israel.
  • Kremyanskaya M; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
  • Levine MF; Center for Hematologic Malignancies, Memorial Sloan-Kettering Cancer Center, New York, NY.
  • Arango Ossa JE; Center for Hematologic Malignancies, Memorial Sloan-Kettering Cancer Center, New York, NY.
  • McGovern E; Center for Hematologic Malignancies, Memorial Sloan-Kettering Cancer Center, New York, NY.
  • Sandy L; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
  • Salama ME; Mayo Clinic, Rochester, MN.
  • Najfeld V; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
  • Tripodi J; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
  • Farnoud N; Center for Hematologic Malignancies, Memorial Sloan-Kettering Cancer Center, New York, NY.
  • Penson AV; Center for Hematologic Malignancies, Memorial Sloan-Kettering Cancer Center, New York, NY.
  • Weinberg RS; New York Blood Center, New York, NY.
  • Price L; Department of Population Health and.
  • Goldberg JD; Department of Population Health and.
  • Barbui T; Department of Environmental Medicine, New York University School of Medicine, New York, NY.
  • Marchioli R; Papa Giovanni XXIII Hospital, Foundation for Clinical Research (FROM), Bergamo, Italy.
  • Tognoni G; Cardiovascular, Renal and Metabolic Medical and Scientific Services, IQVIA, Milan, Italy.
  • Rampal RK; Department of Anaesthesia and Emergency Urgency, IRCCS, Ospedale Maggiore Policlinico, Milan, Italy.
  • Mesa RA; Leukemia Service, Department of Medicine, Center for Hematologic Malignancies, Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center, Myeloproliferative Neoplasm Research Consortium (MPN-RC), New York, NY; and.
  • Dueck AC; UT Health San Antonio Cancer Center, San Antonio, TX.
  • Hoffman R; Department of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ.
Blood ; 139(19): 2931-2941, 2022 05 12.
Article en En | MEDLINE | ID: mdl-35007321
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-α (IFN-α) 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-α (PEG) in treatment-naïve, 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Policitemia Vera / Trombosis / Trombocitemia Esencial Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Blood Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Policitemia Vera / Trombosis / Trombocitemia Esencial Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Blood Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos