European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013

Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A European LeukemiaNet expert panel reviewed prior and new studies to update recommendations made in 2009. We recommend as initial treatment imatini...

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Published in	Blood Vol. 122; no. 6; pp. 872 - 884
Main Authors	Baccarani, Michele, Deininger, Michael W., Rosti, Gianantonio, Hochhaus, Andreas, Soverini, Simona, Apperley, Jane F., Cervantes, Francisco, Clark, Richard E., Cortes, Jorge E., Guilhot, François, Hjorth-Hansen, Henrik, Hughes, Timothy P., Kantarjian, Hagop M., Kim, Dong-Wook, Larson, Richard A., Lipton, Jeffrey H., Mahon, François-Xavier, Martinelli, Giovanni, Mayer, Jiri, Müller, Martin C., Niederwieser, Dietger, Pane, Fabrizio, Radich, Jerald P., Rousselot, Philippe, Saglio, Giuseppe, Saußele, Susanne, Schiffer, Charles, Silver, Richard, Simonsson, Bengt, Steegmann, Juan-Luis, Goldman, John M., Hehlmann, Rüdiger
Format	Journal Article
Language	English
Published	United States Elsevier Inc 08.08.2013 American Society of Hematology
Subjects	Antineoplastic Agents - therapeutic use Benzamides - therapeutic use Dasatinib Europe Fusion Proteins, bcr-abl - metabolism Human health and pathology Humans Imatinib Mesylate Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy Leukemia, Myelogenous, Chronic, BCR-ABL Positive - therapy Life Sciences Piperazines - therapeutic use Prognosis Pyrimidines - therapeutic use Randomized Controlled Trials as Topic Review Stem Cell Transplantation Thiazoles - therapeutic use Treatment Outcome Europe leukemia dasatinib nilotinib myelocytic second line treatment imatinib mesylate withdrawing treatment cytogenetics chronic protein-tyrosine kinase inhibitor polymerase chain reaction allogeneic stem cell transplant
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Abstract	Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A European LeukemiaNet expert panel reviewed prior and new studies to update recommendations made in 2009. We recommend as initial treatment imatinib, nilotinib, or dasatinib. Response is assessed with standardized real quantitative polymerase chain reaction and/or cytogenetics at 3, 6, and 12 months. BCR-ABL1 transcript levels ≤10% at 3 months, <1% at 6 months, and ≤0.1% from 12 months onward define optimal response, whereas >10% at 6 months and >1% from 12 months onward define failure, mandating a change in treatment. Similarly, partial cytogenetic response (PCyR) at 3 months and complete cytogenetic response (CCyR) from 6 months onward define optimal response, whereas no CyR (Philadelphia chromosome–positive [Ph+] >95%) at 3 months, less than PCyR at 6 months, and less than CCyR from 12 months onward define failure. Between optimal and failure, there is an intermediate warning zone requiring more frequent monitoring. Similar definitions are provided for response to second-line therapy. Specific recommendations are made for patients in the accelerated and blastic phases, and for allogeneic stem cell transplantation. Optimal responders should continue therapy indefinitely, with careful surveillance, or they can be enrolled in controlled studies of treatment discontinuation once a deeper molecular response is achieved.
AbstractList	Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A European LeukemiaNet expert panel reviewed prior and new studies to update recommendations made in 2009. We recommend as initial treatment imatinib, nilotinib, or dasatinib. Response is assessed with standardized real quantitative polymerase chain reaction and/or cytogenetics at 3, 6, and 12 months. BCR-ABL1 transcript levels ≤10% at 3 months, <1% at 6 months, and ≤0.1% from 12 months onward define optimal response, whereas >10% at 6 months and >1% from 12 months onward define failure, mandating a change in treatment. Similarly, partial cytogenetic response (PCyR) at 3 months and complete cytogenetic response (CCyR) from 6 months onward define optimal response, whereas no CyR (Philadelphia chromosome–positive [Ph+] >95%) at 3 months, less than PCyR at 6 months, and less than CCyR from 12 months onward define failure. Between optimal and failure, there is an intermediate warning zone requiring more frequent monitoring. Similar definitions are provided for response to second-line therapy. Specific recommendations are made for patients in the accelerated and blastic phases, and for allogeneic stem cell transplantation. Optimal responders should continue therapy indefinitely, with careful surveillance, or they can be enrolled in controlled studies of treatment discontinuation once a deeper molecular response is achieved. Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A European LeukemiaNet expert panel reviewed prior and new studies to update recommendations made in 2009. We recommend as initial treatment imatinib, nilotinib, or dasatinib. Response is assessed with standardized real quantitative polymerase chain reaction and/or cytogenetics at 3, 6, and 12 months. BCR-ABL1 transcript levels ≤10% at 3 months, <1% at 6 months, and ≤0.1% from 12 months onward define optimal response, whereas >10% at 6 months and >1% from 12 months onward define failure, mandating a change in treatment. Similarly, partial cytogenetic response (PCyR) at 3 months and complete cytogenetic response (CCyR) from 6 months onward define optimal response, whereas no CyR (Philadelphia chromosome-positive [Ph+] >95%) at 3 months, less than PCyR at 6 months, and less than CCyR from 12 months onward define failure. Between optimal and failure, there is an intermediate warning zone requiring more frequent monitoring. Similar definitions are provided for response to second-line therapy. Specific recommendations are made for patients in the accelerated and blastic phases, and for allogeneic stem cell transplantation. Optimal responders should continue therapy indefinitely, with careful surveillance, or they can be enrolled in controlled studies of treatment discontinuation once a deeper molecular response is achieved.Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A European LeukemiaNet expert panel reviewed prior and new studies to update recommendations made in 2009. We recommend as initial treatment imatinib, nilotinib, or dasatinib. Response is assessed with standardized real quantitative polymerase chain reaction and/or cytogenetics at 3, 6, and 12 months. BCR-ABL1 transcript levels ≤10% at 3 months, <1% at 6 months, and ≤0.1% from 12 months onward define optimal response, whereas >10% at 6 months and >1% from 12 months onward define failure, mandating a change in treatment. Similarly, partial cytogenetic response (PCyR) at 3 months and complete cytogenetic response (CCyR) from 6 months onward define optimal response, whereas no CyR (Philadelphia chromosome-positive [Ph+] >95%) at 3 months, less than PCyR at 6 months, and less than CCyR from 12 months onward define failure. Between optimal and failure, there is an intermediate warning zone requiring more frequent monitoring. Similar definitions are provided for response to second-line therapy. Specific recommendations are made for patients in the accelerated and blastic phases, and for allogeneic stem cell transplantation. Optimal responders should continue therapy indefinitely, with careful surveillance, or they can be enrolled in controlled studies of treatment discontinuation once a deeper molecular response is achieved. Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A European LeukemiaNet expert panel reviewed prior and new studies to update recommendations made in 2009. We recommend as initial treatment imatinib, nilotinib, or dasatinib. Response is assessed with standardized real quantitative polymerase chain reaction and/or cytogenetics at 3, 6, and 12 months. BCR-ABL1 transcript levels ≤10% at 3 months, 10% at 6 months and >1% from 12 months onward define failure, mandating a change in treatment. Similarly, partial cytogenetic response (PCyR) at 3 months and complete cytogenetic response (CCyR) from 6 months onward define optimal response, whereas no CyR (Philadelphia chromosome–positive [Ph+] >95%) at 3 months, less than PCyR at 6 months, and less than CCyR from 12 months onward define failure. Between optimal and failure, there is an intermediate warning zone requiring more frequent monitoring. Similar definitions are provided for response to second-line therapy. Specific recommendations are made for patients in the accelerated and blastic phases, and for allogeneic stem cell transplantation. Optimal responders should continue therapy indefinitely, with careful surveillance, or they can be enrolled in controlled studies of treatment discontinuation once a deeper molecular response is achieved.
Author	Saußele, Susanne Pane, Fabrizio Rousselot, Philippe Cortes, Jorge E. Rosti, Gianantonio Radich, Jerald P. Deininger, Michael W. Saglio, Giuseppe Clark, Richard E. Kim, Dong-Wook Schiffer, Charles Mahon, François-Xavier Lipton, Jeffrey H. Guilhot, François Soverini, Simona Niederwieser, Dietger Larson, Richard A. Kantarjian, Hagop M. Simonsson, Bengt Cervantes, Francisco Hjorth-Hansen, Henrik Hehlmann, Rüdiger Apperley, Jane F. Mayer, Jiri Müller, Martin C. Goldman, John M. Hochhaus, Andreas Baccarani, Michele Martinelli, Giovanni Hughes, Timothy P. Silver, Richard Steegmann, Juan-Luis
Author_xml	– sequence: 1 givenname: Michele surname: Baccarani fullname: Baccarani, Michele email: michele.baccarani@unibo.it organization: Department of Hematology “L. and A. Seràgnoli,” S.Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy – sequence: 2 givenname: Michael W. surname: Deininger fullname: Deininger, Michael W. organization: Division of Hematology and Hematologic Malignancies, University of Utah Huntsman Cancer Institute, Salt Lake City, UT – sequence: 3 givenname: Gianantonio surname: Rosti fullname: Rosti, Gianantonio organization: Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna and S.Orsola-Malpighi Hospital, Bologna, Italy – sequence: 4 givenname: Andreas surname: Hochhaus fullname: Hochhaus, Andreas organization: Hematology/Oncology, Universitätsklinikum Jena, Jena, Germany – sequence: 5 givenname: Simona surname: Soverini fullname: Soverini, Simona organization: Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna and S.Orsola-Malpighi Hospital, Bologna, Italy – sequence: 6 givenname: Jane F. surname: Apperley fullname: Apperley, Jane F. organization: Centre for Hematology, Imperial College, London, United Kingdom – sequence: 7 givenname: Francisco surname: Cervantes fullname: Cervantes, Francisco organization: Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain – sequence: 8 givenname: Richard E. surname: Clark fullname: Clark, Richard E. organization: Royal Liverpool University Hospital, Liverpool, United Kingdom – sequence: 9 givenname: Jorge E. surname: Cortes fullname: Cortes, Jorge E. organization: Department of Leukemia, MD Anderson Cancer Center, Houston, TX – sequence: 10 givenname: François surname: Guilhot fullname: Guilhot, François organization: Institut National de la Santé et de la Recherche Médicale Centres d'investigation clinique 0802, CHU de Poitiers, Université de Poitiers, Poitiers, France – sequence: 11 givenname: Henrik surname: Hjorth-Hansen fullname: Hjorth-Hansen, Henrik organization: Department of Hematology, St. Olavs Hospital, and Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway – sequence: 12 givenname: Timothy P. surname: Hughes fullname: Hughes, Timothy P. organization: SA Pathology and University of Adelaide, Adelaide, SA, Australia – sequence: 13 givenname: Hagop M. surname: Kantarjian fullname: Kantarjian, Hagop M. organization: Department of Leukemia, MD Anderson Cancer Center, Houston, TX – sequence: 14 givenname: Dong-Wook surname: Kim fullname: Kim, Dong-Wook organization: Department of Hematology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea – sequence: 15 givenname: Richard A. surname: Larson fullname: Larson, Richard A. organization: The University of Chicago, Chicago, IL – sequence: 16 givenname: Jeffrey H. surname: Lipton fullname: Lipton, Jeffrey H. organization: Princess Margaret Hospital, University of Toronto, ON, Canada – sequence: 17 givenname: François-Xavier surname: Mahon fullname: Mahon, François-Xavier organization: Laboratoire d' Hématologie CHU de Bordeaux et Laboratoire Hématopoïese Leucémique et Cible Therapeutique, Université Bordeaux Ségalen, Institut National de la Santé et de la Recherche Médicale 1035, Bordeaux, France – sequence: 18 givenname: Giovanni surname: Martinelli fullname: Martinelli, Giovanni organization: Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna and S.Orsola-Malpighi Hospital, Bologna, Italy – sequence: 19 givenname: Jiri surname: Mayer fullname: Mayer, Jiri organization: University Hospital Brno and Central European Institute of Technology Masaryk University, Brno, Czech Republic – sequence: 20 givenname: Martin C. surname: Müller fullname: Müller, Martin C. organization: III Medizinische Klinik, Universitätsmedizin Mannheim, Mannheim, Germany – sequence: 21 givenname: Dietger surname: Niederwieser fullname: Niederwieser, Dietger organization: Department of Hematology and Oncology, University of Leipzig, Leipzig, Germany – sequence: 22 givenname: Fabrizio surname: Pane fullname: Pane, Fabrizio organization: Dipartimento di Medicina Clinica e Chirurgia, Università di Napoli Federico II, and CEINGE Biotecnologie Avanzate, Napoli, Italy – sequence: 23 givenname: Jerald P. surname: Radich fullname: Radich, Jerald P. organization: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA – sequence: 24 givenname: Philippe surname: Rousselot fullname: Rousselot, Philippe organization: Service d' Hématologie et d' Oncologie, Hôpital Mignot, Université Versailles Saint-Qentin-en-Yvelines, Versailles, France – sequence: 25 givenname: Giuseppe surname: Saglio fullname: Saglio, Giuseppe organization: Department of Oncology, University of Turin, Turin, Italy – sequence: 26 givenname: Susanne surname: Saußele fullname: Saußele, Susanne organization: III Medizinische Klinik, Universitätsmedizin Mannheim, Mannheim, Germany – sequence: 27 givenname: Charles surname: Schiffer fullname: Schiffer, Charles organization: Division of Medicine and Oncology, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI – sequence: 28 givenname: Richard surname: Silver fullname: Silver, Richard organization: Weill Cornell Medical College, New York, NY – sequence: 29 givenname: Bengt surname: Simonsson fullname: Simonsson, Bengt organization: University Hospital, Uppsala, Sweden – sequence: 30 givenname: Juan-Luis surname: Steegmann fullname: Steegmann, Juan-Luis organization: Servicio de Hematologia, Hospital Universitario de la Princesa, IIS-IP, Madrid, Spain – sequence: 31 givenname: John M. surname: Goldman fullname: Goldman, John M. organization: Department of Hematology, Imperial College, London, United Kingdom – sequence: 32 givenname: Rüdiger surname: Hehlmann fullname: Hehlmann, Rüdiger organization: III Medizinische Klinik, Universitätsmedizin Mannheim, Mannheim, Germany
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/23803709$$D View this record in MEDLINE/PubMed https://hal.science/hal-03136357$$DView record in HAL
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28 Tefferi (2019111818231357400_B151) 2011; 86 Kantarjian (2019111818231357400_B36) 2011; 12 Gruber (2019111818231357400_B61) 2012; 26 Soverini (2019111818231357400_B66) Nicolini (2019111818231357400_B120) 2011; 118 Experts in Chronic Myeloid Leukemia (2019111818231357400_B169) 2013; 121 Chomel (2019111818231357400_B131) 2011; 118 Huang (2019111818231357400_B168) 2012; 118 Khorashad (2019111818231357400_B62) 2013; 121 Giles (2019111818231357400_B117) 2010; 24 Jabbour (2019111818231357400_B118) 2011; 117 Kantarjian (2019111818231357400_B43) 2011; 117 Pemmaraju (2019111818231357400_B166) 2012; 97 Jabbour (2019111818231357400_B69) 2009; 114 Neelakantan (2019111818231357400_B103) 2013; 121 Soverini (2019111818231357400_B58) 2009; 114 le Coutre (2019111818231357400_B122) 2012; 26 Hehlmann (2019111818231357400_B1) 2007; 370 Jain (2019111818231357400_B99) 2012; 120 Cervantes (2019111818231357400_B27) 2010; 95 Dulucq (2019111818231357400_B86) 2008; 112 Andolina (2019111818231357400_B165) 2012; 119 Gugliotta (2019111818231357400_B29) 2011; 117 Khoury (2019111818231357400_B48) 2012; 119 Hoffmann (2019111818231357400_B80) Marin (2019111818231357400_B139) 2010; 28 Larson (2019111818231357400_B73) 2012; 68 Russo (2019111818231357400_B134) Saussele (2019111818231357400_B53) 2010; 115 Deininger (2019111818231357400_B78) 2007; 110 Verma (2019111818231357400_B85) 2010; 116 Kerkelä (2019111818231357400_B144) 2006; 12 Kantarjian (2019111818231357400_B52) 2012; 120 O’Hare (2019111818231357400_B71) 2005; 65 Jabbour (2019111818231357400_B109) 2013; 13 Ernst (2019111818231357400_B67) 2008; 93 Talpaz (2019111818231357400_B113) 2013; 27 O’Hare (2019111818231357400_B49) 2009; 16 Brummendorf (2019111818231357400_B98) 2012; 120 Saglio (2019111818231357400_B102) 2012; 120 Kantarjian (2019111818231357400_B116) 2009; 113 Fava (2019111818231357400_B105) 2009; 113 Baccarani (2019111818231357400_B24) 2009; 113 Jabbour (2019111818231357400_B107) 2011; 117 Vandyke (2019111818231357400_B147) 2010; 115 Millot (2019111818231357400_B167) 2012; 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[abstract] publication-title: Blood – volume: 121 start-page: 489 year: 2013 end-page: 498 ident: bib62 article-title: BCR-ABL1 compound mutations in tyrosine kinase inhibitor-resistant CML: frequency and clonal relationships publication-title: Blood – volume: 119 start-page: 1123 year: 2012 end-page: 1129 ident: bib39 article-title: Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION) publication-title: Blood – volume: 117 start-page: 1822 year: 2011 end-page: 1827 ident: bib107 article-title: Predictive factors for outcome and response in patients treated with second-generation tyrosine kinase inhibitors for chronic myeloid leukemia in chronic phase after imatinib failure publication-title: Blood – volume: 26 start-page: 172 year: 2012 end-page: 177 ident: bib61 article-title: Dynamics of the emergence of dasatinib and nilotinib resistance in imatinib-resistant CML patients publication-title: Leukemia – volume: 26 start-page: 959 year: 2012 end-page: 962 ident: bib121 article-title: Nilotinib is effective in imatinib-resistant or -intolerant patients with chronic myeloid leukemia in blastic phase publication-title: Leukemia – volume: 27 start-page: 1310 year: 2013 end-page: 1315 ident: bib158 article-title: Rates of peripheral arterial occlusive disease in patients with chronic myeloid leukemia in the chronic phase treated with imatinib, nilotinib, or non-tyrosine kinase therapy: a retrospective cohort analysis publication-title: Leukemia – volume: 118 start-page: 686 year: 2011 end-page: 692 ident: bib9 article-title: Predicting complete cytogenetic response and subsequent progression-free survival in 2060 patients with CML on imatinib treatment: the EUTOS score publication-title: Blood – volume: 117 start-page: 572 year: 2011 end-page: 580 ident: bib41 article-title: Immune modulation of minimal residual disease in early chronic phase chronic myelogenous leukemia: a randomized trial of frontline high-dose imatinib mesylate with or without pegylated interferon alpha-2b and granulocyte-macrophage colony-stimulating factor publication-title: Cancer – volume: 12 start-page: 908 year: 2006 end-page: 916 ident: bib144 article-title: Cardiotoxicity of the cancer therapeutic agent imatinib mesylate publication-title: Nat Med – volume: 120 year: 2012 ident: bib110 article-title: Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL tyrosine kinase inhibitors. [abstract] publication-title: Blood – volume: 30 start-page: 4323 year: 2012 end-page: 4329 ident: bib95 article-title: Initial molecular response at 3 months may predict both response and event-free survival at 24 months in imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with nilotinib publication-title: J Clin Oncol – volume: 114 year: 2009 ident: bib19 article-title: International randomized study of interferon and STI571 (IRIS) 8-year follow-up: sustained survival and low risk for progression in patients with newly diagnosed chronic myeloid leukemia in chronic phase treated with imatinib. [abstract] publication-title: Blood – volume: 120 year: 2012 ident: bib52 article-title: Efficacy and safety of ponatinib in patients with accelerated phase or blast phase chronic myeloid leukemia or Philadelphia-positive acute lymphoblastic leukemia: 12-month follow-up of the PACE trial. 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Snippet	Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A...
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SubjectTerms	Antineoplastic Agents - therapeutic use Benzamides - therapeutic use Dasatinib Europe Fusion Proteins, bcr-abl - metabolism Human health and pathology Humans Imatinib Mesylate Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy Leukemia, Myelogenous, Chronic, BCR-ABL Positive - therapy Life Sciences Piperazines - therapeutic use Prognosis Pyrimidines - therapeutic use Randomized Controlled Trials as Topic Review Stem Cell Transplantation Thiazoles - therapeutic use Treatment Outcome
Title	European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013
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