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

Michele Baccarani, Michael W. Deininger, Gianantonio Rosti, Andreas Hochhaus, Simona Soverini, Jane F. Apperley, Francisco Cervantes, Richard E. Clark, Jorge E. Cortes, François Guilhot, Henrik Hjorth-Hansen, Timothy P. Hughes, Hagop M. Kantarjian, Dong-Wook Kim, Richard A. Larson, Jeffrey H. Lipton, François-Xavier Mahon, Giovanni Martinelli, Jiri Mayer, Martin C. Müller, Dietger Niederwieser, Fabrizio Pane, Jerald P. Radich, Philippe Rousselot, Giuseppe Saglio, Susanne Saußele, Charles Schiffer, Richard Silver, Bengt Simonsson, Juan-Luis Steegmann, John M. Goldman and Rüdiger Hehlmann

Abstract

Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors (TKIs), mandate regular updating of concepts and management. An ELN expert panel reviewed prior and new studies, to update recommendations made in 2009. We recommend as initial treatment imatinib or nilotinib or dasatinib. Response is assessed with standardized RQ-PCR 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, while >10% at 6 months and >1% from 12 months onward define failure, mandating a change of treatment. Similarly, partial cytogenetic response (PCyR) at 3 months and complete CyR (CCyR) from 6 months onward define optimal response, while no CyR (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 2nd line therapy. Specific recommendations are made for patients in accelerated and blastic phase, and for allogeneic stem cell transplantation. Optimal responders should continue therapy indefinitely, with careful surveillance, or can be enrolled in controlled studies of treatment discontinuation, once a deeper molecular response is achieved.

  • Submitted May 8, 2013.
  • Accepted June 10, 2013.