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Blood, 1 December 2008, Vol. 112, No. 12, pp. 4437-4444.
Prepublished online as a Blood First Edition Paper on August 20, 2008August 27, 2008; DOI 10.1182/blood-2008-06-162388.
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Submitted June 10, 2008
Accepted August 8, 2008
European LeukemiaNet criteria for failure or sub-optimal response reliably identify patients with CML in early chronic phase treated with imatinib whose eventual outcome is poor
David Marin*, Dragana Milojkovic, Eduardo Olavarria, Jamshid S Khorashad, Hugues de Lavallade, Alistair G Reid, Letizia Foroni, Katayoun Rezvani, Marco Bua, Francesco Dazzi, Jiri Pavlu, Matthias Klammer, Jaspal Kaeda, John M Goldman, and Jane F Apperley
Haematology Department, Hammersmith Hospital, Imperial College London, London, United Kingdom
* Corresponding author; email: d.marin{at}imperial.ac.uk.
The majority of patients with CML in chronic phase (CP) gain substantial benefit from imatinib but some fail to respond or lose their initial response. In 2006 the European LeukemiaNet published recommendations designed to help identify patients responding poorly to imatinib. Patients were evaluated at 3, 6, 12 and 18 months and some were classified as 'failure' or 'suboptimal responders'. We analyzed outcomes for 224 patients with CML-CP treated in a single institution to validate these recommendations. Patients were followed for a median of 46.1 months. At each time-point patients classified as 'failure' showed significantly worse survival, progression-free survival (PFS) and cytogenetic response than other patients; for example based on the assessment at 12 months the 5-year survival was 87.1% vs 95.1%, (p=0.02), PFS 76.% vs 90%, (p=0.002), and complete cytogenetic response rate 26.7% vs 94.1% (p<0.0001). Similarly the criteria for 'sub-optimal response' at 6 and 12 months identified patients destined to fare badly, though criteria at 18 months were less useful. The predictive value of some other individual criteria varied. In general the LeukemiaNet criteria have useful predictive value, but a case could now be made for combining the categories 'failure' and 'sub-optimal response'.

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