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Evaluating an Unsatisfactory or Suboptimal Response

The majority of patients with Ph+ CML receiving tyrosine kinase inhibitor (TKI) treatment respond with normalization of peripheral blood counts within 3 months and of cell cytogenetics within 12 months. There are, however, some patients who respond to treatment, but at a slower pace—and others for whom initial treatment will be ineffective.1,2

Consensus guidelines issued by European LeukemiaNet have set benchmarks for determining when a patient is experiencing a suboptimal response or treatment failure (Table). Monitoring at the recommended intervals helps the clinician to evaluate if and when a treatment should be adjusted or changed.

Criteria for Suboptimal Response and Treatment Failure with TKI Therapy

Abbreviations:TKI, tyrosine kinase inhibitor; CHR, complete hematologic response; PCyR, partial cytogenetic response; CCyR, complete cytogenetic response; MMR, major molecular response; ACA, additional chromosomal abnormalities; Ph+ CML, Philadelphia chromosome-positive chronic myelogenous leukemia; HR, hematologic response; CyR, cytogenetic response; Del 9q+, deletion of the abl-bcr rearrangement on the derivative chromosome 9q+; AP, accelerated phase; BC, blast crisis.

aTo be confirmed on 2 occasions unless associated with CHR or CCyR loss.

bMutations should be interpreted within clinical context.

cTo be confirmed on 2 occasions unless associated with progression to AP or BC.

dTo be confirmed on 2 occasions unless associated with CHR loss or progression to AP or BC.

Click to view and/or download the criteria for hematologic, cytogenetic, and molecular response.

  1. Druker BJ, Talpaz M, Resta DJ. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001; 344(14):1031-1037.
  2. Mauro MJ. Response dynamics in chronic-phase chronic myeloid leukemia. Clin Lymphoma Myeloma. 2009;9(3):217-222.
  3. Baccarani M, Saglio G, Goldman J, et al. Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet. Blood. 2006;108(6):1809-1820.
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