Altering Disease Natural History

1. Complete remission (CR)

Bone marrow evaluation: Repeat bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia.3 When erythroid precursors constitute less than 50% of bone marrow nucleated cells, the percenage of blasts is based on all nucleated cells; when there are 50% or more erythroid cells, the percentage blasts should be based on the nonerythroid cells.

Peripheral blood evaluation (absolute values must last at least 2 months)b:

Hemoglobin greater than 11 g/dL (untransfused, patient not on erythropoietin) Neutrophils 1500/mm3 or more (not on a myeloid growth factor) Platelets 100 000/mm3 or more (not on a thrombopoetic agent) Blasts, 0% No dysplasia8

2. Partial remission (PR) (absolute values must last at least 2 months): All the CR criteria (if abnormal before treatment), except:

Bone marrow evaluation: Blasts decreased by 50% or more over pretreatment, or a less advanced MDS FAB classification than pretreatment. Cellularity and morphology are not relevant.

3. Stable disease

Failure to achieve at least a PR, but with no evidence of progression for at least 2 months.

4. Failure

Death during treatment or disease progression characterized by worsening of cytopenias, increase in the percentage bone marrow blasts, or progression to an MDS FAB subtype more advanced than pretreatment.

5. Relapse after CR or RR—one or more of the following:

a) Return to pretreatment bone marrow blast percentage b) Decrement of 50% or greater from maximum remission/response levels in granulocytes or platelets c) Reduction in hemoglobin concentration by at least 2g/dL or transfusion dependence0

6. Disease progression a) For patients with less than 5% blasts: a 50% or more increase in blasts to more than 5% blasts b) For patients with 5-10% blasts: a 50% or more increase to more than 10% blasts c) for patients with 10-20% blasts: a 50% or more increase to more than 20% blasts d) For patients with 20-30% blasts: a 50% or more increase to more than 30% blasts e) One or more of the following: 50% or greater decrement from maximum remission/response levels in granulocytes or platelets, reduction in hemoglobin concentration by at least 2 g/dL, or transfusion dependencec

7. Disease transformation Transformation to AML (30% or more blasts)

8. Survival and progression-free survival (see Table 43.2)

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