Table 2. Proposed modified International Working Group response criteria.
For altering natural history of myelodysplastic syndrome | |
---|---|
Category | Response Criteria (responses must last at least 4 wk) |
Complete remission | Bone marrow: ≤5% myeloblasts with normal maturation of all cell lines |
Persistent dysplasia will be noted | |
Peripheral blood | |
Hgb ≥11 g/dL | |
Platelets ≥100×109/L | |
Neutrophils ≥1.0×106/L | |
Blasts 0% | |
Partial remission | All CR criteria if abnormal before treatment expect: one marrow blasts decreased by ≥50% over pre-treatment but still > 5% |
Cellurarity and morphology not relevant | |
Marrow CR | Bone marrow: ≤5% myeloblasts and decrease by ≥50% over treatment |
Peripheral blood: if HI responses, they will be noted in addition to marrow CR | |
Stable disease | Failure to achieve at least PR, but no evidence of progression for > 8 wks |
For hematologic improvement | |
---|---|
Hematologic improvement | Response Criteria (responses must last at least 8 wk) |
Erythroid response (pretreatment, < 11 g/dL) |
Hgb increase by ≥1.5 g/dL |
Relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC | |
transfusions/8 wk compared with the pre-treatment transfusion number in the previous 8 wk. | |
Only RBC transfusions given for a Hgb of ≤9.0 g/dL | |
pre-treatment will count in the RBC transfusion response evaluation | |
Platelet response (pre-treatment, < 100×109/L) |
Absolute increase of ≥30×109/L for the patients starting with >20×109/L platelets |
Increase from <20×109/L to > 20×109/L and by at least 100% | |
Neutrophil response (pretreatment, < 1.0×109/L) |
At least 100% increase and an absolute increase >0.5×109/L |
Progression or relapse after HI | At least one of the following: |
At least 50% decrement from maximum response levels in granulocytes or platelets | |
Reduction in Hgb by ≥1.5 g/dL | |
Transfusion dependence |
From Zou50