Proposed modified International Working Group response criteria for altering natural history of MDS7
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 × 109/L† | |
| Blasts 0% | |
| Partial remission | All CR criteria if abnormal before treatment except: |
| Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5% | |
| Cellularity and morphology not relevant | |
| Marrow CR† | Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment† |
| 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 |
| Failure | Death during treatment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment |
| Relapse after CR or PR | At least 1 of the following: |
| Return to pretreatment bone marrow blast percentage | |
| Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets | |
| Reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence | |
| Cytogenetic response | Complete |
| Disappearance of the chromosomal abnormality without appearance of new ones | |
| Partial | |
| At least 50% reduction of the chromosomal abnormality | |
| Disease progression | For patients with: |
| Less than 5% blasts: ≥ 50% increase in blasts to > 5% blasts | |
| 5%-10% blasts: ≥ 50% increase to > 10% blasts | |
| 10%-20% blasts: ≥ 50% increase to > 20% blasts | |
| 20%-30% blasts: ≥ 50% increase to > 30% blasts | |
| Any of the following: | |
| At least 50% decrement from maximum remission/response in granulocytes or platelets | |
| Reduction in Hgb by ≥ 2 g/dL | |
| Transfusion dependence | |
| Survival | Endpoints: |
| Overall: death from any cause | |
| Event free: failure or death from any cause | |
| PFS: disease progression or death from MDS | |
| DFS: time to relapse | |
| Cause-specific death: death related to MDS |
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 × 109/L† | |
| Blasts 0% | |
| Partial remission | All CR criteria if abnormal before treatment except: |
| Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5% | |
| Cellularity and morphology not relevant | |
| Marrow CR† | Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment† |
| 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 |
| Failure | Death during treatment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment |
| Relapse after CR or PR | At least 1 of the following: |
| Return to pretreatment bone marrow blast percentage | |
| Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets | |
| Reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence | |
| Cytogenetic response | Complete |
| Disappearance of the chromosomal abnormality without appearance of new ones | |
| Partial | |
| At least 50% reduction of the chromosomal abnormality | |
| Disease progression | For patients with: |
| Less than 5% blasts: ≥ 50% increase in blasts to > 5% blasts | |
| 5%-10% blasts: ≥ 50% increase to > 10% blasts | |
| 10%-20% blasts: ≥ 50% increase to > 20% blasts | |
| 20%-30% blasts: ≥ 50% increase to > 30% blasts | |
| Any of the following: | |
| At least 50% decrement from maximum remission/response in granulocytes or platelets | |
| Reduction in Hgb by ≥ 2 g/dL | |
| Transfusion dependence | |
| Survival | Endpoints: |
| Overall: death from any cause | |
| Event free: failure or death from any cause | |
| PFS: disease progression or death from MDS | |
| DFS: time to relapse | |
| Cause-specific death: death related to MDS |
Deletions to IWG response criteria are not shown.
To convert hemoglobin from grams per deciliter to grams per liter, multiply grams per deciliter by 10.
MDS indicates myelodysplastic syndromes; Hgb, hemoglobin; CR, complete remission; HI, hematologic improvement; PR, partial remission; FAB, French-American-British; AML, acute myeloid leukemia; PFS, progression-free survival; DFS, disease-free survival.
Dysplastic changes should consider the normal range of dysplastic changes (modification).41
Modification to IWG response criteria.
In some circumstances, protocol therapy may require the initiation of further treatment (eg, consolidation, maintenance) before the 4-week period. Such patients can be included in the response category into which they fit at the time the therapy is started. Transient cytopenias during repeated chemotherapy courses should not be considered as interrupting durability of response, as long as they recover to the improved counts of the previous course.