Version June 2024
| Complete response (presence of all of the following improvements)* |
| Bone marrow: ≤5% myeloblasts (including monocytic blast equivalent in case of CMML) with normal maturation of all cell lines and return to normal cellularity* |
| Osteomyelofibrosis absent or equal to "mild reticulin fibrosis" (≤grade 1 fibrosis)¶ |
| Peripheral bloodΔ |
| WBC ≤10 x 109 cells/L |
| Hgb ≥11 g/dL |
| Platelets ≥100 x 109/L; ≤450 x 109/L |
| Neutrophils ≥1.0 x 109/L |
| Blasts 0% |
| Neutrophil precursors reduced to ≤2% |
| Monocytes ≤1 x 109/L |
| Extramedullary disease: Complete resolution of extramedullary disease present before therapy (eg, cutaneous disease, disease-related serous effusions), including palpable hepatosplenomegaly |
| Provisional category of CR with resolution of symptoms:Δ CR as described above, and complete resolution of disease-related symptoms as noted by the MPN-SAF TSS |
| Persistent low-level dysplasia is permitted given subjectivity of assignment of dysplasia* |
| Complete cytogenetic remission |
| Resolution of previously present chromosomal abnormality (known to be associated with myelodysplastic syndrome, myeloproliferative neoplasms, or MDS/MPN), as seen on classic karyotyping with minimal of 20 metaphases or FISH◊ |
| Partial remission |
| Normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts (and blast equivalents) reduced by 50%, but remaining >5% of cellularity except in cases of MDS/MPN with ≤5% bone marrow blasts at baseline |
| Marrow response |
| Optimal marrow response: Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices as presented above |
| Partial marrow response: Bone marrow blasts (and blast equivalents) reduced by 50%, but remaining >5% of cellularity, or reduction in grading of reticulin fibrosis from baseline on at least two bone marrow evaluations spaced at least two months apart |
| Clinical benefit |
| Requires one of the following in the absence of progression or CR/partial response and independent of marrow response (cord blood response must be verified at ≥8 weeks) to be considered a clinical benefit |
| Erythroid response |
| Hgb increase by ≥2.0 g/dL |
| TI for ≥8 weeks for patients requiring at least four packed red blood cell transfusions in the previous eight weeks |
| Only red blood cell transfusions given based on physician's judgment for a pretreatment Hgb of ≤8.5 g/dL will count in the red blood cell TI response evaluation§ |
| Platelet response |
| Transfusion independence when previously requiring platelet transfusions of at least a rate of four platelet transfusions in the previous eight weeks |
| Pretreatment ≤20 x 109/L: Increase from <20 x 109/L to >20 x 109/L and by at least 100% |
| Pretreatment >20 x 109/L but ≤100 x 109/L: Absolute increase of ≥30 x 109/L§ |
| Neutrophil response |
| Pretreatment ≤0.5 x 109/L at least 100% increase and an absolute increase ≥0.5 x 109/L |
| Pretreatment >0.5 x 109/L and ≤1.0 x 109/L at least 50% increase and an absolute increase ≥0.5 x 109/L§ |
| Spleen response |
| Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable |
| Symptom response |
| Improvement in symptoms as noted by decrease of ≥50% as per the MPN-SAF TSS scoring <20 were not considered eligible for measuring clinical benefit¥ |
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