Response criteria
| Response . | Criteria . |
|---|---|
| cCR | Patients achieving criteria for either CR or CRi: |
| CR: M1 marrow,* absence of peripheral blasts (morphologic), absence of extramedullary sites of disease,† peripheral blood neutrophil count ≥1000/μL, and platelet count ≥100 000/μL | |
| CRi: above CR criteria without specified blood counts | |
| PR | M2 marrow* and decrease in percentage of marrow blasts by ≥50%, absence of peripheral blasts (morphologic), absence of extramedullary sites of disease† |
| Hematologic activity | Does not meet criteria for CR or PR, with any of the following: |
| ≥50% decrease in percentage of marrow blasts | |
| ≥50% decrease in absolute peripheral blast count | |
| Improvement of peripheral blood neutrophil count to ≥1000/μL or platelet count to ≥100 000/μL | |
| Stable disease | Does not meet criteria for CR, PR, HA, or PD |
| Progressive disease or relapse | Deterioration in marrow classification (ie, M status*) with ≥50% increase in percentage of marrow blasts compared with best response OR |
| No change in marrow classification (ie, M status*) but ≥50% increase in absolute peripheral blast count or extent of extramedullary disease† compared with best response |
| Response . | Criteria . |
|---|---|
| cCR | Patients achieving criteria for either CR or CRi: |
| CR: M1 marrow,* absence of peripheral blasts (morphologic), absence of extramedullary sites of disease,† peripheral blood neutrophil count ≥1000/μL, and platelet count ≥100 000/μL | |
| CRi: above CR criteria without specified blood counts | |
| PR | M2 marrow* and decrease in percentage of marrow blasts by ≥50%, absence of peripheral blasts (morphologic), absence of extramedullary sites of disease† |
| Hematologic activity | Does not meet criteria for CR or PR, with any of the following: |
| ≥50% decrease in percentage of marrow blasts | |
| ≥50% decrease in absolute peripheral blast count | |
| Improvement of peripheral blood neutrophil count to ≥1000/μL or platelet count to ≥100 000/μL | |
| Stable disease | Does not meet criteria for CR, PR, HA, or PD |
| Progressive disease or relapse | Deterioration in marrow classification (ie, M status*) with ≥50% increase in percentage of marrow blasts compared with best response OR |
| No change in marrow classification (ie, M status*) but ≥50% increase in absolute peripheral blast count or extent of extramedullary disease† compared with best response |
cCR, composite CR; CRi, CR with incomplete blood count recovery; HA, hematologic activity; PD, progressive disease; PR, partial response.
Bone marrow classification (blast percentage, ≥200 cells counted): M1, <5%; M2, 5% to 25%; M3, >25%.
Central nervous system classification (cerebrospinal fluid cell count and cytology): CNS1, 0 blasts on cytospin; CNS2, white cell count <5/µL and blasts on cytospin; CNS3, white cell count ≥5/µL and blasts on cytospin.