Comparison of Princess Margaret Cancer Centre–defined treatment response criteria to ELN 2022 response criteria
PM-criteria responses . | . | ELN 2022 responses . | . |
---|---|---|---|
CR | No circulating blasts and/or BM blast <5% Platelets >100 × 109/L and ANC >1 × 109/L | CR | BM blasts <5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥1.0 × 109/L (1 000/μL); platelet count ≥100 × 109/L (100 000/μL) |
CRi | No circulating blasts BM blast <5% Platelets <100 × 109/L or ANC <1 × 109/L acceptable | CRi | All CR criteria except for residual neutropenia < .0 × 109/L (1 000/μL) or thrombocytopenia <100 × 109/L (100 000/μL) |
Reversion to cMPN | PB blasts <10% or BM blasts 5%-9% BM blasts <5% and MPN features on BM biopsy (not just fibrosis) | CR with partial hematologic recovery (CRh) | ANC ≥0.5 × 109/L (500/μL) and platelet count ≥50 × 109/L (50 000/μL), otherwise all other CR criteria met |
Platelets <100 × 109/L and/or ANC <1 × 109/L acceptable (also clinical features ie, hepatosplenomegaly, thrombocytosis, leukocytosis) | Morphologic leukemia free state (MLFS) | BM blasts <5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery required | |
Partial response (PR) | All hematologic criteria of CR; decrease of BM blast percentage to 5%-25%; and decrease of pretreatment BM blast percentage by at least 50% | ||
SD | SD No significant change in blast count from baseline and increase in PB/BM blasts <50% from baseline | No response | Patients evaluable for response but not meeting the criteria for CR, CRh, CRi, MLFS, or PR are categorized as having no response prior to the response landmark. Patients failing to achieve response by the designated landmark are designated as having refractory disease |
Progressive disease (PD) | Increase in PB/BM blasts ≥50% New extramedullary disease | Refractory disease | No CR, CRh, or CRi at the response landmark, ie, after 2 courses of intensive induction treatment or a defined landmark, eg, 180 d after commencing less-intensive therapy |
Relapse | PB/BM blasts ≥5% after initial CR/CRi PB/BM blasts ≥10% after initial cMPN | Relapse | BM blasts ≥5%; or reappearance of blasts in the blood in at least 2 PB samples at least 1 wk apart; or development of extramedullary disease |
Early death (ED) | Death within first 30 d of induction chemotherapy or HMA treatment | ED | Death from any cause within a timeframe relevant for the therapy being investigated (eg, 30 and 60 d from commencing therapy) |
PM-criteria responses . | . | ELN 2022 responses . | . |
---|---|---|---|
CR | No circulating blasts and/or BM blast <5% Platelets >100 × 109/L and ANC >1 × 109/L | CR | BM blasts <5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥1.0 × 109/L (1 000/μL); platelet count ≥100 × 109/L (100 000/μL) |
CRi | No circulating blasts BM blast <5% Platelets <100 × 109/L or ANC <1 × 109/L acceptable | CRi | All CR criteria except for residual neutropenia < .0 × 109/L (1 000/μL) or thrombocytopenia <100 × 109/L (100 000/μL) |
Reversion to cMPN | PB blasts <10% or BM blasts 5%-9% BM blasts <5% and MPN features on BM biopsy (not just fibrosis) | CR with partial hematologic recovery (CRh) | ANC ≥0.5 × 109/L (500/μL) and platelet count ≥50 × 109/L (50 000/μL), otherwise all other CR criteria met |
Platelets <100 × 109/L and/or ANC <1 × 109/L acceptable (also clinical features ie, hepatosplenomegaly, thrombocytosis, leukocytosis) | Morphologic leukemia free state (MLFS) | BM blasts <5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery required | |
Partial response (PR) | All hematologic criteria of CR; decrease of BM blast percentage to 5%-25%; and decrease of pretreatment BM blast percentage by at least 50% | ||
SD | SD No significant change in blast count from baseline and increase in PB/BM blasts <50% from baseline | No response | Patients evaluable for response but not meeting the criteria for CR, CRh, CRi, MLFS, or PR are categorized as having no response prior to the response landmark. Patients failing to achieve response by the designated landmark are designated as having refractory disease |
Progressive disease (PD) | Increase in PB/BM blasts ≥50% New extramedullary disease | Refractory disease | No CR, CRh, or CRi at the response landmark, ie, after 2 courses of intensive induction treatment or a defined landmark, eg, 180 d after commencing less-intensive therapy |
Relapse | PB/BM blasts ≥5% after initial CR/CRi PB/BM blasts ≥10% after initial cMPN | Relapse | BM blasts ≥5%; or reappearance of blasts in the blood in at least 2 PB samples at least 1 wk apart; or development of extramedullary disease |
Early death (ED) | Death within first 30 d of induction chemotherapy or HMA treatment | ED | Death from any cause within a timeframe relevant for the therapy being investigated (eg, 30 and 60 d from commencing therapy) |
ANC, absolute neutrophil count; MLFS, morphologic leukemia free state.