Figure 1.
Response assessment flowchart for patients with ≥5% BM blasts at baseline. A flowchart for response assessment per the IWG 2023 response criteria is depicted. Responses shown in green (CR, CR equivalent, CRuni, CRbi, CRh, PR, and HI) are considered an objective response, whereas PD (shown in red) is considered treatment failure. CRL is a composite of CRuni and CRbi, depending on the number of lineages with cell counts at or above the threshold for CR. Of note, patients require ≥5% blasts before treatment initiation to be considered evaluable for CR, PR, CRh, or CRL but response is independent of baseline PB counts. Among patients with <5% blasts at baseline, patients who achieve hematologic recovery consistent with thresholds for CR (ie, Hb ≥ 10 g/dL, platelets ≥ 100 × 109/L, and ANC ≥ 1.0 × 109/L) as well as complete clearance of all baseline cytogenetic abnormalities should be reported as a CR equivalent and included in the ORR (see Figure 2 for details). For patients with MDS-IB2 and/or AML/MDS overlap, reporting of CRh can be considered to enhance consistency with AML trials. Both CRL and CRh are considered provisional response criteria requiring additional prospective validation (shown in light green).

Response assessment flowchart for patients with ≥5% BM blasts at baseline. A flowchart for response assessment per the IWG 2023 response criteria is depicted. Responses shown in green (CR, CR equivalent, CRuni, CRbi, CRh, PR, and HI) are considered an objective response, whereas PD (shown in red) is considered treatment failure. CRL is a composite of CRuni and CRbi, depending on the number of lineages with cell counts at or above the threshold for CR. Of note, patients require ≥5% blasts before treatment initiation to be considered evaluable for CR, PR, CRh, or CRL but response is independent of baseline PB counts. Among patients with <5% blasts at baseline, patients who achieve hematologic recovery consistent with thresholds for CR (ie, Hb ≥ 10 g/dL, platelets ≥ 100 × 109/L, and ANC ≥ 1.0 × 109/L) as well as complete clearance of all baseline cytogenetic abnormalities should be reported as a CR equivalent and included in the ORR (see Figure 2 for details). For patients with MDS-IB2 and/or AML/MDS overlap, reporting of CRh can be considered to enhance consistency with AML trials. Both CRL and CRh are considered provisional response criteria requiring additional prospective validation (shown in light green).

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