Response assessment flowchart for patients with <5% BM blasts at baseline (ie, prior to the current line of therapy). A response assessment flowchart for patients with HR-MDS with <5% BM blasts at baseline is depicted. High-risk disease status in these patients can result from high-risk cytogenetic abnormalities (eg, complex karyotype) and/or the degree of cytopenia. If a patient achieves 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, this should be reported as a CR equivalent. Patients who do not achieve complete cytogenetic remission (or who are not evaluable for cytogenetic clearance because of a normal karyotype at baseline) should be evaluated for HI and PD and reported as such. For patients with <5% BM blasts at baseline the definition of PD might be applied to patients with a ≥50% relative increase in BM blast count who do not have an absolute increase of ≥5% blasts in the right clinical context (eg, worsening disease-related cytopenias). Criteria for CR, HI, SD, and PD are provided in Table 1.
