Table 2.

Efficacy of nilotinib in CML-CP and CML-AP

Cytogenetic response rate (unconfirmed)*CML-CP % (n = 232)
Major (95%CI)40 (33,46)
    Complete (95% CI)28 (22,34)
    Partial (95% CI)12 (8,16)

CML-AP % (n = 105)
Hematologic response rate, confirmed (95%CI)26 (18,35)
CHR (95% CI)18 (11,27)
NEL (95% CI)8 (3,15)
  • NOTE: CHR: neutrophils ≥1.5 × 109/L, platelets ≥100 × 109/L, no myeloblasts in peripheral blood, myeloblasts <5% in bone marrow, and no extramedullary involvement. NEL: same criteria as for CHR but neutrophils ≥1.0 × 109/L and platelets ≥20 × 109/L without transfusions or bleeding.

  • * Cytogenetic response criteria: complete (0% Ph + metaphases) or partial (1-35%). Cytogenetic responses were based on the percentage of Ph-positive metaphases among ≥20 metaphase cells in each bone marrow sample.

  • Hematologic response (all responses confirmed after 4 wk) = CHR + NEL.