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MK in EORTC/GIMEMA AML-10&12
pared to those randomized to the standard-dose cytarabine arm (OR=1.51, 95% CI: 1.12-2.04; CR/CRi rate 80% vs. 73%, respectively). Among MK+ patients, 19 (1 without hematologic recovery and 2 with missing hematologic recovery data) out of 46 patients from the high-dose cytarabine arm and 28 (5 without hematologic recovery and 1 with missing hematologic recovery data) out of 47 patients in the standard-dose cytarabine arm reached CR/CRi. In other words, in MK+ patients the trend was even in a different direction (OR=0.48, 95% CI: 0.21-1.09; CR/CRi rate 41% in the high-dose cytarabine arm vs. 60% in the standard-dose cytarabine arm, P=0.080). Excluding
six patients without hematologic recovery, the CR rate was 39% in the high-dose cytarabine arm versus 49% in the standard-dose cytarabine arm. Furthermore, among 38 patients with reported CR with a full hematologic recovery after induction, six (including 2 high-dose cytarabine and 4 standard-dose cytarabine patients) were reported not to have had a full hematologic recovery after consolidation.
Interestingly, no benefit of high-dose cytarabine on OS was observed in the subgroup of MK+ patients (HR=1.03, 95% CI: 0.68-1.57; P=0.88) (Figure 2D). The estimate of the hazard ratio for OS after CR/CRi among MK+ patients was 0.82 (95% CI: 0.44-1.53; P=0.53).
Figure 1. Flow chart of the patients included in the current analyses. MK: monosomal karyotype (MK-: without MK; MK+: with MK); OS: overall survival; CR/Cri: com- plete remission/complete remission with incomplete blood count recovery; Allo-HSCT: allogeneic hematopoietic stem cell transplantation; Auto-HSCT: autologous hematopoietic stem cell transplantation.
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