Summary of idarubicin, ATRA, and ATO doses delivered according to protocol specifications and treatment cycle
| . | No. of patients with data available . | Protocol-specified maximum/minimum* total dose . | Median total dose delivered (range)† . | No. that received at least 80% of the maximum total dose (%) . | No. that received at least 100% of the minimum* total dose (%) . |
|---|---|---|---|---|---|
| Induction (n = 121)‡ | |||||
| Idarubicin, mg/m2 | 121 | 24-48§/NA¶ | 47.5 (22.2-52.4) | 118 (97) | NA |
| ATRA, mg/m2 | 118 | 1620/850 | 1584.2 (136.1-1988.1) | 106 (90) | 112 (95) |
| ATO, mg/kg | 117 | 4.2/2.08 | 4.03 (0-4.94) | 84 (72) | 109 (93) |
| Consolidation cycle 1 (n = 112) | |||||
| ATRA, mg/m2 | 110 | 1260/650 | 1269.8 (515.9-2655.0) | 108 (98) | 108 (98) |
| ATO, mg/kg | 109 | 4.2/2.08 | 4.2 (1.97-4.72) | 100 (92) | 108 (99) |
| Consolidation cycle 2 (n = 112) | |||||
| ATRA, mg/m2 | 109 | 945/475 | 948.4 (522.6-1260.0) | 106 (97) | 109 (100) |
| ATO, mg/kg | 111 | 3.75/1.84 | 3.75 (1.66-4.48) | 100 (90) | 110 (99) |
| . | No. of patients with data available . | Protocol-specified maximum/minimum* total dose . | Median total dose delivered (range)† . | No. that received at least 80% of the maximum total dose (%) . | No. that received at least 100% of the minimum* total dose (%) . |
|---|---|---|---|---|---|
| Induction (n = 121)‡ | |||||
| Idarubicin, mg/m2 | 121 | 24-48§/NA¶ | 47.5 (22.2-52.4) | 118 (97) | NA |
| ATRA, mg/m2 | 118 | 1620/850 | 1584.2 (136.1-1988.1) | 106 (90) | 112 (95) |
| ATO, mg/kg | 117 | 4.2/2.08 | 4.03 (0-4.94) | 84 (72) | 109 (93) |
| Consolidation cycle 1 (n = 112) | |||||
| ATRA, mg/m2 | 110 | 1260/650 | 1269.8 (515.9-2655.0) | 108 (98) | 108 (98) |
| ATO, mg/kg | 109 | 4.2/2.08 | 4.2 (1.97-4.72) | 100 (92) | 108 (99) |
| Consolidation cycle 2 (n = 112) | |||||
| ATRA, mg/m2 | 109 | 945/475 | 948.4 (522.6-1260.0) | 106 (97) | 109 (100) |
| ATO, mg/kg | 111 | 3.75/1.84 | 3.75 (1.66-4.48) | 100 (90) | 110 (99) |
Protocol-specified dose reductions for ATRA (25 mg/m2/d) and ATO (0.08 mg/kg/d), and omission of up to 2 days per cycle for both drugs were permitted according to clinical circumstances.
In each cycle, 1%-3% of patients received more than 110% of the maximum specified doses due to protocol deviations.
Induction dose delivery data excludes the 3 patients who died prior to commencement of ATO therapy (day 9).
Idarubicin dosing was age adjusted (Table 1).
Not applicable (NA) because there was no protocol-specified minimum idarubicin dose (apart from dose reduction for age > 60).