Efficacy
The pivotal CALGB trial of Mayer et al.r in patients up to the age of 60 compared 100 mg/m2, 400 mg/m2 and 3 g/m2 doses of cytarabine in consolidation and showed a statistically significant chance of complete remission at 4 years for the 3 g/m2 dosing (Q12H days 1,3,5 IVI 3 hours) compared to the lower doses of cytarabine. Current best practice would be to consolidate with high dose cytarabine containing regimens in the patient population up to the age of 60.r
The optimal management of patients age greater than 60 is not clear; however, consolidation with an anthracycline and conventional-dose cytarabine appears to be a reasonable option, at least up to the age of 74.r Wiernik et al.r included adults of all ages and randomised to two consolidation cycles with standard-dose cytarabine (100 mg/m2 D1-5) plus daunorubicin (45 mg/m2) or idarubicin (13 mg/m2) (both for 2 days) and showed a significant survival benefit of idarubicin over daunorubicin. The use of idarubicin 12 mg/m2 corresponds to the dose used by Berman et al.r in a randomised trial of daunorubicin (50 mg/m2) versus idarubicin (12 mg/m2), showing a survival superiority of idarubicin in patients up to the age of 60.
In summary, the main place of this regimen is in consolidation chemotherapy (typically two cycles) in patients over the age of 60. It usually should not be used in the younger patient population, where more intensive consolidation regimens are indicated in most cases. Randomised trial data comparing this regimen to other consolidation strategies is limited.
A search of the literature found limited evidence to support the use of cytarabine and idarubicin 5-2 in the consolidation treatment of AML. The expert reference panel supported publication of the protocol on the basis of the information summarised below. The committee was most strongly influenced by the study by Wiernik et al.r and Berman et al..r
Source |
Study & Year Published |
Supports Use |
Is the dose and regimen consistent with the protocol? |
Comments |
Randomised trials |
Wiernik et al. 1992r |
Yes |
No |
Idarubicin 13 mg/m2 days 1-2 and cytarabine 100 mg/m2 days 1-5 for 2 cycles |
|
Berman et al. 1991 |
Yes |
No |
Idarubicin 12 mg/m2 days 1-2 and cytarabine 200 mg/m2 days 1-4 for 2 cycles |
Observational studies |
N/A |
N/A |
N/A |
- |
Case series |
N/A |
N/A |
N/A |
- |
Guidelines |
Date published/revised |
Supports Use |
Is the dose and regimen consistent with the protocol? |
Comments |
NCCN |
V.1.2022 |
Yes |
Yes |
- |
BCCA |
N/A |
N/A |
N/A |
- |
CCO |
N/A |
N/A |
N/A |
- |