AIDA-PETHEMA Group

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Regimen

Induction therapy

Oral ATRA (45 mg/m2/d), divided into 2 daily doses, until complete hematologic remission, or for a maximum of 90 days
Idarubicin (12 mg/m2/d) given as an intravenous bolus dose on days 2, 4, 6, and 8.
Idarubicin on day 8 was omitted for patients older than 70 years of age.

Consolidation therapy

Risk of relapse assessment

Established at diagnosis according to a predictive model based on patient leukocyte and platelet counts at diagnosis
Low-risk patients had a WBC count less than 10 x 109/L and a platelet count more than 40 x 109/L
Intermediate-risk patients had a WBC count less than 10 x 109/L and a platelet count less than 40 x 109/L
High-risk patients had a WBC count equal to or more than 10 x 109/L

Intermediate- and high-risk patients

ATRA (45 mg/m2/d) was given on days 1 through 15 in combination with the 3 single-agent chemotherapy courses
Idarubicin 7 mg/m2 IV daily for 4 days (course no. 1)
mitoxantrone 10 mg/m2 IV daily for 5 days (course no. 2)
Idarubicin 12 mg/m2 IV daily for 2 days (course no. 3)

Interval 4 weeks in between courses

Low-risk patients

Idarubicin 5 mg/m2 IV daily for 4 days (course no. 1)
mitoxantrone 10 mg/m2 IV daily for 5 days (course no. 2)
Idarubicin 12 mg/m2 IV on only 1 day (course no. 3)

Interval 4 weeks in between courses

Maintenance therapy

Oral mercaptopurine (50 mg/m2/d)
Intramuscular methotrexate (15 mg/m2/wk
Oral ATRA (45 mg/m2/d) for 15 days every 3 months
Doses of mercaptopurine and methotrexate were decreased by 50% if the white blood cell (WBC) count was less than 3.5 x 109/L and discontinued if it was less than 2.5x109/L

Maintenance therapy for 2 years

Supportive therapy

Treatment of coagulopathy during induction was based on fresh frozen plasma and/or fibrinogen transfusion, as well as on platelet support to maintain the platelet counts above 30 until disappearance of significant coagulopathy.

Once the coagulopathy was under control, platelet transfusions were only used in patients with infectious or hemorrhagic manifestations or when the platelet count dropped below 20

At the first signs of suspected ATRA syndrome, ATRA was discontinued and patients were given 10 mg dexamethasone every 12 hours.

Prophylactic dexamethasone, using the same doses, was also administered in cases where the WBC count was greater than 5

References

Miguel A. Sanz et al, Risk-adapted treatment of acute promyelocytic leukemia with all-trans-retinoic acid and anthracycline monochemotherapy: a multicenter study by the PETHEMA group Blood, 15 February 2004, Vol. 103, No. 4, pp. 1237-1243

Miguel A. Sanz et al, A Modified AIDA Protocol With Anthracycline-Based Consolidation Results in High Antileukemic Efficacy and Reduced Toxicity in Newly Diagnosed PML/RAR -Positive Acute Promyelocytic Leukemia, PETHEMA Group Blood, Vol. 94 No. 9 (November 1), 1999: pp. 3015-3021