Comparable Toxicity and Outcome of Acute Myeloid Leukemia (AML) Fit Patients Therapy Independently If Daunorubicin or Idarubicin Were Added to Cytarabine/Cladribine Induction Regimens – the Single Centre Study

Abstract 4337

This trial is a continuation of the earlier studies concerning optimalization of induction chemotherapy in acute myeloid (AML) patients using purine analogues (Ho≥owiecki J., Grosicki S., Robak T. et al. Leukemia 2004, Holowiecki J, Grosicki S, Giebel S. et al. J Clin Oncol. 2012).

The goal of the study was to evaluate the toxicity and efficacy of combination including idarubicin – IAC (idarubicin 10 mg/m²/d iv, d 1–3; cytarabine 200 mg/m²/d ci, d 1–7, cladribine 5 mg/m²/d d 1–5) in comparison with DAC (daunorubicin 60 mg/m²/d iv d 1–3 in place of idarubicin).

The primary endpoints were complete remission rate (CR) and toxicity, the secondary one was overall survival (OS).

Patients who achieved CR received two courses of subsequent intensive consolidation: HAM (HD AraC, mitoxantrone) and HD AraC. Reduction of consolidation was accepted in patients treated with early alloBMT. In case of partial remission (PR) after the first induction course the same regimen was repeated. Patients with no remission (NR) or with PR after 2 induction courses were withdrawn from the study.

Between 03.2009 and 03.2012, 52 adult untreated patients aged median 57 years (20–72), treated in one center - Department of Hematology of City Hospital in Chorzow/Poland were included to this study; 46% of study participants were male, 54% female and they were evaluated as fit with possibility of intensive chemotherapy including HSCT. PML/RAR alfa positive – FAB M3 cases were excluded.

DAC regimen was a standard induction in this group of AML patients. When there was no possibility to apply DAC regimen because of not having access to daunorubicin in our center, the IAC regimen was used.

Material and the results are summarized in the table.

The study groups were well balanced with respect to age, sex, WBC and cytogenetics. The entire CR rates in both groups did not differ, and they were similar to previously published results after DAC induction regimen. All patients developed WHO grade IV thrombocytopenia and agranulocytosis. The frequency and severity of infections, mucositis, vomiting, diarrhea, alopecia, polyneuropathy as well as of cardiac, liver or kidney dysfunctions were comparable in particular arms. There were no significant differences in the OS and LFS rates.

In conclusion, the results of our study authorize the replacement of daunorubicin to idarubicin in DAC induction regimen without risk of additional toxicity, and with similar outcome.