Idarubicin versus Doxorubicin in Acute Myeloid Leukemia: A Parallel Randomized Trial with Pharmacoeconomic Analysis

Abstract

Background: Acute Myeloid Leukemia (AML) is the most common form of acute leukemia among adults. Treatment of acute leukemia has been divided into induction chemotherapy and post-remission therapy. The goal of induction chemotherapy, that consists of anthracycline and cytarabine, is to achieve morphologic complete remission (CR), but the main problem is that it has a high economic burden. Idarubicin is the anthracycline of choice used in AML, while doxorubicin, is mainly used in other types of cancer. The aims of this study were evaluating the use of doxorubicin versus idarubicin in the induction phase for the treatment of AML and analysis the impact of the adoption of this anthracycline in Egypt’s public health system. Methods: A randomized controlled trial was undertaken in 244 patients with AML. A decision tree was developed based on the clinical outcome of the study, safety and efficacy, aiming to get the expected cost of doxorubicin compared with idarubicin in AML management. Results: In the doxorubicin group, 52.5% had a CR, versus 49.2 % in the idarubicin group (P=0.6). The most common toxicities among the 2 groups were febrile neutropenia, diarrhea and vomiting. Oral mucositis (OM) was higher in the doxorubicin group (70.8% vs 37%, P=0.0001), while invasive fungal infections were greater in the idarubicin group (75% vs 88.7%, P=0.004). Doxorubicin arm had a lower cost than idarubicin arm in treatment success group (39,492 LE vs 44,323 LE). Conclusion: Doxorubicin provides a treatment option with comparable efficacy, toxicity profile and survival rates at a lower cost compared to the traditional treatment, idarubicin.