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- Title
Pilot study of Mylotarg, idarubicin and cytarabine combination regimen in patients with primary resistant or relapsed acute myeloid leukemia.
- Authors
Alvarado, Yesid; Tsimberidou, Apostolia; Kantarjian, Hagop; Cortes, Jorge; Garcia-Manero, Guillermo; Faderl, Stefan; Thomas, Deborah; Estey, Elihu; Giles, Francis J.
- Abstract
<bold>Purpose: </bold>Mylotarg has moderate activity as a single agent in patients with CD33-positive refractory or relapsed acute myelogenous leukemia (AML). A combination of an anthracycline and cytarabine (ara-C) is the core of most AML induction regimens. We conducted a pilot study of Mylotarg combined with idarubicin and ara-C in patients with refractory or relapsed AML.<bold>Methods: </bold>Mylotarg was administered at 6 mg/m(2) intravenously on days 1 and 15, idarubicin 12 mg/m(2) daily on days 2 through 4, and ara-C at 1.5 g/m(2) daily on days 2 through 5 (MIA) RESULTS: Of 14 patients were treated, 4 (29%) had primary resistant AML, and 10 (71%) relapsed AML. The median age of the patients was 61 years (range 34-74 years). MIA induced complete remission (CR) in three patients (21%) and CR with incomplete platelet recovery (CRp) in three patients (21%). The median survival was 8 weeks (range 2-64 weeks), and the median failure-free survival of CR patients was 27 weeks (range 11-64 weeks). All patients developed grade 3/4 myelosuppression - severe sepsis occurred in ten patients (71%). Other grade 3/4 nonhematologic toxicities included hepatic transaminitis, oral mucositis, and diarrhea. Two patients (14%) developed hepatic venoocclusive disease (VOD).<bold>Conclusions: </bold>The addition of Mylotarg to idarubicin and ara-C is feasible. MIA has significant activity in patients with refractory AML. Hepatotoxicity and VOD are significant toxicities of Mylotarg-based combinations.
- Subjects
STANDARD deviations; ACUTE myeloid leukemia; MYELOID leukemia; SEPSIS; HEPATOTOXICOLOGY; COMMUNICABLE diseases
- Publication
Cancer Chemotherapy & Pharmacology, 2003, Vol 51, Issue 1, p87
- ISSN
0344-5704
- Publication type
journal article
- DOI
10.1007/s00280-002-0546-z