Mylotarg combined with topotecan and cytarabine in patients with refractory acute myelogenous leukemia

Jorge Cortes; Apostolia M Tsimberidou; Ricardo Alvarez; Deborah Thomas; Miloslav Beran; Hagop Kantarjian; Elihu Estey; Francis J Giles

doi:10.1007/s00280-002-0539-y

Mylotarg combined with topotecan and cytarabine in patients with refractory acute myelogenous leukemia

Cancer Chemother Pharmacol. 2002 Dec;50(6):497-500. doi: 10.1007/s00280-002-0539-y. Epub 2002 Oct 22.

Authors

Jorge Cortes¹, Apostolia M Tsimberidou, Ricardo Alvarez, Deborah Thomas, Miloslav Beran, Hagop Kantarjian, Elihu Estey, Francis J Giles

Affiliation

¹ Department of Leukemia, The University of Texas, M.D. Anderson Cancer Center, 1400 Holcombe Boulevard, Houston, Texas 77030, USA.

PMID: 12451477
DOI: 10.1007/s00280-002-0539-y

Abstract

Purpose: Mylotarg, a humanized anti-CD33 antibody linked to an antitumor antibiotic, is approved for the treatment of patients with relapsed acute myeloid leukemia (AML). Topotecan and cytarabine (ara-C) is an effective anti-AML regimen. A pilot study of Mylotarg combined with topotecan and ara-C (MTA) was conducted in patients with refractory AML.

Methods: MTA consisted of Mylotarg 9 mg/m(2) intravenously (i.v.) over 2 h on day 1, ara-C 1 g/m(2) over 2 h i.v. on days 1 through 5, and topotecan 1.25 mg/m(2) by continuous infusion i.v. on days 1 through 5.

Results: A group of 17 patients (9 primary resistant, 8 relapsed) with AML or advanced myelodysplastic syndrome (MDS) received 20 courses of MTA. The median age of the patients was 55 years (20-70 years). Two patients (12%) achieved complete remission. The median overall survival was 8.2 weeks. Five patients (29%) developed grade 3/4 hepatic transaminitis, including one patient (6%) who died with hepatic venoocclusive disease.

Conclusions: MTA was moderately effective and associated with significant toxicity in patients with refractory AML.

Publication types

Clinical Trial

MeSH terms

Acute Disease
Adult
Aged
Aminoglycosides*
Anti-Bacterial Agents / administration & dosage
Antibodies, Monoclonal / administration & dosage
Antibodies, Monoclonal, Humanized
Antigens, CD / immunology
Antigens, CD / metabolism
Antigens, Differentiation, Myelomonocytic / immunology
Antigens, Differentiation, Myelomonocytic / metabolism
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Cytarabine / administration & dosage
Gemtuzumab
Humans
Infusions, Intravenous
Leukemia, Myeloid / drug therapy*
Leukemia, Myeloid / metabolism
Middle Aged
Neoplasm Recurrence, Local / drug therapy*
Neoplasm Recurrence, Local / metabolism
Pilot Projects
Remission Induction
Salvage Therapy
Sialic Acid Binding Ig-like Lectin 3
Survival Rate
Topotecan / administration & dosage
Treatment Outcome

Substances

Aminoglycosides
Anti-Bacterial Agents
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antigens, CD
Antigens, Differentiation, Myelomonocytic
CD33 protein, human
Sialic Acid Binding Ig-like Lectin 3
Cytarabine
Topotecan
Gemtuzumab