Mylotarg combined with topotecan and cytarabine in patients with refractory acute myelogenous leukemia.
OBJECTIVE
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.
Cortes
Jorge
J
Department of Leukemia, The University of Texas, M.D. Anderson Cancer Center, 1400 Holcombe Boulevard, Houston, Texas 77030, USA.
Tsimberidou
Apostolia M
AM
Alvarez
Ricardo
R
Thomas
Deborah
D
Beran
Miloslav
M
Kantarjian
Hagop
H
Estey
Elihu
E
Giles
Francis J
FJ
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D015703:Antigens, CD / Q000276:immunology / Q000378:metabolism; D015214:Antigens, Differentiation, Myelomonocytic / Q000276:immunology / Q000378:metabolism; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D000079982:Gemtuzumab; D006801:Humans; D007262:Infusions, Intravenous; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000378:metabolism; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000378:metabolism; D010865:Pilot Projects; D012074:Remission Induction; D016879:Salvage Therapy; D063268:Sialic Acid Binding Ig-like Lectin 3; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage; D016896:Treatment Outcome
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D015703:Antigens, CD; D015214:Antigens, Differentiation, Myelomonocytic; C571163:CD33 protein, human; D063268:Sialic Acid Binding Ig-like Lectin 3; D003561:Cytarabine; D019772:Topotecan; D000079982:Gemtuzumab