title: Pilot study of gemtuzumab ozogamicin, liposomal daunorubicin, cytarabine and cyclosporine regimen in patients with refractory acute myelogenous leukemia.
abstract: Multi-drug resistance (MDR) protein expression is associated with reduced gemtuzumab ozogamicin (Mylotarg) activity. Both cyclosporine-A (CSA) and liposome-encapsulated daunorubicin, DaunoXome (DNX) may reduce the negative impact of MDR. A gemtuzumab ozogamicin, DNX, cytarabine (ara-C) and CSA (MDAC) regimen was piloted in patients with refractory acute myelogenous leukemia (AML) (relapsed 10, primary refractory 1) (median age 37 years (16-67)). One (9%) patient achieved a transient CR, one CRp. Grade 3/4 toxicities included sepsis (seven patients; 63%); hyperbilirubinemia (six patients; 54%), with transaminitis in one patient; mucositis (three patients; 27%). The inclusion of CSA in a gemtuzumab ozogamicin-containing regimen is feasible. The MDAC regimen was associated with significant toxicity in a cohort of patients with very advanced AML.
authors.affiliation: Department of Leukemia, M.D. Anderson Cancer Center, University of Texas, Box 428, 1515 Holcombe Blvd., Houston, TX 77030, USA.
authors.forename: Efrosyni
authors.initials: E
authors.lastname: Apostolidou
authors.forename: Jorge
authors.initials: J
authors.lastname: Cortes
authors.forename: Apostolia
authors.initials: A
authors.lastname: Tsimberidou
authors.forename: Elihu
authors.initials: E
authors.lastname: Estey
authors.forename: Hagop
authors.initials: H
authors.lastname: Kantarjian
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Giles
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000617:Aminoglycosides; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000633:toxicity*; D016572:Cyclosporine / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000150:complications / Q000188:drug therapy*; D008081:Liposomes / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012074:Remission Induction; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D008081:Liposomes; D003561:Cytarabine; D016572:Cyclosporine; D000079982:Gemtuzumab; D003630:Daunorubicin