title: Mitoxantrone and prolonged infusion gemcitabine as salvage therapy in patients with acute myelogenous leukemia.
abstract: In a recent phase I study, a combination of gemcitabine at 10 mg/(m(2)min) for 12 h and mitoxantrone 12 mg/m(2) daily for 3 days, achieved a complete remission (CR) in 3 of 12 (25%) patients with refractory leukemia. A pilot assessment of this regimen was conducted to determine its tolerability in patients with refractory acute myeloid leukemia (AML). In a cohort of 18 patients with very refractory disease (6 primary refractory, 12 relapsed, mean initial CR duration 3.5 months), one patient achieved a CR, a second CR with incomplete platelet recovery (CRp). Sepsis and mucositis were significant extramedullary toxicities. The gemcitabine and mitoxantrone regimen was feasible to administer even in heavily pre-treated patients. It was not active in patients who had failed a prior salvage regimen. It may warrant further study in patients with primary resistant AML.
authors.affiliation: Department of Leukemia, M.D. Anderson Cancer Center, University of Texas, P.O. Box 428, 1515 Holcombe Boulevard, Houston, TX 77030, USA.
authors.forename: Efrosyni
authors.initials: E
authors.lastname: Apostolidou
authors.forename: Elihu
authors.initials: E
authors.lastname: Estey
authors.forename: Jorge
authors.initials: J
authors.lastname: Cortes
authors.forename: Guillermo
authors.initials: G
authors.lastname: Garcia-Manero
authors.forename: Stefan
authors.initials: S
authors.lastname: Faderl
authors.forename: Deborah
authors.initials: D
authors.lastname: Thomas
authors.forename: Apostolia
authors.initials: A
authors.lastname: Tsimberidou
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; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000633:toxicity; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D006801:Humans; D007263:Infusions, Parenteral; D015470:Leukemia, Myeloid, Acute / Q000150:complications / Q000188:drug therapy*; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage*; D009061:Mouth Mucosa; D010865:Pilot Projects; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy; D018805:Sepsis / Q000209:etiology; D013280:Stomatitis / Q000209:etiology; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D008942:Mitoxantrone; D000093542:Gemcitabine