Mitoxantrone and prolonged infusion gemcitabine as salvage therapy in patients with acute myelogenous leukemia.
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.
Apostolidou
Efrosyni
E
Department of Leukemia, M.D. Anderson Cancer Center, University of Texas, P.O. Box 428, 1515 Holcombe Boulevard, Houston, TX 77030, USA.
Estey
Elihu
E
Cortes
Jorge
J
Garcia-Manero
Guillermo
G
Faderl
Stefan
S
Thomas
Deborah
D
Tsimberidou
Apostolia
A
Kantarjian
Hagop
H
Giles
Francis J
FJ
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
D000970:Antineoplastic Agents; D003841:Deoxycytidine; D008942:Mitoxantrone; D000093542:Gemcitabine