title: Non-infusional vs intravenous consolidation chemotherapy in elderly patients with acute myeloid leukemia: final results of the EORTC-GIMEMA AML-13 randomized phase III trial.
abstract: In this trial, acute myeloid leukemia patients (pts) aged 61-80 years received MICE (mitoxantrone, etoposide and cytarabine) induction chemotherapy in combination with different schedules of granulocyte colony-stimulating factor administration. Pts in complete remission were subsequently randomized for two cycles of consolidation therapy: mini-ICE regimen (idarubicin, etoposide and cytarabine) given according to either an intravenous (i.v.) or a 'non-infusional' schedule. Among the 346 pts randomized for the second step, 331 pts received consolidation-1 and 182 consolidation-2. A total of 290 events (255 relapses, 35 deaths in first CR) have been reported. The median follow-up was 4.4 years. No significant differences were detected in terms of disease-free survival (median 9 vs 10.4 months, P=0.15, hazard ratio (HR) =1.18, 95% confidence interval (CI) 0.94-1.49) - primary end point - and survival (median 15.7 vs 17.8 months, P=0.19, HR=1.17, 95% CI 0.92-1.50). In the 'non-infusional' arm grade 3-4 vomiting (10 vs 2%; P=0.001) and diarrhea (10 vs 4%; P=0.03) were higher than in the 'i.v.' arm, whereas time to platelet recovery >20 x 10(9)/l (median: 19 vs 23 days; P=0.02) and duration of hospitalization (mean: 15 vs 27 days; P<0.0001) was shorter. The 'non-infusional' consolidation regimen resulted in an antileukemic effect similar to the intravenous regimen, which was less myelosuppressive and associated with less hospitalization days.
authors.affiliation: Department of Hematology, Klinikum Grosshadern, Ludwig-Maximilians University, Munich, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Jehn
authors.forename: S
authors.initials: S
authors.lastname: Suciu
authors.forename: X
authors.initials: X
authors.lastname: Thomas
authors.forename: F
authors.initials: F
authors.lastname: Lefrère
authors.forename: P
authors.initials: P
authors.lastname: Muus
authors.forename: Z
authors.initials: Z
authors.lastname: Berneman
authors.forename: J-P
authors.initials: JP
authors.lastname: Marie
authors.forename: F
authors.initials: F
authors.lastname: Adamo
authors.forename: G
authors.initials: G
authors.lastname: Fillet
authors.forename: F
authors.initials: F
authors.lastname: Nobile
authors.forename: F
authors.initials: F
authors.lastname: Ricciuti
authors.forename: G
authors.initials: G
authors.lastname: Leone
authors.forename: V
authors.initials: V
authors.lastname: Rizzoli
authors.forename: M
authors.initials: M
authors.lastname: Montanaro
authors.forename: F
authors.initials: F
authors.lastname: Beeldens
authors.forename: P
authors.initials: P
authors.lastname: Fazi
authors.forename: F
authors.initials: F
authors.lastname: Mandelli
authors.forename: R
authors.initials: R
authors.lastname: Willemze
authors.forename: T
authors.initials: T
authors.lastname: de Witte
authors.forename: S
authors.initials: S
authors.lastname: Amadori
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003561:Cytarabine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007262:Infusions, Intravenous; D007902:Length of Stay; D007951:Leukemia, Myeloid / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D010198:Pancytopenia; D010349:Patient Compliance; D012307:Risk Factors
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D003561:Cytarabine; D005047:Etoposide; D008942:Mitoxantrone; D015255:Idarubicin