title: Comparison of high-dose cytarabine and timed-sequential chemotherapy as consolidation for younger adults with AML in first remission: the ALFA-9802 study.
abstract: To assess the value of administering timed-sequential chemotherapy (TSC; 2 therapeutic sequences separated by a 4-day interval-free chemotherapy) or high-dose cytarabine (HDAraC) cycles in consolidation therapy for acute myeloid leukemia (AML), 459 patients 15 to 50 years of age were enrolled in the prospective randomized Acute Leukemia French Association-9802 trial. Complete remission was achieved in 89%. A total of 237 patients were then randomized to either TSC consolidation (120 patients) or HDAraC consolidation cycles (117 patients). Overall, there was no significant difference between the 2 consolidation arms (5-year event-free survival [EFS]: 41% for HDAraC vs 35% for TSC), or cumulative incidence of relapse, or treatment-related mortality. Cytogenetically normal AML NPM1(+) or CEBPA(+) and FLT3-ITD(-) had the same outcome as those with favorable cytogenetics. When considering favorable and unfavorable risk groups, the trend was in favor of HDAraC. However, the difference became significant when considering intermediate cytogenetics (5-year EFS: 49% vs 29%; P = .02), especially cytogenetically normal AML (5-year EFS: 48% vs 31%; P = .04), which was related to lower relapse rate and less toxicity. This study demonstrates that TSC did not produce any benefit when used as consolidation therapy in younger adults compared with HDAraC. This trial was registered at www.clinicaltrials.gov as #NCT00880243.
authors.affiliation: Department of Hematology, Hôpital Edouard Herriot, Lyon, France. xavier.thomas@chu-lyon.fr
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Mohamed
authors.initials: M
authors.lastname: Elhamri
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Aline
authors.initials: A
authors.lastname: Renneville
authors.forename: Cécile
authors.initials: C
authors.lastname: Pautas
authors.forename: Stéphane
authors.initials: S
authors.lastname: de Botton
authors.forename: Thierry
authors.initials: T
authors.lastname: de Revel
authors.forename: Oumedaly
authors.initials: O
authors.lastname: Reman
authors.forename: Christine
authors.initials: C
authors.lastname: Terré
authors.forename: Claude
authors.initials: C
authors.lastname: Gardin
authors.forename: Youcef
authors.initials: Y
authors.lastname: Chelghoum
authors.forename: Nicolas
authors.initials: N
authors.lastname: Boissel
authors.forename: Bruno
authors.initials: B
authors.lastname: Quesnel
authors.forename: Yosr
authors.initials: Y
authors.lastname: Hicheri
authors.forename: Jean-Henri
authors.initials: JH
authors.lastname: Bourhis
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
authors.forename: Claude
authors.initials: C
authors.lastname: Preudhomme
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Sylvie
authors.initials: S
authors.lastname: Castaigne
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage* / Q000627:therapeutic use*; D020732:Cytogenetic Analysis; D018572:Disease-Free Survival; D004358:Drug Therapy / Q000379:methods; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000235:genetics / Q000628:therapy; D008875:Middle Aged; D000090243:Nucleophosmin; D011446:Prospective Studies; D012074:Remission Induction; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; C000716967:NPM1 protein, human; D003561:Cytarabine; D000090243:Nucleophosmin