title: Treatment of newly diagnosed acute promyelocytic leukemia (APL): a comparison of French-Belgian-Swiss and PETHEMA results.
abstract: All-trans retinoic acid (ATRA) plus anthracycline chemotherapy is the reference treatment of newly diagnosed acute promyelocytic leukemia (APL), whereas the role of cytosine arabinoside (AraC) remains disputed. We performed a joint analysis of patients younger than 65 years included in Programa para el Estudio de la Terapéutica en Hemopatía Maligna (PETHEMA) LPA 99 trial, where patients received no AraC in addition to ATRA, high cumulative dose idarubicin, and mitoxantrone, and APL 2000 trial, where patients received AraC in addition to ATRA and lower cumulative dose daunorubicin. In patients with white blood cell (WBC) count less than 10 x 10(9)/L, complete remission (CR) rates were similar, but 3-year cumulative incidence of relapse (CIR) was significantly lower in LPA 99 trial: 4.2% versus 14.3% (P = .03), although 3-year survival was similar in both trials. This suggested that AraC is not required in APL with WBC count less than 10 x 10(9)/L, at least in trials with high-dose anthracycline and maintenance treatment. In patients with WBC of 10 x 10(9)/L or more, however, the CR rate (95.1% vs 83.6% P = .018) and 3-year survival (91.5% vs 80.8%, P = .026) were significantly higher in APL 2000 trial, and there was a trend for lower 3-year CIR (9.9% vs 18.5%, P = .12), suggesting a beneficial role for AraC in those patients.
authors.affiliation: Hôpital Avicenne, Université Paris 13, Paris, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Adès
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Sanz
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Pau
authors.initials: P
authors.lastname: Montesinos
authors.forename: Patrice
authors.initials: P
authors.lastname: Chevallier
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Edo
authors.initials: E
authors.lastname: Vellenga
authors.forename: Agnès
authors.initials: A
authors.lastname: Guerci
authors.forename: Arnaud
authors.initials: A
authors.lastname: Pigneux
authors.forename: Francoise
authors.initials: F
authors.lastname: Huguet
authors.forename: Consuelo
authors.initials: C
authors.lastname: Rayon
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Stoppa
authors.forename: Javier
authors.initials: J
authors.lastname: de la Serna
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Cahn
authors.forename: Sandrine
authors.initials: S
authors.lastname: Meyer-Monard
authors.forename: Thomas
authors.initials: T
authors.lastname: Pabst
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Stéphane
authors.initials: S
authors.lastname: de Botton
authors.forename: Ricardo
authors.initials: R
authors.lastname: Parody
authors.forename: Juan
authors.initials: J
authors.lastname: Bergua
authors.forename: Thierry
authors.initials: T
authors.lastname: Lamy
authors.forename: Anne
authors.initials: A
authors.lastname: Vekhoff
authors.forename: Silvia
authors.initials: S
authors.lastname: Negri
authors.forename: Norbert
authors.initials: N
authors.lastname: Ifrah
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
authors.forename: Augustin
authors.initials: A
authors.lastname: Ferrant
authors.forename: Dominique
authors.initials: D
authors.lastname: Bron
authors.forename: Laurent
authors.initials: L
authors.lastname: Degos
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome