title: Very long-term outcome of acute promyelocytic leukemia after treatment with all-trans retinoic acid and chemotherapy: the European APL Group experience.
abstract: Acute promyelocytic leukemia (APL) is highly curable with the combination of all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy (CT), but very long-term results of this treatment, when CT should be added to ATRA and the role of maintenance treatment, remain uncertain. In our APL93 trial that included 576 newly diagnosed APL patients, with a median follow-up of 10 years, 10-year survival was 77%. Maintenance treatment significantly reduced 10-year cumulative incidence of relapses, from 43.2% to 33%, 23.4%, and 13.4% with no maintenance, maintenance using intermittent ATRA, continuous 6 mercaptopurine plus methotrexate, and both treatments, respectively (P < .001). Maintenance particularly benefited patients with white blood cell (WBC) count higher than 5 x 10(9)/L (5000/microL). Early addition of CT to ATRA significantly improved 10-year event-free survival (EFS), but without significant effect on overall survival (OS). The 10-year cumulative incidence of deaths in complete response (CR), resulting mainly from myelosuppression, was 5.7%, 15.4%, and 21.7% in patients younger than 55, 55 to 65, and older than 65 years, respectively, supporting the need for less myelosuppressive treatments, particularly for consolidation therapy. This study is registered at http://clinicaltrials.gov as NCT00599937.
authors.affiliation: Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Université Paris 13, Paris, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Adès
authors.forename: Agnes
authors.initials: A
authors.lastname: Guerci
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Miguel
authors.initials: M
authors.lastname: Sanz
authors.forename: Patrice
authors.initials: P
authors.lastname: Chevallier
authors.forename: Simona
authors.initials: S
authors.lastname: Lapusan
authors.forename: Christian
authors.initials: C
authors.lastname: Recher
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Consuelo
authors.initials: C
authors.lastname: Rayon
authors.forename: Sylvie
authors.initials: S
authors.lastname: Castaigne
authors.forename: Olivier
authors.initials: O
authors.lastname: Tournilhac
authors.forename: Stephane
authors.initials: S
authors.lastname: de Botton
authors.forename: Norbert
authors.initials: N
authors.lastname: Ifrah
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Cahn
authors.forename: Eric
authors.initials: E
authors.lastname: Solary
authors.forename: Claude
authors.initials: C
authors.lastname: Gardin
authors.forename: Nathalie
authors.initials: N
authors.lastname: Fegeux
authors.forename: Dominique
authors.initials: D
authors.lastname: Bordessoule
authors.forename: Augustin
authors.initials: A
authors.lastname: Ferrant
authors.forename: Sandrine
authors.initials: S
authors.lastname: Meyer-Monard
authors.forename: Norbert
authors.initials: N
authors.lastname: Vey
authors.forename: Herve
authors.initials: H
authors.lastname: Dombret
authors.forename: Laurent
authors.initials: L
authors.lastname: Degos
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D003561:Cytarabine; D014212:Tretinoin