title: Long-term follow-up of European APL 2000 trial, evaluating the role of cytarabine combined with ATRA and Daunorubicin in the treatment of nonelderly APL patients.
abstract: All-trans retinoic acid (ATRA) combined to anthracycline-based chemotherapy is the reference treatment of acute promyelocytic leukemia (APL). Whereas, in high-risk patients, cytarabine (AraC) is often considered useful in combination with anthracycline to prevent relapse, its usefulness in standard-risk APL is uncertain. In APL 2000 trial, patients with standard-risk APL [i.e., with baseline white blood cell (WBC) count <10,000/mm(3) ] were randomized between treatment with ATRA with Daunorubicin (DNR) and AraC (AraC group) and ATRA with DNR but without AraC (no AraC group). All patients subsequently received combined maintenance treatment. The trial had been prematurely terminated due to significantly more relapses in the no AraC group (J Clin Oncol, (24) 2006, 5703-10), but follow-up was still relatively short. With long-term follow-up (median 103 months), the 7-year cumulative incidence of relapses was 28.6% in the no AraC group, compared to 12.9% in the AraC group (P = 0.0065). In standard-risk APL, at least when the anthracycline used is DNR, avoiding AraC may lead to an increased risk of relapse suggesting that the need for AraC is regimen-dependent.
authors.affiliation: Hopital Avicenne, université paris 13, Bobigny, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Adès
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Agnes
authors.initials: A
authors.lastname: Guerci-Bresler
authors.forename: Arnaud
authors.initials: A
authors.lastname: Pigneux
authors.forename: Nobert
authors.initials: N
authors.lastname: Vey
authors.forename: Thierry
authors.initials: T
authors.lastname: Lamy
authors.forename: Francoise
authors.initials: F
authors.lastname: Huguet
authors.forename: Anne
authors.initials: A
authors.lastname: Vekhoff
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Lambert
authors.forename: Bruno
authors.initials: B
authors.lastname: Lioure
authors.forename: Stephane
authors.initials: S
authors.lastname: de Botton
authors.forename: Erick
authors.initials: E
authors.lastname: Deconinck
authors.forename: Augustin
authors.initials: A
authors.lastname: Ferrant
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Bruno
authors.initials: B
authors.lastname: Quesnel
authors.forename: Bruno
authors.initials: B
authors.lastname: Cassinat
authors.forename: Christine
authors.initials: C
authors.lastname: Chomienne
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
authors.forename: Laurent
authors.initials: L
authors.lastname: Degos
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D057239:Early Termination of Clinical Trials; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012307:Risk Factors; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage
chemical_list: D003561:Cytarabine; D014212:Tretinoin; D003630:Daunorubicin