title: Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group.
abstract: After the identification of discrete relapse-risk categories in patients with acute promyelocytic leukemia (APL) receiving all-trans retinoic and idarubicin (AIDA)-like therapies, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) designed a protocol for newly diagnosed APL (AIDA-2000) in which postremission treatment was risk-adapted. Patients with low/intermediate risk received remission at 3 anthracycline-based consolidation courses, whereas high-risk patients received the same schedule as in the previous, non-risk-adapted AIDA-0493 trial including cytarabine. In addition, all patients in the AIDA-2000 received all-trans retinoic acid (ATRA) for 15 days during each consolidation. After induction, 600 of 636 (94.3%) and 420 of 445 (94.4%) patients achieved complete remission in the AIDA-0493 and AIDA-2000, respectively. The 6-year overall survival and cumulative incidence of relapse (CIR) rates were 78.1% versus 87.4% (P = .001) and 27.7% versus 10.7% (P < .0001). Significantly lower CIR rates for patients in the AIDA-2000 were most evident in the high-risk group (49.7% vs 9.3%, respectively, P < .0001). Our data confirm that anthracycline-based consolidation is at least equally effective as cytarabine-containing regimens for low-/intermediate-risk patients and suggest that a risk-adapted strategy including ATRA for consolidation improves outcome in newly diagnosed APL. Furthermore, our results highlight the role of cytarabine coupled to anthracyclines and ATRA during consolidation in the high-risk group.
authors.affiliation: Department of Biopathology, University Tor Vergata of Rome, Via Montpellier 1, Rome, Italy. francesco.lo.coco@uniroma2.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Lo-Coco
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Avvisati
authors.forename: Marco
authors.initials: M
authors.lastname: Vignetti
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.forename: Eugenio
authors.initials: E
authors.lastname: Gallo
authors.forename: Alessandro
authors.initials: A
authors.lastname: Rambaldi
authors.forename: Francesca
authors.initials: F
authors.lastname: Paoloni
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fioritoni
authors.forename: Felicetto
authors.initials: F
authors.lastname: Ferrara
authors.forename: Giorgina
authors.initials: G
authors.lastname: Specchia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cimino
authors.forename: Daniela
authors.initials: D
authors.lastname: Diverio
authors.forename: Erika
authors.initials: E
authors.lastname: Borlenghi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martinelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Eros
authors.initials: E
authors.lastname: Di Bona
authors.forename: Paola
authors.initials: P
authors.lastname: Fazi
authors.forename: Antonio
authors.initials: A
authors.lastname: Peta
authors.forename: Alberto
authors.initials: A
authors.lastname: Bosi
authors.forename: Angelo M
authors.initials: AM
authors.lastname: Carella
authors.forename: Francesco
authors.initials: F
authors.lastname: Fabbiano
authors.forename: Enrico M
authors.initials: EM
authors.lastname: Pogliani
authors.forename: Maria C
authors.initials: MC
authors.lastname: Petti
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
mesh_terms: D000293:Adolescent; D000328:Adult; D018943:Anthracyclines / Q000008:administration & dosage / Q000627:therapeutic use; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000627:therapeutic use*; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis / Q000188:drug therapy*; D008875:Middle Aged; D012074:Remission Induction; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D000970:Antineoplastic Agents; D003561:Cytarabine; D014212:Tretinoin; D015255:Idarubicin