title: Two cycles of risk-adapted consolidation therapy in patients with acute promyelocytic leukemia. Results from the SAL-AIDA2000 trial.
abstract: The combination of all-trans retinoic acid (ATRA) and idarubicin (AIDA) for induction therapy followed by three cycles of risk-adapted consolidation cycles is considered standard of care for patients with acute promyelocytic leukemia (APL). We report the outcome of 141 patients (median age 51 years; range, 19-82, 31 % ≥60 years) enrolled into the prospective Study Alliance Leukemia (SAL)-AIDA2000 trial, which comprised AIDA-based induction followed by only two courses of risk-adapted consolidation (daunorubicin or mitoxantrone ± cytarabine) followed by 2-year maintenance treatment. The early death rate was 7 % (median age 66 years), and additional 9 % stopped further treatment after induction. The estimated 6-year disease-free survival (DFS) was 80 % in all patients, 84 % in patients ≤60 and 72 % in patients >60 years (p = 0.140). No significant survival differences were observed between the high-risk and the non-high-risk patients (6-year OS 78 vs. 81 %, p = 0.625). Our results confirm the efficacy of a risk-adapted approach in APL patients. Furthermore, long-term outcomes are comparable to the results obtained with three cycles of consolidation. A modification of the number and intensity of conventional consolidation treatment may be a less toxic but equally effective approach and should be considered for further evaluation in randomized clinical trials in APL.
authors.affiliation: Medizinische Klinik und Poliklinik I, Universitätsklinikum Dresden, Fetscherstraße 74, 01307, Dresden, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Röllig
authors.forename: Kerstin
authors.initials: K
authors.lastname: Schäfer-Eckardt
authors.forename: Matthias
authors.initials: M
authors.lastname: Hänel
authors.forename: Michael
authors.initials: M
authors.lastname: Kramer
authors.forename: Markus
authors.initials: M
authors.lastname: Schaich
authors.forename: Christian
authors.initials: C
authors.lastname: Thiede
authors.forename: Uta
authors.initials: U
authors.lastname: Oelschlägel
authors.forename: Brigitte
authors.initials: B
authors.lastname: Mohr
authors.forename: Thomas
authors.initials: T
authors.lastname: Wagner
authors.forename: Hermann
authors.initials: H
authors.lastname: Einsele
authors.forename: Stefan W
authors.initials: SW
authors.lastname: Krause
authors.forename: Heinrich
authors.initials: H
authors.lastname: Bodenstein
authors.forename: Sonja
authors.initials: S
authors.lastname: Martin
authors.forename: Reingard
authors.initials: R
authors.lastname: Stuhlmann
authors.forename: Antony D
authors.initials: AD
authors.lastname: Ho
authors.forename: Martin
authors.initials: M
authors.lastname: Bornhäuser
authors.forename: Gerhard
authors.initials: G
authors.lastname: Ehninger
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schuler
authors.forename: Uwe
authors.initials: U
authors.lastname: Platzbecker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D060830:Consolidation Chemotherapy / Q000379:methods*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage*; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D057285:Precision Medicine; D012306:Risk; D016019:Survival Analysis; D014212:Tretinoin / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014212:Tretinoin; D015255:Idarubicin