title: Incidence rates of treatment-emergent adverse events and related hospitalization are reduced with azacitidine compared with conventional care regimens in older patients with acute myeloid leukemia.
abstract: Relative risks of treatment-emergent adverse events (TEAEs) and related hospitalization is most accurate when accounting for treatment exposure. AZA-AML-001 showed azacitidine (AZA) prolonged overall survival versus conventional care regimens (CCR) in older patients (≥65 years) with acute myeloid leukemia (AML) by 3.9 months. Preselection of CCR before study randomization allows evaluation of AZA safety in patient subgroups with similar clinical features. Within preselection groups, AZA exposure was greater than each CCR. Incidence rates (IRs; numbers of events normalized for drug exposure time) of hospitalizations and days in hospital for TEAEs per patient-year of exposure were to varying degrees lower with AZA versus each CCR. Overall survival was significantly prolonged with AZA versus best supportive care (BSC) in AZA-AML-001; this analysis showed 55% and 41% reductions in IRs of TEAE-related hospitalization and days in hospital, respectively, with AZA versus BSC. Older patients with AML unable to tolerate intensive therapy should be offered active low-intensity treatment.
authors.affiliation: a Peter MacCallum Cancer Center, University of Melbourne , Parkville , Melbourne , Australia.
authors.forename: John F
authors.initials: JF
authors.lastname: Seymour
authors.affiliation: b Universitätsklinikum Ulm , Ulm , Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Döhner
authors.affiliation: c Princess Margaret Hospital , Toronto , Ontario , Canada.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Minden
authors.affiliation: d Dana-Farber Cancer Institute , Boston , MA , USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Stone
authors.affiliation: e Celgene Corporation , Summit , NJ , USA.
authors.forename: Dominique
authors.initials: D
authors.lastname: Gambini
authors.affiliation: e Celgene Corporation , Summit , NJ , USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Dougherty
authors.affiliation: e Celgene Corporation , Summit , NJ , USA.
authors.forename: C L
authors.initials: CL
authors.lastname: Beach
authors.affiliation: e Celgene Corporation , Summit , NJ , USA.
authors.forename: Jerry
authors.initials: J
authors.lastname: Weaver
authors.affiliation: f Hôpital Saint Louis, Institut Universitaire d'Hématologie , Paris , France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001374:Azacitidine / Q000009:adverse effects* / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology*; D005260:Female; D006295:Health Resources; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D015470:Leukemia, Myeloid, Acute / Q000150:complications* / Q000453:epidemiology* / Q000401:mortality / Q000628:therapy; D008297:Male; D009026:Mortality
chemical_list: D001374:Azacitidine
keywords: AE; Azacitidine; TEAE; hospitalization; treatment-emergent adverse event