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.
journal_name
Leuk Lymphomajournal_title
Leukemia & lymphomaauthors
Seymour JF,Döhner H,Minden MD,Stone R,Gambini D,Dougherty D,Beach CL,Weaver J,Dombret Hdoi
10.1080/10428194.2016.1243680subject
Has Abstractpub_date
2017-06-01 00:00:00pages
1412-1423issue
6eissn
1042-8194issn
1029-2403journal_volume
58pub_type
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