Do Results From Clinical Trials in Acute Myeloid Leukemia Reflect Clinical Reality? A Danish National Cohort Study of 813 Patients

• Published in: Blood 2012-11, Vol.120 (21), p.1477-1477
• Main Authors: Ostgard, Lene Sofie Granfeldt, Nørgaard, Mette, Sengeløv, Henrik, Kjeldsen, Lars, Friis, Lone S., Jensen, Morten K., Kallenbach, Maria, Norgaard, Jan M.
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V120.21.1477.1477

Abstract 1477▪▪This icon denotes a clinically relevant abstract Previous studies have documented the underrepresentation of women and elderly patients in American clinical trials of leukemia. If, characteristics of patients included in clinical protocols differ markedly from the characteristics of the majority of patients treated outside protocols the external validity of clinical trials may be threatened. The Danish National Acute Leukaemia Database (ALDB) includes detailed data on a large well-defined non-selected population of 2729 AML patients (covering >95% of AML patients diagnosed since Jan 2000). Since 2000 Danish AML patients have been included in 3 different British protocols (AML15, 16 and 17). We analysed a cohort of 2624 patients diagnosed with AML in Denmark since Jan. 2000 (105 APL-patients were excluded). We compared patients treated with curative intent according to the British protocols with patients treated with curative intent off-protocol with regard to characteristics, possible prognostic factors, CR-rate, and survival. For comparable groups we divided patients into 2 age groups (