Aarhus University Seal / Aarhus Universitets segl

Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

  • Lene Sofie Granfeldt Østgård
  • Mette Nørgaard
  • Henrik Sengeløv, Department of Hematology, The University Hospital Rigshospitalet, Copenhagen, Denmark.
  • ,
  • Bruno C Medeiros, Stanford University
  • ,
  • Lars Kjeldsen, Department of Hematology, The University Hospital Rigshospitalet, Copenhagen, Denmark.
  • ,
  • Ulrik Malthe Overgaard, Department of Hematology, Herlev University Hospital, Copenhagen, Denmark.
  • ,
  • Marianne Tang Severinsen, Aalborg Universitet
  • ,
  • Claus Werenberg Marcher, Department of Hematology, Odense University Hospital, Odense, Denmark.
  • ,
  • Morten Krogh Jensen, Department of Hematology, Copenhagen University Hospital, Roskilde, Denmark.
  • ,
  • Jan Maxwell Nørgaard

Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial.We conducted a population-based cohort study of newly diagnosed Danish AML patients treated with intensive chemotherapy between 2000-2013. We estimated accrual rates and compared characteristics, complete remission (CR) rates, and relative risks (RRs) of death at 90-day, 1-year, and 3-years in clinical trial patients to patients treated off-trial.Of 867 patients, 58.3% (n = 504) were included in a clinical trial. Accrual rates were similar across age groups (p = 0.55). Patients with poor performance status, comorbidity, therapy-related and secondary AML were less likely to be enrolled in trials. CR rates were 80.2% in trial-patients versus 68.6% in patients treated off- trial. Also, trial-patients had superior survival at 1-year; 72%, vs. 54% (adjusted RR of death 1.28(CI = 1.06-1.54)), and at 3 years; 45% vs. 29% (adjusted RR 1.14(CI = 1.03-1.26)) compared to patients treated off-trial.Despite high accrual rates, patients enrolled in clinical trials had a favorable prognostic profile and a better survival than patients treated off-trial. In conclusion, all trial results should be extrapolated with caution and population-based studies of "real world patients" have a prominent role in examining the prognosis of AML.

Sider (fra-til)72044-72056
Antal sider13
StatusUdgivet - 6 okt. 2016

Se relationer på Aarhus Universitet Citationsformater

ID: 104307232