79 O - An approach for evaluating the cost-effectiveness and impact on quality of life of inpatient treatment versus outpatient trea1ment during consolidation chemotherapy in elderly patients with acute myeloid leukemia (AML)

In elderly patients with AML, the induction treatment requires 4–5 weeks of hospitalization. The aim of the phase III AML-13 trial of the EORTC Leukemia Group is to assess two types of consolidation chemotherapy in patients who reach complete remission after the induction cycle : 3 drugs during 7 days, using a classical continuous infusion, on an inpatient basis, or the same kind of drugs but delivered subcutaneously or orally, on an outpatient basis. In the second group, patients are hospitalized only in case of complications. The evaluation parameters are not only disease-free survival and overall survival, but also cost-effectiveness and quality of life. The latter endpoints pose specific methodological challenges. We decided to use a diary to collect information concerning treatment compliance, side-effects of treatment and their impact on quality of life, and use of health care facilities. In addition information concerning resource utilisation during hospital treatment is being collected through the clinical Case Report Forms. This communication aims to discuss the methodological approach to integrate economic and quality of life aspects in this large scale clinical trial.