DECITABINE REDUCES TRANSFUSION DEPENDENCE IN OLDER PATIENTS WITH ACUTE MYELOID LEUKAEMIA- RESULTS FROM A POST-HOC ANALYSIS OF A RANDOMISED PHASE III TRIAL
Author(s)
Dass RN1, Howes A1, Spencer M2, Xiu L3, Thomas XG4, Al-Dakkak I51Janssen-Cilag Limited, High Wycombe, United Kingdom, 2Janssen-Cilag Limited, High Wycombe, Bucks, United Kingdom, 3Janssen-Cilag Limited, Raritan, NJ, USA, 4Centre Hospitalier Lyon Sud, Pierre-Benite cedex, France, 5HERON Health, Luton, United Kingdom
OBJECTIVES: The incidence of acute myeloid leukaemia (AML) increases with age; older patients have limited treatment options and poorer outcomes. Dependence on blood transfusions (correcting anaemia and preventing bleeding) and repeated hospitalisation reduce health-related quality of life and increase treatment expenditure. This post-hoc analysis assessed the impact of decitabine on transfusion dependence. METHODS: The DACO-16 phase III trial (NCT00260832) was conducted in newly-diagnosed AML patients (≥65 years; N=485) (Kantarjian, JCO; ePub 11Jun2012). Every 4 weeks, patients received decitabine (DACOGEN) 20 mg/m2 (1-h intravenously; 5 successive days) or treatment choice with physician’s advice (TC) with supportive care or cytarabine (20 mg/m2 subcutaneously daily; 10 successive days). Treatment duration was longer in the DACOGEN than TC arm (median: 4 cycles vs. 2 cycles). We measured red blood cell (RBC) and platelet (PLT) transfusion-independence (no transfusions for ≥ 8 consecutive weeks) and hospitalisation length (% hospital nights relative to treatment days) in both DACOGEN (n=242) and TC (n=243) arms. RESULTS: In patients who were PLT transfusion-dependent at baseline (85 in DACOGEN and 83 in TC arms), more became transfusion-independent in the DACOGEN arm (26 [31%]) than the TC arm (11 [13%]) (p=0.0069). Likewise, in RBC transfusion-dependent patients at baseline (168 in DACOGEN and 162 in TC arms), transfusion-independence was higher for DACOGEN (44 [26%]) than TC (21 [13%]) (p=0.0026). For hospitalised patients (182 in TC, 191 in DACOGEN arms), the median % of hospital nights was higher in the TC arm (39%) than the DACOGEN arm (34%). Similarly, for adverse event-hospitalised patients (100 in TC, 132 in DACOGEN arms), the median was 20.0% vs. 17.5% in the TC and DACOGEN arms, respectively. CONCLUSIONS: Dacogen leads to a statistically-significant reduction in transfusion-dependence, when compared with TC. This reduction is an important factor in the economic and humanistic burden of AML in older patients.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PCN121
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology