The effectiveness of darbepoetin alfa administered at 300 mcg every 3 weeks on clinical outcomes in elderly patients with chemotherapy-induced anemia

Abstract

18511 Background: Chemotherapy-induced anemia (CIA) is common in patients (pts) receiving chemotherapy, and reduces health-related quality of life. The primary objective of this exploratory analysis was to describe the effectiveness of darbepoetin alfa administered at 300 mcg every 3 weeks (Q3W) in elderly (≥ 65 years old) and younger pts (< 65 years old) with CIA. Methods: We analyzed data on 1493 pts, enrolled in a multicenter, open-label, 16-week study and who received ≥ 1 dose of darbepoetin alfa. Eligible pts were ≥ 18 years old, had a non-myeloid malignancy, and were anemic (hemoglobin [Hb] < 11 g/dL). Pts were analyzed stratified by age (≥ 65 and < 65 years old) and baseline (BL) Hb (< 10 or ≥ 10 g/dL). Hb-based endpoints were analyzed using 2 approaches: the last value carried forward (LVCF) method, where missing Hb values or values within 28 days of a red blood cell (RBC) transfusion were imputed, or an available data approach, where missing Hb values were not imputed. Pt-reported outcomes were assessed using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. Results: Pt demographics and disease characteristics varied between the age strata: in the ≥ 65-stratum (mean age = 73.7, n = 724), 52% of pts were women and the most common cancer was gastrointestinal (27%); in the < 65-stratum (mean age = 52.1, n = 769), 69% of pts were women and the most common cancer was breast (41%). Mean (SD) BL FACT-F scores for pts ≥ 65 and < 65 were 27.5 (12.8) vs 27.2 (12.1) for the < 10-g/dL strata and 29.0 (12.5) vs 27.5 (12.0) for the ≥ 10-g/dL strata. Study endpoints are shown in the table. The safety profile was as expected for each age group. Conclusions: Darbepoetin alfa 300 mcg Q3W appears to be as effective in achieving and maintaining Hb between 11 to 13 g/dL in elderly pts as in younger pts with CIA. Since chemotherapy is often administered Q3W, synchronizing darbepoetin alfa treatment with pts’ chemotherapy schedules may simplify the treatment of CIA in this pt population. [Table: see text] [Table: see text]