Final results of a prospective, observational study of the effectiveness of darbepoetin alfa administered every three weeks for the treatment of chemotherapy-induced anaemia in elderly patients

Abstract

e20654 Background: Cancer incidence is increasing in elderly but specific treatment data in this population is not often available. The objectives of this study were to evaluate the effectiveness and safety of darbepoetin alfa (DA) administered once every 3 weeks (Q3W) for the treatment of chemotherapy-induced anaemia (CIA) in elderly within routine clinical practice. Methods: Prospective, observational, single-arm, multicentre study performed in 28 centres across Spain. Eligible patients (pts):≥65 years, anaemic (haemoglobin [Hb] 11 g/dl), with non-myeloid malignancies, and scheduled to receive ≥9 weeks (wks) of chemotherapy. Pts were treated with a fixed dose of DA 500 μg Q3W and treatment stopped if Hb levels exceeded 13g/dl. Primary endpoint was hematopoietic response (Hb increase ≥2g/dl or Hb ≥12g/dl without transfusions in the previous 28 days). Secondary endpoints included percentage of pts achieving target Hb (>11g/dl from wk 5 till end of treatment without red blood cell transfusion within 28 days), changes in the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale and the incidence of adverse reactions. Results: Data were prospectively collected from 153 pts: women (56.86%), mean (SD) age 73.43 (5.77) years, ECOG Performance Status 0–1 (65.36%) with solid tumors (66.67%) and lymphoproliferative malignancies (33.33%) and stage III/IV (63.40%). Most pts (90.20%) had baseline Hb levels between 9–11g/dL. DA was administered for a median of 9.0 wks (range: 1–22.57). The Kaplan-Meier percentage (KM; 95% CI) of pts who achieved hematopoietic response was 69.70% (56.06–83.34) and 72.22% (57.5–86.94) for pts who achieved target Hb (>11g/dL). FACT-F median score at baseline was 29.00 and 33.00 at the end of the study. Only one (0.7%) non-serious adverse reaction (cutaneous eruption) was reported. Conclusions: These results suggest that DA given at 500 μg Q3W to elderly pts with non-myeloid malignancies is an effective and well-tolerated treatment for CIA. [Table: see text]