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A prospective, observational study of the effectiveness, safety and impact on quality of life (QoL) of a weekly fixed dose of darbepoetin alfa (DA) for the treatment of chemotherapy-induced anemia (CIA) in patients (pts) with non-myeloid malignancies.

18588 Background: CIA in cancer pts results in fatigue and reduction of QoL. DA is a unique erythropoiesis-stimulating agent (ESA) effective for the treatment of CIA when administered weekly (QW), every 2 weeks (wks, Q2W) or every 3 wks(Q3W).Fixed dosing of DA is routinely used in clinical practice, but little data are available on its patterns of use and effectiveness.


METHODS
Prospective, observational, multicenter study performed in 30 centres across Spain. Eligible pts: ≥18 yrs, anemic(Hb ≤11 g/dL), with non-myeloid malignancies, and scheduled to receive ≥12 wks of chemotherapy. Data were collected from pts starting treatment with DA 150mcgQW for a maximum of 16 wks (dose to be doubled if Hb increased <1 g/dL after 4 wks). Primary endpoint: hematopoietic response (Hb increase ≥2 g/dL or Hb ≥12 g/dL without transfusions in the previous 28 days). Secondary endpoints include QoL measured by FACT-F score and safety. QoL was evaluated by changes in FACT-F score from baseline to 6 wks (sc0-sc6), 12 wks (sc0 - sc12) and to the end of treatment (EOT) (sc0-sc16).


RESULTS
A total of 293 pts were recruited. Most pts were women (56.4%), median age: 64.9 yrs (range: 20.6-88.4), median weight: 67.0 Kg (range: 40.5-115.0) with lymphoproliferative malignancies (44.3%) and solid tumours (55.7%). Stage III/IV: 75.6%. Most (83.7%) pts had baseline Hb between 9-11 g/dL; 16.3% with Hb <9 g/dL. DA was administered for a median of 15.0 wks (range: 1-16). At wk 5, 21% pts had dose doubled to 300 mcg QW. Hematopoietic response: 63.8% (95% CI: 58.1; 69.4). Proportion of pts transfused from wk 5 to EOT: 12%, median: 2 units (range 1-3). DA was well-tolerated with only 6 pts experiencing adverse events considered related to the study drug (thromboembolic events, 3pts (1.03%)). Changes in FACT-F score showed significant improvement in sc0-sc6 (mean difference: -1.73, p = 0.0083), in sc0-sc12 (-1.98, p = 0.0088) and particularly in sc0-sc16 (-3.75, p < 0.001).


CONCLUSIONS
Fixed dose of DA is an effective and well-tolerated treatment for CIA in pts with non-myeloid malignancies. DA significantly improved health-related quality of life in this clinical practice-based study. [Table: see text].