Gordon D et al. - In a study to examine the efficacy of darbepoetin alfa for treating anemia of cancer (AoC) in pts not receiving chemotherapy or radiotherapy, it was shown that darbepoetin alfa appeared to be well tolerated and significantly increased hemoglobin levels Methods
Pts were randomized 3:1 to receive darbepoetin alfa or placebo every 4 weeks; the end of the study was at week 17
Primary endpoint was the percentage of pts with hematopoietic response
Secondary endpoints included transfusion incidence and safety parameters
Efficacy analyses were performed on 162 pts in the darbepoetin alfa group and 56 pts in the placebo group
Results
Kaplan–Meier percentages of pts who achieved a hematopoietic response or achieved the target hemoglobin differed significantly between treatment groups
The transfusion incidence did not differ between treatment groups probably because of the low baseline transfusion rates in AoC pts
Incidence of adverse events (including on-study deaths) was similar in both groups