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Article Summary

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Treating anemia of cancer with every-4-week darbepoetin alfa: final efficacy and safety results from a phase II, randomized, double-blind, placebo-controlled study
The Oncologist, 07/02/08
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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

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