Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia

Michael Auerbach, Peter T. Silberstein, R. Timothy Webb, Svetlana Averyanova, Tudor Eliade Ciuleanu, James Shao, Kenneth Bridges

Research output: Contribution to journalArticle

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Abstract

This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 lg with or without intravenous (IV) iron in treating anemia in patients receiving multi-cycle chemotherapy. This Phase 2, double-blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 μg (n = 62), darbepoetin alfa 300 μg plus IV iron (n = 60), darbepoetin alfa 500 μg (n = 60), or darbepoetin alfa 500 μg plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ≤10 g dL-1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (≥11 g dL-1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT-F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin (75 and 78%, respectively); Kaplan-Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82%) than not receiving IV iron (72%) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit, while added IV iron improved treatment response in these patients.

Original languageEnglish
Pages (from-to)655-663
Number of pages9
JournalAmerican Journal of Hematology
Volume85
Issue number9
DOIs
StatePublished - 2010

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Anemia
Iron
Drug Therapy
Hemoglobins
Darbepoetin alfa
Safety
Incidence
Therapeutics
Fatigue
Neoplasms

All Science Journal Classification (ASJC) codes

  • Hematology
  • Medicine(all)

Cite this

Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. / Auerbach, Michael; Silberstein, Peter T.; Webb, R. Timothy; Averyanova, Svetlana; Ciuleanu, Tudor Eliade; Shao, James; Bridges, Kenneth.

In: American Journal of Hematology, Vol. 85, No. 9, 2010, p. 655-663.

Research output: Contribution to journalArticle

Auerbach, Michael ; Silberstein, Peter T. ; Webb, R. Timothy ; Averyanova, Svetlana ; Ciuleanu, Tudor Eliade ; Shao, James ; Bridges, Kenneth. / Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. In: American Journal of Hematology. 2010 ; Vol. 85, No. 9. pp. 655-663.
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abstract = "This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks (Q3W) at fixed doses of 300 or 500 lg with or without intravenous (IV) iron in treating anemia in patients receiving multi-cycle chemotherapy. This Phase 2, double-blind, 2 × 2 factorial study randomized patients to one of four treatment arms; darbepoetin alfa 300 μg (n = 62), darbepoetin alfa 300 μg plus IV iron (n = 60), darbepoetin alfa 500 μg (n = 60), or darbepoetin alfa 500 μg plus IV iron (n = 60). Patients had nonmyeloid malignancies, hemoglobin levels ≤10 g dL-1, and no iron deficiency. Primary endpoint was achievement of target hemoglobin (≥11 g dL-1). Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue (FACT-F) score from baseline to end of study. Safety was evaluated by incidence of adverse events. No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed, therefore, results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups. Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin (75 and 78{\%}, respectively); Kaplan-Meier median time to target hemoglobin was 10 and 8 weeks, respectively. More patients receiving IV iron (82{\%}) than not receiving IV iron (72{\%}) achieved hemoglobin target. Adverse events profiles were similar for darbepoetin alfa treatment groups. Transient anaphylactoid reactions were reported in two patients receiving IV iron. Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit, while added IV iron improved treatment response in these patients.",
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