Treatment of chemotherapy-induced anemia in breast cancer: Results of a randomized controlled trial of darbepoetin alfa 200 μg every 2 weeks versus epoetin alfa 40,000 U weekly

Frank M. Senecal, Lorrin Yee, Nashat Gabrail, Veena Charu, Dianne Tomita, Greg Rossi, Lee Schwartzberg

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22 Citations (Scopus)

Abstract

Background: Current chemotherapy regimens for breast cancer result in high incidences of anemia, which can be treated with erythropoietic agents. The relative efficacy of darbepoetin alfa and epoetin alfa was explored in this phase II, open-label, randomized, multicenter trial in anemic patients with breast cancer receiving chemotherapy. Patients and methods: Patients were randomized at a 1:1 ratio to receive darbepoetin alfa 200 μg every 2 weeks (n = 72) or epoetin alfa 40,000 U weekly (n = 69) for ≤ 16 weeks. Clinical and hematologic endpoints and validation of a novel patient satisfaction questionnaire for anemia treatment were evaluated for all patients randomized to receive ≥ 1 dose of study drug. Results: Baseline characteristics were generally similar between treatment groups. Mean changes in hemoglobin (Hb) level from baseline were similar at 1.9 g/dL for darbepoetin alfa and 1.7 g/dL for epoetin alfa. Hematopoietic responses (≥ 2 g/dL increase in Hb level from baseline or Hb level ≥ 12 g/dL) were also similar between groups (88% for darbepoetin alfa and 81% for epoetin alfa). The proportions of patients who received a transfusion during treatment were 6% (95% CI, 0-11%) for darbepoetin alfa and 16% (95% CI, 7%-25%) for epoetin alfa. Most patients (67 patients receiving darbepoetin alfa [93%]; 61 patients receiving epoetin alfa [90%]) exhibited a clinically meaningful target Hb level ≥ 11 g/dL. No differences in safety were observed. Conclusion: These results suggest that, in patients with breast cancer, darbepoetin alfa 200 μg every 2 weeks and epoetin alfa 40,000 U weekly result in comparable clinical outcomes for the treatment of chemotherapy-induced anemia.

Original languageEnglish (US)
Pages (from-to)446-454
Number of pages9
JournalClinical Breast Cancer
Volume6
Issue number5
DOIs
StatePublished - Jan 1 2005

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Epoetin Alfa
Anemia
Randomized Controlled Trials
Breast Neoplasms
Drug Therapy
Hemoglobins
Therapeutics
Darbepoetin alfa

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Treatment of chemotherapy-induced anemia in breast cancer : Results of a randomized controlled trial of darbepoetin alfa 200 μg every 2 weeks versus epoetin alfa 40,000 U weekly. / Senecal, Frank M.; Yee, Lorrin; Gabrail, Nashat; Charu, Veena; Tomita, Dianne; Rossi, Greg; Schwartzberg, Lee.

In: Clinical Breast Cancer, Vol. 6, No. 5, 01.01.2005, p. 446-454.

Research output: Contribution to journalArticle

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title = "Treatment of chemotherapy-induced anemia in breast cancer: Results of a randomized controlled trial of darbepoetin alfa 200 μg every 2 weeks versus epoetin alfa 40,000 U weekly",
abstract = "Background: Current chemotherapy regimens for breast cancer result in high incidences of anemia, which can be treated with erythropoietic agents. The relative efficacy of darbepoetin alfa and epoetin alfa was explored in this phase II, open-label, randomized, multicenter trial in anemic patients with breast cancer receiving chemotherapy. Patients and methods: Patients were randomized at a 1:1 ratio to receive darbepoetin alfa 200 μg every 2 weeks (n = 72) or epoetin alfa 40,000 U weekly (n = 69) for ≤ 16 weeks. Clinical and hematologic endpoints and validation of a novel patient satisfaction questionnaire for anemia treatment were evaluated for all patients randomized to receive ≥ 1 dose of study drug. Results: Baseline characteristics were generally similar between treatment groups. Mean changes in hemoglobin (Hb) level from baseline were similar at 1.9 g/dL for darbepoetin alfa and 1.7 g/dL for epoetin alfa. Hematopoietic responses (≥ 2 g/dL increase in Hb level from baseline or Hb level ≥ 12 g/dL) were also similar between groups (88{\%} for darbepoetin alfa and 81{\%} for epoetin alfa). The proportions of patients who received a transfusion during treatment were 6{\%} (95{\%} CI, 0-11{\%}) for darbepoetin alfa and 16{\%} (95{\%} CI, 7{\%}-25{\%}) for epoetin alfa. Most patients (67 patients receiving darbepoetin alfa [93{\%}]; 61 patients receiving epoetin alfa [90{\%}]) exhibited a clinically meaningful target Hb level ≥ 11 g/dL. No differences in safety were observed. Conclusion: These results suggest that, in patients with breast cancer, darbepoetin alfa 200 μg every 2 weeks and epoetin alfa 40,000 U weekly result in comparable clinical outcomes for the treatment of chemotherapy-induced anemia.",
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