1. 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
- Author
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Nashat Y. Gabrail, Lorrin Yee, Greg Rossi, Veena Charu, Lee S. Schwartzberg, Dianne Tomita, and Frank M. Senecal
- Subjects
Adult ,Cancer Research ,medicine.medical_specialty ,Darbepoetin alfa ,Anemia ,medicine.medical_treatment ,Breast Neoplasms ,Gastroenterology ,Drug Administration Schedule ,law.invention ,Breast cancer ,stomatognathic system ,Randomized controlled trial ,law ,hemic and lymphatic diseases ,Internal medicine ,Multicenter trial ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Erythropoietin ,Aged ,Aged, 80 and over ,Chemotherapy ,business.industry ,virus diseases ,Epoetin alfa ,Middle Aged ,medicine.disease ,Recombinant Proteins ,digestive system diseases ,Epoetin Alfa ,Treatment Outcome ,Oncology ,Patient Satisfaction ,Female ,business ,therapeutics ,medicine.drug - 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.
- Published
- 2005
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