A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer

Oncologist. 2004;9(6):696-707. doi: 10.1634/theoncologist.9-6-696.

Abstract

An important clinical question is the relative efficacy of the most common dosages of darbepoetin alfa (Aranesp; Amgen Inc.; Thousand Oaks, CA) 200 microg every 2 weeks (Q2W) and epoetin alfa (Procrit; Ortho Biotech Products, LP; Raritan, NJ) 40,000 U weekly (QW) for the treatment of chemotherapy-induced anemia. We designed three concurrent randomized, open-label, multicenter, identical trials (with the exception of tumor type criteria of breast, gynecologic, or lung cancer) of darbepoetin alfa and epoetin alfa in patients with chemotherapy-induced anemia to validate the Patient Satisfaction Questionnaire for Anemia (PSQ-An) treatment tool and to compare the efficacies and safety profiles of these two agents. In each trial, patients were randomized 1:1 to receive either darbepoetin alfa at a dose of 200 microg Q2W or epoetin alfa at a dose of 40,000 U QW for up to 16 weeks. The PSQ-An was assessed for validity, feasibility, and reliability. Secondary clinical endpoints were analyzed using the primary analysis set. Both individual trial analyses and a protocol-specified combined analysis of data from all three trials were conducted. Overall, 312 patients (157 darbepoetin alfa; 155 epoetin alfa) were randomized and received study drug. Baseline characteristics were similar in both treatment groups in each trial and overall. The PSQ-An was valid, feasible, and reliable. In general, no difference between treatment groups was observed for hemoglobin- and transfusion-based endpoints in each individual trial or in the combined analysis. From exploratory analyses, achievement and maintenance of a hemoglobin target range (11-13 g/dl) were similar in both groups. No differences in safety were observed. With the PSQ-An, formal comparisons of the impact of anemia therapies on patients and caregivers can be made in future prospective studies. Further, darbepoetin alfa (200 microg Q2W) and epoetin alfa (40,000 U QW) appear to achieve comparable clinical and hematologic outcomes.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Anemia / chemically induced
  • Anemia / drug therapy*
  • Antineoplastic Agents / adverse effects*
  • Breast Neoplasms / drug therapy
  • Darbepoetin alfa
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Epoetin Alfa
  • Erythrocyte Transfusion / statistics & numerical data
  • Erythropoietin / administration & dosage*
  • Erythropoietin / analogs & derivatives*
  • Female
  • Genital Neoplasms, Female / drug therapy
  • Hematinics / administration & dosage*
  • Hemoglobins / analysis
  • Humans
  • Lung Neoplasms / drug therapy
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Recombinant Proteins
  • Reproducibility of Results
  • Surveys and Questionnaires

Substances

  • Antineoplastic Agents
  • Hematinics
  • Hemoglobins
  • Recombinant Proteins
  • Erythropoietin
  • Darbepoetin alfa
  • Epoetin Alfa