Document Detail


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.
MedLine Citation:
PMID:  15561813     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Lee S Schwartzberg; Lorrin K Yee; Frank M Senecal; Veena Charu; Dianne Tomita; Joel Wallace; Greg Rossi
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Validation Studies    
Journal Detail:
Title:  The oncologist     Volume:  9     ISSN:  1083-7159     ISO Abbreviation:  Oncologist     Publication Date:  2004  
Date Detail:
Created Date:  2004-11-24     Completed Date:  2005-03-22     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  9607837     Medline TA:  Oncologist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  696-707     Citation Subset:  IM    
Affiliation:
The West Clinic, 100 North Humphreys Boulevard, Memphis, Tennessee 38120, USA. lschwartzberg@westclinic.com
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MeSH Terms
Descriptor/Qualifier:
Anemia / chemically induced,  drug therapy*
Antineoplastic Agents / adverse effects*
Breast Neoplasms / drug therapy
Dose-Response Relationship, Drug
Drug Administration Schedule
Erythrocyte Transfusion / statistics & numerical data
Erythropoietin / administration & dosage*,  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
Questionnaires
Recombinant Proteins
Reproducibility of Results
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Hematinics; 0/Hemoglobins; 0/Recombinant Proteins; 11096-26-7/Erythropoietin; 113427-24-0/epoetin alfa; 15UQ94PT4P/darbepoetin alfa

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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