Linked Life Data

15561813

Source:http://linkedlifedata.com/resource/pubmed/id/15561813

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PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2004-11-24
pubmed:abstractText
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.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
1083-7159
pubmed:author
pubmed:issnType
Print
pubmed:volume
9
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
696-707
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:15561813-Anemia, pubmed-meshheading:15561813-Antineoplastic Agents, pubmed-meshheading:15561813-Breast Neoplasms, pubmed-meshheading:15561813-Dose-Response Relationship, Drug, pubmed-meshheading:15561813-Drug Administration Schedule, pubmed-meshheading:15561813-Erythrocyte Transfusion, pubmed-meshheading:15561813-Erythropoietin, pubmed-meshheading:15561813-Female, pubmed-meshheading:15561813-Genital Neoplasms, Female, pubmed-meshheading:15561813-Hematinics, pubmed-meshheading:15561813-Hemoglobins, pubmed-meshheading:15561813-Humans, pubmed-meshheading:15561813-Lung Neoplasms, pubmed-meshheading:15561813-Male, pubmed-meshheading:15561813-Middle Aged, pubmed-meshheading:15561813-Prospective Studies, pubmed-meshheading:15561813-Quality of Life, pubmed-meshheading:15561813-Questionnaires, pubmed-meshheading:15561813-Recombinant Proteins, pubmed-meshheading:15561813-Reproducibility of Results
pubmed:year
2004
pubmed:articleTitle
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.
pubmed:affiliation
The West Clinic, 100 North Humphreys Boulevard, Memphis, Tennessee 38120, USA. lschwartzberg@westclinic.com
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Validation Studies