Source:http://linkedlifedata.com/resource/pubmed/id/15352656
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
2
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pubmed:dateCreated |
2004-9-8
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pubmed:abstractText |
The objective of this ongoing trial is to study the ability of darbepoetin alfa to reverse chemotherapy-induced anemia in cancer patients, and to relate improvement in hemoglobin with changes in fatigue and functional capacity. Eligible subjects had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic, as defined by a screening hemoglobin < or = 11 g/dL. Darbepoetin alfa was administered at a starting dosage of 3 microg/kg every 2 weeks for up to eight doses (16 weeks) in an open-label, noncomparative setting. A total of 194 oncology practices contributed 1,173 subjects to this interim analysis. The mean increase in hemoglobin was 1.7 g/dL (95% CI: 1.6, 1.8) to last value on study (intent-to-treat analysis) and 2.1 g/dL (95% CI: 1.9, 2.2) for those patients receiving the full 16 weeks of therapy. The Kaplan-Meier estimate of the proportion of subjects with a hematopoietic response (increase in hemoglobin > or = 2 g/dL and/or hemoglobin value > or = 12 g/dL) was 84% (95% CI:81,86). Subjects in the lower baseline hemoglobin category (< 10 g/dL) tended to have a greater hemoglobin response during treatment. The Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue) subscale score increased by a mean of 6.8 points (26%) during the study, and improvements in fatigue paralleled the increases observed in hemoglobin. Study treatment-related toxicity was minimal, with the most common event being injection-site pain, seen in 2% of subjects. Experience to date with an every-2-week regimen of darbepoetin alfa indicated efficacy comparable to historical experience with weekly and 3-times-weekly regimens of epoetin alfa in treating chemotherapy-induced anemia in cancer subjects.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Antineoplastic Agents,
http://linkedlifedata.com/resource/pubmed/chemical/Biological Markers,
http://linkedlifedata.com/resource/pubmed/chemical/Erythropoietin,
http://linkedlifedata.com/resource/pubmed/chemical/Hemoglobins,
http://linkedlifedata.com/resource/pubmed/chemical/darbepoetin alfa
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pubmed:status |
MEDLINE
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pubmed:issn |
1544-6794
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
1
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
131-8
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pubmed:dateRevised |
2009-11-3
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pubmed:meshHeading |
pubmed-meshheading:15352656-Adult,
pubmed-meshheading:15352656-Aged,
pubmed-meshheading:15352656-Aged, 80 and over,
pubmed-meshheading:15352656-Anemia, Hypochromic,
pubmed-meshheading:15352656-Antineoplastic Agents,
pubmed-meshheading:15352656-Biological Markers,
pubmed-meshheading:15352656-Dose-Response Relationship, Drug,
pubmed-meshheading:15352656-Erythropoietin,
pubmed-meshheading:15352656-Fatigue,
pubmed-meshheading:15352656-Female,
pubmed-meshheading:15352656-Hemoglobins,
pubmed-meshheading:15352656-Humans,
pubmed-meshheading:15352656-Injections, Subcutaneous,
pubmed-meshheading:15352656-Male,
pubmed-meshheading:15352656-Middle Aged,
pubmed-meshheading:15352656-Neoplasms,
pubmed-meshheading:15352656-Sickness Impact Profile,
pubmed-meshheading:15352656-Time Factors,
pubmed-meshheading:15352656-Treatment Outcome
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pubmed:articleTitle |
Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks.
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pubmed:affiliation |
Section of Cytokines and Targeted Therapies, Anderson Cancer Center, Houston, TX 77030, USA. svadhanraj@mail.mdanderson.org
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pubmed:publicationType |
Journal Article,
Comparative Study,
Multicenter Study
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