title: The effectiveness of darbepoetin alfa administered every 3 weeks on hematologic outcomes and quality of life in older patients with chemotherapy-induced anemia.
abstract: Chemotherapy-induced anemia (CIA) may substantially impact the health-related quality of life (HRQoL) of older cancer patients. This exploratory analysis evaluated the effect of darbepoetin alfa administered as a fixed dose (300 microg) every 3 weeks (Q3W) on hematologic outcomes, HRQoL, and safety in older (> or =65 years old) versus younger (<65 years old) patients with CIA (hemoglobin <11 g/dl). Patients were categorized by age at screening: <65, > or =65 to <70, > or =70 to <75, > or =75 to <80, and > or =80 years old. Patients who received at least one dose of darbepoetin alfa were included in the analysis; of 1,493 patients, 724 were > or =65 years old. Age did not appear to influence hematologic outcomes after treatment with darbepoetin alfa; in all age categories, similar percentages of patients (78%-80%) achieved the target hemoglobin in approximately the same time (4-5 weeks). Also, the percentage of patients in each age category who received RBC transfusions was reduced from 10%-13% in month 1 to 2%-4% in month 4. Although younger patients reported the greatest improvement in HRQoL scores, approximately one half in each older age category reported clinically significant improvement in fatigue, and improvement in the Energy and Overall Health Assessment and Work Productivity and Activity Impairment scales. There were no treatment-related deaths. Treatment-related thromboembolic events were reported by <1% of patients <65 years old and <1% of patients > or =65 to <70 and > or =70 to <75 years old. Darbepoetin alfa Q3W appeared well tolerated and effective for treating older patients with CIA.
authors.affiliation: Georgetown University/Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, USA. rboccia@ccbdmd.com
authors.forename: Ralph
authors.initials: R
authors.lastname: Boccia
authors.forename: Tom
authors.initials: T
authors.lastname: Lillie
authors.forename: Dianne
authors.initials: D
authors.lastname: Tomita
authors.forename: Lodovico
authors.initials: L
authors.lastname: Balducci
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005221:Fatigue / Q000139:chemically induced / Q000188:drug therapy; D005260:Female; D005500:Follow-Up Studies; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000187:drug effects*; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa