title: Darbepoetin alfa administered every three weeks is effective for the treatment of chemotherapy-induced anemia.
abstract: Patients with cancer receiving chemotherapy often have chemotherapy-induced anemia (CIA) and reduced quality of life. Darbepoetin alfa can effectively treat CIA when administered at an extended dosing interval of once every 3 weeks (Q3W). Darbepoetin alfa administered Q3W may allow synchronization of darbepoetin alfa therapy with chemotherapy administered Q3W. This multicenter, open-label, 16-week study evaluated the effectiveness and safety of darbepoetin alfa administered as a fixed dose (300 mug) Q3W in patients with CIA. Eligible patients (> or =18 years) were anemic (hemoglobin <11g/dl), had a nonmyeloid malignancy, and were receiving multicycle chemotherapy. This analysis includes 1,493 patients who received at least one dose of darbepoetin alfa. The effect of baseline hemoglobin (<10 or > or =10 g/dl) on clinical outcomes was evaluated. Patients in the > or =10-g/dl stratum achieved the hemoglobin target range (11-13 g/dl)in less time than patients in the <10-g/dlstratum (3 weeks vs. 9 weeks). More patients in the > or =10-g/dl stratum achieved the hemoglobin target range (87% vs. 66%); however, similar proportions of patients in both strata maintained hemoglobin within the target range (73% vs. 71%). Fewer patients in the > or =10-g/dl stratum received RBC transfusions from week 5 to the end of the study (12% vs. 28%). Over 50% of patients in both strata reported clinically significant improvements (> or =3-point increase) in Functional Assessment of Cancer Therapy-Fatigue score. Twenty-eight percent of patients reported serious adverse events; 3% of all patients had a venous or arterial thrombotic event. This study demonstrates that darbepoetin alfa Q3W is well tolerated and effective for treating CIA.
authors.affiliation: Georgetown University/Center for Cancer and Blood Disorders, Bethesda, Maryland, USA.
authors.forename: Ralph
authors.initials: R
authors.lastname: Boccia
authors.forename: Imtiaz A
authors.initials: IA
authors.lastname: Malik
authors.forename: Vinay
authors.initials: V
authors.lastname: Raja
authors.forename: Stephen
authors.initials: S
authors.lastname: Kahanic
authors.forename: Randall
authors.initials: R
authors.lastname: Liu
authors.forename: Tom
authors.initials: T
authors.lastname: Lillie
authors.forename: Dianne
authors.initials: D
authors.lastname: Tomita
authors.forename: Billy
authors.initials: B
authors.lastname: Clowney
authors.forename: Peter
authors.initials: P
authors.lastname: Silberstein
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa