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Symptom Management and Supportive Care |
a Georgetown University/Center for Cancer and Blood Disorders, Bethesda, Maryland, USA; b Loma Linda University Medical Center, Loma Linda, California, USA; c Bond Clinic, Rolla, Missouri, USA; d Sioux Land Regional Cancer Center, Sioux City, Iowa, USA; e Hawaii Pacific Health at Straub Clinic and Hospital, Honolulu, Hawaii, USA; f Amgen Inc., Thousand Oaks, California, USA; g Santee Hematology/Oncology Inc, Sumter, South Carolina, USA; h Creighton University Medical Center, Omaha, Nebraska, USA
Key Words. Chemotherapy • Anemia • Darbepoetin alfa • Hemoglobin • Cancer
Correspondence: Peter Silberstein, M.D., Creighton University Medical Center, 601 North 30th Street, Suite 2565, Omaha, Nebraska 68131, USA. Telephone: 402-280-3432; Fax: 402-280-4638; e-mail: PeterSilberstein{at}creighton.edu
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 µg) Q3W in patients with CIA. Eligible patients (
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
10 g/dl) on clinical outcomes was evaluated. Patients in the
10-g/dl stratum achieved the hemoglobin target range (1113g/dl)in less time than patients in the <10-g/dlstratum (3 weeks vs. 9 weeks). More patients in the
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
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 (
3-point increase) in Functional Assessment of Cancer TherapyFatigue 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.
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