We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Efficacy and Safety of Every-2-Week Darbepoetin Alfa in Patients with Anemia of Cancer: A Controlled, Randomized, Open-Label Phase II Trial.
- Authors
Charu, Veena; Belani, Chandra P.; Gill, Ahmad N.; Bhatt, Mukesh; Tomita, Dianne; Rossi, Greg; Ben-Jacob, Ali
- Abstract
This randomized, controlled trial evaluated the effect of darbepoetin alfa on hospitalization days, transfusion requirements, hemoglobin levels, and fatigue in patients with anemia of cancer (AOC). Eligible patients were anemic (hemoglobin≤11 g/dl) due to cancer,≥18 years old, and had not received chemotherapy or radiotherapy within 4 weeks of study screening. Patients were randomized 4:1 to receive darbepoetin alfa, 3.0 µg/kg every 2 weeks (Q2W) (n = 226), or observation only for 12 weeks (n = 59), followed by an optional 9 weeks of darbepoetin alfa, 3.0 µg/kg Q2W. Endpoints were compared between the two treatment arms at week 13. A planned interim analysis indicated that assumptions regarding hospitalization in the study design were incorrect, so the study was terminated early. Therefore, results for the primary endpoint should be interpreted cautiously. The hospitalization rate was similar (0.5 days) for both the darbepoetin alfa and observation groups (p = .73). Transfusion incidence (weeks 5-12) was significantly lower for darbepoetin alfa patients (8%) than for observation patients (22%) (p = .0092). By week 13, hemoglobin increased by 2.1 g/dl in patients receiving darbepoetin alfa, compared with 0.1 g/dl in the observation group p > .0001. Hemoglobin improvements were paralleled by an increase in Functional Assessment of Cancer Therapy-Fatigue score (mean change in score at week 13: darbepoetin alfa, 6.0; observation, 2.2; p < .05). Darbepoetin alfa Q2W can significantly improve hemoglobin levels and reduce transfusion requirements in patients with AOC, resulting in significant improvements in health-related quality of life.
- Subjects
DRUG efficacy; ANEMIA treatment; CANCER patients; LENGTH of stay in hospitals; HEMOGLOBINS; BLOOD transfusion; RANDOMIZED controlled trials
- Publication
Oncologist, 2007, Vol 12, Issue 6, p727
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.12-6-727