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Symptom Management and Supportive Care

Efficacy and Safety of Every-2-Week Darbepoetin Alfa in Patients with Anemia of Cancer: A Controlled, Randomized, Open-Label Phase II Trial

^aPacific Cancer Medical Center, Anaheim, California, USA; ^bUniversity of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA; ^cCarolina Cancer Center, Aiken, South Carolina; ^dMedina General Hospital, Medina, Ohio, USA; ^eAmgen Inc., Thousand Oaks, California, USA; ^fCache Valley Cancer Treatment and Research Center, Logan, Utah

Key Words. Randomized controlled trial • Darbepoetin alfa • Anemia of cancer

Correspondence: Ali Ben-Jacob, M.D., Cache Valley Cancer Treatment and Research Center, 550 East 1400 North Ste. W, Logan, Utah 84341, USA. Telephone: 435-752-5999; Fax: 714-999-1701; e-mail: aliben{at}comcast.net

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.

Disclosure of potential conflicts of interest is found at the end of this article.

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