Darbepoetin Alfa and Anemia of Cancer

A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer

This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).

Inclusion Criteria:

• nonmyeloid malignancies (including lymphocytic leukemias)
• anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
• Eastern Cooperative Oncology Group performance status of 0 to 2
• adequate liver and renal functions
• 18 years or older

Exclusion Criteria:

• history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
• acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
• known hematologic disorders that could cause anemia
• inflammatory or cardiac disorders
• previous positive antibody response to any erythropoietic agent
• history of pure red cell aplasia