Table 1.
Clinical trials on treatment of chemotherapy-induced anemia with Darbepoetin alfa administered once weekly
| Ref | n | Study design | Study population | Main results |
|---|---|---|---|---|
| (Glaspy et al 2002) | 269 | Phase II randomized, open label | Solid tumors; receiving chemotherapy; Hb ≤ 1.0 g/dL | Evident dose-response relationship for Hb response up to doses of 4.5 μg/kg |
| Darbepoetin alfa: 0.5, 1.0, 1.5, 2.25, 4.5, 6.0, and 8.0 μg/kg/week versus Epoetin alfa: 150I U/kg 3 times/week (increase to 300 IU/kg) 12-week treatment | ||||
| (Hedenus et al 2002) | 66 | Phase II randomized, double-blind | Lymphoproliferative malignancies receiving chemotherapy; Hb ≤ 11.0 g/dL | Proportion of patients achieving Hb response is higher with any dose of Darbepoetin alfa compared with placebo |
| Darbepoetin alfa: 1.0, 2.25, and 4.5 μg/kg/week versus Placebo: 12-week treatment | ||||
| (Vansteenkiste et al 2002) | 314 | Phase III randomized, double-blind | Lung cancer receiving platinum-based chemotherapy; Hb ≤ 11 g/dL | Significant reduction of incidence of transfusion and number of units transfused. |
| Darbepoetin alfa: 2.25 μg/kg/week versus Placebo: 12-week treatment | ||||
| (Hedenus et al 2003) | 344 | Phase III randomized, double-blind | Lymphoproliferative malignancies receiving chemotherapy; Hb ≤ 11 g/dL | Better hematopoietic response and QoL. Significant reduction of RBC transfusions and higher Hb response. |
| Darbepoetin alfa: 2.25 μg/kg/week versus Placebo: 12-week treatment |
Abbreviations: Hb, hemoglobin; RBC, red blood cells; QoL,quality of life.