Table 2.

Clinical trials on treatment of chemotherapy-induced anemia with Darbepoetin alfa administered once every 3 weeks

Ref	n	Study design	Study population	Main results
(Kotasek et al 2003)	249	Phase II randomized, double-blind	Solid tumors receiving chemotherapy; Hb ≤ 11.0 g/dL	Evident dose-response relationship for hematopoietic response and mean change in Hb up to doses 12.0 μg/kg
		Darbepoetin alfa: 4.5, 6.75, 9.0, 12.0, 1 3.5, and 15 μg/kg every 3 weeks versus Placebo: 12-week treatment		Lower percentage of patients receiving RBC transfusions (any group) compared with placebo
(Glaspy et al 2005)	81	Phase II randomized, open label	Non myeloid malignancies receiving chemotherapy; Hb ≤ 11 g/dL	Similar mean increase in Hb after 6 weeks
		Darbepoetin alfa 6.75 μg/kg every 3 weeks synchronous (day 1)versus asynchronous (day 15) with chemotherapy: 16-week treatment
(Canon et al 2006)	705	Phase III randomized, double blind	Non-myeloid malignancies receiving chemotherapy; Hb ≤ 11 g/dL	Noninferiority of every 3 weeks dosing versus every week dosing
		Darbepoetin alfa 500 μg every 3 weeks versus Darbepoetin alfa 2.25 μg/kg every week: 16-week treatment

Abbreviations: Hb, hemoglobin; RBC, red blood cells