• David H Henry, Lucio N Gordan, Veena Charu, Francois E Wilhelm, Denise Williams, John Xie, and Richard C Woodman.
• Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, PA, USA.
• Curr Med Res Opin. 2006 Jul 1; 22 (7): 1403-13.

ObjectiveThis randomized, open-label, multicenter study compared the efficacy and safety of epoetin alfa (EPO) 80 000 U every 2 weeks (Q2W) to the FDA-approved regimen of 40 000 U weekly (QW) in patients with chemotherapy-induced anemia.Research Design And MethodsA total of 310 patients with nonmyeloid malignancy and baseline hemoglobin (Hb) ResultsAnalysis of the primary endpoint revealed that the mean change in Hb from baseline to study end was comparable between the Q2W and QW groups in the per-protocol population (1.6 g/dL vs 1.8 g/dL, respectively; treatment difference, -0.2 g/dL; one-sided 95% confidence interval [-0.56, -]); similar results were observed in the mITT population. Among patients on study at Day 29, 9.6% (13/135) and 11.1% (14/126) of patients in the Q2W and QW groups, respectively, received a transfusion between Day 29 and the end of the study (p = 0.709). Dose withholds (21% vs 42%, p < 0.001) and dose reductions (41% vs 59%, p = 0.003) were less common for Q2W than QW. Safety profiles were similar between groups; clinically relevant thrombotic vascular events occurred in 8% of patients in each group. The open-label dosing and the patient attrition rate did not appear to influence overall study results.ConclusionsExtended dosing (80 000 U Q2W) and once-weekly dosing (40 000 U QW) of EPO provided comparable safety and efficacy for chemotherapy-induced anemia.

16 keywords...

hide…