1.
Final results of a randomized study comparing two dosing regimens of epoetin alfa in patients with chemotherapy-induced anemia: 80,000 U every two weeks vs 40,000 U weekly
Henry DH, Kamin M, Wilhelm F, Williams D, Xie J, Woodman RC
Journal of Clinical Oncology. 2006;24((18_suppl)):8624.
Abstract
8624 Background: Epoetin alfa is typically administered weekly (QW) for the treatment of chemotherapy (CT)-induced anemia. Less frequent dosing can be more convenient for patients (pts) and healthcare providers. This is the first study to examine extended interval initial dosing with epoetin alfa 80,000 U every two weeks (Q2W) vs the standard 40,000 U QW regimen. METHODS This randomized, open-label, 13-week study enrolled pts with non-myeloid malignancies with baseline (BL) hemoglobin (Hb) < 11 g/dL and CT planned for > 12 weeks. Pts were assigned (1:1) to receive epoetin alfa 40,000 U QW or 80,000 U Q2W subcutaneously. Drug was held for Hb > 13 g/dL and dose was reduced for Hb > 12 g/dL or rate of rise > 1 g/dL in any 2-week period. For inadequate Hb response, 80,000 U Q2W pts were switched to 40,000 U QW and 40,000 U QW patients were increased to 60,000 U QW. The primary analysis was a comparison of the mean Hb change from BL to end of study (EOS). RESULTS 298 pts received > 1 dose of drug (153 Q2W, 145 QW). BL characteristics were comparable between groups: 66% female, overall mean age 62 yrs, and BL Hb 10.0 g/dL. Most common tumor types were breast (25%), NSCLC (15%) and colorectal (14%). Efficacy was analyzed in 295 pts (151 Q2W, 144 QW) who had > 1 post-BL Hb value. The mean Hb change from BL to EOS for Q2W was 1.27 +/- 1.48 g/dL compared to 1.28 +/- 1.60 g/dL for QW [difference 0, 1-sided 95% CI -0.25,-]. In the per protocol population, the difference in mean Hb change was similar. Mean Hb values over time were also similar between groups. Kaplan-Meier estimates of post-28 day transfusion rates were 11.2% in Q2W vs. 12.0% in QW. Fewer Q2W pts compared to QW pts required dose holds (21% vs 42%) or dose reductions (41% vs 59%). 13% of Q2W pts were switched to QW dosing and 37% of QW pts required a dose increase. The incidences of clinically relevant TVEs and deaths were similar in the Q2W vs QW groups (7.8% vs 7.6% and 6.5% vs 6.2%, respectively). CONCLUSIONS Pts treated with epoetin alfa 80,000 U Q2W demonstrated similar Hb increases, transfusion rates, and safety outcomes compared to pts treated with 40,000 U QW. Epoetin alfa 80,000 U every other week is an effective regimen that may provide a more convenient dosing option for pts with CT-induced anemia. [Table: see text].