Epoetin alfa (EPO) 40,000–60,000 U administered SC QW has been shown to significantly reduce transfusion utilization, increase Hb, and improve quality of life in anemic patients (pts) with cancer receiving chemotherapy (CT). The use of higher initiation doses of epoetin alfa followed by less frequent maintenance dosing was evaluated to provide convenience and dosing flexibility for both pts and clinicians. This open-label, multicenter, pilot study investigated the efficacy of EPO at a starting dose of 60,000 U SC QW for 4 weeks (wks) followed by 60,000 U SC administered every 2 weeks (Q2W) for up to 12 wks in anemic (Hb<11 g/dL) pts with cancer receiving CT. Pts were excluded for planned radiation therapy, prior treatment with an erythropoietic agent within 3 months, and RBC transfusion within 28 days. The primary endpoint was the proportion of pts with a ≥1-g/dL Hb increase from baseline (BL) with QW dosing. Secondary endpoints included mean time to 1-g/dL increase with QW dosing, the proportion of pts in the Q2W dosing phase with ≥1-g/dL Hb increase above the final Hb or maintenance of ≥ the final Hb achieved with QW dosing, and transfusion requirements. Pts with an Hb increase <1 g/dL with QW dosing or an Hb decrease ≥2 g/dL with Q2W dosing were withdrawn for lack of response. If Hb increased to >13 g/dL or if increase was >1.3 g/dL in 2 wks, EPO was held until Hb was <12 g/dL then resumed at 40,000 U SC QW or Q2W. All 51 pts (mean age 66 y, 63% women, 86% ECOG 0-1) enrolled received at least 1 dose of study drug and were evaluable for efficacy and safety. The most common tumor types were lung and breast. Mean BL Hb was 10.1 ± 0.79 g/dL. The dose of EPO was reduced in 45% of pts overall (24% of pts during QW dosing; 41% of pts during Q2W dosing) and held in 63% of pts overall (20% of pts during QW dosing; 59% of pts during Q2W dosing). Thirty-four (67%) pts achieved ≥1-g/dL Hb increase from BL with QW dosing in a mean period of 16 days. Twenty-nine (57%) out of 51 pts went on to receive Q2W dosing. Of these pts, 3 (10%) pts achieved a ≥1-g/dL Hb increase above the Hb achieved with QW dosing and 9 (31%) pts maintained at least the Hb achieved with QW dosing. The mean change in Hb from BL was 1.6 g/dL (n=41) after 4 wks, 1.7 g/dL (n=27) after 8 wks, and 1.7 g/dL (n=10) after 16 wks. Four (7.8%) pts were transfused during the study. The most commonly reported adverse events (AEs) were nausea, asthenia, and fatigue. Thirteen (26%) pts had ≥1 serious AE. One (2%) pt had a clinically relevant thrombotic vascular event (deep venous thrombosis). Three (6%) pts discontinued due to an AE, 2 of whom subsequently died. The total number of deaths on study was 3 (6%). In conclusion, the majority (67%) of pts responded (Hb increase >1 g/dL) to this initial dosing regimen, which compares favorably with responses seen with a lower starting dose (40,000 U SC QW with dose escalation to 60,000 U SC QW). In addition, pts were able to maintain or extend this response with a 60,000 U SC Q2W dosing regimen thereafter.

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