Abstract

8203 Background: PK and PD profiles of epoetin alfa for healthy subjects after subcutaneous (SC) administration of epoetin alfa 150 IU/kg 3 times weekly (TIW) or 40,000 IU weekly (QW) have been previously described. This is our first report of PK/PD profiles in anemic cancer patients (pts) receiving chemotherapy (CT). Methods: This was a randomized, open-label, parallel-design, 6-week, multicenter study to determine PK/PD profiles of epoetin alfa 150 IU/kg TIW and 40,000 IU QW in cancer pts. Measurements began when cancer pts received their first dose of epoetin alfa and were scheduled to receive at least 1 cytotoxic CT agent (Day 1). All subjects had a PK profile during Week 1 and an optional profile again at Week 3 (cancer pts not scheduled to receive chemotherapy between Days 15 and 21). Any transfusions were recorded. Results: 29 of 36 cancer pts were evaluable for PK. The 40,000 IU QW regimen had a higher Cmax, higher exposure to epoetin alfa/erythropoietin in serum (in terms of AUC0–7days), and a lo...

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