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• W2589911704 abstract "8229 Background: The efficacy of EPO in anemic pts receiving CT and RT is well established. Less is known about the efficacy of EPO in anemic pts with cancer not receiving CT or RT, particularly in regimens less frequent than QW. Methods: This open-label, multicenter, pilot study is fully enrolled and ongoing. 57 pts with nonmyeloid malignancy; Hb ≤11 g/dL; and who had not received CT, RT, or pRBC transfusion (TFN) in the previous 8 weeks (wks), 4 wks, or 28 days, respectively, nor planned to receive these therapies, were enrolled. Hormonal, androgen deprivation, or immunotherapies were allowed. Pts were to receive oral iron daily. EPO was administered 60,000 U SC Q2W; escalation to 80,000 U Q2W after 4 wks if Hb increased <1 g/dL. The dose was titrated or held to maintain Hb ∼12 g/dL. Pts were treated up to 12 wks. The primary efficacy endpoint was hematopoietic response (HR; Hb increase ≥2 g/dL from baseline [BL] or Hb ≥12 g/dL on study) exclusive of Hb obtained within 28 days of TFN. Hb change from BL and TFN were also measured. Efficacy analyses were performed on the modified intent-to-treat population (MITT; pts who received ≥1 dose of EPO and had ≥1 postBL Hb or TFN). Results: Mean age, 70 yrs; mean BL Hb, 10.2 ± 0.76 g/dL (MITT population, N=45). Preliminary results showed 32/45 (71%) pts achieved HR. Hb increased 1.6 ± 0.8 g/dL (n=37) after 4 weeks, and 2.0 ± 1.2 g/dL (n=27) after 8 weeks on study. 1 pt received pRBC TFN after day 28. Most common adverse events were peripheral edema (8.9%), nausea (6.7%), and dizziness (6.7%). No deaths or clinically relevant thrombovascular events reported. Conclusion: Preliminary results suggest that EPO 60,000 U Q2W is effective and safe in anemic pts with cancer not receiving CT or RT. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho-Biotech/ Johnson & Johnson Johnson & Johnson/ Ortho-Biotech, Ortho-Biotech Ortho Biotech/ Johnson & Johnson Johnson & Johnson/ Ortho-Biotech, Ortho-Biotech Johnson & Johnson/ Ortho-Biotech, Ortho-Biotech Ortho-Biotech/ Johnson & Johnson" @default.
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• W2589911704 date "2005-06-01" @default.
• W2589911704 modified "2023-10-18" @default.
• W2589911704 title "Epoetin alfa (EPO) 60,000 U every 2 weeks (Q2W) in patients (pts) with cancer not receiving chemotherapy (CT) or radiotherapy (RT)" @default.
• W2589911704 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.8229" @default.
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