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• W3012307142 abstract "14634 Background: While EPO is widely used in the management of CT-related anemia, anemia in cancer pts may stem from causes other than CT. Tumor invasion of the bone marrow and cytokine-mediated inhibition of erythropoiesis are among the many disease-related causes of anemia in cancer. Data evaluating the use of EPO in pts not receiving CT or RT, particularly in specific tumor types, would be important information to healthcare providers. Methods: An open-label, prospective, non-randomized, multicenter pilot study was conducted to evaluate the efficacy and safety of EPO 40,000 U QW in anemic (hemoglobin [Hb] ≤ 11 g/dL) cancer pts not receiving CT or RT 1 . (Blood 2004;104:abstract 4223.) Treatment duration was up to 12 wks with a 4-wk post-treatment observation period. Primary efficacy endpoint was hematopoietic response during the treatment period (% of pts achieving a ≥ 1 or ≥ 2 g/dL Hb increase from baseline [BL]). Secondary endpoints included change from BL in quality of life as measured by the Linear Analog Scale Assessment (LASA). This is a retrospective subset analysis of PC pts (n = 24) enrolled in the prospective study. Results: For the safety population (all pts who received ≥ 1 EPO dose, n = 23), mean age was 71.4 ± 6.8 yrs; 21 (91.3%) had ECOG status of 0 or 1; and mean BL Hb was 10.4 ± 0.8 g/dL. Of 21 pts evaluated for efficacy, 17 (81.0%) achieved Hb increase from BL ≥ 2 g/dL, while 19 (90.5%) achieved ≥ 1 g/dL by wk 17/early withdrawal. EPO dose was increased in 5 (23.8%) pts (to 60,000 U for Hb increase < 1 g/dL after 4 wks) and held in 16 (76.2%) pts (due to Hb > 13 g/dL, with dosing resumed when Hb was ≤12 g/dL, at 30,000 U from 40,000 U or at 40,000 U from 60,000 U). Both Wk 9 and 17 LASA scores increased significantly from BL in all categories (Energy Level, Daily Activities, and Quality of Life; P < 0.001). 15 of 23 pts (65.2%) had at least one adverse event (AE); 4 (17.4%) pts had at least one serious AE. No clinically relevant thrombotic vascular events were noted. No pt received transfusion. 5 pts discontinued: 2 for AEs, 1 at pt request, and 2 at study sponsor request. Conclusions: This retrospective analysis suggests that EPO 40,000 U QW is safe and effective for treating anemia in PC pts not receiving CT or RT. [Table: see text]" @default.
• W3012307142 created "2020-03-23" @default.
• W3012307142 creator A5059816419 @default.
• W3012307142 date "2006-06-20" @default.
• W3012307142 modified "2023-10-18" @default.
• W3012307142 title "Weekly (QW) epoetin alfa (EPO) in prostate cancer (PC) patients (pts) with anemia not receiving chemotherapy (CT) or radiation therapy (RT)" @default.
• W3012307142 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.14634" @default.
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