Abstract
4747 Background: Thalidomide (thal) (Celgene) produces tumor responses in some pts with mRCC, but also causes dose dependent fatigue. EPO (Ortho Biotech Products) improves overall quality of life [QOL] in cancer pts by raising hemoglobin (hgb) and reducing fatigue. We added EPO to thal in an effort to enhance its tolerability and efficacy. Methods: Pts with mRCC refractory to immune Rx were randomized to thal (100mg/d) or thal (100mg/d) + EPO (40,000 IU/wk). The dose of thal was escalated by 100mg/wk to 1g or MTD and EPO to 60,000 IU/wk in pts who failed to develop an hgb increase of 1g/dl after 4 wks. Tumor response was assessed by CT scan every 12 wks and QOL (FACT-An and Linear Analog scale) at baseline and q 4 wks for 24 wks. Results: To date, 25 patients (16 M, 9 F); median age 60 yrs (range 36–78); median prior Rx 2 (range 0–4); median number of metastatic sites 3.5 (range 1–7); median Motzer prognostic score 1 (range 0–3) have been enrolled since 4/11/01. 13 have received thal and 12 thal + EPO. Pt...
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