1.
A randomized phase II study of thalidomide with or without erythropoietin (EPO) in metastatic renal cell carcinoma (RCC)
Famoyin C, Byrnes C, Roberts S, Gollob J, Atkins M, Mier J, Ko YJ, Gautam S, McDemott D
Journal of Clinical Oncology. 2004;22((14_suppl)):4747.
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. Pts on thal had an MTD range from 100-700 (median 200), duration of Rx 2-59 wks (median 8 wks), mean baseline hgb (11.47 g/dl) and hgb variation from baseline range -3.3 to +1.8 (median -1.1 g/dl). Pts on thal + EPO had an MTD range from 100-800 (median 350), duration of Rx 1-119 wks (median 9 wks), mean baseline hgb (10.68 g/dl) and hgb variation from baseline -1.8 to +3.9 (median +0.95 g/dl). The mean change in hgb has been greater for pts on the thal + EPO arm (P=0.08, CI 1.062) Side effects (grade 1-2) including fatigue (80%), constipation (72%), N/V (52%), and neuropathy (40%) have occurred equally between arms. No responses (CR/PR) have been seen in either arm but 3 pts (thal [1pt], thal + EPO [2pts]) had SD lasting 24-119+ wks. So far, 21 of 25 pts have come off the study at or before wk 12 due to disease progression. CONCLUSIONS Addition of EPO to thal produced an improvement in baseline hgb. However, this improvement has not reached statistical significance. The effect of this rise in hgb on QOL will be analyzed at the completion of the study. Rapid disease progression in this poor prognosis pt population limits the ability to determine the impact of EPO on the clinical efficacy of thal at present. [Table: see text].
2.
A randomized phase II study of thalidomide with or without erytropoetin (EPO) in metastatic renal cell carcinoma (RCC)
Famoyin C, Byrnes C, Roberts S, Gollob J, Atkins M, Mier J, Ko Y-J, Gautam S, McDermott D
Journal of Clinical Oncology. 2004;22((14S):):441. Abstract No. 4747.