Thalidomide Treatment of Metastatic Renal-Cell Carcinoma

November 1, 2000

Thalidomide (Thalomid) has antiangiogenic and immunomodulatory properties with activity in myeloma and other tumors. We treated 15 patients with advanced progressive metastatic renal-cell cancer with escalating divided daily doses of thalidomide beginning at 400 mg/d and increasing 200 mg every 14 days to 1,200 mg/d (50% of each dose was given at bedtime). Nine of 15 patients had a performance status > 1. Currently, 12 patients have received 4+ weeks of therapy and are evaluable for response.

One patient with an initial performance status of 3 has a partial response of 11+ months duration and one patient has a minor response of 3+ months. Three patients have stable disease and seven have progressive disease. Both responders had failed high-dose interleukin-2 therapy. Maximally tolerated doses of thalidomide were 600 to 1,200 mg/d. The usual toxicities of somnolence and constipation were seen, but no cytopenias, neuropathy, or respiratory depression. Some patients developed either arterial or venous thrombi or impaired wound healing, but these events may have been unrelated to thalidomide. Vascular endothelial growth factor levels will be measured in some patients.

CONCLUSION: Thalidomide can produce occasional responses in poor performance status patients with metastatic renal-cell cancer. This study continues to define the maximally tolerated dose in this patient population as well as the response rate.

Click here to read Wen-Jen Hwu's commentary on this abstract.