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.
© 2000 by PRR, Inc. All rights reserved.