Interferon-alpha plus capecitabine and thalidomide in patients with metastatic renal cell carcinoma: a pilot study.

PURPOSE: To assess the activity and toxicity of interferon-alpha (IFN-alpha), capecitabine, and thalidomide in patients with metastatic renal cell carcinoma (MRCC). PATIENTS AND METHODS: Twenty-seven patients were enrolled in a pilot study to receive oral capecitabine 1,900 mg/m2/day in 2 daily doses, 2 weeks on, l week off; daily subcutaneous IFN-alpha 1 mIU without interruption; and daily oral thalidomide 200 mg/day for the first seven days, then escalated to 400 mg/day without interruption. Dosages were reduced for toxicity as necessary.
RESULTS: Two patients discontinued treatment during the first week of the study, leaving 25 patients evaluable. There were 5 (20%) partial responses (PRs), 1 (4%) minor response (MR), 6 (24%) cases of stable disease (SD) > or = 6 months, and 13 (52%) cases of progressive disease (PD). The interval from first response to disease progression varied from 0-23 months: 17 patients progressed in 0-6 months; 4 progressed in 7-12 months; and 4 progressed in 12-24 months. Median survival was > 22 months, 14 months, and 1 month, respectively, for patients with PR, SD, and PD. Grade 3/4 toxicities consisted of hand-foot syndrome, neuropathy, fatigue, anemia, and deep venous thrombosis were common.
CONCLUSION: This study demonstrates antitumor activity of combination IFN-alpha/capecitabine/thalidomide in MRCC. The 20% PR rate was notable, as the patient population had advanced disease and inferior performance status. Treatment was generally well tolerated, and further research is warranted to explore the efficacy of this combination for treating MRCC.