Abstract

PURPOSE:

To review the use of thalidomide as a therapeutic option for patients with metastatic renal cell carcinoma (RCC).

MATERIALS AND METHODS:

Studies of thalidomide alone or in combination with immunotherapy or chemotherapy were identified. The clinical benefit of thalidomide was assessed on the basis of objective response (complete and partial) and stable disease rates.

RESULTS:

Single-agent thalidomide was evaluated in nine phase II studies, producing partial responses in a median of 7% of patients (range: 0-17%) and stable disease in a median of 31% of patients. On average, 40-45% of patients derived benefit from thalidomide. Common toxicities included constipation, lethargy, and with prolonged therapy, neuropathy. Four studies reported deep vein thrombosis and/or pulmonary embolism at rates ranging from 3 to 23%. On the basis of these findings, phase I/II studies of thalidomide in combination with interleukin-2 (IL-2), interferon (IFN), or chemotherapy have been conducted. Although some of these early combination regimens were limited by toxicity, promising findings have been seen with thalidomide/IL-2 and thalidomide/IFN/capecitabine. A phase III trial of IFN versus IFN/thalidomide is nearing completion.

CONCLUSION:

Thalidomide is active in metastatic RCC, but additional experience with thalidomide-based combinations is needed to better define how this agent should be used in the management of this malignancy.