Thalidomide reduces serum C‐reactive protein and interleukin‐6 and induces response to IL‐2 in a fraction of metastatic renal cell cancer patients who failed IL‐2‐based therapy

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Abstract
Interleukin‐2 (IL‐2) has some antitumor activity in patients with renal cell carcinoma. It has been noted that response to IL‐2 and prognosis may be adversely affected by elevated serum levels of C‐reactive protein (CRP) or interleukin‐6 (IL‐6). We used thalidomide to treat patients with cancer‐induced cachexia and noted that the drug significantly reduced serum levels of CRP and IL‐6 to normal or near normal levels in a substantial fraction of patients. We tested whether thalidomide might potentiate the response of patients with renal cell carcinoma to IL‐2. Four patients with metastatic renal cell carcinoma and high serum levels of CRP and IL‐6 who had experienced disease progression on IL‐2 were retreated with the same IL‐2 regimen combined with thalidomide 300 mg p.o. daily. Two patients achieved good partial responses and 2 patients had prolonged disease stabilization with the combination of IL‐2 plus thalidomide. The regimen was well tolerated without increased IL‐2‐associated toxicity. Reduction of serum CRP or IL‐6 levels with thalidomide may enhance the responsiveness of renal cell carcinoma to IL‐2. A Phase II study of the combination is in order. It is possible that the thalidomide‐induced normalization of serum acute phase proteins might improve the response of other types of malignancy to IL‐2 or other immune‐based therapies.