BERKELEY, CA (UroToday.com) - Both thalidomide and -interferon (IFN) have been utilized as monotherapy in the treatment of patients with metastatic renal cell carcinoma (RCC), each with modest evidence of activity and acceptable toxicity profiles.

One can only wonder as to the relevance of these agents as treatment options, in the era of targeted therapy for patients with metastatic RCC. Here Vaishampayan and colleagues examine the activity of IFN and thalidomide, in combination, in the context of a phase II clinical trial.

Twenty patients were enrolled in this phase II clinical trial. Of these, 14 patients had received and failed other prior regimens. . Median patient age was 60.5 years (range 39-75) and 55% of patients had undergone prior nephrectomy. Fourteen patients were evaluable for response. There were no complete or partial responses, although one patient had a minor response (38% reduction in tumor volume) and another had prolonged stabilization of disease. The regimen was associated with considerable toxicity in that 60% of patients had grade 3 adverse events. Four patients had to stop therapy due to significant treatment related toxicity. The median time to progression was 1 month, and the median survival was 2.8 months.

Therapy for metastatic RCC with interferon and thalidomide, in combination, demonstrated significant toxicity and minimal efficacy and should not be recommended for further study or as a therapeutic option.

Ulka Vaishampayan, Lance K. Heilbrun, Ralph E. Parchment, Vikash Jain, James Zwiebel, Ramesh R. Boinpally, Patricia LoRusso and Maha Hussain

Invest New Drugs (ePub):25(1)February, 2007

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Written by Christopher G. Wood, MD, a Contributing Editor with UroToday.

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