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Phase II Study Of Lenalidomide In Patients With Metastatic Renal Cell Carcinoma

UroToday.com - The treatment of metastatic renal cell carcinoma (RCC) has undergone a dramatic evolution over the past year, with the introduction of new targeted therapies that have demonstrated improved response rates, delayed time to progression, and improved survival over traditional immunotherapeutic approaches.

These agents are largely anti-angiogenic, thus these findings further validate the importance of angiogenesis in the biology of RCC and suggest that other agents targeting this pathway might prove effective. Previous studies have suggested that the drug thalidomide, which is thought to have both immunomodulatory and anti-angiogenic effects, had modest activity in metastatic RCC. Here, the group from Cleveland Clinic examines the activity of a derivative of thalidomide, lenalidomide, which is thought to be more potent with less hematological side effects, in metastatic RCC.

Twenty-eight patients with metastatic RCC were enrolled in the trial. All had prior nephrectomy and 57% had failed prior treatment regimens. Patients received lenalidomide 25 mg for 21 days out of a 28 day cycle. With a median follow-up of 13.5 months, there were 3 partial responses (11%) that remained progression free for greater than 15 months, and 39% of patients demonstrated stable disease or minor disease responses that lasted greater than 3 months. Median survival in the trial has thus far not been reached. Median time to treatment failure was 3.7 months. Toxicity was mild and easily treated.

Of note, all of the responders in the trial demonstrated abnormalities in their thyroid function tests. Previous studies with cytokine therapies have demonstrated that thyroid dysfunction has been linked to favorable disease response.

The thalidomide derivative, lenalidomide, demonstrates activity in the setting of metastatic RCC. Further studies are needed to identify the most appropriate patient population to apply this drug, and to consider novel combinatorial therapies with agents that have activity in metastatic RCC.

Toni K. Choueiri, Robert Dreicer, Brian I. Rini, Paul Elson, Jorge A. Garcia, Snehal G. Thakkar, Rachid C. Baz, Tarek M. Mekhail, Holly A. Jinks, Ronald M. Bukowski
Cancer 107: 2609-16, 2006.

Reviewed by UroToday Contributing Editor Christopher G. Wood, MD, FACS

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Studiu de fazã II Lenalidomide la pacienþii cu carcinom cu celule renale metastatice - Phase II Study Of Lenalidomide In Patients With Metastatic Renal Cell Carcinoma - articole medicale engleza - startsanatate