Revlimid for renal cell carcinoma – pro

Thalidomide is an agent with complex antiangiogenic and immunomodulatory properties. It has been demonstrated to reduce mRNA and protein expression of bFGF and VEGF with resulting inhibitory effects on endothelial cell proliferation. Several small studies of thalidomide as a single agent in RCC have reported no complete responses, partial responses ranging from 0-17%, and stable disease in 17-64% of patients. In these studies, thalidomide was generally started at a low dose of 100-200 mg per day, and further escalated to higher doses until toxicity was achieved. When thalidomide analog, lenalidomide became available, it was studied in renal cell carcinoma as well.

Thalidomide has minimal activity. In a recent metastatic study(Margulis et al), single-agent thalidomide was inactive, and that the risk-benefit ratio clearly did not favor the use of thalidomide In small randomized, controlled 2009 trial (Jonasch et al), adjuvant thalidomide therapy after complete resection of high-risk RCC did not improve the 2- and 3-year RFS rates or cancer-specific death rates.

Lee CP, Patel PM, Selby PJ, Hancock BW, Mak I, Pyle L, James MG, Beirne DA, Steeds

Randomized phase II study comparing thalidomide with medroxyprogesterone acetate in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006 Feb 20;24(6):898-903.

Choueiri TK, Dreicer R, Rini BI, Elson P, Garcia JA, Thakkar SG, Baz RC, Mekhail TM, Jinks HA, Bukowski RM. Phase II study of lenalidomide in patients with metastatic renal cell carcinoma. Cancer. 2006 Dec 1; 107 (11): 2609-16.

Motzer, Robert J., Berg, William, Ginsberg, Michelle, Russo, Paul, Vuky, Jacqueline, Yu, Richard, Bacik, Jennifer, Mazumdar, Madhu Phase II Trial of Thalidomide for Patients With Advanced Renal Cell Carcinoma J Clin Oncol 2002 20: 302-306

Novik Y, Dutcher JP, Larkin M, Wiernik PH. Phase II Study of Thalidomide (T) in Advanced Refractory Metastatic Renal Cell Cancer (MRCC): a Single Institution Experience. Proc Am Soc Clin Oncol 2001; 20 (abstr 1057).

Margulis V, Matin SF, Tannir N, Tamboli P, Shen Y, Lozano M, Swanson DA, Jonasch E, Wood CG. Randomized trial of adjuvant thalidomide versus observation in patients with completely resected high-risk renal cell carcinoma. Urology. 2009 Feb;73(2):337-41

NCCN, renal cell carcinoma


Revised 8/24/2011

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