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A New Treatment Option for Patients with Renal Cancer

LONDON, Dec. 20, 2007-Treatment with bevacizumab plus interferon improves progression-free survival in patients with metastatic renal cell carcinoma compared with interferon alone, and will provide a new first-line treatment option for patients with renal cancer, according to an Article in this week’s issue of The Lancet.

There are 120 000 new cases of renal cell carcinoma in Europe and the USA every year, and it causes 60 000 deaths. Until recently the standard treatment options for metastatic renal cell carcinoma were limited to immunotherapy with either interleukin 2 or interferon, both of which had modest response rates (<20%) along with substantial toxicities. Newer antiangiogenesis-targeting agents* such as sunitinib, and temsirolimus have provided further options for treatment and improved prognosis in patients with metastatic renal cell carcinoma. Bevacizumab, another antiangiogenesis-targeting agent, has shown an improvement in time to progression in phase II studies of metastatic renal cell carcinoma, and has a well-defined safety profile that includes more than 10 000 patients.

Dr Bernard Escudier (Institut Gustave Roussy, Villejuif, France) and colleagues did an international, multicentre, randomised, double-blind, phase III trial of 649 patients with previously untreated metastatic renal cell carcinoma to determine whether first-line treatment with bevacizumab plus interferon alfa improved efficacy compared to interferon alfa alone. The authors unblinded their study early. Data for the primary endpoint of overall survival were not mature, but the secondary endpoint of progression-free survival from the interim analysis were sufficient for reporting.

325 patients received bevacizumab with interferon and 316 received placebo plus interferon. According to the authors there were 230 progression events in the bevacizumab plus interferon alfa group and 275 in the control group. There were 114 deaths in the bevacizumab plus interferon alfa group and 137 in the control group. The authors note that median progression-free survival was significantly longer in the bevacizumab arm compared with the control group (10·2 months vs 5·4 months). Furthermore, the safety profile was consistent with previous observations, and the grade 3/4 adverse events were manageable with standard therapies.

The authors conclude: "This treatment [bevacizumab plus interferon] is clearly comparable with the most active treatment, and with a very good safety profile, will provide new options for renal cancer patients."** They go on: "The availability of a variety of active agents provides increased treatment options and the opportunity to provide several lines of therapy and improved survival."

In an accompanying Comment, Dr Robert Motzer and Dr Ethan Basch (Memorial Sloan-Kettering Cancer Center, New York, USA) say: "Phase II trials of bevacizumab as first-line and second-line monotherapy report response rates (15% and 10% respectively) similar to those observed with interferon alone. The high response rate (31%) seen in Escudier’s trial suggests that interferon does contribute to the efficacy of this regimen." They go on: "The study supports the vascular endothelial growth factor blockade as a therapeutic approach to the treatment of metastatic renal cell carcinoma and highlights the need for further research to define the optimum in the rapidly changing era of targeted therapy".

Dr Bernard Escudier, Institut Gustave Roussy, Villejuif, France. T) +33 1 42 11 54 10

Comment Jeanne D’Agostino, Media Relations, Memorial Sloan-Kettering Cancer Center, New York, USA. T) +1 646 227 3137

escudier@igr.fr

dagostij@mskcc.org

Note to Editors

*Antiangiogenesis-targeting agents stop tumor growth by preventing the formation of new blood vessels by targeting and inhibiting the function of a natural protein called vascular endothelial growth factor (VEGF) that stimulates new blood vessel formation.

**Quote directly from author and cannot be found in the article.

Posted: December 2007

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