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Title: Second-line Therapy With Sorafenib Improves Survival in Patients With Advanced Renal-Cell Cancer: Presented at AUA

"Second-line Therapy With Sorafenib Improves Survival in Patients With Advanced Renal-Cell Cancer: Presented at AUA"

By Laura Gater ANAHEIM, CA -- May 24, 2007 -- Second-line therapy with sorafenib improves survival in patients with metastatic renal-cell carcinoma (mRCC), according to study results presented here at the American Urological Association (AUA) annual meeting. The phase 3 trial, presented on May 20[^th, enrolled 903 patients worldwide and evaluated the efficacy of sorafenib (800 mg/day) versus placebo and best supportive care on overall survival. This randomised, double-blind trial examined secondary endpoints as well, including progression-free survival (PFS), best response (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), health-related quality of life, symptom response and adverse events in patients with mRCC after initial systemic therapy.

Patients were included in the study from March 2004 until March 2005. The inclusion criterion was a second-line indication for systemic treatment after failed initial therapy within the last 8 months. All patients had initial nephrectomy, as well as metastases in more than 1 organ.

Ludwig Maximilian University (LMU) of Munich, Germany, as the largest urological center in this trial, included 31 patients (9 female, 22 male); 12 of these patients were initially in the placebo group while 22 were treated with sorafenib. After an interim analysis of this unicentric group in May 2005, all of the LMU patients from the placebo group were crossed over to the sorafenib group. Three placebo patients died, and 6 sorafenib patients died.

The response rate to sorafenib in the LMU group was 3 times higher than in other series, although it was assessed independently, reported Michael Staehler, MD, department of urology, LMU, University Hospital of Grosshadern, Grosshadern Medical Center, Munich, Germany.

PFS with sorafenib at Dr. Staehler's centre was 19.3 months, and overall survival was 27.9 months. PFS under placebo was 9.8 months and overall survival was 21.8 months.

The best response under placebo for LMU patients was as follows: 4 patients achieved stable disease (16%) while 8 patients experienced progressive disease (30%). Under sorafenib, the results were ameliorated: 12 patients achieved stable disease (50%), 2 experienced progressive disease (8%), and 8 achieved a partial response (30%).

Adverse events -- diarrhoea, nausea, hand-foot syndrome, hypertension, rush, erectile dysfunction, and stomatitis -- were manageable, according to Dr. Staehler.

Most of these patients had had stable disease for a long time, so partial response as measured by RECIST does not seem to be the main criterion for response evaluation in anti-angiogenetic treatment in mRCC.

[Presentation title: Sorafenib (BAY 43-9006) in Patients with Advanced Renal Cell Cancer (mRCC) as Second Line Therapy – Unicentric Results of a Multicentric Randomised Phase III Trial of the Multi Kinase Inhibitor. Abstract 499]

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