Safety and activity of sorafenib in advanced renal cell cancer: A single institution experience

Abstract

15604 Background: Sorafenib is an oral multitargeted tyrosine kinase inhibitor of RAF-kinase and VEGFR2, with antiangiogenic and antitumor activity in pretreated advanced renal cell cancer (RCC). Methods: In our institution, from December 2005 to November 2006, 131 consecutive patients(pts) with advanced RCC received sorafenib 400mg/bid/continuously. Main patient characteristics were: clear-cell cancer 106 pts, papillary-cell 15 pts, cromophobe-cell 3pts, collecting duct carcinoma 3pts, other histotypes 4pts. Previous nephrectomy was performed in 122 pts with median relapse free survival of 23 months (range 3–180 mos). The most common site of disease was lung, whereas 94 pts had 2 or more secondary disease locations. According to Motzer’s prognostic score 85 pts were at low risk, 36 pts and 10 pts at intermediate and high risk respectively . 12 pts were treatment naïve for metastatic disease. 68 and 51pts received one or at least two systemic treatments respectively. Results: Currently, 106 pts are evaluable for safety and objective response. According to the RECIST criteria, the activity of sorafenib in terms of tumor shrinkage was observed in 32 pts(31%) with 10 partial response (9.5%) and 22 minor response (21%) respectively. Stable disease was seen in 42 pts (41%) and progressive disease in 28 pts (26%), 4 pts were not evaluable for response. Overall, 74 pts (72%) had disease growth control. Median duration of response was 8 months and median time to progression was 6.5 mos, median overall survival has not been reached yet. The most common treatment-emergent adverse effects seen in 78% of pts, were grade (G) 1/2 (NCI-CTC) and included hand foot syndrome, rash, diarrhea, fatigue, hypertension and mucositis. Dose modification due to G3–4 adverse event, such as skin toxicity and cardiovascular events, was performed in 35 pts(32%). Conclusion: sorafenib is effective in terms of tumor growth control in untreated as well as in pretreated patients and in different hystotypes of renal cell cancer. Particularly, in heavily pretreated patients the number and severity of drug related toxicity suggests the dose reduction as possible standard therapy. The Authors would like to thank (I.T.M.O) Italian Trials in Medical Oncology for editorial assistance. No significant financial relationships to disclose.