ÿþ<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"> <html> <head> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1"> <title>EASL 2009 - Poster Presentations</title> <link rel="stylesheet" type="text/css" href="style.css"> </head> <body> <table width="750" align="center" border="0" cellspacing="0" cellpadding="0" class="MainTable"> <tr> <td><img src="http://www2.kenes.com/liver-congress/PublishingImages/top760.jpg" width="760" height="181" /></td> </tr> <tr> <td class="content"><h1>Poster Presentations</h1> <P><b>Session Title:</b> LIVER TUMORS b) CLINICAL (EPIDEMIOLOGY, DIAGNOSIS, MANAGEMENT)<br><b>Presentation Date:</b> Apr 25, 2009</P><h2 align='left'><b>SORAFENIB FOR THE TREATMENT OF ADVANCED HEPATOCELLULAR CARCINOMA. FEASIBILITY AND SAFETY OUTSIDE RESEARCH TRIALS</b></h2> <p align='left'><b>M. Reig</b><sup>1</sup>, A. Forner<sup>1</sup>, J. Rimola<sup>2</sup>, C. Rodriguez de Lope<sup>1</sup>, C. Ayuso<sup>2</sup>, J.M. Llovet<sup>1</sup>, J. Bruix<sup>1</sup><br> <em><sup>1</sup>BCLC Group. Liver Unit, Hospital Clinic, CIBEREHD, IDIBAPS, <sup>2</sup>BCLC Group. Radiology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain</em></p><br> <p align='justify'><b>Background: </b> Sorafenib (an oral tyrosine kinase inhibitor that blocks the Raf/MEK/ERK pathway and the receptor for VEGFR 2 and PDGFR-beta) has been shown to improve survival of patients with advanced Hepatocellular Carcinoma (HCC). However, presence of comorbidities and toxicity may not reproduce the data of the pivotal SHARP trial. <br><b>Aim: </b> To assess the applicability of sorafenib in patients with advanced HCC within a referral liver cancer centre and to establish the safety and tolerance of treatment outside a prospective trial. <br> <b>Methods: </b> Between October 2007 and October 2008 we prospectively registered the feasibility and tolerance of sorafenib in patients with advanced HCC, liver function should fit into Child-Pugh A-B up to 7 points. Uncontrolled arterial hypertension and/or unstable arterial disease were taken as formal contraindication. <br><b>Results: </b> 120 patients had indication for Sorafenib treatment, but 53 presented contraindication for the drug. Median age of the patients in treatment was 63 years, 84% males, all cirrhotics (58,7% HCV+). 84% Child-Pugh A, BCLC stage was B in 60% and C in 40%. 49 of the patients needed dose modification at a median follow-up time of 26 days (range: 3-296): in 23 pts the dose was halved (median 28 days, range: 3-224) while in 26 pts the treatment was discontinued after a median of 18 days (range: 3-296). The cause or modification doses were: Hand-foot syndrome (27.4%), arterial hypertension (10%), performance status impairment (16%), acute pancreatitis in 5, 9% and other complains in the remaining. In 55% of the cases it was possible to return to reinitiate the therapy after controlling the adverse events. According to CTCAE (v 3.0) the grades of secondary effects were 79% I, 14% II, 6% III and less 1% grade IV. <br><b>Conclusion: </b> Sorafenib treatment was feasible in 53% of the HCC patients evaluated for this option outside the trials. The majority of the events leading to dose modification are registered within the first 3 weeks. Hence, careful follow-up has to be established during the early treatment phase in order to detect and manage any adverse event and thus allow prompt recovery and potential return to conventional dosing. <br></p> <br><a href='Session-Category 3b.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>