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>IMPACT OF LUNG AND LYMPH NODE METASTASIS ON EFFICACY AND SAFETY FOLLOWING TREATMENT WITH SORAFENIB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA FROM THE ASIA-PACIFIC REGION</b></h2> <p align='left'><b>H. Pan</b><sup>1</sup>, Z. Guan<sup>2</sup>, Y.K. Kang<sup>3</sup>, Z. Chen<sup>4</sup>, C.J. Tsao<sup>5</sup>, A.L. Cheng<sup>6</sup>, J.S. Kim<sup>7</sup>, K. Burock<sup>8</sup>, J. Zou<sup>9</sup>, D. Voliotis<sup>10</sup>, S. Qin<sup>11</sup><br> <em><sup>1</sup>Sir Run Run Shaw Hospital, Medical School of Zhejiang University, Hangzhou, China, <sup>2</sup>Sun Yat-sen University Cancer Center, Guangzhou, China, <sup>3</sup>ASAN Medical Center, Songpa-gu, Seoul, South Korea, <sup>4</sup>First Affiliated Hospital of Anhui Medical University, Hefei, China, <sup>5</sup>Chi Mei Medical Center, Liou Ying Campus, Tainan, <sup>6</sup>National Taiwan University Hospital, Taipei, Taiwan R.O.C., <sup>7</sup>Korea University Guro Hospital, Seoul, South Korea, <sup>8</sup>Bayer Schering Pharma, Wuppertal, Germany, <sup>9</sup>Bayer Schering Pharma, Shanghai, China, <sup>10</sup>Bayer HealthCare Pharmaceuticals, Montville, NJ, USA, <sup>11</sup>Nanjing 81 Hospital, Nanjing, China</em></p><br> <p align='justify'><b><b>Background and aims: </b></b> Results of a multinational, phase III, randomized, double-blind, placebo-controlled trial in a population made up entirely of patients from the Asia-Pacific (AP) region, indicate that sorafenib is effective and safe for the treatment of advanced hepatocellular carcinoma (HCC). Early metastasis is a prominent feature of HCC, and is associated with poor prognosis and advanced disease. We performed subset analyses to evaluate the efficacy and safety of sorafenib in patients with or without lung metastasis and those with or without lymph node (LN) metastasis at baseline. <br><b><b>Methods: </b></b> Patients (N=226) with advanced, unresectable, measurable HCC, ECOG PS 0-2, Child-Pugh class A, and no prior systemic therapy for HCC were randomized 2:1 to sorafenib 400 mg BID or placebo. Endpoints included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for e"28 days from first demonstration of response), time to progression (TTP), and safety. <br><b><b>Results: </b></b> Median TTP, OS, and DCR by subset are shown in the table. The incidence of grade 3/4 drug-related adverse events (AEs) across subgroups was consistent with that reported for the overall population. The most common grade 3/4 AEs in the sorafenib subpopulations were hand-foot skin reaction and diarrhea. <br><b><b>Conclusions: </b></b> Sorafenib was effective and safe in patients from the AP region with advanced HCC, regardless of the presence of lung or LN metastasis at baseline. These results are consistent with those for the overall study population. Further studies with larger sample sizes are warranted to confirm the efficacy and safety of sorafenib in these patient subsets. <br><br><br><table border=1> <tr><td width='10%' align='left'> </td> <td width='10%' align='center' colspan='2'><span style='font-weight:normal; font-style:normal'>n</span></td> <td width='10%' align='center' colspan='3'><span style='font-weight:normal; font-style:normal'>TTP<br> (Sorafenib/<br>Placebo)</span></td> <td width='10%' align='center' colspan='3'><span style='font-weight:normal; font-style:normal'>OS <br>(Sorafenib/<br>Placebo)</span></td> <td width='10%' align='center'> </td> </tr><tr><td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>Population</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>Sorafenib</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>Placebo</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>Median<br> (mo)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>HR <br>(95% CI)</span></td> <td width='10%' align='center'><span style='font-weight:bold; font-style:italic'>P</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>Median<br> (mo)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>HR <br>(95% CI)</span></td> <td width='10%' align='center'><span style='font-weight:bold; font-style:italic'>P</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>DCR (%)<br> (Sorafenib/<br>Placebo)</span></td> </tr><tr><td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>Overall</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>150</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>76</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>2.8/1.4</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.57 <br>(0.42, 0.79)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'><0.001</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>6.5/4.2</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.68 <br>(0.50, 0.93)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.014</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>35.3/15.8</span></td> </tr><tr><td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>Lung<br> Metastasis</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>78</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>34</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>2.4/1.3</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.57 <br>(0.36, 0.88)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.009</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>5.6/4.2</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.87 <br>(0.56, 1.37)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.552</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>28.2/8.8</span></td> </tr><tr><td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>No Lung<br> Metastasis</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>72</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>42</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>3.6/1.5</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.55 <br>(0.34, 0.89)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.011</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>7.7/4.0</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.53 <br>(0.34, 0.82)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.004</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>43.1/21.4</span></td> </tr><tr><td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>LN<br> Metastasis</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>46</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>26</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>2.8/1.4</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.52 <br>(0.29, 0.93)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.023</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>5.6/3.2</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.64 <br>(0.38, 1.08)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.089</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>30.4/11.5</span></td> </tr><tr><td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>No LN<br> Metastasis</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>104</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>50</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>2.7/1.3</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.61 <br>(0.41, 0.90)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.010</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>7.3/4.3</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.70 <br>(0.47, 1.04)</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>0.078</span></td> <td width='10%' align='center'><span style='font-weight:normal; font-style:normal'>37.5/18.0</span></td> </tr></table></p> <br><a href='Session-Category 3b.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>