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>EFFICACY, SAFETY AND IMPACT ON QUALITY OF LIFE OF SORAFENIB IN ELDERLY PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA. PRELIMINARY RESULTS OF A PHASE II STUDY</b></h2> <p align='left'>G. Mantovani<sup>1</sup>, E. Massa<sup>1</sup>, C. Spiga<sup>1</sup>, <b>L. Chessa</b><sup>2</sup>, C. Madeddu<sup>1</sup>, T. Zolfino<sup>3</sup>, S. Lepori<sup>1</sup>, G. Serra<sup>2</sup>, M.R. Piras<sup>3</sup>, S. Marini<sup>4</sup><br> <em><sup>1</sup>Department of Medical Oncology, <sup>2</sup>Department of Internal Medicine, University of Cagliari, <sup>3</sup>Department of Gastroenterology, Ospedale San Michele, <sup>4</sup>Department of Radiodiagnostic, University of Cagliari, Cagliari, Italy</em></p><br> <p align='justify'><b><b>Introduction: </b></b> Sorafenib is the only systemic therapy that has prolonged the median survival and time to progression in patients with advanced hepatocellular carcinoma.<br><b><b>Methods: </b></b> The primary aim of this open prospective non-randomized phase II study was to assess efficacy and safety of sorafenib in a selected population of elderly patients with advanced hepatocellular carcinoma not previously treated. Secondary aims included quality of life (QoL) assessment using SF-36 questionnaire and changes of serum IL-6. All patients underwent multidimensional geriatric assessment (MGA) and accordingly were assigned to 3 different categories: fit, intermediate and frail. Scheduled sorafenib dose was 800 mg/day until disease progression or unacceptable toxicity. Efficacy was assessed every 3 months and defined as objective clinical response (RECIST) and disease-control rate (DCR), i.e. the percentage of patients who had a best-response ( complete response -CR or partial response- PR or stable disease- SD) maintained for at least 28 days. <b><br><b>Results: </b> </b>From January to November 2008 14 patients (M/F ratio, 12:2; mean age 70.7 ±3.1 years; range, 66-76) were enrolled and 13 were evaluable after 3 months: 28.6% had ECOG PS 0, 57.1% PS 1, and 14.3% PS 2. According to MGA, 3 patients were fit, 8 intermediate and 3 frail. At 3-month evaluation no CR/PR, 8/13 (61.5%) SD, 5/13 (38.5%) PD were observed. DCR was 75.0% (6/8 patients). The toxicity was moderate and the worst was grade 3: hand-foot and skin reactions (30.7%), hypertension (15.4%), diarrhea (30.7%), nausea and vomiting (7.7%), asthenia (15.4%). The treatment was interrupted for a mean of 9 days (range 4-19) due to toxicities in 84.6% of patients and restarted at a reduced dosage (400 mg/day) which was well tolerated. The mean dosage was 552 mg/day. QoL improved globally and in particular for: pain, energy, physical activity and patient perception of self-health status. Serum IL-6 were high at enrolment and did not change thereafter. At Novembrer 2008, 10/13 patients are alive. <b><br><b>Conclusion: </b> </b>In elderly cancer patients with advanced hepatocellular carcinoma sorafenib demonstrated a good DCR<b>, </b>a moderate toxicity at 800 mg/day, an optimal acceptability at 400 mg/day and a significant improvement of quality of life. <br></p> <br><a href='Session-Category 3b.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>