Poster Presentations

Session Title: LIVER TUMORS b) CLINICAL (EPIDEMIOLOGY, DIAGNOSIS, MANAGEMENT)
Presentation Date: Apr 25, 2009

EVALUATION OF TOLERANCE AND OUTCOME OF PATIENTS WITH HEPATOCELLULAR CARCINOMA TREATED BY SORAFENIB (AFTER THE SHARP STUDY)

V. Ozenne¹, S. Pernot¹, M.-P. Vullierme², V. Paradis³, T. Serste^1,4, C. Castelnau¹, D. Valla¹, T. Boulet⁵, F. Degos^1
1Hepatology, ²Radiology, ³Pathology, Hopital Beaujon APHP, Clichy, France, ⁴Hepato-Gastro-Enterology, Hopital Saint Pierre, Bruxelles, Belgium, ⁵Pharmacology, Hopital Beaujon APHP, Clichy, France

Background and aims: The SHARP study showed that sorafenib increased survival of patients with hepatocellular carcinoma (HCC) non eligible for a curative therapy. The aim of the present study was to evaluate tolerance of the treatment and survival of patients in a post pivotal study.
Methods: In this retrospective monocentric study, every consecutive patient treated by sorafenib between April 2007 and June 2008 were included. For each patient, age, sex, aetiology of cirrhosis, Child score, presence of portal vein thrombosis, characteristics of the tumor, presence of extra hepatic metastases, alpha fetoprotein level were recorded. Side effects were recorded. The duration of treatment until interruption for bad tolerance and survival were studied using Kaplan Meier technique.
Results: 35 patients were included: 92 % male sex, mean age 63 years, Child A 66%, Child B 34% (B7: 5pts, B8-9:7 patients). Portal vein thrombosis was present in 63% and extra hepatic metastases in 29%. Tumor was infiltrative in 50% of patients. HCC was histologicaly proven in 80%. Sorafenib was the first line treatment for 60% of patients. Side effects were as frequent in patients Child A or B : asthenia 67%, anorexia 54% diarrhoea 50% hand foot syndrome 32%. Interruption of treatment for bad tolerance or liver failure was as frequent in Child A or B patients, but duration of treatment was shorter in Child B patients: median 29 days vs 4.9 months (LR 0.02). Survival was respectively 7.4 months and 2.06 months for patients Child A and B (LR 0.006).
Conclusion: Most patients with HCC treated with sorafenib displayed side effects. Although they are similar to those previously reported in the SHARP study, they are more frequent, independently of the Child score. Global survival was shorter in our study, probably because of more advanced stages especially infiltrative diseases, which could not be evaluated by RECIST criteria. The benefit of sorafenib in Child B patients needs further investigations.