If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Sorafenib Safe in Patients With Unresectable Hepatocellular Carcinoma and Advanced Liver Cirrhosis: Presented at EASL By Emma Hitt, PhD MILAN, Italy -- April 28, 2008 -- Sorafenib appears to be safe in patients with multifocal hepatocellular carcinoma (HCC) and liver dysfunction, although the survival benefit for patients with Child-Pugh C liver dysfunction appears to be minimal, according to research presented here at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL). Senior author Markus Peck-Radosavljevic, MD, Professor, Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria, presented the findings of this retrospective analysis here on April 24. "The underlying cirrhosis has a profound impact on survival in these patients and any drug that only targets the tumour but not the underlying liver disease will probably show limited impact on survival," noted Dr. Peck-Radosavljevic. Previously, the randomised, phase 3, Sorafenib HCC Assessment Randomized Protocol (SHARP) trial showed a significant survival benefit with sorafenib versus placebo in patients with Child-Pugh A liver function status and HCC. But the feasibility and safety of using sorafenib in patients with more advanced liver disease has been unclear. In the current study, the researchers analysed data from 45 patients with unresectable HCC with mild to advanced liver disease. Liver function was Child-Pugh A in 22 patients, B in 14 patients, and C in 9 patients. The Barcelona Clinic Liver Cancer (BCLC) stage (which combines Child-Pugh score and HCC stage) was B, C, and D in 3, 28, and 14 patients, respectively. Patients were treated with oral sorafenib at a target dose of 400 mg twice daily. Radiological assessments were performed every 2 to 4 months. Out of 38 evaluable patients, 1 patient had a partial response for a median of 2.3 months, 9 had stable disease for 2.9 months, and 28 had progressive disease at the first radiological control. Overall, median progression-free survival was 2.8 months (range, 1.4-6.5 months). Median overall survival of the intention-to-treat group (n = 45) was 7.9 months (range, 0.4-16.3 months). In patients with Child-Pugh A, at a median follow-up of 6.6 months, 17 of 22 (77.5%) patients were alive. In Child-Pugh B patients, median survival was 6.5 months and 5 of 14 (35.7%) patients were alive. In Child-Pugh C patients, median survival was 1.6 months, and 2 out of 9 (22.2%) were alive. The difference in survival between the groups were statistically significant (P = .0001). Survival times were shorter in patients with increasing BCLC score (P = .0001). Out of 14 patients with BCLC stage D, 3 (21.4%) were alive at follow-up, and the median survival was 1.5 months, which is similar to the expected survival without treatment in this patient group, according to the researchers. Treatment with sorafenib was feasible even in patients with advanced liver disease, the researchers noted. Similar to the phase 3 trial, diarrhoea was the most notable adverse effect. "Sorafenib appears to be safe, but the survival benefit gained seems to be little in Child-Pugh C patients," Dr. Peck-Radosavljevic said in an interview. "The data will need to be confirmed in a prospective trial including a control group treated with standard of care."
[Presentation title: Sorafenib in Unresectable Hepatocellular Carcinoma and Advanced Liver Cirrhosis. Abstract 27]
|
