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Sorafenib in Unresectable Hepatocellular Carcinoma from Mild to Advanced Stage Liver Cirrhosis

^aDepartment of Gastroenterology and Hepatology, ^fDepartment of Oncology, and ^gDepartment of Radiology, AKH & Medizinische Universität Wien, Wien, Austria; ^bDepartment of Gastroenterology and Hepatology, LKH & Medizinische Universität Innsbruck, Innsbruck, Austria; ^cFourth Medical Department, KH Elisabethinen Linz, Linz, Austria; ^dKaiser Franz Josef-Spital, Third Medical Department, Centre for Oncology and Hematology, CEADDP, Applied Cancer Research, Institution for Translational Research Vienna (ACR-ITR VIEnna), and Ludwig Boltzmann-Institute for Applied Cancer Research (LBI-ACR VIEnna), Vienna, Austria; ^eDepartment of Oncology and Hematology, Wilhelminenspital Wien, Wien, Austria

Key Words. Hepatocellular carcinoma • Liver cirrhosis • Sorafenib • Multikinase inhibitors

Correspondence: Correspondence: Markus Peck-Radosavljevic, M.D., AKH & Medizinische Universität Wien, Klinik Innere Medizin III, Abteilung Gastroenterologie & Hepatologie, Währinger Gürtel 18-20, A-1090 Wien, Austria. Telephone: 43-1-40400-6589; Fax: 43-1-40400-4735; e-mail: markus.peck@meduniwien.ac.at

Received August 25, 2008; accepted for publication December 22, 2008.

Disclosure: Employment/leadership position: None; Intellectual property rights/inventor/patent holder: None; Consultant/advisory role: Markus Peck-Radosavljevic, BayerSchering Pharma; Honoraria: Markus Peck-Radosavljevic, BayerSchering Pharma; Research funding/contracted research: Markus Peck-Radosavljevic, BayerSchering Pharma; Ownership interest: None; Expert testimony: None; Other: None. The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the authors, planners, independent peer reviewers, or staff managers.

Background. Few data are available on the safety and efficacy of sorafenib in patients with multifocal hepatocellular carcinoma (HCC) and advanced liver cirrhosis.

Methods. Between May 2006 and December 2007, we treated 59 patients (Child-Pugh class A/B/C, 26/23/10) with unresectable HCC with sorafenib (daily target dose, 400 mg twice daily). Data were collected retrospectively. Survival curves were calculated via the Kaplan–Meier method.

Results. One patient (Child-Pugh class B) had a partial response, 14 patients (Child-Pugh class A/B/C, 5/7/2) had stable disease, and 32 patients (Child-Pugh class A/B/C, 15/11/6) had progressive disease; 12 patients were not evaluable because they had no follow-up radiologic evaluation. In the intention-to-treat group, the median time to progression and overall survival (OS) time were 2.8 months (range, 1.4–6.5 months) and 6.5 months (range, 0.4–17.4 months), respectively. Well-preserved liver function and lower Barcelona Clinic Liver Cancer stage were associated with a longer OS time on univariate analysis. There were four severe gastrointestinal bleedings (grade 4–5; Child-Pugh class B/C, 2/2). Most drug-related side effects were low grade and manageable irrespective of liver function.

Conclusions. Sorafenib is effective and safe in patients with multifocal HCC and Child-Pugh class A cirrhosis. Survival in Child-Pugh class B patients is significantly less than in Child-Pugh class A patients, warranting a prospective randomized trial with a placebo group. Child-Pugh class C patients have a limited life expectancy despite sorafenib treatment because of their severe underlying disease and derive little benefit from sorafenib treatment.

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