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Hepatobiliary |
Departments of aGastroenterology and Hepatology, fOncology, and gRadiology, 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: 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{at}meduniwien.ac.at
Received August 25, 2008; accepted for publication December 22, 2008; first published online in THE ONCOLOGIST Express on January 14, 2009.
Disclosures
Matthias Pinter: None; Wolfgang Sieghart: None; Ivo Graziadei: None; Wolfgang Vogel: None; Andreas Maieron: None; Robert Königsberg: None; Adalbert Weissmann: None; Gabriela Kornek: None; Christina Plank: None; Markus Peck-Radosavljevic: Consultant/advisory role: BayerSchering Pharma; Honoraria: BayerSchering Pharma; Research funding/ contracted research: BayerSchering Pharma
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 independent peer reviewers.
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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A. X. Zhu and J. W. Clark Commentary: Sorafenib Use in Patients with Advanced Hepatocellular Carcinoma and Underlying Child-Pugh B Cirrhosis--Evidence and Controversy Oncologist, January 1, 2009; 14(1): 67 - 69. [Full Text] [PDF] |
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