Safety and effectiveness of sorafenib in patients with hepatocellular carcinoma in clinical practice

Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
Giovan Giuseppe Di CostanzoMassimo De Luca

Abstract

Sorafenib is currently the only approved systemic treatment for hepatocellular carcinoma. to evaluate safety and effectiveness of sorafenib in the field of practice. We report a single-centre experience on 116 advanced hepatocellular carcinoma patients treated with sorafenib between February 2008 and March 2011. Every 4 weeks, adverse events were graded using Common Toxicity Criteria version 3.0, and every 3 months tumour response was assessed according to modified Response Evaluation Criteria in Solid Tumours for hepatocellular carcinoma. Cirrhosis was present in 95.7% of patients (83.6% Child-Pugh A class), hepatitis C was the main etiological factor. Median therapy duration was 3 months and median daily dose was 642 mg. Median time-to-radiological progression in the per-protocol population was 12 months and median overall survival in the intention-to-treat population was 13 months. 91.4% of patients experienced mild adverse events (grade 1 or 2), the most frequent were gastrointestinal and dermatological. Jaundice and bleeding were the main causes of definitive drug discontinuation. 3-month overall disease control rate was 70.6%: stable disease in 37.2%, partial response in 30.8%, and complete response in 2.6% patients. The ...Continue Reading

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Citations

Jan 8, 2013·Medical Oncology·Ji-Wen Cheng, Yi Lv
Aug 26, 2014·World Journal of Gastroenterology : WJG·Jie WuJing Liu
Oct 11, 2013·Future Oncology·Gaetano BertinoMichele Malaguarnera
Aug 5, 2014·BioMed Research International·Gaetano BertinoIsidoro Di Carlo
Apr 9, 2013·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Fabio PiscagliaLaura Venerandi
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Mar 12, 2015·Future Oncology·Giovan Giuseppe Di CostanzoNicola Caporaso
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Nov 20, 2020·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Robert J Cersosimo

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