Safety and effectiveness of sorafenib in patients with hepatocellular carcinoma in clinical practice.
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 3-month radiological response correlated with overall survival.
In daily clinical practice, sorafenib confirmed its safety and efficacy in hepatocellular carcinoma patients.
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ABSTRACT: Hypoxia is a common phenomenon in solid tumors, associated with chemotherapy and radiotherapy resistance, recurrence and metastasis. Hyperbaric oxygen (HBO) therapy can increase tissue oxygen pressure and content to prevent the resistance, recurrence and metastasis of cancer. Presently, Sorafenib is a first-line drug, targeted for hepatocellular carcinoma (HCC) but effective in only a small portion of patients and can induce hypoxia. The purpose of this study is to investigate the effect of HBO in combination with sorafenib on hepatoma cells.PLoS ONE 01/2014; 9(6):e100814. · 3.53 Impact Factor
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ABSTRACT: Backgroundsorafenib and transarterial 90Y-radioembolization (TARE) are possible treatments for Barcelona Clinic Liver Cancer (BCLC) intermediate-advanced stage hepatocellular carcinoma (HCC). No study directly comparing sorafenib and TARE is currently available. Aim: This single-center retrospective study compares the outcomes achieved with sorafenib and TARE in HCC patients potentially amenable to either therapy.Methods Seventy-four sorafenib (71±10 years, male 87%, BCLC B/C 53%/47%) and 63 TARE HCC patients (66±9 years, male 79%, BCLC B/C 41%/59%) were included based on the following criteria: Child-Pugh class A/B, performance status ≤1, HCC unfit for other effective therapies, no metastases, no previous systemic chemotherapy.Resultsmedian overall survivals of the two groups were comparable, being 14.4 months (95% Confidence Interval: 4.3-24.5) in sorafenib and 13.2 months (95% Confidence Interval: 6.1-20.2) in TARE patients, with 1-, 2- and 3-year survival rates of 52.1%, 29.3% and 14.7% versus 51.8%, 27.8% and 21.6%, respectively. Two TARE patients underwent liver transplantation after successful downstaging. To minimize the impact of confounding factors on survival analysis, propensity model matched 32 patients of each group for median age, tumor gross pathology and the independent prognostic factors (portal vein thrombosis, performance status, Model for End Liver Disease). Even after matching, the median survival did not differ between sorafenib (13.1 months; 95% Confidence Interval: 1.2-25.9) and TARE patients (11.2 months; 95% Confidence Interval: 6.7-15.7), with comparable 1-, 2- and 3-year survival rates.Conclusionsin cirrhotic patients with intermediate-advanced or not-otherwise-treatable HCC, sorafenib and TARE provide similar survivals. Down-staging allowing liver transplantation only occurred after TARE.This article is protected by copyright. All rights reserved.Liver international: official journal of the International Association for the Study of the Liver 04/2014; · 3.87 Impact Factor
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ABSTRACT: To compare the efficacy of different chemotherapeutic agents during conventional transarterial chemoembolization (cTACE) in the treatment of unresectable hepatocellular carcinoma (HCC).World journal of gastroenterology : WJG. 08/2014; 20(31):10960-8.