Worns, M.A. et al. (2009) Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma in consideration of concimitant stage of liver cirrhosis. Journal of Clinical Gastroenterology, 43(5), pp. 489-495.
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Abstract
<p><b>GOALS AND BACKGROUND:</b> The multikinase inhibitor sorafenib provides survival benefit for patients with advanced hepatocellular carcinoma (HCC) and liver cirrhosis (LCI) Child-Pugh A. We report our experiences with sorafenib in advanced HCC, particularly in patients with LCI Child-Pugh B/C, where only limited data are available in regard to safety and efficacy of sorafenib.</p> <p><b>METHODS:</b> Thirty-four patients with advanced HCC were treated with sorafenib regardless of liver function and prior anticancer therapy. Adverse events (AEs) were graded using Common Toxicity Criteria version 3.0, tumor response was assessed according to Response Evaluation Criteria in Solid Tumors.</p> <p><b>RESULTS:</b> Fifteen patients presented without LCI or with LCI Child- Pugh A, 15/4 patients had LCI Child-Pugh B/C. Barcelona Clinic Liver Cancer stage was B/C/D in 4/22/8 patients. During treatment period (median 2.2 mo), therapy was discontinued in 61.8% of patients due to tumor progression (32.3%), death (17.6%), AEs (8.8%), or noncompliance (2.9%). Most common grade 3/4 AEs included liver dysfunction (23.5%), diarrhea (14.7%), increased lipase (8.8%), fatigue (8.8%), and hand-foot skin reaction (5.9%). Worsening liver dysfunction/failure was more frequent (P=0.036) in patients with LCI Child-Pugh B/C compared with patients with maintained liver function (no LCI/LCI Child-Pugh A). Median overall survival was 7.2 months for patients with maintained liver function versus 3.3/3.4 months for patients with LCI Child-Pugh B/C.M</p> <p><b>CONCLUSIONS:</b> These data do not support the use of sorafenib in patients with LCI Child-Pugh C, and patients with LCI Child-Pugh B should be treated with caution until larger trials provide more safety data and a clinically relevant survival benefit under sorafenib therapy.</p>
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Messow, Dr Martina |
| Authors: | Worns, M.A., Weinmann, A., Pfingst, K., Schulte-Sasse, C., Messow, C., Schulze-Bergkamen, H., Teufel, A., Schuchmann, M., Kanzler, S., Duber, C., Otto, G., and Galle, P.R. |
| Subjects: | R Medicine > R Medicine (General) |
| College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre ?? 20206000 ?? |
| Journal Name: | Journal of Clinical Gastroenterology |
| Publisher: | Lippincott Williams & Wilkins |
| ISSN: | 0192-0790 |
| ISSN (Online): | 1539-2031 |
| Published Online: | 01 January 2009 |
| Related URLs: |
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