PMID- 25789012 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220331 IS - 1792-1074 (Print) IS - 1792-1082 (Electronic) IS - 1792-1074 (Linking) VI - 9 IP - 4 DP - 2015 Apr TI - Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma and Child-Pugh A or B cirrhosis. PG - 1628-1632 AB - Sorafenib confers a survival benefit for patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh (CP) A liver cirrhosis. At present, limited data exists with regard to the safety and efficacy of sorafenib in treating CP-B HCC patients. The present study describes the use of sorafenib in patients with HCC and CP-A or -B cirrhosis. Clinical data was obtained from patients with HCC who were treated with sorafenib at the Department of Clinical and Experimental Medicine, Second University of Naples (Naples, Italy) and were analyzed retrospectively in terms of tumor response, tolerance and survival. The treatment outcomes were analyzed according to the respective CP status. The adverse events (AEs) were graded using the Common Terminology Criteria for Adverse Events, version 3.0, and the tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors, version 1.2. In total, 26 patients received sorafenib at 400 mg twice daily. The median age was 69 years (range, 58-81 years) and the ratio of males to females was 18:8. Overall, 15 patients were infected with the hepatitis C virus (HCV), eight with HBV and three were co-infected with HCV/HBV. In total, 20 (77%) patients presented with an underlying CP-A (CP-A5 and CP-A6) cirrhosis and six (23%) with CP-B (CP-B7). Previous treatments included surgery (n=4), transarterial chemoembolization (n=5) and percutaneous ethanol injection or radiofrequency interstitial thermal ablation (n=12). A partial response was observed in three patients (12%), a stable disease lasting at least 12 weeks in 13 patients (50%) and a progression of disease in 10 patients (38%). The median overall survival (OS) time was 7.4 months [95% confidence interval (CI), 3.2-11.6) and the median progression-free survival (PFS) time was 3.7 months (95% CI, 1.9-5.5). The median OS and PFS times differed between patients with CP-A and CP-B, with a trend (P=0.06) toward a worse outcome in those with CP-B, although this was not statistically significant. The CP-A and CP-B groups experienced a similar incidence in the majority of AEs. A reduction in dose was required in 59% of the patients. The CP-A5, CP-A6 and CP-B7 patients tolerated sorafenib similarly, and derived comparable clinical and survival benefits. FAU - Federico, Alessandro AU - Federico A AD - Division of Hepatogastroenterology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Orditura, Michele AU - Orditura M AD - Division of Oncology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Cotticelli, Gaetano AU - Cotticelli G AD - Division of Hepatogastroenterology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - DE Sio, Ilario AU - DE Sio I AD - Division of Hepatogastroenterology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Romano, Marco AU - Romano M AD - Division of Hepatogastroenterology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Gravina, Antonietta Gerarda AU - Gravina AG AD - Division of Hepatogastroenterology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Dallio, Marcello AU - Dallio M AD - Division of Hepatogastroenterology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Fabozzi, Alessio AU - Fabozzi A AD - Division of Oncology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Ciardiello, Fortunato AU - Ciardiello F AD - Division of Oncology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - Loguercio, Carmela AU - Loguercio C AD - Division of Hepatogastroenterology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. FAU - DE Vita, Ferdinando AU - DE Vita F AD - Division of Oncology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples 80131, Italy. LA - eng PT - Journal Article DEP - 20150212 PL - Greece TA - Oncol Lett JT - Oncology letters JID - 101531236 PMC - PMC4356395 OTO - NOTNLM OT - hepatocellular carcinoma OT - sorafenib OT - systemic treatment OT - targeted therapy EDAT- 2015/03/20 06:00 MHDA- 2015/03/20 06:01 PMCR- 2015/02/12 CRDT- 2015/03/20 06:00 PHST- 2014/04/08 00:00 [received] PHST- 2014/12/12 00:00 [accepted] PHST- 2015/03/20 06:00 [entrez] PHST- 2015/03/20 06:00 [pubmed] PHST- 2015/03/20 06:01 [medline] PHST- 2015/02/12 00:00 [pmc-release] AID - ol-09-04-1628 [pii] AID - 10.3892/ol.2015.2960 [doi] PST - ppublish SO - Oncol Lett. 2015 Apr;9(4):1628-1632. doi: 10.3892/ol.2015.2960. Epub 2015 Feb 12.