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Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma and Child-Pugh A or B cirrhosis

  • Authors:
    • Alessandro Federico
    • Michele Orditura
    • Gaetano Cotticelli
    • Ilario De Sio
    • Marco Romano
    • Antonietta Gerarda Gravina
    • Marcello Dallio
    • Alessio Fabozzi
    • Fortunato Ciardiello
    • Carmela Loguercio
    • Ferdinando De Vita

  • View Affiliations

  • Published online on: February 12, 2015     https://doi.org/10.3892/ol.2015.2960
  • Pages: 1628-1632
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Abstract

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.
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April-2015
Volume 9 Issue 4

Print ISSN: 1792-1074
Online ISSN:1792-1082

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  • Impact Factor: 2.5
  • Ranked Oncology
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  • CiteScore: 5.7
  • CiteScore Rank: Q2: #139/404 Oncology
  • Source Normalized Impact per Paper (SNIP): 0.574
  • SCImago Journal Rank (SJR): 0.644
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Spandidos Publications style
Federico A, Orditura M, Cotticelli G, De Sio I, Romano M, Gravina AG, Dallio M, Fabozzi A, Ciardiello F, Loguercio C, Loguercio C, et al: Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma and Child-Pugh A or B cirrhosis. Oncol Lett 9: 1628-1632, 2015.
APA
Federico, A., Orditura, M., Cotticelli, G., De Sio, I., Romano, M., Gravina, A.G. ... De Vita, F. (2015). Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma and Child-Pugh A or B cirrhosis. Oncology Letters, 9, 1628-1632. https://doi.org/10.3892/ol.2015.2960
MLA
Federico, A., Orditura, M., Cotticelli, G., De Sio, I., Romano, M., Gravina, A. G., Dallio, M., Fabozzi, A., Ciardiello, F., Loguercio, C., De Vita, F."Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma and Child-Pugh A or B cirrhosis". Oncology Letters 9.4 (2015): 1628-1632.
Chicago
Federico, A., Orditura, M., Cotticelli, G., De Sio, I., Romano, M., Gravina, A. G., Dallio, M., Fabozzi, A., Ciardiello, F., Loguercio, C., De Vita, F."Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma and Child-Pugh A or B cirrhosis". Oncology Letters 9, no. 4 (2015): 1628-1632. https://doi.org/10.3892/ol.2015.2960