Sorafenib in hepatocellular carcinoma: prospective study on adverse events, quality of life, and related feasibility under daily conditions

Med Oncol. 2013 Mar;30(1):345. doi: 10.1007/s12032-012-0345-2. Epub 2012 Dec 22.


Sorafenib is an oral multikinase inhibitor approved for the treatment of hepatocellular carcinoma (HCC). In two randomized trials, sorafenib was reported to be safe without a significant impact on quality of life (QoL). The aim of this study was to evaluate the occurrence of adverse events, QoL variations, and treatment discontinuations in HCC patients treated with sorafenib. Between November 2009 and March 2011, all patients evaluated as suitable for sorafenib treatment were enrolled. Every patient was invited to complete the Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire before starting therapy, at week 1, and at months 1 and 2. QoL scores were analyzed by the Wilcoxon matched-pairs test. Side effects were classified according to the Common Terminology Criteria for Adverse Events v.3.0. Thirty-six patients were enrolled. The cumulative incidence of therapy discontinuation for drug-related adverse events was 33 % (95 % confidence interval, 20.2-49.7). The most common adverse event was fatigue (66.7 %). The worst score decrease was detected from baseline to week 1 in physical well-being, with a median reduction of -8.3 (range -60.1 to 17.9; P = 0.0003). Treatment withdrawal from adverse events was higher than previously reported, significant QoL decrease occurred, and estimated feasibility was 66.7 %.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / adverse effects*
  • Carcinoma, Hepatocellular / drug therapy*
  • Female
  • Humans
  • Liver Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Niacinamide / adverse effects
  • Niacinamide / analogs & derivatives*
  • Phenylurea Compounds / adverse effects*
  • Quality of Life*
  • Sorafenib
  • Surveys and Questionnaires


  • Antineoplastic Agents
  • Phenylurea Compounds
  • Niacinamide
  • Sorafenib