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

Abstract

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 %.

Human and Mouse VEGFA-Amplified Hepatocellular Carcinomas Are Highly Sensitive to Sorafenib Treatment

“…The response to sorafenib seems to be variable, and treatment is associated with signifi cant side effects (3)(4)(5)(6)(7)(8). Importantly, there are no clinically applied biomarkers for predicting sorafenib response in HCC ( 10 ).…”

“…Sorafenib is the mainstay of therapy for advanced HCC and the only systemic drug that has shown any survival advantage in HCC so far ( 3,4 ). However, patients' response is modest, and sorafenib treatment is associated with side effects (3)(4)(5)(6)(7)(8). Thus, several studies looked for predictive markers for sorafenib response (9)(10)(11), yet no such biomarkers have entered the clinical setting.…”

Efficiency and Side Effects of Sorafenib Therapy for Advanced Hepatocellular Carcinoma: A Retrospective Study by the Anatolian Society of Medical Oncology

“…Among side effects of any grade, asthenia is seen is 66% of the patients (Brunocilla et al, 2013). Asthenia is usually at grade 1-2 level.…”

Sorafenib: 10 years after the first pivotal trial

“…Brunocilla et al recently reported the results of a prospective study on HRQOL in HCC patients receiving sorafenib under standard clinical care; the aim of the study was to evaluate the incidence of AEs and changes in QoL -by the FACT-Hep tool -during the first 2 months of sorafenib administration. Overall, a reduction in the median FACTHep score of physical well-being was observed at week 1 of treatment (-8.3; range: -60-17.9; p = 0.0003), thus suggesting the need for early medical counseling [132].…”