Background and importance Hepatocarcinoma (HCC) is the leading cause of mortality in cirrhotic patients. Sorafenib has been shown to increase survival and is considered firstline therapy for patients with advanced unresectable HCC who are unsuitable for locoregional therapy and whose liver function is adequate to tolerate therapy (Child Pugh A/B).
Aim and objectives The aim of this study was to evaluate the effectiveness and safety of sorafenib in adults with metastatic HCC in our clinical practice, based on overall survival (OS) and report of adverse events.
Material and methods An observational, retrospective, descriptive study was conducted between January 2018 and October 2020. Age, sex, Barcelona Clinic Liver Cancer (BCLC) staging, adverse events (AEs), need for dose reduction or discontinuation, and time to progression or death were collected from our electronic records. None of the patients had received previous systemic therapy. The analysis was performed using R 4.0.3.
Results 47 patients with metastatic HCC were treated with sorafenib. Patient characteristics are shown in table 1.
Median overall survival (mOS) was 17.9 months (range 0.5–24.0; 95% CI 15.5 to not reached). The main AEs observed were: fatigue (42.5%), hand–foot skin reactions (42.5%), anorexia (40.4%), diarrhoea (38.3%), hypertension (14.9%), abdominal pain (14.9%), digestive bleeding (12.7%) and pruritus (10.6%). The most common reasons for treatment discontinuation were AEs (14 patients) and progression (22 patients). The rate of discontinuation due to AEs was 29.8%. 34 patients (72.3%) required dose reduction.
Conclusion and relevance In our setting, mOS was superior to that reported in the pivotal clinical trial even though baseline characteristics were similar. Some of the AEs were more frequent, such as fatigue, hand–foot skin reactions, hypertension and anorexia, although the rate of discontinuation due to AEs was lower than reported in the SHARP trial.
References and/or acknowledgements
Llovet JM, Ricci S, Mazzaferro V, et al. SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378–90. doi: 10.1056/NEJMoa0708857. PMID: 18650514.
Conflict of interest No conflict of interest
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