Real-world evidence of sorafenib for the treatment of hepatocellular carcinoma: A single-center study.

CONTEXT

Hepatocellular carcinoma is the third leading cause of cancer death. Currently, sorafenib is the treatment of choice in advanced hepatocarcinoma.

AIMS

Assessing the effectiveness and toxicity of sorafenib in real-word clinical practice in patients with hepatocarcinoma.

SETTINGS AND DESIGN

Single-centered observational retrospective study.

METHODS AND MATERIAL

We included patients with hepatocarcinoma who began treatment with sorafenib between 2008 and 2018. We evaluated overall survival, time to progression, and response using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 5. 2020.

STATISTICAL ANALYSIS USED

Kaplan-Meier curves and the log-rank test were used to determine the survival time and estimate factors associated with these events. Data were analyzed with SPSS 19.0 software.

RESULTS

We included 36 patients (88.9% male) with an average age of 64 ± 3.4 years. The tumor stage was advanced (C) in 21 patients (61.8%). We obtained a median overall survival of 8.5 months (IQR 3.14-18.9) and a time to progression of 4.5 months (IQR 2.4-8.8). The main degree of response was progression in 19 patients (36.1%), followed by stable disease in 13 (52.8%). The most commonly reported adverse reactions were: constitutional (83.3%), gastrointestinal (55%) and dermatological symptoms (50.0%). The development of grades 3 or 4 toxicity was not associated with increased overall survival (P = 0.719).

CONCLUSIONS

The findings of the survival analysis obtained in real practice are similar to those obtained in pivotal clinical trials. Adverse reactions were different from those expected.