AI Article Synopsis

  • Hepatocellular carcinoma, a leading cause of cancer deaths, is primarily treated with sorafenib, and this study evaluates its effectiveness and toxicity in real-world settings.
  • A total of 36 patients were studied, revealing an average overall survival of 8.5 months and common adverse effects including constitutional, gastrointestinal, and dermatological issues.
  • The results indicate that while survival outcomes in clinical practice align with clinical trials, the toxicity profile showed unexpected variations.

Article Abstract

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.

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Source
http://dx.doi.org/10.4103/jcrt.jcrt_308_21DOI Listing

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