Effect of early adverse events resulting in sorafenib dose adjustments on survival outcomes of advanced hepatocellular carcinoma patients

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Abstract

Background: Sorafenib is a current first-line treatment option for advanced hepatocellular carcinoma (HCC). This study aimed to evaluate the impact of early adverse events (AEs) requiring sorafenib dose adjustment on survival outcomes of patients with advanced HCC. Methods: The study was a secondary analysis of the phase III clinical trial NCT00699374. A landmark Cox proportional hazard analysis was used to evaluate the association between early AEs requiring sorafenib dose adjustment with survival outcomes. The primary outcome was overall survival (OS) with progression-free survival (PFS) as secondary. Results: AEs requiring sorafenib dose adjustment within the first 28 days of therapy were significantly associated with OS (HR [95% CI]; dose interruption = 0.9 [0.7–1.2]; dose reduction = 0.6 [0.5–0.9]; discontinuation = 1.7 [0.9–3.4]; P = 0.005). No statistically significant association with PFS was identified (P = 0.148). Conclusion: Sorafenib dose interruptions and reduction due to AEs did not compromise the survival outcomes of patient with advanced HCC. Patients who required a sorafenib dose reduction were observed to have more favourable OS compared to those who did not experience an AE which required a dose adjustment.

Original languageEnglish
Pages (from-to)1672-1677
Number of pages6
JournalInternational Journal of Clinical Oncology
Volume25
Issue number9
Early online date1 Jan 2020
DOIs
Publication statusPublished - 1 Sep 2020

Keywords

  • Adverse events
  • Dose adjustment
  • Prediction
  • Response
  • Sorafenib
  • Survival

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