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Abstract Details
Effect of Early Adverse Events Resulting in Sorafenib Dose Adjustments on Survival Outcomes of Advanced Hepatocellular Carcinoma Patients
Int J Clin Oncol. 2020 May 16.doi: 10.1007/s10147-020-01698-7. Online ahead of print.
Warit Ruanglertboon1, Michael J Sorich2, Andrew Rowland2, Ashley M Hopkins2
Author information
1Department of Clinical Pharmacology, College of Medicine and Public Health, Flinders University, Adelaide, Australia. warit.ruanglertboon@flinders.edu.au.
2Department of Clinical Pharmacology, College of Medicine and Public Health, Flinders University, Adelaide, Australia.
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.