Siegel AB et al. - In a study to determine the clinical and biologic effects of bevacizumab in unresectable hepatocellular carcinoma (HCC), significant clinical and biologic activity was demonstrated for bevacizumab in nonmetastatic HCC and it achieved the primary study end point. Serious bleeding complications occurred in 11% of pts Methods
Adults with organ-confined HCC, ECOG performance status of 0 to 2, and compensated liver disease were eligible
12 pts received bevacizumab 5 mg/kg and 34 received 10 mg/kg every 2 weeks until disease progression or treatment-limiting toxicity
Primary objective was to determine whether bevacizumab improved the 6-month progression-free survival (PFS) rate from 40% to 60%
Secondary end points included determining the effects of bevacizumab on arterial enhancement and on plasma cytokine levels and the capacity of pts' plasma to support angiogenesis via an in vitro assay
Results
The study included 46 pts, of whom 6 had objective responses, and 65% were progression free at 6 months
Median PFS time was 6.9 months; overall survival rate was 53% at 1 year, 28% at 2 years, and 23% at 3 years
Grade 3 to 4 adverse events included hypertension (15%) and thrombosis; grade 3 or higher hemorrhage occurred in 11% of pts, including 1 fatal variceal bleed
Bevacizumab was associated with significant reductions in tumor enhancement
Functional angiogenic activity was associated with VEGF-A levels in pt plasma
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