Clinical

Bevacizumab shows significant activity in liver cancer

Last Updated: 2008-07-09 10:22:05 -0400 (Reuters Health)

By Martha Kerr

NEW YORK (Reuters Health) - Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), may be an option in nonmetastatic unresectable hepatocellular carcinoma (HCC), according to the results of a phase 2 study reported in the July issue of the Journal of Clinical Oncology.

The multicenter study, led by Dr. Abby B. Siegel of Columbia University College of Physicians and Surgeons in New York, involved 46 patients with HCC and compensated liver disease. Twelve patients received bevacizumab 5 mg/kg and 34 patients received 10 mg/kg every two weeks until disease progression or treatment-limiting toxicity occurred.

Six patients (13%) had objective responses, and 65% of patients were progression-free at 6 months.

Overall survival was 53% at 1 year, 28% at 2 years and 23% at 3 years.

Grade 3-4 adverse events included hypertension in 15% and thrombosis in 6%. Grade 3 or higher hemorrhage occurred in 11%, including one fatal variceal bleed.

"After we amended the protocol to require endoscopy for at-risk patients, we had no further variceal bleeds," Dr. Siegel noted during an interview with Reuters Health. "We subsequently had two more serious bleeds (4%), which is within the same range as bleeding rates seen in trials of bevacizumab in lung cancer."

Her group is planning several trials using bevacizumab "with other targeted and chemotherapeutic agents in hepatocellular carcinoma both at Columbia and across the country," Dr. Siegel noted.

"Several studies are evaluating whether moving bevacizumab 'up front' to the adjuvant setting may be helpful," she added. "This is a mechanistic question, because nobody knows whether bevacizumab will be able to help eradicate minimal residual disease, or whether it works best when there is existing measurable disease."

J Clin Oncol 2008;26:2992-2998.