Phase II study of bevacizumab (A) plus capecitabine (X) in patients (pts) with advanced/metastatic hepatocellular carcinoma (HCC): Final report

4603 Background: Asian pts (∼60–80% HBV etiology) with advanced or metastatic HCC have a dismal prognosis, with a median survival (OS) ∼2–4 months with best supportive care (BSC). A, an anti-VEGF antibody targeting tumor angiogenesis, induced objective tumor response in pts with unresectable HCC [Schwartz et al. ASCO 2006;abs 4144]. The oral fluoropyrimidine X was safe and moderately active for pts with advanced HCC in a retrospective study [Patt et al. Cancer 2004;101:578]. We evaluated the efficacy and toxicity of A+X in pts with advanced/metastatic HCC. Methods: Pts with histologically-proven or clinically diagnosed HCC who could not be treated by surgery or other loco-regional therapies received A 7.5 mg/kg iv d1 and X 825 mg/m2 bid orally d1–14, q3w. Tumor assessment was performed q6w. Primary endpoint was overall response rate (ORR) by RECIST. Results: Between May05 and Aug06, 45 Asian pts were enrolled. Baseline characteristics: male/female 40/5; median age 54 (range 23–75); Child Pugh A; TNM stage...