Phase I/II trial of bortezomib in patients with unresectable hepatocellular carcinoma (HCC)

4089 Background: Bortezomib (Velcade) is a potent and reversible inhibitor of the proteasome and causes apoptotic cell death in a dose dependent matter in the human malignant hepatoma cell line HepG2. Available chemotherapeutic agents offer limited benefit to patients (pts) with HCC. The primary objective of this phase I/II study was to assess the dose limiting (DLT) and maximum tolerated dose (MTD) of bortezomib given as an iv bolus on days 1, 4, 8 and 11 of a 3 week cycle. Secondary objectives included response assessment, safety and pharmacodynamics of bortezomib. Methods: Eligibility criteria included histologically documented or diagnostic evidence of diagnosis of hepatocellular carcinoma and measurable surgically unresectable disease. So far 18 pts have been accrued to the study (17 male/1 female; Child-Pugh score A/B - 13/5 pts), median age 62 (range 33–82), a median KPS 80% (range 70–100). A prior history of hepatitis B and/or C or alcoholic cirrhosis was present in 39% and 17%, respectively.The D...