Abstract
4169 Background: Prolonged survival for patients (pts) with unresectable hepatocellular cancer (HCC) has remained elusive, with median overall survival consistently less than 6 months. Oxaliplatin has recently demonstrated promise activity in HCC. The aim of this study is to determine the response rate, survival, time to progression and toxicity in pts with poor prognosis HCC treated with single agent oxaliplatin. Methods: pts were required to have measurable recurrent, metastatic or unresectable HCC, exposed to no more than 2 prior chemotherapy regimens. Prior radiation, chemoembolization, and/or alcohol injections were permitted. Karnofsky performance of 70% or above and adequate organ and hematologic function were required. All patients (pts) received treatment with oxaliplatin 100 mg/m2 on day 1 and 15 as a two hour IV infusion and were pretreated with antiemetics. Treatment was repeated every 28 days. Results: Fifteen pts have been enrolled and fourteen eligible patients are evaluable for response; there are five Caucasians, one African-American, and eight Asians. 12 are males and 2 females. Median age at study entry was 62 years, (range 34–80). Karnofsky performance status was 70/80/90/100% in 1/1/3/9 pts; thirteen pts had previous surgery. Among the 14 evaluable pts, one PR was deserved and six had stable disease. The pt experiencing a PR normalized his AFP; has only a small residual liver mass remaining; and is free of progression at nine months. Median time to progression or death on this study is 2.7 months (mo); the overall median survival is 10 mo. Six mo survival is 51% (95% CI 28%–94%) and 6 mo event-free survival is 29% (95% CI 11%–72%). Five pts died from progressive disease, and one pt died of pneumonia. Grade III toxicities included neutropenia (1), anemia (1), fatigue (2), transaminitis (2), hyperbilirubinemia (1), elevated alkaline phosphatase (1), hyperglycemia (1), hyponatremia (1), and neuropathy (1). Conclusion: Oxaliplatin as a single agent has demonstrated potential activity in the treatment of poor prognosis HCC; accrual to this study will continue past the interim analysis. (Supported by CA62505 and N01-CM17101) No significant financial relationships to disclose.
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