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Hepatic arterial infusion (HAI) of oxaliplatin in advanced hepatocellular cancer (HCC): A phase I study.

14010 Background: We performed this phase I study is to evaluate the feasibility and determine the Maximally Tolerated Dose of HAI-oxaliplatin given every 3 weeks in advanced HCC.


METHODS
Patients (pts) with unresectable or recurrent HCC were eligible for therapy on this protocol. HAI-oxaliplatin was administered over 2 hours via a percutaneously placed hepatic arterial catheter or a surgically inserted hepatic arterial infusion pump. Therapy was continued until disease progression or excessive toxicity not amenable to appropriate modifications. Restaging was performed after every 2 cycles. Dose escalation levels for HAI-oxaliplatin are 90 mg/m2, 110 mg/m2, 130 mg/m2 and 150 mg/m2 given every 3 weeks.


RESULTS
A total of 16 patients have been enrolled and toxicity data are available for all patients. Median age was 61 yrs (range 47-84 yrs), there were 15 men and 1 woman. The stage distribution is: stage II-3 pts, stage III- 7 pts, stage IV- 6 pts. Prior therapies including chemoembolization (CE) in 3 pts, radiofrequency ablation (RFA) in 3 pts, and both RFA and CE in 1 pt. A total of 37 cycles (range 1-3) have been delivered. Levels 1 and 3 had to be expanded to 6 pts each due to major toxicity in 2 pts at each level. Level 2 was expanded as 1 pt was non-compliant. Major toxicities are shown below. One patient developed embolic bowel ischemia after his HAI procedure. There was one episode each of duodenal perforation and duodenal ulceration. Traditional grade 3/4 hematologic and gastrointestinal toxicities were infrequent. Among 13 pts receiving at least 2 cycles, 3 pts had partial responses (PR) and 4 pts had stable disease (SD). Greater than 50% reduction in AFP was seen in the 3 pts with PR and 2 pts with SD.


CONCLUSIONS
HAI-oxaliplatin is feasible, well tolerable, and demonstrates activity in this population of pts with advanced HCC. [Table: see text] No significant financial relationships to disclose.