A phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis

Abstract

15556 Background: The objective of this study was to evaluate the antitumor, survival, and adverse effects of hepatic arterial infusion chemotherapy using cisplatin in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). Methods: Twenty-five patients with advanced HCC with PVTT in the main or first branch who had no prior chemotherapy, with measurable lesions, adequate liver and renal function, and adequate bone marrow reserve, were enrolled. A dose of 65 mg/m2 cisplatin was administered from the proper hepatic artery. Treatment was repeated every 4 to 6 weeks for a maximum of six courses, if there was no evidence of tumor progression or unacceptable toxicity. The primary end-point was the tumor response to this regimen, and the secondary end-point was toxicity, survival and progression-free survival. Results: The median number of treatments was 3 (range: 1–6). Among the 25 enrolled patients, 1 (4%) achieved a complete response, 6 (24%) had a partial response, and the response rate was 28% (95% confidence interval: 12–49%). The serum AFP and PIVKA II levels were reduced by more than 50% in 44% and 68% of the patients who had shown a pretreatment level of 100 U/ml or greater and 100 mAU/ml or greater, respectively. The median survival time, 1-year survival rate and median progression-free survival for the patients as a whole were 10.3 months, 40.3%, and 4.4 months, respectively. The main grade 3 and 4 non-hematological toxicities of this treatment were elevation of the aspartate aminotransferase (44%) and alanine aminotransferase (24%) levels, but no grade 4 hematological toxicity was seen. These toxicities were generally brief and well tolerated. Conclusions: Hepatic arterial infusion chemotherapy with cisplatin has moderate activity with mild toxicity in HCC patients with PVTT, and this is expected to be confirmed in a prospective randomized controlled study. No significant financial relationships to disclose.