A new chemoimmunotherapy regimen (OXAFI) for advanced hepatocellular carcinoma.

Background: Chemotherapeutic treatment options for advanced unresectable and/or metastatic hepatocellular carcinoma (HCC) are limited. Currently available treatments are associated with low response rates and little evidence of improved survival, so we evaluated a new chemoimmunotherapy regimen.

Methods: Seven patients with unresectable and/or metastatic HCC were treated with intravenous oxaliplatin (30mg/m2) and doxorubicin (20mg/m2) given on days 1, 8 and 15 in a 28-day cycle, a daily continuous infusion of fluorouracil (200mg/m2) and subcutaneous interferon alfa-2b 5 MU administered thrice weekly (OXAFI). Treatment was administered to a maximum of six cycles. Data on the response to treatment, toxicity, surgical procedures and survival outcome was reviewed.

Results: The best response was three partial responses, three stable disease responses and one progressive disease response. Two patients underwent interval hepatic resection, and histological analysis in one patient showed a complete pathological response. Another patient underwent a liver transplant after four cycles of treatment. These three patients were alive with no evidence of disease at 23, 21 and 18 months follow-up, respectively. At a median follow-up of 14 months (range 2-23 months), one patient died 2 months after diagnosis due to progressive disease, while all six other patients were alive. Neutropenia was the predominant toxicity, but there were no episodes of febrile neutropenia, hospital admissions or deaths. There were no cases of hepatitis B virus re-activation.

Conclusions: OXAFI shows activity in HCC and has manageable toxicity. Complete pathological remission is possible with this regimen.