A phase II study of oxaliplatin in combination with doxorubicin as first-line systemic chemotherapy in patients with inoperable hepatocellular carcinoma

Abstract

Purpose: We designed a phase II trial of the combination with oxaliplatin and doxorubicin for patients with unresectable HCC to evaluate the overall response rate (ORR) and the toxicity.

Methods: Forty patients with inoperable, systemic chemotherapy naive HCC were enrolled. Finally, 32 patients received oxaliplatin (130 mg/m(2)) and doxorubicin (60 mg/m(2)) every 3 weeks.

Results: Eighty-two treatment cycles were administered (median 2 cycles, range 1-6). There was no treatment-related mortality. The ORR was 15.6% (95% CI, 3.3-28.7) with five partial responses. The median overall survival and median overall progression free survival were 31 weeks (95% CI, 22-40 weeks) and 12 weeks (95% CI, 5-19 weeks). Nausea and peripheral neuropathy were most frequent non-hematologic toxicities (nausea, n = 15; peripheral neuropathy, n = 10). The most frequent grade 3-4 hematologic adverse event was neutropenia (14 of 82 cycles) including three cases of febrile neutropenia.

Conclusions: The combination of oxaliplatin and doxorubicin showed modest activity and a tolerable toxicity profile in advanced HCC patients.