Background. We evaluated the anti-tumor efficacy and toxicity of 5-fluorouracil (5-FU), mitoxantrone, and cisplatin (FMP) in patients with advanced hepatocellular carcinoma (HCC), and conducted an analysis of the prognostic factors for response to such therapy and patient survival. Methods. Sixty-three patients suffering from unresectable and non-embolizable HCC and who had objectively measurable tumors, adequate liver and renal function, and adequate bone-marrow reserve were enrolled in this study. The therapeutic regimen consisted of cisplatin 80mg/m2 and mitoxantrone 6mg/m2 intravenously on day 1, and 5-FU 450mg/m2 per day continuous infusion for a period of 5 days. Univariate and multivariate analyses of patient and disease characteristics were used to identify factors predicting patient response and survival. Results. The objective response was 23.8% (95% confidence interval [CI], 13.0-34.6%). The median survival for all 63 patients was 4.9 months (95% CI, 3.2-6.6 months). The median time to progression was 2.5 months (95% CI, 1.7-3.3 months). Multi-variate analysis identified only performance status (P = 0.050) and liver tumor size (P = 0.012) as being significantly related to patient objective response. Independent variables associated with a better patient survival included: the absence of ascites (P = 0.003), a lower total bilirubin level (P = 0.026), and the patient being a positive chemotherapy responder (P = 0.009). Conclusions. The response rate to an FMP regimen was still unsatisfactory, although a specific subgroup of patients (good performance status, smaller liver tumor mass, good liver reserve, and distant metastasis) may benefit from this regimen.
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