Abstract
346 Background: Several studies have demonstrated the effectiveness of combining a pyrimidine fluoride drug with interferon. Therefore, this study examined the dose of capecitabine in combination with peginterferon alfa-2a (PEG-IFN α-2a) (Phase I part) and evaluated its safety and efficacy in sorafenib-refractory advanced hepatocellular carcinoma patients (Phase II part). Methods: Capecitabine was administrated daily on days 1–14 and PEG-IFN α-2a was given on days 1, 8, and 15. The cycles were repeated every 21 days. Patients were scheduled to received capecitabine (mg/m2/day) and PEG-IFN α-2a (μg/week) at one of three dose levels in phase I: 1200/90, 1600/90, and 2000/90 (levels 1–3, respectively). Results: Thirty patients were enrolled. The recommended dose was level 3. Of the 24 patients given the drug at the recommended dosage, two (8%) showed partial responses, nine (38%) had stable disease, ten (42%) had progressive disease, and three (13%) were not evaluated. The median time to progression was 3.0 months. The most common toxicities were decreased white blood cell, neutrophil, and platelet counts, palmar-plantar erythrodysesthesia syndrome, and fatigue. Dose modification was required in ten (42%) patients. Four (17%) patients discontinued treatment because of severe adverse events. Conclusions: Capecitabine at 2000 mg/m2/day combined with PEG-IFN α-2a 90 μg/week had moderate, but manageable toxicity. Further investigation is needed to refine the efficacy. Clinical trial information: UMIN000005697.
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