Systemic chemotherapy with capecitabine, doxorubicin and cisplatin for metastatic hepatocellular carcinoma

Abstract

4177 Background: Metastatic hepatocellular carcinoma (HCC) is associated with a very poor prognosis. Although numerous chemotherapeutic agents have been tested, the role of systemic chemotherapy for HCC has not been clarified. New therapeutic strategies are thus needed to improve outcomes, and we designed this study with new effective drug combination. Methods: Patients with histologically-confirmed, metastatic HCC received a combination chemotherapy with doxorubicin 50 mg/m2, cisplatin 60 mg/m2 on day 1, plus capecitabine 2,000 mg/m2/day as an intermittent regimen of 2 weeks of treatment followed by a 1-week rest. Treatment was repeated every 3 weeks. Results: Of 27 patients accrued, 2 were ineligible or never received protocol therapy. The median age was 49 years (range, 32–64) and 18 patients were hepatitis B virus seropositive. Child-Pugh grade was A in all patients and 3 had ECOG performance status of 2. The objective response rate was 26% (95% CI, 9–42) with 5 stable diseases. Median survival time was 11.6 months (95% CI, 2.2–21.0) and the median time to progression was 3.7 months (95% CI, 2.0–5.5). Of 25 evaluable patients, 33% showed more than 50% decrease in serum alpha-fetoprotein level from their baseline. In total, 90 chemotherapy cycles were given, with a median of 3 cycles per patient (range, 0–6). The chemotherapy was generally well tolerated with one treatment-related death. Conclusions: Combination chemotherapy with capecitabine, doxorubicin and cisplatin in patients with metastatic HCC showed significant antitumor activity with tolerable adverse effects. Further studies of this combination should be considered. No significant financial relationships to disclose.