Korean J Med.
2005 Feb;68(2):203-210.
A phase II study of doxorubicin and cisplatin combination chemotherapy for advanced hepatocellular carcinoma
- Affiliations
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- 1Department of Internal Medicine, Sanggye paik hospital, Inje University College of Medicine, Seoul, Korea. sungrkim@sanggyepaik.ac.kr
- 2Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
- 3Department of Internal Medicine, College of Medicine, Ewha Womens University, Seoul Korea.
- 4Department of Internal Medicine, Gachon Medical School, Incheon, Korea.
- 5Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
- 6Department of Internal Medicine, Seoul Adventist Hospital, Seoul, Korea.
Abstract
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BACKGROUND: There still is no standard treatment for the patients with advanced hepatocellular carcinoma. Both doxorubicin and cisplatin have modest activity with the response rates less than 20%, but have synergistic effect. This prospective phase II trial was performed to determine the efficacy and toxicity of doxorubicin and cisplatin combination chemotherapy for patients with advanced hepatocellular carcinoma.
METHODS
Patients with advanced hepatocellular carcinoma were entered into this study. Eligibility criteria are described below: histologically proven HCC or mass lesion on radiogram with liver cirrhosis and serum a-fetoprotein level >or=400 ng/mL, UICC stage IV, recurred after any loco-regional treatment, no prior cytotoxic chemotherapy, measurable disease, ECOG performance scale 0~2, age 18~65 year old, adequate bone marrow, cardiac and renal function, total bilirubin
Between January 1997 and August 2002, 23 patients were enrolled into this study. Among them, 21 patients were evaluable for response. 6 patients (28.6%, 95% CI: 8.9~48.1%) had an objective response. The median time to progression was 162 days. The median duration of survival was 144 days and 794 days in patients without response and with response, respectively. This difference was statistically significant. Four patients lived longer than a year. Grade 3 or 4 neutropenia and thrombocytopenia were observed in 26.1% and 24.9% of all the cycles, respectively.
CONCLUSION
Doxorubicin and cisplatin combination chemotherapy may be effective and may have survival benefit especially in the responders with acceptable toxicities.
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