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Phase II study with a combination of epirubicin, cisplatin, UFT, and leucovorin in advanced hepatocellular carcinoma

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Abstract

Purpose: Hepatocellular carcinoma (HCC) is one of the most common malignancies worldwide. Because HCC usually presents as an advanced disease and occurs in the background of liver cirrhosis, most patients are not suitable for treatment with curative intent, thus effective systemic chemotherapy is required. However, the outcome of systemic chemotherapy has been disappointing in advanced HCC. This study was conducted to test the efficacy and toxicity of the combined regimen of epirubicin, cisplatin, and UFT moderated by leucovorin in advanced or recurrent HCC. Patients and methods: All 53 patients received epirubicin (50 mg/m2 i.v.) on day 1 and cisplatin (60 mg/m2 i.v.) after epirubicin administration. Oral UFT 400–600 mg/day, determined by body surface area, and leucovorin 75 mg/day were administered for 21 consecutive days, followed by a 7-day drug free interval. Results: Nine had a partial response, representing 16.9% of response rate (95% confidence interval rate; 7.0–26.8%) with median response duration of 17.1 weeks (95% CI; 5.0–29.3 weeks, range; 7.1–51.7 weeks). Fifteen patients had stable disease and the disease progressed in 26 patients. The median overall survival for the patients was 24.6 weeks (95% CI; 17.3–31.9 weeks, range; 3.0–131.3 weeks). The main toxicities were hematologic toxicities including neutropenia, which reached grade 3/4 in 17 patients (38.5%), and grade 3 or 4 thrombocytopenia in five patients (9.4%). Conclusion: The combination of epirubicin, cisplatin, and UFT moderated by leucovorin showed modest anti-tumor activity with relatively tolerable toxicities. However, a randomized phase III trial based on this regimen is warranted to clarify its survival benefit in patients with advanced HCC.

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Acknowledgements

This work was supported by a grant of the Brain Korea 21 project in 2002 and the Korea Health 21 R & D Project, Ministry of Health & Welfare, Republic of Korea (01-PG3-PG6-01GN07-0004).

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  1. Division of Hematology/Oncology Department of Internal Medicine, Korea University Medical Center, 126-1, Anam-dong 5-ga, Sungbuk-ku, Seoul, 136-705, Korea

    Seok Jin Kim, Hee Yun Seo, Jong Gwon Choi, Hye Ryoung Sul, Hwa Jung Sung, Kyong Hwa Park, In Keun Choi, Sang Cheul Oh, So Young Yoon, Jae Hong Seo, Chul Won Choi, Byung Soo Kim, Sang Won Shin, Yeul Hong Kim & Jun Suk Kim

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  1. Seok Jin Kim
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Correspondence to Sang Won Shin.

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Contract grant sponsor: Brain Korea 21 Project in 2002 and Korea Health 21 R &D Project, Ministry of Health & Welfare, Republic of Korea: 01-PG3-PG6-01GN07-0004.

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Kim, S.J., Seo, H.Y., Choi, J.G. et al. Phase II study with a combination of epirubicin, cisplatin, UFT, and leucovorin in advanced hepatocellular carcinoma. Cancer Chemother Pharmacol 57, 436–442 (2006). https://doi.org/10.1007/s00280-005-0067-7

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  • DOI: https://doi.org/10.1007/s00280-005-0067-7

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