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Japanese Journal of Clinical Oncology 2005 35(1):13-17; doi:10.1093/jjco/hyi009
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© 2005 Foundation for Promotion of Cancer Research

A Phase II Study of Epirubicin, Cisplatin and Uracil–Tegafur for Advanced Gastric Carcinoma

In Sook Woo, Do Ho Moon, Byoung Young Shim, Myung Ah Lee, Jae Ho Byun, Kee Won Kim, Jin-Hyoung Kang, Myung Gyu Choi, In-Sik Chung, Young Seon Hong, Suk-Young Park and Kyung Shik Lee

Department of Internal Medicine, College of Medicine, Catholic University, Seoul, Korea

For reprints and all correspondence: Dr Jin-Hyoung Kang, Department of Internal Medicine, Kangnam St Mary's Hospital, The Catholic University of Korea, Banpo-dong 505, Seocho-gu, Seoul 137-040, Korea. E-mail: insookwoo{at}catholic.ac.kr

Received August 6, 2004; accepted November 23, 2004

Background: Due to its greater convenience, a combination of uracil and tegafur (referred to as UFT) taken orally is an attractive alternative to continuous intravenous (i.v.) 5-fluorouracil (5-FU) infusion. This phase II study assessed the response rate and toxicity profile of the combination of epirubicin, cisplatin and UFT in patients with metastatic adenocarcinoma of the stomach.

Methods: Epirubicin (50 mg/m2) and cisplatin (60 mg/m2) were administered i.v. to 35 patients with metastatic gastric carcinoma on day 1, and subsequently UFT (300 mg/m2/day) was administered orally in divided doses for 21 days. The treatment was repeated every 3 weeks. The response rate, time to disease progression, survival and toxic effects were analyzed.

Results: Thirty-two of the 35 enrolled patients were assessed subsequently for response. The median number of cycles was four. Thirteen patients (40.6%) showed partial responses, while none showed a complete response. The median time to progression of carcinoma was 20.4 weeks, and the median survival was 37 weeks. Grade 3 and 4 neutropenia was observed in 25% of patients. Grade 3 nausea and vomiting was observed in 28% of patients. No treatment-related death was observed. All patients received doses as planned, except for one who required a 75% dose reduction due to nephrotoxicity. Six of 132 cycles were delayed >7 days after four cycles.

Conclusions: The combination of epirubicin, cisplatin and UFT showed anticancer activity against metastatic gastric adenocarcinoma, had a tolerable toxicity profile and showed excellent patient compliance.

Key Words: epirubicin • cisplatin • tegafur • gastric cancer


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 Ann OncolHome page
N. F. Aykan and E. Idelevich
The role of UFT in advanced gastric cancer
Ann. Onc., June 1, 2008; 19(6): 1045 - 1052.
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