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Japanese Journal of Clinical Oncology 31:605-609 (2001)
© 2001 Foundation for Promotion of Cancer Research

Weekly High-dose 5-Fluorouracil (5-FU), Leucovorin (LV) and Bimonthly Cisplatin in Patients with Advanced Gastric Cancer

Yung-Chang Lin1, Jen-Shi Chen1, Cheng-Hsu Wang1, Hung-Ming Wang1, Hseng-Kun Chang1, Chi-Ting Liau1, Tsai-Shen Yang1, Chuang-Chi Liaw1 and Hsueh-Erh Liu2,+,§

1Division of Hematology–Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei and 2School of Nursing, Chang Gung University, Taipei, Taiwan

Background: A phase II clinical trial was performed to evaluate the activity and toxicity of bimonthly cisplatin and weekly 24-h infusion of high-dose 5-fluorouracil and leucovorin in patients with advanced gastric cancer.

Patients and methods: From September 1997 to March 1998, 23 chemo-naive patients of advanced gastric cancer were enrolled in this study. The regimen consisted of weekly 24-h infusion of 5-FU (2600 mg/m2) and LV 150 mg and bimonthly cisplatin (25–50 mg/m2) bolus for 12 weeks followed by a 2-week break.

Results: There were 10 male and 13 female patients with a median age of 52 years. A total of 428 chemotherapy treatments were given with a mean of 11. Seventeen patients were evaluable for response. There were 41% (7/17) partial response, 18% (3/17) stable disease and 41% (7/17) progressive disease. The grade III or IV toxicity included anorexia 35% (8/23), fatigue 26% (6/23), vomiting 17% (4/23) and mucositis 9% (2/23). One patient developed perforated duodenal stump after chemotherapy. One patient died of hyperammonemia-related coma. The median times to disease progression and overall survival were 3.5 and 7 months, respectively.

Conclusions: This regimen showed modest activity against gastric cancer. However, there was no survival advantage and there was greater toxicity than with weekly high-dose 5-FU–LV alone.

+ For reprints and all correspondence: Yung-Chang Lin, Division of Hematology–Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, 199 Tung-Hwa North Road, Taipei, Taiwan. E-mail: yclinof@adm.cgmh.org.tw

§ Abbreviations: 5-FU, 5-fluorouracil; LV, leucovorin; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; WHO, World Health Organization


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