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

• Published in: Japanese journal of clinical oncology Vol. 31; no. 12; pp. 605 - 609
• Main Authors: Lin, Yung-Chang, Chen, Jen-Shi, Wang, Cheng-Hsu, Wang, Hung-Ming, Chang, Hseng-Kun, Liau, Chi-Ting, Yang, Tsai-Shen, Liaw, Chuang-Chi, Liu, Hsueh-Erh
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.12.2001; Oxford Publishing Limited (England)
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Cisplatin - administration & dosage; Drug Administration Schedule; Female; Fluorouracil - administration & dosage; Humans; Key words: chemotherapy – stomach neoplasms – fluorouracil – cisplatin; Leucovorin - administration & dosage; Male; Middle Aged; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Survival Rate
• ISSN: 0368-2811; 1465-3621; 1465-3621
• DOI: 10.1093/jjco/hye130

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.