Randomized Phase II Study Comparing Mitomycin, Cisplatin Plus Doxifluridine with Cisplatin Plus Doxifluridine in Advanced Unresectable Gastric Cancer

• Published in: Anticancer research 2004-07, Vol.24 (4), p.2465-2470
• Main Authors: KOIZUMI, Wasaburo, FUKUYAMA, Yoshio, FUKUDA, Takahiro, AKIYA, Toshikazu, HASEGAWA, Kouichi, KOJIMA, Yasuaki, OHNO, Nobutsugu, KURIHARA, Minoru
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Cisplatin - administration & dosage; Cisplatin - adverse effects; Female; Floxuridine - administration & dosage; Floxuridine - adverse effects; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Male; Medical sciences; Middle Aged; Mitomycin - administration & dosage; Mitomycin - adverse effects; Stomach Neoplasms - drug therapy; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors
• ISSN: 0250-7005; 1791-7530

Various chemotherapies have been used to treat inoperable gastric cancer. Most combination therapies include cisplatin (CDDP) and fluoropyrimidine (5-FUs), which are thought of as key drugs. In the present study, we randomly compared mitomycin (MMC) and CDDP plus doxifluridine (5’-DFUR), which is an oral 5-FU and an intermediate metabolite of capecitabine (Xeloda), with CDDP plus 5’-DFUR in advanced unresectable gastric cancer. Regimen A was CDDP (70 mg/m 2 , by 2-hour intravenous drip infusion on day 1), MMC (7 mg/m 2 , injected intravenously on day 2), and oral 5’-DFUR (1200 mg/m 2 , on days 4 to 7, 11 to 14, 18 to 21 and 25 to 28; 3 days rest and 4 days administration). Regimen B was identical to regimen A without MMC. Results: The response rate was 25.0% (8/32 patients) in Regimen A, 17.2% (5/29) in Regimen B (p=0.541). The median survival time was 241 days in Regimen A and 179 days in Regimen B (p=0.498). In Regimen A, although no significant difference was observed, end points such as response rate and survival improved. Thus, we concluded that a randomized controlled phase III study with more subjects should be conducted.