Adjuvant chemotherapy for gastric cancer: a randomised phase 3 trial of mitomycin-C plus either short-term doxifluridine or long-term doxifluridine plus cisplatin after curative D2 gastrectomy (AMC0201)

• Published in: British journal of cancer Vol. 108; no. 6; pp. 1245 - 1251
• Main Authors: Kang, Y-K, Chang, H-M, Yook, J H, Ryu, M-H, Park, I, Min, Y J, Zang, D Y, Kim, G Y, Yang, D H, Jang, S J, Park, Y S, Lee, J-L, Kim, T W, Oh, S T, Park, B K, Jung, H-Y, Kim, B S
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 02.04.2013; Nature Publishing Group
• Subjects: 631/154/436/108; 631/67/1059/99; 692/699/67/1504/1829; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cancer Research; Cancer therapies; Chemotherapy; Cisplatin - administration & dosage; Clinical medicine; Clinical Study; Drug dosages; Drug Resistance; Epidemiology; Female; Floxuridine - administration & dosage; Follow-Up Studies; Gastrectomy; Gastric cancer; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal surgery; Hospitals; Humans; Internal medicine; Lymphatic Metastasis; Male; Medical prognosis; Medical schools; Medical sciences; Medicine; Middle Aged; Mitomycin - administration & dosage; Molecular Medicine; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - mortality; Neoplasm Recurrence, Local - surgery; Neoplasm Staging; Oncology; Prognosis; Prospective Studies; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Stomach Neoplasms - surgery; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Survival Rate; Time Factors; Tumors; Young Adult; mitomycin-C; adjuvant chemotherapy; gastric cancer; cisplatin; doxifluridine; D2 gastrectomy; Antineoplastic agent; Short term; Phase III trial; Adjuvant treatment; Stomach cancer; Randomization; Cancerology; Surgery; Clinical trial; Gastric disease; Platinum II Complexes; Mitomycin; Doxifluridine; Fluoropyrimidine derivatives; Malignant tumor; Gastrectomy; Long term; Cisplatin; Alkylating agent; Antibiotic; Chemotherapy; Treatment; Pyrimidine derivatives; Digestive diseases; Cancer
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/bjc.2013.86

Background: This phase 3 study evaluated the efficacy of new adjuvant chemotherapy (MFP), which intensified the mitomycin-C (MMC) plus short-term doxifluridine (Mf) for gastric cancer. Patients and methods: A total of 855 patients (424 in Mf, 431 in MFP) with pathological stage II–IV (M0) gastric cancer after D2 gastrectomy were randomly assigned to receive either Mf (MMC 20 mg m −2 , followed by oral doxifluridine 460–600 mg m −2 per day for 3 months) or MFP (MMC 20 mg m −2 , followed by oral doxifluridine 460–600 mg m −2 per day for 12 months with 6 monthly infusions of 60 mg m −2 of cisplatin) chemotherapy. Results: With a median follow-up of 6.6 years, there was no difference between the two groups in recurrence-free survival (RFS) (5-year RFS 61.1% in Mf and 57.9% in MFP; hazard ratio 1.10 (95% CI 0.89–1.35); P =0.39) and overall survival (OS) (5-year OS 66.5% in Mf and 65.0% in MFP; hazard ratio 1.11 (95% CI 0.89–1.39); P =0.33). Conclusion: Intensification of Mf adjuvant chemotherapy by prolonging the duration of oral fluoropyrimidine and adding cisplatin was safe but not effective to improve the survivals in curatively resected gastric cancer patients.