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)

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. A total of 855 patients (424 in Mf, 431 in MFP) with pathological stage II-IV (M0) gastric cancer after D2 gastrectomy were ran...

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Bibliographic Details
Published in:British journal of cancer 2013-04, Vol.108 (6), p.1245-1251
Main Authors: KANG, Y.-K, CHANG, H.-M, PARK, Y. S, LEE, J.-L, KIM, T. W, OH, S. T, PARK, B. K, JUNG, H.-Y, KIM, B. S, YOOK, J. H, RYU, M.-H, PARK, I, MIN, Y. J, ZANG, D. Y, KIM, G. Y, YANG, D. H, JANG, S. J
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Cancer therapies
Chemotherapy
Cisplatin - administration & dosage
Clinical medicine
Clinical Study
Drug dosages
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
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
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Summary: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. 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. 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). 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.
ISSN:0007-0920
1532-1827
DOI:10.1038/bjc.2013.86