title: 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).
abstract: 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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea. ykkang@amc.seoul.kr
authors: Y-K
authors: YK
authors: Kang
authors: H-M
authors: HM
authors: Chang
authors: J H
authors: JH
authors: Yook
authors: M-H
authors: MH
authors: Ryu
authors: I
authors: I
authors: Park
authors: Y J
authors: YJ
authors: Min
authors: D Y
authors: DY
authors: Zang
authors: G Y
authors: GY
authors: Kim
authors: D H
authors: DH
authors: Yang
authors: S J
authors: SJ
authors: Jang
authors: Y S
authors: YS
authors: Park
authors: J-L
authors: JL
authors: Lee
authors: T W
authors: TW
authors: Kim
authors: S T
authors: ST
authors: Oh
authors: B K
authors: BK
authors: Park
authors: H-Y
authors: HY
authors: Jung
authors: B S
authors: BS
authors: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D005500:Follow-Up Studies; D005743:Gastrectomy; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D015996:Survival Rate; D013997:Time Factors; D055815:Young Adult
chemical_list: D005467:Floxuridine; D016685:Mitomycin; D002945:Cisplatin; C025034:doxifluridine