title: Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG.
abstract: BACKGROUND
  In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil+adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm.
  
  
  METHODS
  This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan-Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial.
  
  
  RESULTS
  In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P=0.87) or OS (hazards ratio: 0.98, P=0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively.
  
  
  CONCLUSIONS
  Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.
authors.affiliation: Università di Padova, Clinica Chirurgica II, Padova, Italy, and Laurentius Hospital, Roermond, The Netherlands. donato.nitti@unipd.it
authors.forename: D
authors.initials: D
authors.lastname: Nitti
authors.forename: J
authors.initials: J
authors.lastname: Wils
authors.forename: J Guimaraes
authors.initials: JG
authors.lastname: Dos Santos
authors.forename: G
authors.initials: G
authors.lastname: Fountzilas
authors.forename: P F
authors.initials: PF
authors.lastname: Conte
authors.forename: C
authors.initials: C
authors.lastname: Sava
authors.forename: A
authors.initials: A
authors.lastname: Tres
authors.forename: R C
authors.initials: RC
authors.lastname: Coombes
authors.forename: D
authors.initials: D
authors.lastname: Crivellari
authors.forename: A
authors.initials: A
authors.lastname: Marchet
authors.forename: E
authors.initials: E
authors.lastname: Sanchez
authors.forename: J M
authors.initials: JM
authors.lastname: Bliss
authors.forename: J
authors.initials: J
authors.lastname: Homewood
authors.forename: M L
authors.initials: ML
authors.lastname: Couvreur
authors.forename: E
authors.initials: E
authors.lastname: Hall
authors.forename: B
authors.initials: B
authors.lastname: Baron
authors.forename: E
authors.initials: E
authors.lastname: Woods
authors.forename: M
authors.initials: M
authors.lastname: Emson
authors.forename: E
authors.initials: E
authors.lastname: Van Cutsem
authors.forename: M
authors.initials: M
authors.lastname: Lise
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D015251:Epirubicin; D004317:Doxorubicin; D005472:Fluorouracil; D008727:Methotrexate