title: Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial.
abstract: OBJECTIVE
  After curative resection, the prognosis of gastroesophageal adenocarcinoma is poor. This phase III trial was designed to evaluate the benefit in overall survival (OS) of perioperative fluorouracil plus cisplatin in resectable gastroesophageal adenocarcinoma.
  
  
  METHODS
  Overall, 224 patients with resectable adenocarcinoma of the lower esophagus, gastroesophageal junction (GEJ), or stomach were randomly assigned to either perioperative chemotherapy and surgery (CS group; n = 113) or surgery alone (S group; n = 111). Chemotherapy consisted of two or three preoperative cycles of intravenous cisplatin (100 mg/m(2)) on day 1, and a continuous intravenous infusion of fluorouracil (800 mg/m(2)/d) for 5 consecutive days (days 1 to 5) every 28 days and three or four postoperative cycles of the same regimen. The primary end point was OS.
  
  
  RESULTS
  Compared with the S group, the CS group had a better OS (5-year rate 38% v 24%; hazard ratio [HR] for death: 0.69; 95% CI, 0.50 to 0.95; P = .02); and a better disease-free survival (5-year rate: 34% v 19%; HR, 0.65; 95% CI, 0.48 to 0.89; P = .003). In the multivariable analysis, the favorable prognostic factors for survival were perioperative chemotherapy (P = .01) and stomach tumor localization (P < .01). Perioperative chemotherapy significantly improved the curative resection rate (84% v 73%; P = .04). Grade 3 to 4 toxicity occurred in 38% of CS patients (mainly neutropenia) but postoperative morbidity was similar in the two groups.
  
  
  CONCLUSIONS
  In patients with resectable adenocarcinoma of the lower esophagus, GEJ, or stomach, perioperative chemotherapy using fluorouracil plus cisplatin significantly increased the curative resection rate, disease-free survival, and OS.
authors: Centre Régional de Lutte Contre le Cancer Val d'Aurelle, 298 rue des apothicaires-34298 Montpellier Cedex 05, France. MYchou@valdorel.fnclcc.fr
authors: Marc
authors: M
authors: Ychou
authors: Valérie
authors: V
authors: Boige
authors: Jean-Pierre
authors: JP
authors: Pignon
authors: Thierry
authors: T
authors: Conroy
authors: Olivier
authors: O
authors: Bouché
authors: Gilles
authors: G
authors: Lebreton
authors: Muriel
authors: M
authors: Ducourtieux
authors: Laurent
authors: L
authors: Bedenne
authors: Jean-Michel
authors: JM
authors: Fabre
authors: Bernard
authors: B
authors: Saint-Aubert
authors: Jean
authors: J
authors: Genève
authors: Philippe
authors: P
authors: Lasser
authors: Philippe
authors: P
authors: Rougier
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D004943:Esophagogastric Junction; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D059035:Perioperative Period; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*
chemical_list: D002945:Cisplatin; D005472:Fluorouracil