Marc Ychou1, Valérie Boige1, Jean‐Pierre Pignon1, Thierry Conroy1, Olivier Bouché1,2, Gil Lebreton1, M. Ducourtieux1, Laurent Bedenne1, J Fabré1, B. Saint‐Aubert1, Jean Genève1, P Lasser1, P. Rougier1
1From the Centre Val d'Aurelle; Centre Hospitalier Universitaire Saint-Eloi, Montpellier; Institut de Cancérologie Gustave Roussy, Villejuif; Centre Alexis Vautrin et Centre Hospitalier Universitaire, Nancy; Centre Hospitalier Universitaire Robert Debré, Reims; Centre Hospitalier Universitaire Côte de Nacre, Caen; Centre Hospitalier Universitaire, Dijon; Fédération Nationale des Centres de Lutte contre le Cancer – Bureau d'Etudes Cliniques et Thérapeutiques; and the Hôpital Européen Georges Pompidou,...
2Matrice extracellulaire et dynamique cellulaire - UMR 7369
Tóm tắt
Purpose 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. Patients and 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/m2) on day 1, and a continuous intravenous infusion of fluorouracil (800 mg/m2/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. Conclusion 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.
