1. Perioperative Chemotherapy Compared With Surgery Alone for Resectable Gastroesophageal Adenocarcinoma: An FNCLCC and FFCD Multicenter Phase III Trial
- Author
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Gilles Lebreton, Thierry Conroy, Jean-Pierre Pignon, Philippe Lasser, B. Saint-Aubert, Jean-Michel Fabre, Marc Ychou, Philippe Rougier, Jean Genève, Muriel Ducourtieux, Valérie Boige, Olivier Bouché, Laurent Bedenne, Matrice extracellulaire et dynamique cellulaire - UMR 7369 (MEDyC), Université de Reims Champagne-Ardenne (URCA)-SFR CAP Santé (Champagne-Ardenne Picardie Santé), and Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Université de Reims Champagne-Ardenne (URCA)-Université de Picardie Jules Verne (UPJV)-Centre National de la Recherche Scientifique (CNRS)
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Esophageal Neoplasms ,medicine.medical_treatment ,Gastroesophageal Junction Adenocarcinoma ,Neutropenia ,Disease-Free Survival ,Drug Administration Schedule ,03 medical and health sciences ,0302 clinical medicine ,Stomach Neoplasms ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Medicine ,Perioperative Period ,ComputingMilieux_MISCELLANEOUS ,Aged ,Chemotherapy ,business.industry ,Hazard ratio ,Perioperative ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,3. Good health ,Surgery ,Regimen ,Oncology ,Chemotherapy, Adjuvant ,Fluorouracil ,030220 oncology & carcinogenesis ,Adenocarcinoma ,Female ,030211 gastroenterology & hepatology ,Esophagogastric Junction ,Cisplatin ,business ,medicine.drug - Abstract
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.
- Published
- 2011