13 april 2011, bron: Journal of Clinical Oncology, maart 2011

Chemo vooraf en na operatie van slokdarmkanker (tumoren zaten laag in de slokdarm) en bepaalde vormen van maagkanker (tumoren in de aansluiting met de slokdarm) geeft patienten beduidend meer kans op overleven en langere ziektevrije tijd. Dit blijkt uit een langjarige gerandomiseerde fase III studie met 224 patienten met kanker van de slokdarm en bovenste gedeelte van de maag, waarin de resultaten vergeleken werden met alleen een operatie. De gebruikte chemo was cisplatin en 5-FU.

Resulten vergeleken met de operatiegroep had de combinatiegroep van chemo vooraf en operatie een beter resultaat op de overall overleving (5-jaars overleving 38% v 24%; hazard ratio voor sterfte: 0.69; 95% CI, 0.50 to 0.95; P = .02); en een betere ziektevrije overlevingstijd (5-jaars resultaat: 34% v 19%; HR, 0.65; 95% CI, 0.48 to 0.89; P = .003). In de multivariabele analyse, was pre-operatieve chemo een goede prognostische factor voor overleving (P = .01) en lokatie van de tumor eveneens (P < .01). Pre-operatieve chemotherapie verbeterde significant de kans op genezing van een operatie (84% v 73%; P = .04). Graad 3 tot 4 toxiciteit kwam voor bij 38% van de patienten in de combinatiegroep (vooral neutropenia) maar post operatieve sterfte was gelijk in beide groepen.

In patients with resectable adenocarcinoma of the lower esophagus, GEJ, or stomach, perioperative chemotherapy significantly increased the curative resection rate, disease-free survival, and overall survival

Bron: Journal of Clinical Oncology

Perioperative Chemotherapy Compared With Surgery Alone for Resectable Gastroesophageal Adenocarcinoma: A FNCLCC and FFCD Multicenter Phase III Trial

+ Author Affiliations

From 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, Assistance Publique des Hôpitaux de Paris, Paris, France.

↵Corresponding author: Marc Ychou, MD, PhD, Centre Régional de Lutte Contre le Cancer Val d'Aurelle, 298 rue des apothicaires - 34298 Montpellier Cedex 05, France; e-mail: MYchou@valdorel.fnclcc.fr.

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 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.