title: Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901.
abstract: OBJECTIVE
  Although often investigated in locally advanced esophageal cancer (EC), the impact of neoadjuvant chemoradiotherapy (NCRT) in early stages is unknown. The aim of this multicenter randomized phase III trial was to assess whether NCRT improves outcomes for patients with stage I or II EC.
  
  
  METHODS
  The primary end point was overall survival. Secondary end points were disease-free survival, postoperative morbidity, in-hospital mortality, R0 resection rate, and prognostic factor identification. From June 2000 to June 2009, 195 patients in 30 centers were randomly assigned to surgery alone (group S; n = 97) or NCRT followed by surgery (group CRT; n = 98). CRT protocol was 45 Gy in 25 fractions over 5 weeks with two courses of concomitant chemotherapy composed of fluorouracil 800 mg/m(2) and cisplatin 75 mg/m(2). We report the long-term results of the final analysis, after a median follow-up of 93.6 months.
  
  
  RESULTS
  Pretreatment disease was stage I in 19.0%, IIA in 53.3%, and IIB in 27.7% of patients. For group CRT compared with group S, R0 resection rate was 93.8% versus 92.1% (P = .749), with 3-year overall survival rate of 47.5% versus 53.0% (hazard ratio [HR], 0.99; 95% CI, 0.69 to 1.40; P = .94) and postoperative mortality rate of 11.1% versus 3.4% (P = .049), respectively. Because interim analysis of the primary end point revealed an improbability of demonstrating the superiority of either treatment arm (HR, 1.09; 95% CI, 0.75 to 1.59; P = .66), the trial was stopped for anticipated futility.
  
  
  CONCLUSIONS
  Compared with surgery alone, NCRT with cisplatin plus fluorouracil does not improve R0 resection rate or survival but enhances postoperative mortality in patients with stage I or II EC.
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France. christophe.mariette@chru-lille.fr.
authors: Christophe
authors: C
authors: Mariette
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Laetitia
authors: L
authors: Dahan
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Françoise
authors: F
authors: Mornex
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Emilie
authors: E
authors: Maillard
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Pascal-Alexandre
authors: PA
authors: Thomas
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Bernard
authors: B
authors: Meunier
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Valérie
authors: V
authors: Boige
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Denis
authors: D
authors: Pezet
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: William B
authors: WB
authors: Robb
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Valérie
authors: V
authors: Le Brun-Ly
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Jean-François
authors: JF
authors: Bosset
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Jean-Yves
authors: JY
authors: Mabrut
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Jean-Pierre
authors: JP
authors: Triboulet
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Laurent
authors: L
authors: Bedenne
authors: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille-Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite Hospital; Jean-Yves Mabrut, Croix-Rousse University Hospital, Lyon; Emilie Maillard, Fédération Française de Cancérologie Digestive; Laurent Bedenne, University Hospital, Dijon; Bernard Meunier, University Hospital, Rennes; Valérie Boige, Gustave Roussy, Villejuif; Denis Pezet, University Hospital, Clermont-Ferrand; Valérie Le Brun-Ly, University Hospital, Limoges; and Jean-François Bosset, University Hospital, Besançon, France.
authors: Jean-François
authors: JF
authors: Seitz
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D059186:Chemoradiotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000473:pathology / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D020266:Radiotherapy, Conformal
chemical_list: D002945:Cisplatin; D005472:Fluorouracil