Format

Send to

Choose Destination
J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.

Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901.

Author information

1
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.
2
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.

Abstract

PURPOSE:

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.

CONCLUSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00047112.

PMID:
24982463
DOI:
10.1200/JCO.2013.53.6532
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center