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Annals of Oncology Advance Access published online on March 8, 2006
Annals of Oncology, doi:10.1093/annonc/mdl033
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© 2006 European Society for Medical Oncology
Received October 7, 2005
Revised January 25, 2006
Accepted January 30, 2006

original article

A comparative longitudinal quality of life study using the Spitzer quality of life index in a randomized multicenter phase III trial (FFCD 9102): chemoradiation followed by surgery compared with chemoradiation alone in locally advanced squamous resectable thoracic esophageal cancer

F. Bonnetain 1 *, O. Bouché 2, P. Michel 3, C. Mariette 4, T. Conroy 5, D. Pezet 6, B. Roullet 7, J.-F. Seitz 8, B. Paillot 9, P. Arveux 10, C. Milan 11, and L. Bedenne 1

1 Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon, France; Centre Georges Francois Leclerc, DIM, Dijon, France
2 Centre Hospitalier Universitaire Robert Debré, Reims, France
3 Centre Hospitalier Universitaire Charles Nicolle, Rouen, France
4 Centre Hospitalier Universitaire Claude Huriez, Lille, France
5 Centre Alexis Vautrin, Nancy, France
6 Centre Hospitalier Universitaire Hôtel Dieu, Clermond Ferrand, France
7 Centre Hospitalier Universitaire Dupuytren, Limoges, France
8 Institut Paoli-Calmettes, Marseille, France
9 Centre Hospitalier Universitaire du Rouen, Rouen, France
10 Centre Georges Francois Leclerc, DIM, Dijon, France
11 Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon, France

* To whom correspondence should be addressed.
F. Bonnetain, E-mail: FBonnetain{at}dijon.fnclcc.fr


  Abstract

Background: The aim of the study was to compare the longitudinal quality of life (QoL) between chemoradiation with or without surgery in patients with locally advanced squamous resectable esophageal cancer included in a randomized multicenter phase III trial (FFCD 9102).

Materials and methods: All patients with locally advanced resectable (T3-4 N0-1 M0) epidermoid or glandular esophageal cancer (n = 451) received induction chemoradiation. Responders (n = 259) were randomized between surgery (arm A) and continuation of chemoradiation (arm B). The Spitzer QoL Index was scored (0-10) at inclusion and at each follow-up, every 3 months during 2 years. QoL at baseline and longitudinal changes were respectively compared with univariate ANOVA and mixed-model analysis of variance for repeated measurements. The time interval between the follow-up was assessed and the same analyses were performed among survivors with 2 years of follow-up.

Results: The squamous histology was predominant in both arms. The mean QoL score decreased between baseline and the first follow-up and between the first and the second follow-ups. QoL scores at the first follow-up were comparatively worse in arm A than in arm B (7.52 versus 8.45, P < 0.01), whereas the longitudinal QoL study showed no difference between treatments (adjusted P = 0.26). Furthermore, the longitudinal QoL was not different (adjusted P = 0.23) among survivors with 2 years of follow-up.

Conclusions: Among patients responding to induction chemoradiation, surgery and continuation of chemoradiation had the same impact on QoL in patients with locally advanced, resectable esophageal cancer although a significantly greater decrease in the Spitzer Index was observed in the postoperative period.

Keywords: quality of life; esophageal cancer; clinical trials; longitudinal; surgery; radio-chemotherapy.
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