title: 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.
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).
  
  
  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.
authors.affiliation: Féderation Francophone de Cancérologie Digestive, Faculty of Medicine, 7 Boulevard Jeanne d'Arc, 21079 Dijon Cedex, France. FBonnetain@dijon.fnclcc.fr
authors.forename: F
authors.initials: F
authors.lastname: Bonnetain
authors.forename: O
authors.initials: O
authors.lastname: Bouché
authors.forename: P
authors.initials: P
authors.lastname: Michel
authors.forename: C
authors.initials: C
authors.lastname: Mariette
authors.forename: T
authors.initials: T
authors.lastname: Conroy
authors.forename: D
authors.initials: D
authors.lastname: Pezet
authors.forename: B
authors.initials: B
authors.lastname: Roullet
authors.forename: J-F
authors.initials: JF
authors.lastname: Seitz
authors.forename: B
authors.initials: B
authors.lastname: Paillot
authors.forename: P
authors.initials: P
authors.lastname: Arveux
authors.forename: C
authors.initials: C
authors.lastname: Milan
authors.forename: L
authors.initials: L
authors.lastname: Bedenne
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D016629:Esophagectomy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011879:Radiotherapy Dosage; D015996:Survival Rate