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

• Published in: Annals of oncology Vol. 17; no. 5; pp. 827 - 834
• Main Authors: Bonnetain, F., Bouché, O., Michel, P., Mariette, C., Conroy, T., Pezet, D., Roullet, B., Seitz, J.-F., Paillot, B., Arveux, P., Milan, C., Bedenne, L.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01-05-2006; Oxford Publishing Limited (England)
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - radiotherapy; Adenocarcinoma - surgery; Adenocarcinoma - therapy; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - radiotherapy; Carcinoma, Squamous Cell - surgery; Carcinoma, Squamous Cell - therapy; clinical trials; Combined Modality Therapy; esophageal cancer; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - radiotherapy; Esophageal Neoplasms - surgery; Esophageal Neoplasms - therapy; Esophagectomy; Esophagus; Female; Follow-Up Studies; Gastroenterology. Liver. Pancreas. Abdomen; Humans; longitudinal; Longitudinal Studies; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Quality of Life; radio-chemotherapy; Radiotherapy Dosage; surgery; Survival Rate; Tumors; Phase III trial; Human; esophageal cancer; Esophageal disease; Index; Malignant tumor; Radiotherapy; Esophagus cancer; Quality of life; radio-chemotherapy; Chemotherapy; Randomization; Surgery; Digestive diseases; Clinical trial; Advanced stage; Combined treatment; clinical trials; longitudinal; Comparative study
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdl033

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.