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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

Identifieur interne : 001761 ( Istex/Corpus ); précédent : 001760; suivant : 001762

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

Auteurs : F. Bonnetain ; O. Bouche ; P. Michel ; C. Mariette ; T. Conroy ; D. Pezet ; B. Roullet ; J.-F. Seitz ; B. Paillot ; P. Arveux ; C. Milan ; L. Bedenne

Source :

RBID : ISTEX:FDE39442EAAA5F05C7C30FA79230D923131D83A9

English descriptors

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.

Url:
DOI: 10.1093/annonc/mdl033

Links to Exploration step

ISTEX:FDE39442EAAA5F05C7C30FA79230D923131D83A9

Le document en format XML

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<title level="j">Annals of Oncology</title>
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<term>clinical trials</term>
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<div type="abstract" xml:lang="en">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.</div>
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<name>B. Paillot</name>
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<name>P. Arveux</name>
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<json:string>Centre Georges Francois Leclerc, DIM, Dijon;</json:string>
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<name>L. Bedenne</name>
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<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.</abstract>
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<note>*Correspondence to: Dr F. Bonnetain, Féderation Francophone de Cancérologie Digestive, Faculty of Medicine, 7 Boulevard Jeanne d'Arc, 21079 Dijon Cedex, France. Tel: +33-3-80-39-33-40; Fax: +33-3-80-66-82-51; E-mail: FBonnetain@dijon.fnclcc.fr</note>
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<p>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.</p>
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<article-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</article-title>
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Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon;
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Centre Georges Francois Leclerc, DIM, Dijon;
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Centre Hospitalier Universitaire Robert Debré, Reims;
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Centre Hospitalier Universitaire Charles Nicolle, Rouen;
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Centre Hospitalier Universitaire Claude Huriez, Lille;
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Centre Alexis Vautrin, Nancy;
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Centre Hospitalier Universitaire Hôtel Dieu, Clermond Ferrand;
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Centre Hospitalier Universitaire Dupuytren, Limoges;
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Institut Paoli-Calmettes, Marseille;
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Centre Hospitalier Universitaire du Rouen, Rouen, France</aff>
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<italic>Correspondence to:</italic>
Dr F. Bonnetain, Féderation Francophone de Cancérologie Digestive, Faculty of Medicine, 7 Boulevard Jeanne d'Arc, 21079 Dijon Cedex, France. Tel: +33-3-80-39-33-40; Fax: +33-3-80-66-82-51; E-mail:
<ext-link xlink:href="FBonnetain@dijon.fnclcc.fr" ext-link-type="email">FBonnetain@dijon.fnclcc.fr</ext-link>
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<abstract xml:lang="en">
<p>
<bold>Background:</bold>
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).</p>
<p>
<bold>Materials and methods:</bold>
All patients with locally advanced resectable (T3–4 N0–1 M0) epidermoid or glandular esophageal cancer (
<italic>n</italic>
= 451) received induction chemoradiation. Responders (
<italic>n</italic>
= 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.</p>
<p>
<bold>Results:</bold>
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,
<italic>P</italic>
< 0.01), whereas the longitudinal QoL study showed no difference between treatments (adjusted
<italic>P</italic>
= 0.26). Furthermore, the longitudinal QoL was not different (adjusted
<italic>P</italic>
= 0.23) among survivors with 2 years of follow-up.</p>
<p>
<bold>Conclusions:</bold>
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.</p>
</abstract>
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<affiliation>Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon;</affiliation>
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<dateIssued encoding="w3cdtf">2006-05</dateIssued>
<dateCreated encoding="w3cdtf">2006-03-08</dateCreated>
<copyrightDate encoding="w3cdtf">2006</copyrightDate>
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<abstract lang="en">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.</abstract>
<note type="author-notes">*Correspondence to: Dr F. Bonnetain, Féderation Francophone de Cancérologie Digestive, Faculty of Medicine, 7 Boulevard Jeanne d'Arc, 21079 Dijon Cedex, France. Tel: +33-3-80-39-33-40; Fax: +33-3-80-66-82-51; E-mail: FBonnetain@dijon.fnclcc.fr</note>
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<genre>KWD</genre>
<topic>quality of life</topic>
<topic>esophageal cancer</topic>
<topic>clinical trials</topic>
<topic>longitudinal</topic>
<topic>surgery</topic>
<topic>radio-chemotherapy</topic>
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<title>Annals of Oncology</title>
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<title>Ann Oncol</title>
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<identifier type="ISSN">0923-7534</identifier>
<identifier type="eISSN">1569-8041</identifier>
<identifier type="PublisherID">annonc</identifier>
<identifier type="PublisherID-hwp">annonc</identifier>
<identifier type="PublisherID-nlm-ta">Ann Oncol</identifier>
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<date>2006</date>
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<caption>vol.</caption>
<number>17</number>
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<number>5</number>
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<start>827</start>
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<accessCondition type="use and reproduction" contentType="copyright">© 2006 European Society for Medical Oncology</accessCondition>
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