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 : 001762A 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. BedenneSource :
- Annals of Oncology [ 0923-7534 ] ; 2006-05.
English descriptors
- KwdEn :
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.
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DOI: 10.1093/annonc/mdl033
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<front><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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<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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<notesStmt><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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<author xml:id="author-2"><persName><forename type="first">O.</forename>
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<author xml:id="author-3"><persName><forename type="first">P.</forename>
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<author xml:id="author-5"><persName><forename type="first">T.</forename>
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<author xml:id="author-7"><persName><forename type="first">B.</forename>
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<author xml:id="author-8"><persName><forename type="first">J.-F.</forename>
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<author xml:id="author-9"><persName><forename type="first">B.</forename>
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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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<author xml:id="author-10"><persName><forename type="first">P.</forename>
<surname>Arveux</surname>
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<affiliation>Centre Georges Francois Leclerc, DIM, Dijon;</affiliation>
<affiliation>Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon;</affiliation>
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<author xml:id="author-11"><persName><forename type="first">C.</forename>
<surname>Milan</surname>
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<abstract xml:lang="en"><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-categories><subj-group subj-group-type="heading"><subject>Original article</subject>
<subj-group><subject>gastrointestinal tumors</subject>
</subj-group>
</subj-group>
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<title-group><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>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Bonnetain</surname>
<given-names>F.</given-names>
</name>
<xref rid="AFF1"><sup>1</sup>
</xref>
<xref rid="AFF2"><sup>2</sup>
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<xref rid="COR1"><sup>*</sup>
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</contrib>
<contrib contrib-type="author"><name><surname>Bouché</surname>
<given-names>O.</given-names>
</name>
<xref rid="AFF3"><sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Michel</surname>
<given-names>P.</given-names>
</name>
<xref rid="AFF4"><sup>4</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mariette</surname>
<given-names>C.</given-names>
</name>
<xref rid="AFF5"><sup>5</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Conroy</surname>
<given-names>T.</given-names>
</name>
<xref rid="AFF6"><sup>6</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pezet</surname>
<given-names>D.</given-names>
</name>
<xref rid="AFF7"><sup>7</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Roullet</surname>
<given-names>B.</given-names>
</name>
<xref rid="AFF8"><sup>8</sup>
</xref>
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<contrib contrib-type="author"><name><surname>Seitz</surname>
<given-names>J.-F.</given-names>
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<xref rid="AFF9"><sup>9</sup>
</xref>
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<contrib contrib-type="author"><name><surname>Paillot</surname>
<given-names>B.</given-names>
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<xref rid="AFF10"><sup>10</sup>
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<given-names>P.</given-names>
</name>
<xref rid="AFF2"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Milan</surname>
<given-names>C.</given-names>
</name>
<xref rid="AFF1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bedenne</surname>
<given-names>L.</given-names>
</name>
<xref rid="AFF1"><sup>1</sup>
</xref>
<xref rid="AFF2"><sup>2</sup>
</xref>
</contrib>
<aff><target target-type="aff" id="AFF1"></target>
<label>1</label>
Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon; <target target-type="aff" id="AFF2"></target>
<label>2</label>
Centre Georges Francois Leclerc, DIM, Dijon; <target target-type="aff" id="AFF3"></target>
<label>3</label>
Centre Hospitalier Universitaire Robert Debré, Reims; <target target-type="aff" id="AFF4"></target>
<label>4</label>
Centre Hospitalier Universitaire Charles Nicolle, Rouen; <target target-type="aff" id="AFF5"></target>
<label>5</label>
Centre Hospitalier Universitaire Claude Huriez, Lille; <target target-type="aff" id="AFF6"></target>
<label>6</label>
Centre Alexis Vautrin, Nancy; <target target-type="aff" id="AFF7"></target>
<label>7</label>
Centre Hospitalier Universitaire Hôtel Dieu, Clermond Ferrand; <target target-type="aff" id="AFF8"></target>
<label>8</label>
Centre Hospitalier Universitaire Dupuytren, Limoges; <target target-type="aff" id="AFF9"></target>
<label>9</label>
Institut Paoli-Calmettes, Marseille; <target target-type="aff" id="AFF10"></target>
<label>10</label>
Centre Hospitalier Universitaire du Rouen, Rouen, France</aff>
</contrib-group>
<author-notes><corresp id="COR1"><label>*</label>
<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>
</corresp>
</author-notes>
<pub-date pub-type="epub"><day>8</day>
<month>3</month>
<year>2006</year>
</pub-date>
<pub-date pub-type="ppub"><month>May</month>
<year>2006</year>
</pub-date>
<volume>17</volume>
<issue>5</issue>
<fpage>827</fpage>
<lpage>834</lpage>
<history><date date-type="accepted"><day>30</day>
<month>1</month>
<year>2006</year>
</date>
<date date-type="received"><day>7</day>
<month>10</month>
<year>2005</year>
</date>
<date date-type="rev-recd"><day>25</day>
<month>1</month>
<year>2006</year>
</date>
</history>
<permissions><copyright-statement>© 2006 European Society for Medical Oncology</copyright-statement>
<copyright-year>2006</copyright-year>
</permissions>
<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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<namePart type="family">Milan</namePart>
<affiliation>Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon;</affiliation>
<affiliation>Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon;</affiliation>
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<namePart type="family">Bedenne</namePart>
<affiliation>Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon;</affiliation>
<affiliation>Fédération Francophone de Cancérologie Digestive (FFCD) and Equipe Mixte Inserm (EMI 106), Faculté de Médecine Dijon;</affiliation>
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<originInfo><publisher>Oxford University Press</publisher>
<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>
<subject lang="en"><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>
</subject>
<relatedItem type="host"><titleInfo><title>Annals of Oncology</title>
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<titleInfo type="abbreviated"><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>
<part><date>2006</date>
<detail type="volume"><caption>vol.</caption>
<number>17</number>
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<detail type="issue"><caption>no.</caption>
<number>5</number>
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<extent unit="pages"><start>827</start>
<end>834</end>
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<identifier type="DOI">10.1093/annonc/mdl033</identifier>
<identifier type="local">mdl033</identifier>
<accessCondition type="use and reproduction" contentType="copyright">© 2006 European Society for Medical Oncology</accessCondition>
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