Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma

Metastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with RAS wild-type metastatic colorectal cancer in the PRIME study. A randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 e...

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Autores: Siena, Salvatore|||0000-0002-2681-2846, Tabernero, Josep|||0000-0002-2495-8139, Bodoky, Gyorgy, Cunningham, David, Rivera, Fernando|||0000-0001-8915-226X, Ruff, Paul, Canon, Jean Luc, Koukakis, Reija, Demonty, Gaston, Hechmati, Guy, Douillard, Jean-Yves|||0000-0002-6540-7333
Tipo de recurso: artículo
Fecha de publicación:2016
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:186026
Acceso en línea:https://ddd.uab.cat/record/186026
https://dx.doi.org/urn:doi:10.1136/esmoopen-2016-000041
Access Level:acceso abierto
Palabra clave:Chemotherapy
Tumour shrinkage
Quality of life
EGFR inhibitors
Metastatic colorectal cancer
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spelling Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinomaresults from a randomised controlled trialSiena, Salvatore|||0000-0002-2681-2846Tabernero, Josep|||0000-0002-2495-8139Bodoky, GyorgyCunningham, DavidRivera, Fernando|||0000-0001-8915-226XRuff, PaulCanon, Jean LucKoukakis, ReijaDemonty, GastonHechmati, GuyDouillard, Jean-Yves|||0000-0002-6540-7333ChemotherapyTumour shrinkageQuality of lifeEGFR inhibitorsMetastatic colorectal cancerMetastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with RAS wild-type metastatic colorectal cancer in the PRIME study. A randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 enrolled adults with untreated metastatic colorectal cancer and an Eastern Cooperative Oncology Group performance status of 0-2. This analysis includes patients with wild-type RAS tumours (n=505). Quality of life (prespecified end point) was assessed using the EuroQoL 5-domain health state index and overall health rating in all patients and by early tumour shrinkage status (≥30% reduction in size by week 8; exploratory end point). Differences in quality of life were assessed using analysis of covariance and a mixed-effect piecewise linear model, and were also analysed by skin toxicity severity. There were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Grade 3+ skin toxicity was reported by 38% of patients receiving panitumumab+FOLFOX4 and 2% receiving FOLFOX4 alone. There were no significant differences in quality of life between patients with grade 0-2 skin toxicity and those with grade 3+ skin toxicity. More patients receiving panitumumab+FOLFOX4 vs FOLFOX4 had early tumour shrinkage (p<.001). In patients with tumour symptoms at baseline, there were statistically significant improvements in quality of life in those with early tumour shrinkage versus those without early tumour shrinkage. Addition of panitumumab to FOLFOX4 in first-line therapy for metastatic colorectal cancer prolongs survival and has no negative effect on overall quality of life compared with FOLFOX4 alone. Specific quality of life assessments for skin toxicity should be included in study designs to better define the direct effect of these adverse events. NCT00364013.Universitat Autònoma de Barcelona 22016-01-0120162016-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/186026https://dx.doi.org/urn:doi:10.1136/esmoopen-2016-000041reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:1860262026-06-06T12:50:31Z
dc.title.none.fl_str_mv Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
results from a randomised controlled trial
title Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
spellingShingle Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
Siena, Salvatore|||0000-0002-2681-2846
Chemotherapy
Tumour shrinkage
Quality of life
EGFR inhibitors
Metastatic colorectal cancer
title_short Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
title_full Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
title_fullStr Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
title_full_unstemmed Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
title_sort Quality of life during first-line FOLFOX4±panitumumab in RAS wild-type metastatic colorectal carcinoma
dc.creator.none.fl_str_mv Siena, Salvatore|||0000-0002-2681-2846
Tabernero, Josep|||0000-0002-2495-8139
Bodoky, Gyorgy
Cunningham, David
Rivera, Fernando|||0000-0001-8915-226X
Ruff, Paul
Canon, Jean Luc
Koukakis, Reija
Demonty, Gaston
Hechmati, Guy
Douillard, Jean-Yves|||0000-0002-6540-7333
author Siena, Salvatore|||0000-0002-2681-2846
author_facet Siena, Salvatore|||0000-0002-2681-2846
Tabernero, Josep|||0000-0002-2495-8139
Bodoky, Gyorgy
Cunningham, David
Rivera, Fernando|||0000-0001-8915-226X
Ruff, Paul
Canon, Jean Luc
Koukakis, Reija
Demonty, Gaston
Hechmati, Guy
Douillard, Jean-Yves|||0000-0002-6540-7333
author_role author
author2 Tabernero, Josep|||0000-0002-2495-8139
Bodoky, Gyorgy
Cunningham, David
Rivera, Fernando|||0000-0001-8915-226X
Ruff, Paul
Canon, Jean Luc
Koukakis, Reija
Demonty, Gaston
Hechmati, Guy
Douillard, Jean-Yves|||0000-0002-6540-7333
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Chemotherapy
Tumour shrinkage
Quality of life
EGFR inhibitors
Metastatic colorectal cancer
topic Chemotherapy
Tumour shrinkage
Quality of life
EGFR inhibitors
Metastatic colorectal cancer
description Metastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with RAS wild-type metastatic colorectal cancer in the PRIME study. A randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 enrolled adults with untreated metastatic colorectal cancer and an Eastern Cooperative Oncology Group performance status of 0-2. This analysis includes patients with wild-type RAS tumours (n=505). Quality of life (prespecified end point) was assessed using the EuroQoL 5-domain health state index and overall health rating in all patients and by early tumour shrinkage status (≥30% reduction in size by week 8; exploratory end point). Differences in quality of life were assessed using analysis of covariance and a mixed-effect piecewise linear model, and were also analysed by skin toxicity severity. There were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Grade 3+ skin toxicity was reported by 38% of patients receiving panitumumab+FOLFOX4 and 2% receiving FOLFOX4 alone. There were no significant differences in quality of life between patients with grade 0-2 skin toxicity and those with grade 3+ skin toxicity. More patients receiving panitumumab+FOLFOX4 vs FOLFOX4 had early tumour shrinkage (p<.001). In patients with tumour symptoms at baseline, there were statistically significant improvements in quality of life in those with early tumour shrinkage versus those without early tumour shrinkage. Addition of panitumumab to FOLFOX4 in first-line therapy for metastatic colorectal cancer prolongs survival and has no negative effect on overall quality of life compared with FOLFOX4 alone. Specific quality of life assessments for skin toxicity should be included in study designs to better define the direct effect of these adverse events. NCT00364013.
publishDate 2016
dc.date.none.fl_str_mv 2
2016-01-01
2016
2016-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/186026
https://dx.doi.org/urn:doi:10.1136/esmoopen-2016-000041
url https://ddd.uab.cat/record/186026
https://dx.doi.org/urn:doi:10.1136/esmoopen-2016-000041
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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