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Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab

In a randomised phase 3 trial, panitumumab significantly improved progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC). This analysis characterises the association of PFS with CRC symptoms, health-related quality of life (HRQoL), and overall survival (OS)....

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Autores principales: Siena, S, Peeters, M, Van Cutsem, E, Humblet, Y, Conte, P, Bajetta, E, Comandini, D, Bodoky, G, Van Hazel, G, Salek, T, Wolf, M, Devercelli, G, Woolley, M, Amado, R G
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360255/
https://www.ncbi.nlm.nih.gov/pubmed/18040272
http://dx.doi.org/10.1038/sj.bjc.6604053
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author Siena, S
Peeters, M
Van Cutsem, E
Humblet, Y
Conte, P
Bajetta, E
Comandini, D
Bodoky, G
Van Hazel, G
Salek, T
Wolf, M
Devercelli, G
Woolley, M
Amado, R G
author_facet Siena, S
Peeters, M
Van Cutsem, E
Humblet, Y
Conte, P
Bajetta, E
Comandini, D
Bodoky, G
Van Hazel, G
Salek, T
Wolf, M
Devercelli, G
Woolley, M
Amado, R G
author_sort Siena, S
collection PubMed
description In a randomised phase 3 trial, panitumumab significantly improved progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC). This analysis characterises the association of PFS with CRC symptoms, health-related quality of life (HRQoL), and overall survival (OS). CRC symptoms (NCCN/FACT CRC symptom index, FCSI) and HRQoL (EQ-5D) were assessed for 207 panitumumab patients and 184 best supportive care (BSC) patients who had at least one post-baseline patient-reported outcome (PRO) assessment. Patients alive at week 8 were included in the PRO and OS analyses and categorised by their week 8 progression status as follows: no progressive disease (no PD; best response of at least stable disease) vs progressive disease (PD). Standard imputation methods were used to assign missing values. Significantly more patients were progression free at weeks 8–24 with panitumumab vs BSC. After excluding responders, a significant difference in PFS remained favouring panitumumab (HR=0.63, 95% CI=0.52–0.77; P<0.0001). At week 8, lack of disease progression was associated with significantly and clinically meaningful lower CRC symptomatology for both treatment groups and higher HRQoL for panitumumab patients only. Overall survival favoured no PD patients vs PD patients alive at week 8. Lack of disease progression was associated with better symptom control, HRQoL, and OS.
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spelling pubmed-23602552009-09-10 Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab Siena, S Peeters, M Van Cutsem, E Humblet, Y Conte, P Bajetta, E Comandini, D Bodoky, G Van Hazel, G Salek, T Wolf, M Devercelli, G Woolley, M Amado, R G Br J Cancer Clinical Study In a randomised phase 3 trial, panitumumab significantly improved progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC). This analysis characterises the association of PFS with CRC symptoms, health-related quality of life (HRQoL), and overall survival (OS). CRC symptoms (NCCN/FACT CRC symptom index, FCSI) and HRQoL (EQ-5D) were assessed for 207 panitumumab patients and 184 best supportive care (BSC) patients who had at least one post-baseline patient-reported outcome (PRO) assessment. Patients alive at week 8 were included in the PRO and OS analyses and categorised by their week 8 progression status as follows: no progressive disease (no PD; best response of at least stable disease) vs progressive disease (PD). Standard imputation methods were used to assign missing values. Significantly more patients were progression free at weeks 8–24 with panitumumab vs BSC. After excluding responders, a significant difference in PFS remained favouring panitumumab (HR=0.63, 95% CI=0.52–0.77; P<0.0001). At week 8, lack of disease progression was associated with significantly and clinically meaningful lower CRC symptomatology for both treatment groups and higher HRQoL for panitumumab patients only. Overall survival favoured no PD patients vs PD patients alive at week 8. Lack of disease progression was associated with better symptom control, HRQoL, and OS. Nature Publishing Group 2007-12-03 2007-11-27 /pmc/articles/PMC2360255/ /pubmed/18040272 http://dx.doi.org/10.1038/sj.bjc.6604053 Text en Copyright © 2007 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
spellingShingle Clinical Study
Siena, S
Peeters, M
Van Cutsem, E
Humblet, Y
Conte, P
Bajetta, E
Comandini, D
Bodoky, G
Van Hazel, G
Salek, T
Wolf, M
Devercelli, G
Woolley, M
Amado, R G
Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab
title Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab
title_full Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab
title_fullStr Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab
title_full_unstemmed Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab
title_short Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab
title_sort association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360255/
https://www.ncbi.nlm.nih.gov/pubmed/18040272
http://dx.doi.org/10.1038/sj.bjc.6604053
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