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Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial
BACKGROUND: The phase II AFUGEM GERCOR trial aimed to assess the efficacy of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine (gemcitabine group) or simplified leucovorin and fluorouracil (sLV5FU2 group) in patients with previously untreated metastatic pancreatic cancer. Results...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6718524/ https://www.ncbi.nlm.nih.gov/pubmed/31314957 http://dx.doi.org/10.1002/cam4.2311 |
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author | Charton, Emilie Bachet, Jean‐Baptiste Hammel, Pascal Desramé, Jérôme Chibaudel, Benoist Cohen, Romain Debourdeau, Philippe Dauba, Jérome Lecomte, Thierry Seitz, Jean‐François Tournigand, Christophe Aparicio, Thomas Guerin‐Meyer, Véronique Taieb, Julien Volet, Julien Louvet, Christophe Anota, Amélie Bonnetain, Franck |
author_facet | Charton, Emilie Bachet, Jean‐Baptiste Hammel, Pascal Desramé, Jérôme Chibaudel, Benoist Cohen, Romain Debourdeau, Philippe Dauba, Jérome Lecomte, Thierry Seitz, Jean‐François Tournigand, Christophe Aparicio, Thomas Guerin‐Meyer, Véronique Taieb, Julien Volet, Julien Louvet, Christophe Anota, Amélie Bonnetain, Franck |
author_sort | Charton, Emilie |
collection | PubMed |
description | BACKGROUND: The phase II AFUGEM GERCOR trial aimed to assess the efficacy of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine (gemcitabine group) or simplified leucovorin and fluorouracil (sLV5FU2 group) in patients with previously untreated metastatic pancreatic cancer. Results of progression‐free survival at 4 months (primary endpoint) were in favor of the sLV5FU2 group. This paper presents health‐related quality of life (HRQoL) data as a secondary endpoint. METHODS: HRQoL was assessed using the EORTC QLQ‐C30 questionnaire at baseline and at each chemotherapy cycle until the end of treatment. The HRQoL deterioration‐free survival (QFS) was used as a modality of longitudinal analysis. QFS was defined as the time between randomization and the first definitive HRQoL score deterioration as compared to the baseline score, or death. Sensitivity analysis was performed excluding death as an event. Univariate Cox models were used to estimate hazard ratios (HRs) and 90% confidence intervals (CIs) of the treatment effect. RESULTS: Between 2013 and 2014, 114 patients were randomized in a 1:2 ratio (39 in the gemcitabine group and 75 in the sLV5FU2 group). Patients in the sLV5FU2 group seemed to present longer QFS than those of the gemcitabine group for 14 out of 15 dimensions, with HRs < 1. Results of the sensitivity analysis excluding death as an event were significantly in favor of the sLV5FU2 group for physical functioning (HR = 0.51 [90% CI 0.27‐0.97]) and pain (HR = 0.26 [90% CI 0.09‐0.74]). CONCLUSION: The nab‐paclitaxel plus simplified leucovorin and fluorouracil combination had no negative impact in exploratory HRQoL analyses. |
format | Online Article Text |
id | pubmed-6718524 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-67185242019-09-06 Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial Charton, Emilie Bachet, Jean‐Baptiste Hammel, Pascal Desramé, Jérôme Chibaudel, Benoist Cohen, Romain Debourdeau, Philippe Dauba, Jérome Lecomte, Thierry Seitz, Jean‐François Tournigand, Christophe Aparicio, Thomas Guerin‐Meyer, Véronique Taieb, Julien Volet, Julien Louvet, Christophe Anota, Amélie Bonnetain, Franck Cancer Med Clinical Cancer Research BACKGROUND: The phase II AFUGEM GERCOR trial aimed to assess the efficacy of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine (gemcitabine group) or simplified leucovorin and fluorouracil (sLV5FU2 group) in patients with previously untreated metastatic pancreatic cancer. Results of progression‐free survival at 4 months (primary endpoint) were in favor of the sLV5FU2 group. This paper presents health‐related quality of life (HRQoL) data as a secondary endpoint. METHODS: HRQoL was assessed using the EORTC QLQ‐C30 questionnaire at baseline and at each chemotherapy cycle until the end of treatment. The HRQoL deterioration‐free survival (QFS) was used as a modality of longitudinal analysis. QFS was defined as the time between randomization and the first definitive HRQoL score deterioration as compared to the baseline score, or death. Sensitivity analysis was performed excluding death as an event. Univariate Cox models were used to estimate hazard ratios (HRs) and 90% confidence intervals (CIs) of the treatment effect. RESULTS: Between 2013 and 2014, 114 patients were randomized in a 1:2 ratio (39 in the gemcitabine group and 75 in the sLV5FU2 group). Patients in the sLV5FU2 group seemed to present longer QFS than those of the gemcitabine group for 14 out of 15 dimensions, with HRs < 1. Results of the sensitivity analysis excluding death as an event were significantly in favor of the sLV5FU2 group for physical functioning (HR = 0.51 [90% CI 0.27‐0.97]) and pain (HR = 0.26 [90% CI 0.09‐0.74]). CONCLUSION: The nab‐paclitaxel plus simplified leucovorin and fluorouracil combination had no negative impact in exploratory HRQoL analyses. John Wiley and Sons Inc. 2019-07-17 /pmc/articles/PMC6718524/ /pubmed/31314957 http://dx.doi.org/10.1002/cam4.2311 Text en © 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Cancer Research Charton, Emilie Bachet, Jean‐Baptiste Hammel, Pascal Desramé, Jérôme Chibaudel, Benoist Cohen, Romain Debourdeau, Philippe Dauba, Jérome Lecomte, Thierry Seitz, Jean‐François Tournigand, Christophe Aparicio, Thomas Guerin‐Meyer, Véronique Taieb, Julien Volet, Julien Louvet, Christophe Anota, Amélie Bonnetain, Franck Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial |
title | Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial |
title_full | Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial |
title_fullStr | Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial |
title_full_unstemmed | Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial |
title_short | Impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial |
title_sort | impact on health‐related quality of life deterioration‐free survival of a first‐line therapy combining nab‐paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: results of the randomized phase ii afugem gercor clinical trial |
topic | Clinical Cancer Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6718524/ https://www.ncbi.nlm.nih.gov/pubmed/31314957 http://dx.doi.org/10.1002/cam4.2311 |
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