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Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase?

BACKGROUND: The ACTION trial was initiated to provide evidence from a randomised trial on the effects of chemotherapy in women aged over 70 years where evidence for risk and benefit are lacking. METHODS: This was a randomised, phase III clinical trial for high risk, oestrogen receptor (ER) negative/...

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Autores principales: Leonard, R, Ballinger, R, Cameron, D, Ellis, P, Fallowfield, L, Gosney, M, Johnson, L, Kilburn, L S, Makris, A, Mansi, J, Reed, M, Ring, A, Robinson, A, Simmonds, P, Thomas, G, Bliss, J M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241551/
https://www.ncbi.nlm.nih.gov/pubmed/21989185
http://dx.doi.org/10.1038/bjc.2011.377
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author Leonard, R
Ballinger, R
Cameron, D
Ellis, P
Fallowfield, L
Gosney, M
Johnson, L
Kilburn, L S
Makris, A
Mansi, J
Reed, M
Ring, A
Robinson, A
Simmonds, P
Thomas, G
Bliss, J M
author_facet Leonard, R
Ballinger, R
Cameron, D
Ellis, P
Fallowfield, L
Gosney, M
Johnson, L
Kilburn, L S
Makris, A
Mansi, J
Reed, M
Ring, A
Robinson, A
Simmonds, P
Thomas, G
Bliss, J M
author_sort Leonard, R
collection PubMed
description BACKGROUND: The ACTION trial was initiated to provide evidence from a randomised trial on the effects of chemotherapy in women aged over 70 years where evidence for risk and benefit are lacking. METHODS: This was a randomised, phase III clinical trial for high risk, oestrogen receptor (ER) negative/ER weakly positive early breast cancer. The trial planned to recruit 1000 women aged 70 years and older, randomised to receive 4 cycles of anthracycline chemotherapy or observation. The primary endpoint was relapse-free interval. The trial included a pilot phase to assess the acceptability and feasibility of recruitment. RESULTS: The trial opened at 43 UK centres. Information on number of patients approached was available from 38 centres. Of the 43 eligible patients that were approached, 39 were not randomised due to patients declining entry. After 10 months only 4 patients had been randomised and after discussion with the research funder, the trial was closed and funding terminated. CONCLUSION: Despite widespread support at several public meetings, input from patient groups including representation on the Trial Management Group, the trial failed to recruit due to the inability to convince patients to accept randomisation. It would therefore seem that randomising the patients to receive chemotherapy vs observation is not a viable design in the current era for this patient population.
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spelling pubmed-32415512012-10-25 Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase? Leonard, R Ballinger, R Cameron, D Ellis, P Fallowfield, L Gosney, M Johnson, L Kilburn, L S Makris, A Mansi, J Reed, M Ring, A Robinson, A Simmonds, P Thomas, G Bliss, J M Br J Cancer Clinical Study BACKGROUND: The ACTION trial was initiated to provide evidence from a randomised trial on the effects of chemotherapy in women aged over 70 years where evidence for risk and benefit are lacking. METHODS: This was a randomised, phase III clinical trial for high risk, oestrogen receptor (ER) negative/ER weakly positive early breast cancer. The trial planned to recruit 1000 women aged 70 years and older, randomised to receive 4 cycles of anthracycline chemotherapy or observation. The primary endpoint was relapse-free interval. The trial included a pilot phase to assess the acceptability and feasibility of recruitment. RESULTS: The trial opened at 43 UK centres. Information on number of patients approached was available from 38 centres. Of the 43 eligible patients that were approached, 39 were not randomised due to patients declining entry. After 10 months only 4 patients had been randomised and after discussion with the research funder, the trial was closed and funding terminated. CONCLUSION: Despite widespread support at several public meetings, input from patient groups including representation on the Trial Management Group, the trial failed to recruit due to the inability to convince patients to accept randomisation. It would therefore seem that randomising the patients to receive chemotherapy vs observation is not a viable design in the current era for this patient population. Nature Publishing Group 2011-10-25 2011-10-11 /pmc/articles/PMC3241551/ /pubmed/21989185 http://dx.doi.org/10.1038/bjc.2011.377 Text en Copyright © 2011 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
Leonard, R
Ballinger, R
Cameron, D
Ellis, P
Fallowfield, L
Gosney, M
Johnson, L
Kilburn, L S
Makris, A
Mansi, J
Reed, M
Ring, A
Robinson, A
Simmonds, P
Thomas, G
Bliss, J M
Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase?
title Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase?
title_full Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase?
title_fullStr Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase?
title_full_unstemmed Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase?
title_short Adjuvant chemotherapy in older women (ACTION) study – what did we learn from the pilot phase?
title_sort adjuvant chemotherapy in older women (action) study – what did we learn from the pilot phase?
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241551/
https://www.ncbi.nlm.nih.gov/pubmed/21989185
http://dx.doi.org/10.1038/bjc.2011.377
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