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Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT

Douglas Adamson, Jane Blazeby, Catharine Porter, Christopher Hurt, Gareth Griffiths, Annmarie Nelson, Berni Sewell Orcid Logo, Mari Jones Orcid Logo, Martina Svobodova, Deborah Fitzsimmons Orcid Logo, Lisette Nixon, Jim Fitzgibbon, Stephen Thomas, Anthony Millin, Tom Crosby, John Staffurth, Anthony Byrne

Health Technology Assessment, Volume: 25, Issue: 31, Pages: 1 - 144

Swansea University Authors: Berni Sewell Orcid Logo, Mari Jones Orcid Logo, Deborah Fitzsimmons Orcid Logo

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DOI (Published version): 10.3310/hta25310

Abstract

BackgroundMost patients with oesophageal cancer present with incurable disease. For those with advanced disease, the mean survival is 3–5 months. Treatment emphasis is therefore on effective palliation, with the majority of patients requiring intervention for dysphagia. Insertion of a self-expanding...

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Published in: Health Technology Assessment
ISSN: 1366-5278 2046-4924
Published: National Institute for Health Research 2021
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For those with advanced disease, the mean survival is 3&#x2013;5 months. Treatment emphasis is therefore on effective palliation, with the majority of patients requiring intervention for dysphagia. Insertion of a self-expanding metal stent provides rapid relief but dysphagia may recur within 3 months owing to tumour progression. Evidence reviews have called for trials of interventions combined with stenting to better maintain the ability to swallow.ObjectivesThe Radiotherapy after Oesophageal Cancer Stenting (ROCS) study examined the effectiveness of palliative radiotherapy, combined with insertion of a stent, in maintaining the ability to swallow. The trial also examined the impact that the ability to swallow had on quality of life, bleeding events, survival and cost-effectiveness.DesignA pragmatic, multicentre, randomised controlled trial with follow-up every 4 weeks for 12 months. An embedded qualitative study examined trial experiences in a participant subgroup.SettingParticipants were recruited in secondary care, with all planned follow-up at home.ParticipantsPatients who were referred for stent insertion as the primary management of dysphagia related to incurable oesophageal cancer.InterventionsFollowing stent insertion, the external beam radiotherapy arm received palliative oesophageal radiotherapy at a dose of 20&#x2009;Gy in five fractions or 30&#x2009;Gy in 10 fractions.Main outcome measuresThe primary outcome was the difference in the proportion of participants with recurrent dysphagia, or death, at 12 weeks. Recurrent dysphagia was defined as deterioration of &#x2265;&#x2009;11 points on the dysphagia scale of the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire oesophago-gastric module questionnaire. Secondary outcomes included quality of life, bleeding risk and survival.ResultsThe study recruited 220 patients: 112 were randomised to the usual-care arm and 108 were randomised to the external beam radiotherapy arm. There was no evidence that radiotherapy reduced recurrence of dysphagia at 12 weeks (48.6% in the usual-care arm compared with 45.3% in the external beam radiotherapy arm; adjusted odds ratio 0.82, 95% confidence interval 0.40 to 1.68; p&#x2009;=&#x2009;0.587) and it was less cost-effective than stent insertion alone. There was no difference in median survival or key quality-of-life outcomes. There were fewer bleeding events in the external beam radiotherapy arm. Exploration of patient experience prompted changes to trial processes. Participants in both trial arms experienced difficulty in managing the physical and psychosocial aspects of eating restriction and uncertainties of living with advanced oesophageal cancer.LimitationsChange in timing of the primary outcome to 12 weeks may affect the ability to detect a true intervention effect. However, consistency of results across sensitivity analyses is robust, including secondary analysis of dysphagia deterioration-free survival.ConclusionsWidely accessible palliative external beam radiotherapy in combination with stent insertion does not reduce the risk of dysphagia recurrence at 12 weeks, does not have an impact on survival and is less cost-effective than inserting a stent alone. Reductions in bleeding events should be considered in the context of patient-described trade-offs of fatigue and burdens of attending hospital. Trial design elements including at-home data capture, regular multicentre nurse meetings and qualitative enquiry improved recruitment/data capture, and should be considered for future studies.Future workFurther studies are required to identify interventions that improve stent efficacy and to address the multidimensional challenges of eating and nutrition in this patient population.Trial registrationCurrent Controlled Trials ISRCTN12376468 and Clinicaltrials.gov NCT01915693.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 31. See the NIHR Journals Library website for further project information.</abstract><type>Journal Article</type><journal>Health Technology Assessment</journal><volume>25</volume><journalNumber>31</journalNumber><paginationStart>1</paginationStart><paginationEnd>144</paginationEnd><publisher>National Institute for Health Research</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1366-5278</issnPrint><issnElectronic>2046-4924</issnElectronic><keywords/><publishedDay>1</publishedDay><publishedMonth>5</publishedMonth><publishedYear>2021</publishedYear><publishedDate>2021-05-01</publishedDate><doi>10.3310/hta25310</doi><url/><notes/><college>COLLEGE NANME</college><department>Public Health</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>PHAC</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><lastEdited>2021-06-15T16:07:44.6187498</lastEdited><Created>2021-05-27T10:40:07.6813650</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care</level></path><authors><author><firstname>Douglas</firstname><surname>Adamson</surname><order>1</order></author><author><firstname>Jane</firstname><surname>Blazeby</surname><order>2</order></author><author><firstname>Catharine</firstname><surname>Porter</surname><order>3</order></author><author><firstname>Christopher</firstname><surname>Hurt</surname><order>4</order></author><author><firstname>Gareth</firstname><surname>Griffiths</surname><order>5</order></author><author><firstname>Annmarie</firstname><surname>Nelson</surname><order>6</order></author><author><firstname>Berni</firstname><surname>Sewell</surname><orcid>0000-0001-5471-922X</orcid><order>7</order></author><author><firstname>Mari</firstname><surname>Jones</surname><orcid>0000-0001-9661-4899</orcid><order>8</order></author><author><firstname>Martina</firstname><surname>Svobodova</surname><order>9</order></author><author><firstname>Deborah</firstname><surname>Fitzsimmons</surname><orcid>0000-0002-7286-8410</orcid><order>10</order></author><author><firstname>Lisette</firstname><surname>Nixon</surname><order>11</order></author><author><firstname>Jim</firstname><surname>Fitzgibbon</surname><order>12</order></author><author><firstname>Stephen</firstname><surname>Thomas</surname><order>13</order></author><author><firstname>Anthony</firstname><surname>Millin</surname><order>14</order></author><author><firstname>Tom</firstname><surname>Crosby</surname><order>15</order></author><author><firstname>John</firstname><surname>Staffurth</surname><order>16</order></author><author><firstname>Anthony</firstname><surname>Byrne</surname><order>17</order></author></authors><documents><document><filename>56975__20166__51c5ea4e040744d79c7feb5ecc55af4f.pdf</filename><originalFilename>56975.pdf</originalFilename><uploaded>2021-06-15T16:04:54.1050744</uploaded><type>Output</type><contentLength>2205844</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>Released under the terms of a UK government&#x2019;s non-commercial license for public sector information</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2021-06-15T16:07:44.6187498 v2 56975 2021-05-27 Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT f6a4af2cfa4275d2a8ebba292fa14421 0000-0001-5471-922X Berni Sewell Berni Sewell true false 8e326860810f5f960b088db10ef58906 0000-0001-9661-4899 Mari Jones Mari Jones true false e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 2021-05-27 PHAC BackgroundMost patients with oesophageal cancer present with incurable disease. For those with advanced disease, the mean survival is 3–5 months. Treatment emphasis is therefore on effective palliation, with the majority of patients requiring intervention for dysphagia. Insertion of a self-expanding metal stent provides rapid relief but dysphagia may recur within 3 months owing to tumour progression. Evidence reviews have called for trials of interventions combined with stenting to better maintain the ability to swallow.ObjectivesThe Radiotherapy after Oesophageal Cancer Stenting (ROCS) study examined the effectiveness of palliative radiotherapy, combined with insertion of a stent, in maintaining the ability to swallow. The trial also examined the impact that the ability to swallow had on quality of life, bleeding events, survival and cost-effectiveness.DesignA pragmatic, multicentre, randomised controlled trial with follow-up every 4 weeks for 12 months. An embedded qualitative study examined trial experiences in a participant subgroup.SettingParticipants were recruited in secondary care, with all planned follow-up at home.ParticipantsPatients who were referred for stent insertion as the primary management of dysphagia related to incurable oesophageal cancer.InterventionsFollowing stent insertion, the external beam radiotherapy arm received palliative oesophageal radiotherapy at a dose of 20 Gy in five fractions or 30 Gy in 10 fractions.Main outcome measuresThe primary outcome was the difference in the proportion of participants with recurrent dysphagia, or death, at 12 weeks. Recurrent dysphagia was defined as deterioration of ≥ 11 points on the dysphagia scale of the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire oesophago-gastric module questionnaire. Secondary outcomes included quality of life, bleeding risk and survival.ResultsThe study recruited 220 patients: 112 were randomised to the usual-care arm and 108 were randomised to the external beam radiotherapy arm. There was no evidence that radiotherapy reduced recurrence of dysphagia at 12 weeks (48.6% in the usual-care arm compared with 45.3% in the external beam radiotherapy arm; adjusted odds ratio 0.82, 95% confidence interval 0.40 to 1.68; p = 0.587) and it was less cost-effective than stent insertion alone. There was no difference in median survival or key quality-of-life outcomes. There were fewer bleeding events in the external beam radiotherapy arm. Exploration of patient experience prompted changes to trial processes. Participants in both trial arms experienced difficulty in managing the physical and psychosocial aspects of eating restriction and uncertainties of living with advanced oesophageal cancer.LimitationsChange in timing of the primary outcome to 12 weeks may affect the ability to detect a true intervention effect. However, consistency of results across sensitivity analyses is robust, including secondary analysis of dysphagia deterioration-free survival.ConclusionsWidely accessible palliative external beam radiotherapy in combination with stent insertion does not reduce the risk of dysphagia recurrence at 12 weeks, does not have an impact on survival and is less cost-effective than inserting a stent alone. Reductions in bleeding events should be considered in the context of patient-described trade-offs of fatigue and burdens of attending hospital. Trial design elements including at-home data capture, regular multicentre nurse meetings and qualitative enquiry improved recruitment/data capture, and should be considered for future studies.Future workFurther studies are required to identify interventions that improve stent efficacy and to address the multidimensional challenges of eating and nutrition in this patient population.Trial registrationCurrent Controlled Trials ISRCTN12376468 and Clinicaltrials.gov NCT01915693.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 31. See the NIHR Journals Library website for further project information. Journal Article Health Technology Assessment 25 31 1 144 National Institute for Health Research 1366-5278 2046-4924 1 5 2021 2021-05-01 10.3310/hta25310 COLLEGE NANME Public Health COLLEGE CODE PHAC Swansea University Another institution paid the OA fee 2021-06-15T16:07:44.6187498 2021-05-27T10:40:07.6813650 Faculty of Medicine, Health and Life Sciences School of Health and Social Care Douglas Adamson 1 Jane Blazeby 2 Catharine Porter 3 Christopher Hurt 4 Gareth Griffiths 5 Annmarie Nelson 6 Berni Sewell 0000-0001-5471-922X 7 Mari Jones 0000-0001-9661-4899 8 Martina Svobodova 9 Deborah Fitzsimmons 0000-0002-7286-8410 10 Lisette Nixon 11 Jim Fitzgibbon 12 Stephen Thomas 13 Anthony Millin 14 Tom Crosby 15 John Staffurth 16 Anthony Byrne 17 56975__20166__51c5ea4e040744d79c7feb5ecc55af4f.pdf 56975.pdf 2021-06-15T16:04:54.1050744 Output 2205844 application/pdf Version of Record true Released under the terms of a UK government’s non-commercial license for public sector information true eng http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/version/2/
title Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT
spellingShingle Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT
Berni Sewell
Mari Jones
Deborah Fitzsimmons
title_short Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT
title_full Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT
title_fullStr Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT
title_full_unstemmed Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT
title_sort Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT
author_id_str_mv f6a4af2cfa4275d2a8ebba292fa14421
8e326860810f5f960b088db10ef58906
e900d99a0977beccf607233b10c66b43
author_id_fullname_str_mv f6a4af2cfa4275d2a8ebba292fa14421_***_Berni Sewell
8e326860810f5f960b088db10ef58906_***_Mari Jones
e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
author Berni Sewell
Mari Jones
Deborah Fitzsimmons
author2 Douglas Adamson
Jane Blazeby
Catharine Porter
Christopher Hurt
Gareth Griffiths
Annmarie Nelson
Berni Sewell
Mari Jones
Martina Svobodova
Deborah Fitzsimmons
Lisette Nixon
Jim Fitzgibbon
Stephen Thomas
Anthony Millin
Tom Crosby
John Staffurth
Anthony Byrne
format Journal article
container_title Health Technology Assessment
container_volume 25
container_issue 31
container_start_page 1
publishDate 2021
institution Swansea University
issn 1366-5278
2046-4924
doi_str_mv 10.3310/hta25310
publisher National Institute for Health Research
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care
document_store_str 1
active_str 0
description BackgroundMost patients with oesophageal cancer present with incurable disease. For those with advanced disease, the mean survival is 3–5 months. Treatment emphasis is therefore on effective palliation, with the majority of patients requiring intervention for dysphagia. Insertion of a self-expanding metal stent provides rapid relief but dysphagia may recur within 3 months owing to tumour progression. Evidence reviews have called for trials of interventions combined with stenting to better maintain the ability to swallow.ObjectivesThe Radiotherapy after Oesophageal Cancer Stenting (ROCS) study examined the effectiveness of palliative radiotherapy, combined with insertion of a stent, in maintaining the ability to swallow. The trial also examined the impact that the ability to swallow had on quality of life, bleeding events, survival and cost-effectiveness.DesignA pragmatic, multicentre, randomised controlled trial with follow-up every 4 weeks for 12 months. An embedded qualitative study examined trial experiences in a participant subgroup.SettingParticipants were recruited in secondary care, with all planned follow-up at home.ParticipantsPatients who were referred for stent insertion as the primary management of dysphagia related to incurable oesophageal cancer.InterventionsFollowing stent insertion, the external beam radiotherapy arm received palliative oesophageal radiotherapy at a dose of 20 Gy in five fractions or 30 Gy in 10 fractions.Main outcome measuresThe primary outcome was the difference in the proportion of participants with recurrent dysphagia, or death, at 12 weeks. Recurrent dysphagia was defined as deterioration of ≥ 11 points on the dysphagia scale of the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire oesophago-gastric module questionnaire. Secondary outcomes included quality of life, bleeding risk and survival.ResultsThe study recruited 220 patients: 112 were randomised to the usual-care arm and 108 were randomised to the external beam radiotherapy arm. There was no evidence that radiotherapy reduced recurrence of dysphagia at 12 weeks (48.6% in the usual-care arm compared with 45.3% in the external beam radiotherapy arm; adjusted odds ratio 0.82, 95% confidence interval 0.40 to 1.68; p = 0.587) and it was less cost-effective than stent insertion alone. There was no difference in median survival or key quality-of-life outcomes. There were fewer bleeding events in the external beam radiotherapy arm. Exploration of patient experience prompted changes to trial processes. Participants in both trial arms experienced difficulty in managing the physical and psychosocial aspects of eating restriction and uncertainties of living with advanced oesophageal cancer.LimitationsChange in timing of the primary outcome to 12 weeks may affect the ability to detect a true intervention effect. However, consistency of results across sensitivity analyses is robust, including secondary analysis of dysphagia deterioration-free survival.ConclusionsWidely accessible palliative external beam radiotherapy in combination with stent insertion does not reduce the risk of dysphagia recurrence at 12 weeks, does not have an impact on survival and is less cost-effective than inserting a stent alone. Reductions in bleeding events should be considered in the context of patient-described trade-offs of fatigue and burdens of attending hospital. Trial design elements including at-home data capture, regular multicentre nurse meetings and qualitative enquiry improved recruitment/data capture, and should be considered for future studies.Future workFurther studies are required to identify interventions that improve stent efficacy and to address the multidimensional challenges of eating and nutrition in this patient population.Trial registrationCurrent Controlled Trials ISRCTN12376468 and Clinicaltrials.gov NCT01915693.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 31. See the NIHR Journals Library website for further project information.
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