A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique

Background: Whole-breast radiotherapy (WBRT) is the standard treatment for breast cancer following breast-conserving surgery. Evidence shows that tumour recurrences occur near the original cancer: the tumour bed. New treatment developments include increasing dose to the tumour bed during WBRT (synch...

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Main Authors: Emma J Harris, Mukesh Mukesh, Rajesh Jena, Angela Baker, Harry Bartelink, Corrinne Brooks, June Dean, Ellen M Donovan, Sandra Collette, Sally Eagle, John D Fenwick, Peter H Graham, Jo S Haviland, Anna M Kirby, Helen Mayles, Robert A Mitchell, Rosalind Perry, Philip Poortmans, Andrew Poynter, Glyn Shentall, Jenny Titley, Alistair Thompson, John R Yarnold, Charlotte E Coles, Philip M Evans, on behalf of the IMPORT Trials Management Group
Format: Article
Language:English
Published: NIHR Journals Library 2014-11-01
Series:Efficacy and Mechanism Evaluation
Subjects:
Online Access:https://doi.org/10.3310/eme01030
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author Emma J Harris
Mukesh Mukesh
Rajesh Jena
Angela Baker
Harry Bartelink
Corrinne Brooks
June Dean
Ellen M Donovan
Sandra Collette
Sally Eagle
John D Fenwick
Peter H Graham
Jo S Haviland
Anna M Kirby
Helen Mayles
Robert A Mitchell
Rosalind Perry
Philip Poortmans
Andrew Poynter
Glyn Shentall
Jenny Titley
Alistair Thompson
John R Yarnold
Charlotte E Coles
Philip M Evans
on behalf of the IMPORT Trials Management Group
author_facet Emma J Harris
Mukesh Mukesh
Rajesh Jena
Angela Baker
Harry Bartelink
Corrinne Brooks
June Dean
Ellen M Donovan
Sandra Collette
Sally Eagle
John D Fenwick
Peter H Graham
Jo S Haviland
Anna M Kirby
Helen Mayles
Robert A Mitchell
Rosalind Perry
Philip Poortmans
Andrew Poynter
Glyn Shentall
Jenny Titley
Alistair Thompson
John R Yarnold
Charlotte E Coles
Philip M Evans
on behalf of the IMPORT Trials Management Group
author_sort Emma J Harris
collection DOAJ
description Background: Whole-breast radiotherapy (WBRT) is the standard treatment for breast cancer following breast-conserving surgery. Evidence shows that tumour recurrences occur near the original cancer: the tumour bed. New treatment developments include increasing dose to the tumour bed during WBRT (synchronous integrated boost) and irradiating only the region around the tumour bed, for patients at high and low risk of tumour recurrence, respectively. Currently, standard imaging uses bony anatomy to ensure accurate delivery of WBRT. It is debatable whether or not more targeted treatments such as synchronous integrated boost and partial-breast radiotherapy require image-guided radiotherapy (IGRT) focusing on implanted tumour bed clips (clip-based IGRT). Objectives: Primary – to compare accuracy of patient set-up using standard imaging compared with clip-based IGRT. Secondary – comparison of imaging techniques using (1) tumour bed radiotherapy safety margins, (2) volume of breast tissue irradiated around tumour bed, (3) estimated breast toxicity following development of a normal tissue control probability model and (4) time taken. Design: Multicentre observational study embedded within a national randomised trial: IMPORT-HIGH (Intensity Modulated and Partial Organ Radiotherapy – HIGHer-risk patient group) testing synchronous integrated boost and using clip-based IGRT. Setting: Five radiotherapy departments, participating in IMPORT-HIGH. Participants: Two-hundred and eighteen patients receiving breast radiotherapy within IMPORT-HIGH. Interventions: There was no direct intervention in patients’ treatment. Experimental and control intervention were clip-based IGRT and standard imaging, respectively. IMPORT-HIGH patients received clip-based IGRT as routine; standard imaging data were obtained from clip-based IGRT images. Main outcome measures: Difference in (1) set-up errors, (2) safety margins, (3) volume of breast tissue irradiated, (4) breast toxicity and (5) time, between clip-based IGRT and standard imaging. Results: The primary outcome of overall mean difference in clip-based IGRT and standard imaging using daily set-up errors was 2–2.6 mm (p < 0.001). Heterogeneity testing between centres found a statistically significant difference in set-up errors at one centre. For four centres (179 patients), clip-based IGRT gave a mean decrease in the systematic set-up error of between 1 mm and 2 mm compared with standard imaging. Secondary outcomes were as follows: clip-based IGRT and standard imaging safety margins were less than 5 mm and 8 mm, respectively. Using clip-based IGRT, the median volume of tissue receiving 95% of prescribed boost dose decreased by 29 cm3 (range 11–193 cm3) compared with standard imaging. Difference in median time required to perform clip-based IGRT compared with standard imaging was X-ray imaging technique dependent (range 8–76 seconds). It was not possible to estimate differences in breast toxicity, the normal tissue control probability model indicated that for breast fibrosis maximum radiotherapy dose is more important than volume of tissue irradiated. Conclusions and implications for clinical practice: Margins of less than 8 mm cannot be used safely without clip-based IGRT for patients receiving concomitant tumour bed boost, as there is a risk of geographical miss of the tumour bed being treated. In principle, smaller but accurately placed margins may influence local control and toxicity rates, but this needs to be evaluated from mature clinical trial data in the future. Funding: This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.
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spelling doaj.art-1dda8bc383744990b5ba37123bbe30572022-12-22T02:04:21ZengNIHR Journals LibraryEfficacy and Mechanism Evaluation2050-43652050-43732014-11-011310.3310/eme0103009/150/16A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging techniqueEmma J Harris0Mukesh Mukesh1Rajesh Jena2Angela Baker3Harry Bartelink4Corrinne Brooks5June Dean6Ellen M Donovan7Sandra Collette8Sally Eagle9John D Fenwick10Peter H Graham11Jo S Haviland12Anna M Kirby13Helen Mayles14Robert A Mitchell15Rosalind Perry16Philip Poortmans17Andrew Poynter18Glyn Shentall19Jenny Titley20Alistair Thompson21John R Yarnold22Charlotte E Coles23Philip M Evans24on behalf of the IMPORT Trials Management GroupJoint Department of Physics at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UKOncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKOncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKDepartment of Radiotherapy and Physics, The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, UKDepartment of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the NetherlandsJoint Department of Physics at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UKOncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKJoint Department of Physics at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UKStatistics Department, EORTC Headquarters, Brussels, BelgiumDepartment of Radiotherapy, Royal Marsden Hospital NHS Foundation Trust, London, UKDepartment of Oncology, University of Oxford, Oxford, UKCancer Care Centre, St George Hospital, Kogarah, Sydney, NSW, AustraliaICR-CTSU, Institute of Cancer Research, London, UKBreast Unit, Royal Marsden NHS Foundation Trust, London, UKDepartment of Radiotherapy and Physics, The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, UKJoint Department of Physics at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UKRadiotherapy Department, Ipswich Hospitals NHS Trust, Ipswich, UKDepartment of Radiation Oncology, Dr Bernard Verbeeten Instituut, Tilburg, the NetherlandsRadiotherapy Department, Peterborough City Hospital, Peterborough, UKRosemere Cancer Centre, Lancashire Teaching Hospitals NHS Trust, Preston, UKICR-CTSU, Institute of Cancer Research, London, UKSchool of Medicine, University of Dundee, Dundee, UKBreast Unit, Royal Marsden NHS Foundation Trust, London, UKOncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKJoint Department of Physics at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UKBackground: Whole-breast radiotherapy (WBRT) is the standard treatment for breast cancer following breast-conserving surgery. Evidence shows that tumour recurrences occur near the original cancer: the tumour bed. New treatment developments include increasing dose to the tumour bed during WBRT (synchronous integrated boost) and irradiating only the region around the tumour bed, for patients at high and low risk of tumour recurrence, respectively. Currently, standard imaging uses bony anatomy to ensure accurate delivery of WBRT. It is debatable whether or not more targeted treatments such as synchronous integrated boost and partial-breast radiotherapy require image-guided radiotherapy (IGRT) focusing on implanted tumour bed clips (clip-based IGRT). Objectives: Primary – to compare accuracy of patient set-up using standard imaging compared with clip-based IGRT. Secondary – comparison of imaging techniques using (1) tumour bed radiotherapy safety margins, (2) volume of breast tissue irradiated around tumour bed, (3) estimated breast toxicity following development of a normal tissue control probability model and (4) time taken. Design: Multicentre observational study embedded within a national randomised trial: IMPORT-HIGH (Intensity Modulated and Partial Organ Radiotherapy – HIGHer-risk patient group) testing synchronous integrated boost and using clip-based IGRT. Setting: Five radiotherapy departments, participating in IMPORT-HIGH. Participants: Two-hundred and eighteen patients receiving breast radiotherapy within IMPORT-HIGH. Interventions: There was no direct intervention in patients’ treatment. Experimental and control intervention were clip-based IGRT and standard imaging, respectively. IMPORT-HIGH patients received clip-based IGRT as routine; standard imaging data were obtained from clip-based IGRT images. Main outcome measures: Difference in (1) set-up errors, (2) safety margins, (3) volume of breast tissue irradiated, (4) breast toxicity and (5) time, between clip-based IGRT and standard imaging. Results: The primary outcome of overall mean difference in clip-based IGRT and standard imaging using daily set-up errors was 2–2.6 mm (p < 0.001). Heterogeneity testing between centres found a statistically significant difference in set-up errors at one centre. For four centres (179 patients), clip-based IGRT gave a mean decrease in the systematic set-up error of between 1 mm and 2 mm compared with standard imaging. Secondary outcomes were as follows: clip-based IGRT and standard imaging safety margins were less than 5 mm and 8 mm, respectively. Using clip-based IGRT, the median volume of tissue receiving 95% of prescribed boost dose decreased by 29 cm3 (range 11–193 cm3) compared with standard imaging. Difference in median time required to perform clip-based IGRT compared with standard imaging was X-ray imaging technique dependent (range 8–76 seconds). It was not possible to estimate differences in breast toxicity, the normal tissue control probability model indicated that for breast fibrosis maximum radiotherapy dose is more important than volume of tissue irradiated. Conclusions and implications for clinical practice: Margins of less than 8 mm cannot be used safely without clip-based IGRT for patients receiving concomitant tumour bed boost, as there is a risk of geographical miss of the tumour bed being treated. In principle, smaller but accurately placed margins may influence local control and toxicity rates, but this needs to be evaluated from mature clinical trial data in the future. Funding: This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.https://doi.org/10.3310/eme01030breastcancerradiotherapyimage-guidanceclip-based imagingbony anatomy imagingx-raycomputed tomography
spellingShingle Emma J Harris
Mukesh Mukesh
Rajesh Jena
Angela Baker
Harry Bartelink
Corrinne Brooks
June Dean
Ellen M Donovan
Sandra Collette
Sally Eagle
John D Fenwick
Peter H Graham
Jo S Haviland
Anna M Kirby
Helen Mayles
Robert A Mitchell
Rosalind Perry
Philip Poortmans
Andrew Poynter
Glyn Shentall
Jenny Titley
Alistair Thompson
John R Yarnold
Charlotte E Coles
Philip M Evans
on behalf of the IMPORT Trials Management Group
A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique
Efficacy and Mechanism Evaluation
breast
cancer
radiotherapy
image-guidance
clip-based imaging
bony anatomy imaging
x-ray
computed tomography
title A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique
title_full A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique
title_fullStr A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique
title_full_unstemmed A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique
title_short A multicentre observational study evaluating image-guided radiotherapy for more accurate partial-breast intensity-modulated radiotherapy: comparison with standard imaging technique
title_sort multicentre observational study evaluating image guided radiotherapy for more accurate partial breast intensity modulated radiotherapy comparison with standard imaging technique
topic breast
cancer
radiotherapy
image-guidance
clip-based imaging
bony anatomy imaging
x-ray
computed tomography
url https://doi.org/10.3310/eme01030
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