TY - JOUR
T1 - Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma
T2 - An Open-Label, Multicenter, Phase III Randomized Trial
AU - Bayman, Neil
AU - Appel, Wiebke
AU - Ashcroft, Linda
AU - Baldwin, David R
AU - Bates, Andrew
AU - Darlison, Liz
AU - Edwards, John G
AU - Ezhil, Veni
AU - Gilligan, David
AU - Hatton, Matthew
AU - Jegannathen, Apurna
AU - Mansy, Talal
AU - Peake, Michael D
AU - Pemberton, Laura
AU - Rintoul, Robert C
AU - Snee, Michael
AU - Ryder, W David
AU - Taylor, Paul
AU - Faivre-Finn, Corinne
N1 - Funding Information:
1The Christie National Health Service Foundation Trust, Manchester, United Kingdom 2Lancashire Teaching Hospitals National Health Service Foundation Trust, Preston, United Kingdom 3Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom 4University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom 5University Hospitals of Leicester National Health Service Trust, Leicester, United Kingdom 6Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom 7Royal Surrey County Hospital, National Health Service Foundation Trust, Guildford, United Kingdom 8Cambridge University Hospital National Health Service Foundation Trust, Cambridge, United Kingdom 9University Hospitals of North Midlands National Health Service Trust, Stoke-on-Trent, United Kingdom 10South Tees Hospitals National Health Service Foundation Trust, Middlesbrough, United Kingdom 11Cancer Research UK Cambridge Centre, Cambridge, United Kingdom 12Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom 13Manchester University National Health Service Foundation Trust, Manchester, United Kingdom 14University of Manchester, Manchester, United Kingdom
Funding Information:
Funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Program (Grant No. PB-PG-1010-23232); C.F.-F. is supported by the NIHR Manchester Biomedical Research Centre.
Funding Information:
Collection and assembly of data: Neil Bayman, Wiebke Appel, Linda Ashcroft, Andrew Bates, Liz Darlison, John G. Edwards, Veni Ezhil, David Gilligan, Matthew Hatton, Apurna Jegannathen, Talal Mansy, Laura Pemberton, Robert C. Rintoul, Paul Taylor, Corinne Faivre-Finn Data analysis and interpretation: Neil Bayman, Linda Ashcroft, Liz Darlison, John G. Edwards, David Gilligan, Matthew Hatton, Apurna Jegannathen, Michael D. Peake, Robert C. Rintoul, W. David Ryder, Corinne Faivre-Finn Manuscript writing: All authors Final approval of manuscript: All authors Accountable for all aspects of the work: All authors ACKNOWLEDGMENT We acknowledge the support of the Manchester Clinical Trials Unit, David Ardron (patient representative), and all the investigators at the participating sites: Dr Mike Bayne (Dorset Cancer Centre, Poole Hospital National Health Service [NHS] Foundation Trust), Dr Adityanarayan Bhatnagar (Salisbury NHS Foundation Trust), Dr Russell Burcombe (Maidstone and Tunbridge Wells NHS Trust), Dr Paul Burt (Leighton Hospital, Mid Cheshire Hospitals NHS Foundation Trust), Dr Samuel Chan (Harrogate and District NHS Foundation Trust), Dr Adhro Chaudhuri (United Lincolnshire Hospitals NHS Trust), Dr Shan Chetiyawardana (Queen’s Hospital, Burton Hospitals NHS Foundation Trust), Dr Mathilda Cominos (East Kent Hospitals University NHS Foundation Trust), Dr Paul Fenton (Isle of Wight NHS Trust), Dr Caroline Humber (South Warwickshire NHS Foundation Trust), Dr Karen Foweraker (Sherwood Forest Hospitals NHS Foundation Trust), Dr Qamar Ghafoor (University Hospitals Birmingham NHS Foundation Trust), Dr Niladri Ghosal (Glan Clwyd Hospital), Dr Anupama Gore (Northampton General Hospital NHS Trust), Dr Nishi Gupta (North Middlesex University Hospital NHS Trust), Dr Maher Hadaki (Medway NHS Foundation Trust), Dr Margaret Harris (Tameside and Glossop Integrated Care NHS Foundation Trust), Dr Mark Hocking (University Hospital Coventry & Warwickshire NHS Trust), Dr Andrew Jackson (Basingstoke & North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust), Dr Pooja Jain (Calderdale and Huddersfield NHS Foundation Trust), Dr Manjusha Keni (Derby Teaching Hospital NHS Foundation Trust), Dr Jason Lester (University Hospital Llandough), Dr Hannah Lord (Ninewells Hospital), Dr Jonathan McAleese (Northern Ireland Cancer Centre), Dr Jamie Morgan (Ipswich Hospital NHS Trust), Dr Sally Morgan (Nottingham University Hospitals NHS Trust), Prof Allan Price (Edinburgh Cancer Centre), Dr Russell Moule (Mount Vernon Cancer Centre, East and North Herts NHS Trust), Dr Ian Sayers (Royal Wolverhampton NHS Trust), Dr Asha Siva (Alexandra Hospital), Dr Muthiah Sivaramalingham (Blackpool Teaching Hospitals NHS Foundation Trust), Dr Geraldine Skailes (University Hospitals of Morecambe Bay NHS Foundation Trust), Dr Hamid Sheikh (Macclesfield District General Hospital, East Cheshire NHS Trust), Dr Thiagarajan Sridhar (University Hospitals of Leicester NHS Trust), Dr Sarah Treece (Peterborough and Stamford Hospitals NHS Foundation Trust), Dr Aisha Tufail (Clatterbridge Cancer Centre NHS Foundation Trust), and Dr Kathryn Waite (Queen Elizabeth Hospital King’s Lynn). The PIT trial protocol was developed at the European Cancer Association–American Association for Cancer Research–European Organization for Research and Treatment of Cancer–European Society for Medical Oncology “Flims” Workshop on Methods in Clinical Cancer Research.
Publisher Copyright:
© 2019 American Society of Clinical Oncology. All rights reserved.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/5/10
Y1 - 2019/5/10
N2 - PURPOSE: Prophylactic irradiation to the chest wall after diagnostic or therapeutic procedures in patients with malignant pleural mesothelioma (MPM) has been a widespread practice across Europe, although the efficacy of this treatment is uncertain. In this study, we aimed to determine the efficacy of prophylactic radiotherapy in reducing the incidence of chest wall metastases (CWM) after a procedure in MPM.METHODS: After undergoing a chest wall procedure, patients with MPM were randomly assigned to receive prophylactic radiotherapy (within 42 days of the procedure) or no radiotherapy. Open thoracotomies, needle biopsies, and indwelling pleural catheters were excluded. Prophylactic radiotherapy was delivered at a dose of 21 Gy in three fractions over three consecutive working days, using a single electron field adapted to maximize coverage of the tract from skin surface to pleura. The primary outcome was the incidence of CWM within 6 months from random assignment, assessed in the intention-to-treat population. Stratification factors included epithelioid histology and intention to give chemotherapy.RESULTS: Between July 30, 2012, and December 12, 2015, 375 patients were recruited from 54 centers and randomly assigned to receive prophylactic radiotherapy (n = 186) or no prophylactic radiotherapy (n = 189). Participants were well matched at baseline. No significant difference was seen in the incidence of CWM at 6 months between the prophylactic radiotherapy and no radiotherapy groups (no. [%]: 6 [3.2] v 10 [5.3], respectively; odds ratio, 0.60; 95% CI, 0.17 to 1.86; P = .44). Skin toxicity was the most common radiotherapy-related adverse event in the prophylactic radiotherapy group, with 96 patients (51.6%) receiving grade 1; 19 (10.2%), grade 2; and 1 (0.5%) grade 3 radiation dermatitis (Common Terminology Criteria for Adverse Events, version 4.0).CONCLUSION: There is no role for the routine use of prophylactic irradiation to chest wall procedure sites in patients with MPM.
AB - PURPOSE: Prophylactic irradiation to the chest wall after diagnostic or therapeutic procedures in patients with malignant pleural mesothelioma (MPM) has been a widespread practice across Europe, although the efficacy of this treatment is uncertain. In this study, we aimed to determine the efficacy of prophylactic radiotherapy in reducing the incidence of chest wall metastases (CWM) after a procedure in MPM.METHODS: After undergoing a chest wall procedure, patients with MPM were randomly assigned to receive prophylactic radiotherapy (within 42 days of the procedure) or no radiotherapy. Open thoracotomies, needle biopsies, and indwelling pleural catheters were excluded. Prophylactic radiotherapy was delivered at a dose of 21 Gy in three fractions over three consecutive working days, using a single electron field adapted to maximize coverage of the tract from skin surface to pleura. The primary outcome was the incidence of CWM within 6 months from random assignment, assessed in the intention-to-treat population. Stratification factors included epithelioid histology and intention to give chemotherapy.RESULTS: Between July 30, 2012, and December 12, 2015, 375 patients were recruited from 54 centers and randomly assigned to receive prophylactic radiotherapy (n = 186) or no prophylactic radiotherapy (n = 189). Participants were well matched at baseline. No significant difference was seen in the incidence of CWM at 6 months between the prophylactic radiotherapy and no radiotherapy groups (no. [%]: 6 [3.2] v 10 [5.3], respectively; odds ratio, 0.60; 95% CI, 0.17 to 1.86; P = .44). Skin toxicity was the most common radiotherapy-related adverse event in the prophylactic radiotherapy group, with 96 patients (51.6%) receiving grade 1; 19 (10.2%), grade 2; and 1 (0.5%) grade 3 radiation dermatitis (Common Terminology Criteria for Adverse Events, version 4.0).CONCLUSION: There is no role for the routine use of prophylactic irradiation to chest wall procedure sites in patients with MPM.
UR - http://www.scopus.com/inward/record.url?scp=85065808295&partnerID=8YFLogxK
U2 - 10.1200/jco.18.01678
DO - 10.1200/jco.18.01678
M3 - Article
C2 - 30920878
SN - 0732-183X
VL - 37
SP - 1200
EP - 1208
JO - J Clin Oncol
JF - J Clin Oncol
IS - 14
ER -
