Neil Bayman1, Wiebke Appel2, Linda Ashcroft1, David R Baldwin3, Andrew Bates4, Liz Darlison5, John G Edwards6, Veni Ezhil7, David Gilligan8, Matthew Hatton6, Apurna Jegannathen9, Talal Mansy10, Michael D Peake5, Laura Pemberton1, Robert C Rintoul11, Michael Snee12, W David Ryder1, Paul Taylor13, Corinne Faivre-Finn1,14. 1. 1 The Christie National Health Service Foundation Trust, Manchester, United Kingdom. 2. 2 Lancashire Teaching Hospitals National Health Service Foundation Trust, Preston, United Kingdom. 3. 3 Nottingham University Hospitals National Health Service Trust, Nottingham, United Kingdom. 4. 4 University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom. 5. 5 University Hospitals of Leicester National Health Service Trust, Leicester, United Kingdom. 6. 6 Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom. 7. 7 Royal Surrey County Hospital, National Health Service Foundation Trust, Guildford, United Kingdom. 8. 8 Cambridge University Hospital National Health Service Foundation Trust, Cambridge, United Kingdom. 9. 9 University Hospitals of North Midlands National Health Service Trust, Stoke-on-Trent, United Kingdom. 10. 10 South Tees Hospitals National Health Service Foundation Trust, Middlesbrough, United Kingdom. 11. 11 Cancer Research UK Cambridge Centre, Cambridge, United Kingdom. 12. 12 Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom. 13. 13 Manchester University National Health Service Foundation Trust, Manchester, United Kingdom. 14. 14 University of Manchester, Manchester, United Kingdom.
Abstract
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.
RCT Entities:
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.
Authors: E Nadal; J de Castro-Carpeño; J Bosch-Barrera; S Cedrés; J Coves; R García-Campelo; M Guirado; R López-Castro; A L Ortega; D Vicente Journal: Clin Transl Oncol Date: 2021-02-04 Impact factor: 3.340