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Lookup NU author(s): Dr Wendy Osborne
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2024 by American Society of Clinical Oncology. PURPOSE The role of consolidation radiotherapy in patients with primary mediastinal B-cell lymphoma (PMBCL) is controversial. METHODS The IELSG37 trial, a randomized noninferiority study, aimed to assess whether irradiation can be omitted in patients with PMBCL with complete metabolic response (CMR) after induction immunochemotherapy. The primary end point was progression-free survival (PFS) at 30 months after random assignment. Patients with CMR were randomly assigned to observation or consolidation radiotherapy (30 Gy). With a noninferiority margin of 10% (assuming a 30-month PFS of 85% in both arms), a sample size of 540 patients was planned with 376 expected to be randomly assigned. RESULTS The observed events were considerably lower than expected; therefore, primary end point analysis was conducted when ≥95% of patients were followed for ≥30 months. Of the 545 patients enrolled, 268 were in CMR after induction and were randomly assigned to observation (n = 132) or radiotherapy (n = 136). The 30-month PFS was 96.2% in the observation arm and 98.5% in the radiotherapy arm, with a stratified hazard ratio of 1.47 (95% CI, 0.34 to 6.28) and absolute risk difference of 0.68% (95% CI, -0.97 to 7.46). The 5-year overall survival (OS) was 99% in both arms. Nonrandomized patients were managed according to local policies. Radiotherapy was the only treatment in 86% of those with Deauville score (DS) 4 and in 57% of those with DS 5. The 5-year PFS and OS of patients with DS 4 (95.8% and 97.5%, respectively) were not significantly different from those of randomly assigned patients. Patients with DS5 had significantly poorer 5-year PFS and OS (60.3% and 74.6%, respectively). CONCLUSION This study, the largest randomized trial of radiotherapy in PMBCL, demonstrated favorable outcomes in patients achieving CMR with no survival impairment for those omitting irradiation.
Author(s): Martelli M, Ceriani L, Ciccone G, Ricardi U, Kriachok I, Botto B, Balzarotti M, Tucci A, Usai SV, Zilioli VR, Pennese E, Arcaini L, Dabrowska-Iwanicka A, Ferreri AJM, Merli F, Zhao W, Rigacci L, Cellini C, Hodgson D, Ionescu C, Minoia C, Lucchini E, Spina M, Fossa A, Janikova A, Cwynarski K, Mikhaeel G, Jerkeman M, Di Rocco A, Stepanishyna Y, Vitolo U, Santoro A, Re A, Puccini B, Olivieri J, Petrucci L, Barrington SF, Malkowski B, Metser U, Versari A, Chauvie S, Walewski J, Trneny M, Cavalli F, Gospodarowicz M, Johnson PWM, Davies A, Zucca E, Kuruvilla J, Wang L, Balada D, Mocikova H, Huettmann A, Angrilli F, Annibali O, Arcaini L, Bagni O, Battistini R, Cabras MG, Calimeri T, Catello C, Cavallo F, Ciammella P, Consoli U, De Sanctis V, Di Renzo N, Fabbri A, Ferrari A, Flenghi L, Gaidano G, Gini G, Gotti M, Guarini A, Liberati AM, Mannina D, Matrone F, Molinari AL, Musuraca G, Nassi L, Passamonti F, Pastore D, Patti C, Pelliccia S, Piazza F, Pisani F, Pizzuti M, Pozzi S, Ravano E, Re F, Sassone M, Stefoni V, Stelitano C, Tarantini G, Tarella C, Vallisa D, Zaja F, Zanni M, Fagerli UM, DaSilva MG, Azinwi NC, Deantonio L, Hitz F, Mingrone W, Moccia A, Novak U, Pirosa MC, Stathis A, Cozens K, Fox CP, Illidge T, Johnson R, McKay P, Milne A, Nimish S, Osborne W, Paneesha S, Pettitt A, Stevens DA, Bonomini L, Ielmini N
Publication type: Article
Publication status: Published
Journal: Journal of Clinical Oncology
Year: 2024
Pages: ePub ahead of Print
Online publication date: 19/08/2024
Acceptance date: 13/08/2024
Date deposited: 17/09/2024
ISSN (print): 0732-183X
ISSN (electronic): 1527-7755
Publisher: Lippincott Williams and Wilkins
URL: https://doi.org/10.1200/JCO-24-01373
DOI: 10.1200/JCO-24-01373
ePrints DOI: 10.57711/qzpc-7a63
PubMed id: 39159403
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