Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results
| Title: | Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results |
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| Authors: | 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; 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 |
| Source: | Journal of Clinical Oncology, 2024 |
| Publisher Information: | Lippincott Williams and Wilkins |
| Publication Year: | 2024 |
| Collection: | Newcastle University Library ePrints Service |
| Description: | © 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. |
| Document Type: | article in journal/newspaper |
| File Description: | application/pdf |
| Language: | unknown |
| Relation: | https://eprints.ncl.ac.uk/301028; https://eprints.ncl.ac.uk/fulltext.aspx?url=301028/BBE9100D-126E-40B8-8C2F-6FEA8E4F0E56.pdf&pub_id=301028 |
| DOI: | 10.57711/qzpc-7a63 |
| Availability: | https://doi.org/10.57711/qzpc-7a63; https://eprints.ncl.ac.uk/301028 |
| Rights: | https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: | edsbas.1677B015 |
| Database: | BASE |