Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results.

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  • Additional Information
    • Corporate Authors:
      International Extranodal Lymphoma Study Group (IELSG)
    • Source:
      Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE
    • Publication Information:
      Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology
      Original Publication: New York, N.Y. : Grune & Stratton, c1983-
    • Subject Terms:
      Lymphoma, B-Cell*/radiotherapy ; Lymphoma, B-Cell*/mortality ; Lymphoma, B-Cell*/pathology ; Mediastinal Neoplasms*/radiotherapy ; Mediastinal Neoplasms*/mortality ; Mediastinal Neoplasms*/pathology; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Progression-Free Survival
    • Abstract:
      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.
    • Contributed Indexing:
      Investigator: M Gospodarowicz; D Hodgson; J Kuruvilla; L Wang; W Zhao; D Balada; A Huettmann; F Angrilli; O Annibali; L Arcaini; O Bagni; M Balzarotti; R Battistini; B Botto; MG Cabras; T Calimeri; C Catello; F Cavallo; C Cellini; P Ciammella; U Consoli; V De Sanctis; N Di Renzo; A Di Rocco; A Fabbri; A Ferrari; AJM Ferreri; L Flenghi; G Gaidano; G Gini; M Gotti; A Guarini; AM Liberati; E Lucchini; D Mannina; M Martelli; F Matrone; F Merli; C Minoia; AL Molinari; G Musuraca; L Nassi; J Olivieri; F Passamonti; D Pastore; C Patti; S Pelliccia; E Pennese; L Petrucci; F Piazza; F Pisani; M Pizzuti; S Pozzi; B Puccini; E Ravano; A Re; F Re; L Rigacci; A Santoro; M Sassone; M Spina; V Stefoni; C Stelitano; G Tarantini; C Tarella; A Tucci; SV Usai; D Vallisa; U Vitolo; F Zaja; M Zanni; VR Zilioli; UM Fagerli; A Fosså; A Dabrowska-Iwanicka; J Walewski; MG DaSilva; M Jerkeman; NC Azinwi; F Cavalli; L Deantonio; F Hitz; C Ionescu; W Mingrone; A Moccia; U Novak; MC Pirosa; A Stathis; E Zucca; I Kriachok; Y Stepanishyna; K Cozens; K Cwynarski; A Davies; CP Fox; T Illidge; R Johnson; P McKay; G Mikhaeel; A Milne; S Nimish; W Osborne; S Paneesha; A Pettitt; DA Stevens; SF Barrington; LC Stephane Chauvie Bogdan Malkowski; U Metser; A Versari; L Bonomini; N Ielmini
    • Molecular Sequence:
      ClinicalTrials.gov NCT01599559
    • Publication Date:
      Date Created: 20240819 Date Completed: 20241125 Latest Revision: 20241209
    • Publication Date:
      20241210
    • Accession Number:
      10.1200/JCO-24-01373
    • Accession Number:
      39159403