Maurizio Martelli, Luca Ceriani, Giovannino Ciccone, Umberto Ricardi, Iryna Kriachok, Barbara Botto, Monica Balzarotti, Alessandra Tucci, Sara Veronica Usai, Vittorio Ruggero Zilioli, Elsa Pennese, Luca Arcaini, Anna Dabrowska-Iwanicka, Andrés Jm Ferreri, Francesco Merli, Weili Zhao, Luigi Rigacci, Claudia Cellini, David Hodgson, Codruta Ionescu, Carla Minoia, Elisa Lucchini, Michele Spina, Alexander Fosså, Andrea Janikova, Kate Cwynarski, George Mikhaeel, Mats Jerkeman, Alice Di Rocco, Yana Stepanishyna, Umberto Vitolo, Armando Santoro, Alessandro Re, Benedetta Puccini, Jacopo Olivieri, Luigi Petrucci, Sally F Barrington, Bogdan Malkowski, Ur Metser, Annibale Versari, Stephane Chauvie, Jan Walewski, Marek Trneny, Franco Cavalli, Mary Gospodarowicz, Peter W M Johnson, Andrew Davies, Emanuele Zucca
{"title":"原发性纵隔 B 细胞淋巴瘤放弃放疗：IELSG37试验结果","authors":"Maurizio Martelli, Luca Ceriani, Giovannino Ciccone, Umberto Ricardi, Iryna Kriachok, Barbara Botto, Monica Balzarotti, Alessandra Tucci, Sara Veronica Usai, Vittorio Ruggero Zilioli, Elsa Pennese, Luca Arcaini, Anna Dabrowska-Iwanicka, Andrés Jm Ferreri, Francesco Merli, Weili Zhao, Luigi Rigacci, Claudia Cellini, David Hodgson, Codruta Ionescu, Carla Minoia, Elisa Lucchini, Michele Spina, Alexander Fosså, Andrea Janikova, Kate Cwynarski, George Mikhaeel, Mats Jerkeman, Alice Di Rocco, Yana Stepanishyna, Umberto Vitolo, Armando Santoro, Alessandro Re, Benedetta Puccini, Jacopo Olivieri, Luigi Petrucci, Sally F Barrington, Bogdan Malkowski, Ur Metser, Annibale Versari, Stephane Chauvie, Jan Walewski, Marek Trneny, Franco Cavalli, Mary Gospodarowicz, Peter W M Johnson, Andrew Davies, Emanuele Zucca","doi":"10.1200/JCO-24-01373","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The role of consolidation radiotherapy in primary mediastinal B-cell lymphoma (PMBCL) patients is controversial.</p><p><strong>Methods: </strong>The IELSG37 trial, a randomized non-inferiority study, aimed to assess whether irradiation can be omitted in PMBCL patients with complete metabolic response (CMR) after induction immunochemotherapy. Primary endpoint was progression-free survival (PFS) at 30 months post-randomization. Patients with CMR were randomly assigned to observation or consolidation radiotherapy (30 Gy). With a non-inferiority 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 randomized.</p><p><strong>Results: </strong>The observed events were considerably lower than expected, therefore, primary endpoint analysis was conducted when ≥95% of patients were followed for ≥30 months. Of 545 patients enrolled, 268 were in CMR after induction and were randomized 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 was 99% in both arms.Non-randomized 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 randomized patients. Patients with DS5 had significantly poorer 5-year PFS and OS (60.3% and 74.6%, respectively).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1000,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results.\",\"authors\":\"Maurizio Martelli, Luca Ceriani, Giovannino Ciccone, Umberto Ricardi, Iryna Kriachok, Barbara Botto, Monica Balzarotti, Alessandra Tucci, Sara Veronica Usai, Vittorio Ruggero Zilioli, Elsa Pennese, Luca Arcaini, Anna Dabrowska-Iwanicka, Andrés Jm Ferreri, Francesco Merli, Weili Zhao, Luigi Rigacci, Claudia Cellini, David Hodgson, Codruta Ionescu, Carla Minoia, Elisa Lucchini, Michele Spina, Alexander Fosså, Andrea Janikova, Kate Cwynarski, George Mikhaeel, Mats Jerkeman, Alice Di Rocco, Yana Stepanishyna, Umberto Vitolo, Armando Santoro, Alessandro Re, Benedetta Puccini, Jacopo Olivieri, Luigi Petrucci, Sally F Barrington, Bogdan Malkowski, Ur Metser, Annibale Versari, Stephane Chauvie, Jan Walewski, Marek Trneny, Franco Cavalli, Mary Gospodarowicz, Peter W M Johnson, Andrew Davies, Emanuele Zucca\",\"doi\":\"10.1200/JCO-24-01373\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The role of consolidation radiotherapy in primary mediastinal B-cell lymphoma (PMBCL) patients is controversial.</p><p><strong>Methods: </strong>The IELSG37 trial, a randomized non-inferiority study, aimed to assess whether irradiation can be omitted in PMBCL patients with complete metabolic response (CMR) after induction immunochemotherapy. Primary endpoint was progression-free survival (PFS) at 30 months post-randomization. Patients with CMR were randomly assigned to observation or consolidation radiotherapy (30 Gy). With a non-inferiority 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 randomized.</p><p><strong>Results: </strong>The observed events were considerably lower than expected, therefore, primary endpoint analysis was conducted when ≥95% of patients were followed for ≥30 months. Of 545 patients enrolled, 268 were in CMR after induction and were randomized 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 was 99% in both arms.Non-randomized 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 randomized patients. Patients with DS5 had significantly poorer 5-year PFS and OS (60.3% and 74.6%, respectively).</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":15384,\"journal\":{\"name\":\"Journal of Clinical Oncology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":42.1000,\"publicationDate\":\"2024-08-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/JCO-24-01373\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/JCO-24-01373","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results.
Background: The role of consolidation radiotherapy in primary mediastinal B-cell lymphoma (PMBCL) patients is controversial.
Methods: The IELSG37 trial, a randomized non-inferiority study, aimed to assess whether irradiation can be omitted in PMBCL patients with complete metabolic response (CMR) after induction immunochemotherapy. Primary endpoint was progression-free survival (PFS) at 30 months post-randomization. Patients with CMR were randomly assigned to observation or consolidation radiotherapy (30 Gy). With a non-inferiority 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 randomized.
Results: The observed events were considerably lower than expected, therefore, primary endpoint analysis was conducted when ≥95% of patients were followed for ≥30 months. Of 545 patients enrolled, 268 were in CMR after induction and were randomized 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 was 99% in both arms.Non-randomized 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 randomized patients. Patients with DS5 had significantly poorer 5-year PFS and OS (60.3% and 74.6%, respectively).
Conclusions: 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.
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The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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