-
Something wrong with this record ?
Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results
M. Martelli, L. Ceriani, G. Ciccone, U. Ricardi, I. Kriachok, B. Botto, M. Balzarotti, A. Tucci, SV. Usai, VR. Zilioli, E. Pennese, L. Arcaini, A. Dabrowska-Iwanicka, AJM. Ferreri, F. Merli, W. Zhao, L. Rigacci, C. Cellini, D. Hodgson, C....
Language English Country United States
Document type Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
Free Medical Journals
from 2004 to 1 year ago
Open Access Digital Library
from 1999-01-01
PubMed
39159403
DOI
10.1200/jco-24-01373
Knihovny.cz E-resources
- MeSH
- Lymphoma, B-Cell * radiotherapy mortality pathology MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Mediastinal Neoplasms * radiotherapy mortality pathology MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Equivalence Trial MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
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.
AO Brotzu Ospedale Oncologico Businco Unit of Hematology and Bone Marrow Transplant Cagliari Italy
AO Santa Croce e Carle Department of Medical Physics Cuneo Italy
AOU Careggi Department of Hematology Florence Italy
AOU Città della Salute e della Scienza Department of Hematology Turin Italy
ASST Grande Ospedale Metropolitano Niguarda Division of Hematology Milan Italy
ASST Spedali Civili Department of Haematology Brescia Italy
ASU Friuli Centrale Unit of Hematology Udine Italy
ASU Giuliano Isontina Ospedale Maggiore Trieste Italy
Azienda USL IRCCS of Reggio Emilia Department of Hematology Reggio Emilia Italy
Charles University General Hospital Department of Medical Oncology Prague Czech Republic
Ente Ospedaliero Cantonale Imaging Institute of Southern Switzerland Lugano Switzerland
Ente Ospedaliero Cantonale Oncology Institute of Southern Switzerland Bellinzona Switzerland
Fondazione del Piemonte per l'Oncologia IRCCS Candiolo Cancer Institute Candiolo Italy
Fondazione IRCCS Policlinico San Matteo Division of Hematology Pavia Italy
Guy's and St Thomas' NHS Foundation Trust Guy's Cancer Center London United Kingdom
Humanitas University Department of Biomedical Sciences Pieve Emanuele Italy
Institute of Oncology Research Bellinzona Switzerland
IRCCS Humanitas Research Hospital Department of Medical Oncology and Hematology Rozzano Milan Italy
IRCCS Istituto Tumori Giovanni Paolo 2 Hematology Unit Bari Italy
IRCCS San Raffaele Scientific Institute Lymphoma Unit Milan Italy
National Cancer Institute Onco Hematology Department Kyiv Ukraine
Nicolaus Copernicus University Department of Diagnostics Imagining Torun Poland
Oslo University Hospital Department of Oncology Oslo Norway
Ospedale Santa Maria delle Croci Department of Hematology Ravenna Italy
Princess Margaret Cancer Centre Radiation Medicine Program Toronto Canada
Skane University Hospital Department of Oncology Lund University Lund Sweden
Università della Svizzera Italiana Faculty of Biomedical Sciences Lugano Switzerland
University College London Hospitals NHS Trust Department of Hematology London United Kingdom
University Hospital Brno Brno Czech Republic
University of Oslo KG Jebsen Center for B cell malignancies Oslo Norway
University of Pavia Department of Molecular Medicine Pavia Italy
University of Southampton Clinical Trials Unit School of Cancer Sciences Southampton United Kingdom
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25003304
- 003
- CZ-PrNML
- 005
- 20250206104235.0
- 007
- ta
- 008
- 250121s2024 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1200/JCO-24-01373 $2 doi
- 035 __
- $a (PubMed)39159403
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Martelli, Maurizio $u Sapienza University, Division of Hematology, Department of Translational and Precision Medicine, Rome, Italy $1 https://orcid.org/0000000310070339
- 245 10
- $a Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results / $c M. Martelli, L. Ceriani, G. Ciccone, U. Ricardi, I. Kriachok, B. Botto, M. Balzarotti, A. Tucci, SV. Usai, VR. Zilioli, E. Pennese, L. Arcaini, A. Dabrowska-Iwanicka, AJM. Ferreri, F. Merli, W. Zhao, L. Rigacci, C. Cellini, D. Hodgson, C. Ionescu, C. Minoia, E. Lucchini, M. Spina, A. Fosså, A. Janikova, K. Cwynarski, G. Mikhaeel, M. Jerkeman, A. Di Rocco, Y. Stepanishyna, U. Vitolo, A. Santoro, A. Re, B. Puccini, J. Olivieri, L. Petrucci, SF. Barrington, B. Malkowski, U. Metser, A. Versari, S. Chauvie, J. Walewski, M. Trneny, F. Cavalli, M. Gospodarowicz, PWM. Johnson, A. Davies, E. Zucca, International Extranodal Lymphoma Study Group (IELSG)
- 520 9_
- $a 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.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a mladý dospělý $7 D055815
- 650 _2
- $a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $7 D000971
- 650 12
- $a B-buněčný lymfom $x radioterapie $x mortalita $x patologie $7 D016393
- 650 12
- $a nádory mediastina $x radioterapie $x mortalita $x patologie $7 D008479
- 650 _2
- $a doba přežití bez progrese choroby $7 D000077982
- 655 _2
- $a hodnocení ekvivalence $7 D000073843
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 700 1_
- $a Ceriani, Luca $u Institute of Oncology Research (IOR), Bellinzona, Switzerland $u Ente Ospedaliero Cantonale, Imaging Institute of Southern Switzerland, Lugano, Switzerland $u Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland $1 https://orcid.org/000000026371097X
- 700 1_
- $a Ciccone, Giovannino $u AOU Città della Salute e della Scienza di Torino and CPO Piemonte, Clinical Epidemiology Unit, Turin, Italy $1 https://orcid.org/0000000176449574
- 700 1_
- $a Ricardi, Umberto $u University of Turin, Department of Oncology, Turin, Italy $1 https://orcid.org/0000000344067621
- 700 1_
- $a Kriachok, Iryna $u National Cancer Institute, Onco-Hematology Department, Kyiv, Ukraine
- 700 1_
- $a Botto, Barbara $u AOU Città della Salute e della Scienza, Department of Hematology, Turin, Italy
- 700 1_
- $a Balzarotti, Monica $u IRCCS Humanitas Research Hospital, Department of Medical Oncology and Hematology, Rozzano Milan, Italy $1 https://orcid.org/0000000346665115
- 700 1_
- $a Tucci, Alessandra $u ASST Spedali Civili, Department of Haematology, Brescia, Italy $1 https://orcid.org/0000000330527463
- 700 1_
- $a Usai, Sara Veronica $u AO Brotzu - Ospedale Oncologico Businco, Unit of Hematology and Bone Marrow Transplant, Cagliari, Italy
- 700 1_
- $a Zilioli, Vittorio Ruggero $u ASST Grande Ospedale Metropolitano Niguarda, Division of Hematology, Milan, Italy $1 https://orcid.org/0000000169152246
- 700 1_
- $a Pennese, Elsa $u Presidio Ospedaliero Pescara, Unità Operativa Semplice Dipartimentale Centro Diagnosi e Terapia Linfomi, Pescara, Italy
- 700 1_
- $a Arcaini, Luca $u University of Pavia, Department of Molecular Medicine, Pavia, Italy $u Fondazione IRCCS Policlinico San Matteo, Division of Hematology, Pavia, Italy $1 https://orcid.org/000000029504991X
- 700 1_
- $a Dabrowska-Iwanicka, Anna $u Maria Sklodowska-Curie National Research Institute of Oncology, Department of Lymphoid Malignancies, Warsaw, Poland
- 700 1_
- $a Ferreri, Andrés J M $u IRCCS San Raffaele Scientific Institute, Lymphoma Unit, Milan, Italy $u University Vita-Salute San Raffaele, Milan, Italy $1 https://orcid.org/0000000196066124
- 700 1_
- $a Merli, Francesco $u Azienda USL-IRCCS of Reggio Emilia, Department of Hematology, Reggio Emilia, Italy $1 https://orcid.org/0000000209797883
- 700 1_
- $a Zhao, Weili $u Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Department of Hematology, Shanghai, China $1 https://orcid.org/0000000268341616
- 700 1_
- $a Rigacci, Luigi $u AOU Careggi, Department of Hematology, Florence, Italy $1 https://orcid.org/0000000293209334
- 700 1_
- $a Cellini, Claudia $u Ospedale Santa Maria delle Croci, Department of Hematology, Ravenna, Italy
- 700 1_
- $a Hodgson, David $u Princess Margaret Cancer Centre, Radiation Medicine Program, Toronto, Canada $1 https://orcid.org/0000000346874582
- 700 1_
- $a Ionescu, Codruta $u Inselspital, Bern University Hospital, University of Bern, Department of Radiation Oncology, Bern, Switzerland
- 700 1_
- $a Minoia, Carla $u IRCCS Istituto Tumori Giovanni Paolo II, Hematology Unit, Bari, Italy
- 700 1_
- $a Lucchini, Elisa $u ASU Friuli Centrale, Unit of Hematology, Udine, Italy $u ASU Giuliano Isontina, Ospedale Maggiore, Trieste, Italy $1 https://orcid.org/0000000248578325
- 700 1_
- $a Spina, Michele $u Centro di Riferimento Oncologico IRCCS, Division of Medical Oncology and Immunerelated Tumors, Aviano, Italy $1 https://orcid.org/0000000165768182
- 700 1_
- $a Fosså, Alexander $u Oslo University Hospital, Department of Oncology, Oslo, Norway $u University of Oslo, KG Jebsen Center for B-cell malignancies, Oslo, Norway
- 700 1_
- $a Janikova, Andrea $u University Hospital Brno, Brno, Czech Republic $1 https://orcid.org/0000000226477769 $7 xx0103433
- 700 1_
- $a Cwynarski, Kate $u University College London Hospitals NHS Trust, Department of Hematology, London, United Kingdom $1 https://orcid.org/0000000199363431
- 700 1_
- $a Mikhaeel, George $u Guy's and St Thomas' NHS Foundation Trust, Guy's Cancer Center, London, United Kingdom $1 https://orcid.org/0000000303590328
- 700 1_
- $a Jerkeman, Mats $u Skane University Hospital, Department of Oncology, Lund University, Lund, Sweden $1 https://orcid.org/0000000345096707
- 700 1_
- $a Di Rocco, Alice $u Sapienza University, Division of Hematology, Department of Translational and Precision Medicine, Rome, Italy
- 700 1_
- $a Stepanishyna, Yana $u National Cancer Institute, Onco-Hematology Department, Kyiv, Ukraine $1 https://orcid.org/000000027884193X
- 700 1_
- $a Vitolo, Umberto $u AOU Città della Salute e della Scienza, Department of Hematology, Turin, Italy $u Fondazione del Piemonte per l'Oncologia-IRCCS, Candiolo Cancer Institute, Candiolo, Italy $1 https://orcid.org/0000000177722747
- 700 1_
- $a Santoro, Armando $u IRCCS Humanitas Research Hospital, Department of Medical Oncology and Hematology, Rozzano Milan, Italy $u Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Italy $1 https://orcid.org/0000000317099492
- 700 1_
- $a Re, Alessandro $u ASST Spedali Civili, Department of Haematology, Brescia, Italy $1 https://orcid.org/0000000311566395
- 700 1_
- $a Puccini, Benedetta $u AOU Careggi, Department of Hematology, Florence, Italy
- 700 1_
- $a Olivieri, Jacopo $u ASU Friuli Centrale, Unit of Hematology, Udine, Italy $1 https://orcid.org/0000000225823500
- 700 1_
- $a Petrucci, Luigi $u Sapienza University, Division of Hematology, Department of Translational and Precision Medicine, Rome, Italy
- 700 1_
- $a Barrington, Sally F $u King's College London and Guy's and St Thomas' PET Centre, School of Biomedical Engineering and Imaging Sciences, King's College London, United Kingdom $1 https://orcid.org/0000000225165288
- 700 1_
- $a Malkowski, Bogdan $u Nicolaus Copernicus University, Department of Diagnostics Imagining, Torun, Poland
- 700 1_
- $a Metser, Ur $u University Health Network, Princess Margaret Hospital, University Medical Imaging Toronto, University of Toronto, Toronto, Canada $1 https://orcid.org/0000000337268994
- 700 1_
- $a Versari, Annibale $u Azienda USL-IRCCS of Reggio Emilia, Department of Nuclear Medicine, Oncology and High Technology, Reggio Emilia, Italy $1 https://orcid.org/0000000286752435
- 700 1_
- $a Chauvie, Stephane $u AO Santa Croce e Carle, Department of Medical Physics, Cuneo, Italy $1 https://orcid.org/0000000343945031
- 700 1_
- $a Walewski, Jan $u Maria Sklodowska-Curie National Research Institute of Oncology, Department of Lymphoid Malignancies, Warsaw, Poland $1 https://orcid.org/0000000342472674
- 700 1_
- $a Trneny, Marek $u Charles University, General Hospital, Department of Medical Oncology, Prague, Czech Republic $1 https://orcid.org/0000000269526073 $7 nlk20000083659
- 700 1_
- $a Cavalli, Franco $u Institute of Oncology Research (IOR), Bellinzona, Switzerland
- 700 1_
- $a Gospodarowicz, Mary $u Princess Margaret Cancer Centre, Radiation Medicine Program, Toronto, Canada $1 https://orcid.org/0000000258877337
- 700 1_
- $a Johnson, Peter W M $u University of Southampton, Clinical Trials Unit, School of Cancer Sciences, Southampton, United Kingdom $1 https://orcid.org/0000000323064974
- 700 1_
- $a Davies, Andrew $u University of Southampton, Clinical Trials Unit, School of Cancer Sciences, Southampton, United Kingdom $1 https://orcid.org/0000000275176938
- 700 1_
- $a Zucca, Emanuele $u Institute of Oncology Research (IOR), Bellinzona, Switzerland $u Università della Svizzera Italiana, Faculty of Biomedical Sciences, Lugano, Switzerland $u Ente Ospedaliero Cantonale, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland $1 https://orcid.org/0000000255226109
- 710 2_
- $a International Extranodal Lymphoma Study Group (IELSG)
- 773 0_
- $w MED00002596 $t Journal of clinical oncology $x 1527-7755 $g Roč. 42, č. 34 (2024), s. 4071-4083
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39159403 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250121 $b ABA008
- 991 __
- $a 20250206104231 $b ABA008
- 999 __
- $a ok $b bmc $g 2263203 $s 1239311
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2024 $b 42 $c 34 $d 4071-4083 $e 20240819 $i 1527-7755 $m Journal of clinical oncology $n J Clin Oncol $x MED00002596
- LZP __
- $a Pubmed-20250121
