Data di Pubblicazione:
2024
Citazione:
Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results / Martelli, M.; Ceriani, L.; Ciccone, G.; Ricardi, U.; Kriachok, I.; Botto, B.; Balzarotti, M.; Tucci, A.; Usai, S. V.; Zilioli, V. R.; Pennese, E.; Arcaini, L.; Dabrowska-Iwanicka, A.; Ferreri, A. J. M.; 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, S. F.; Malkowski, B.; Metser, U.; Versari, A.; Chauvie, S.; Walewski, J.; Trneny, M.; Cavalli, F.; Gospodarowicz, M.; Johnson, P. W. M.; Davies, A.; Zucca, E.; Kuruvilla, J.; Wang, L.; Balada, D.; Mocikova, H.; Huettmann, A.; Angrilli, F.; Annibali, O.; Bagni, O.; Battistini, R.; Cabras, M. G.; Calimeri, T.; Catello, C.; Cavallo, F.; Ciammella, P.; Consoli, U.; De Sanctis, V.; Di Renzo, N.; Fabbri, A.; Ferrari, A.; Ferreri, A. J. M.; Flenghi, L.; Gaidano, G.; Gini, G.; Gotti, M.; Guarini, A.; Liberati, A. M.; Mannina, D.; Martelli, M.; Matrone, F.; Molinari, A. L.; 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, U. M.; Dasilva, M. G.; Azinwi, N. C.; Deantonio, L.; Hitz, F.; Mingrone, W.; Moccia, A.; Novak, U.; Pirosa, M. C.; Stathis, A.; Cozens, K.; Fox, C. P.; Illidge, T.; Johnson, R.; Mckay, P.; Milne, A.; Nimish, S.; Osborne, W.; Paneesha, S.; Pettitt, A.; Stevens, D. A.; Bonomini, L.; Ielmini, N.. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - 42:34(2024), pp. 4071-4083. [10.1200/JCO-24-01373]
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 5 132) or radiotherapy (n 5 136). 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.
Tipologia CRIS:
1.1 Articolo in rivista
Elenco autori:
Martelli, M.; Ceriani, L.; Ciccone, G.; Ricardi, U.; Kriachok, I.; Botto, B.; Balzarotti, M.; Tucci, A.; Usai, S. V.; Zilioli, V. R.; Pennese, E.; Arcaini, L.; Dabrowska-Iwanicka, A.; Ferreri, A. J. M.; 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, S. F.; Malkowski, B.; Metser, U.; Versari, A.; Chauvie, S.; Walewski, J.; Trneny, M.; Cavalli, F.; Gospodarowicz, M.; Johnson, P. W. M.; Davies, A.; Zucca, E.; Kuruvilla, J.; Wang, L.; Balada, D.; Mocikova, H.; Huettmann, A.; Angrilli, F.; Annibali, O.; Bagni, O.; Battistini, R.; Cabras, M. G.; Calimeri, T.; Catello, C.; Cavallo, F.; Ciammella, P.; Consoli, U.; De Sanctis, V.; Di Renzo, N.; Fabbri, A.; Ferrari, A.; Ferreri, A. J. M.; Flenghi, L.; Gaidano, G.; Gini, G.; Gotti, M.; Guarini, A.; Liberati, A. M.; Mannina, D.; Martelli, M.; Matrone, F.; Molinari, A. L.; 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, U. M.; Dasilva, M. G.; Azinwi, N. C.; Deantonio, L.; Hitz, F.; Mingrone, W.; Moccia, A.; Novak, U.; Pirosa, M. C.; Stathis, A.; Cozens, K.; Fox, C. P.; Illidge, T.; Johnson, R.; Mckay, P.; Milne, A.; Nimish, S.; Osborne, W.; Paneesha, S.; Pettitt, A.; Stevens, D. A.; Bonomini, L.; Ielmini, N.
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