Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study

E Iannitto, M Bellei, S Amorim, AJM Ferreri, L Marcheselli, M Cesaretti, C Haioun, S Mancuso, K Bouabdallah, R Gressin, C Tripodo, A Traverse-Glehen, L Baseggio, S Zupo, C Stelitano, B Castagnari, C Patti, I Alvarez, AM Liberati, M MerliG Gini, MG Cabras, J Dupuis, B Tessoulin, A Perrot, F Re, F Palombi, A Gulino, E Zucca, M Federico, C Thieblemont

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Abstract

Splenectomy in addition to immunotherapy with rituximab can provide quick and sometimes durable disease control in patients with splenic marginal zone lymphoma (SMZL). However, systemic chemotherapy is ultimately required in many cases. The BRISMA (Bendamustine-rituximab as first-line treatment of splenic marginal zone lymphoma)/IELSG (International Extranodal Lymphoma Study Group)36 trial is an open-label, single arm phase II study designed by the IELSG in cooperation with the Fondazione Italiana Linfomi and the lymphoma Study Association according to Simon's two-stage method. The primary endpoint was complete response rate. Fifty-six patients with SMZL diagnosis confirmed on central revision were treated with bendamustine (90 mg/m2 days 1, 2) and rituximab (375 mg/m2 day 1) every 28 days for six cycles (B-R). The overall response and CR rates were 91% and 73%, respectively. Duration of response, progression-free survival and overall survival at 3 years were 93% (95% confidence interval [CI] 81–98), 90% (95% CI 77–96) and 96% (95% CI 84–98), respectively. Toxicity was mostly haematological. Neutropenia grade ≥3 was recorded in 43% of patients; infections and febrile neutropenia in 5·4% and 3·6%. Overall, 14 patients (25%) experienced serious adverse events. Five patients (9%) went off-study because of toxicity and one patient died from infection. In conclusion, B-R resulted in a very effective first-line regimen for SMZL. Based on the results achieved in the BRISMA trial, B-R should be considered when a chemotherapy combination with rituximab is deemed necessary for symptomatic SMZL patients. © 2018 British Society for Haematology and John Wiley & Sons Ltd
Original languageEnglish
Pages (from-to)755-765
Number of pages11
JournalBritish Journal of Haematology
Volume183
Issue number5
DOIs
Publication statusPublished - 2018

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Lymphoma
Confidence Intervals
Febrile Neutropenia
Splenectomy
Infection
Rituximab
Bendamustine Hydrochloride
Combination Drug Therapy
Neutropenia
Nuclear Family
Immunotherapy
Disease-Free Survival
Drug Therapy
Survival

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Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study. / Iannitto, E; Bellei, M; Amorim, S; Ferreri, AJM; Marcheselli, L; Cesaretti, M; Haioun, C; Mancuso, S; Bouabdallah, K; Gressin, R; Tripodo, C; Traverse-Glehen, A; Baseggio, L; Zupo, S; Stelitano, C; Castagnari, B; Patti, C; Alvarez, I; Liberati, AM; Merli, M; Gini, G; Cabras, MG; Dupuis, J; Tessoulin, B; Perrot, A; Re, F; Palombi, F; Gulino, A; Zucca, E; Federico, M; Thieblemont, C.

In: British Journal of Haematology, Vol. 183, No. 5, 2018, p. 755-765.

Research output: Contribution to journalArticle

Iannitto, E, Bellei, M, Amorim, S, Ferreri, AJM, Marcheselli, L, Cesaretti, M, Haioun, C, Mancuso, S, Bouabdallah, K, Gressin, R, Tripodo, C, Traverse-Glehen, A, Baseggio, L, Zupo, S, Stelitano, C, Castagnari, B, Patti, C, Alvarez, I, Liberati, AM, Merli, M, Gini, G, Cabras, MG, Dupuis, J, Tessoulin, B, Perrot, A, Re, F, Palombi, F, Gulino, A, Zucca, E, Federico, M & Thieblemont, C 2018, 'Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study', British Journal of Haematology, vol. 183, no. 5, pp. 755-765. https://doi.org/10.1111/bjh.15641
Iannitto, E ; Bellei, M ; Amorim, S ; Ferreri, AJM ; Marcheselli, L ; Cesaretti, M ; Haioun, C ; Mancuso, S ; Bouabdallah, K ; Gressin, R ; Tripodo, C ; Traverse-Glehen, A ; Baseggio, L ; Zupo, S ; Stelitano, C ; Castagnari, B ; Patti, C ; Alvarez, I ; Liberati, AM ; Merli, M ; Gini, G ; Cabras, MG ; Dupuis, J ; Tessoulin, B ; Perrot, A ; Re, F ; Palombi, F ; Gulino, A ; Zucca, E ; Federico, M ; Thieblemont, C. / Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study. In: British Journal of Haematology. 2018 ; Vol. 183, No. 5. pp. 755-765.
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T1 - Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study

AU - Iannitto, E

AU - Bellei, M

AU - Amorim, S

AU - Ferreri, AJM

AU - Marcheselli, L

AU - Cesaretti, M

AU - Haioun, C

AU - Mancuso, S

AU - Bouabdallah, K

AU - Gressin, R

AU - Tripodo, C

AU - Traverse-Glehen, A

AU - Baseggio, L

AU - Zupo, S

AU - Stelitano, C

AU - Castagnari, B

AU - Patti, C

AU - Alvarez, I

AU - Liberati, AM

AU - Merli, M

AU - Gini, G

AU - Cabras, MG

AU - Dupuis, J

AU - Tessoulin, B

AU - Perrot, A

AU - Re, F

AU - Palombi, F

AU - Gulino, A

AU - Zucca, E

AU - Federico, M

AU - Thieblemont, C

PY - 2018

Y1 - 2018

N2 - Splenectomy in addition to immunotherapy with rituximab can provide quick and sometimes durable disease control in patients with splenic marginal zone lymphoma (SMZL). However, systemic chemotherapy is ultimately required in many cases. The BRISMA (Bendamustine-rituximab as first-line treatment of splenic marginal zone lymphoma)/IELSG (International Extranodal Lymphoma Study Group)36 trial is an open-label, single arm phase II study designed by the IELSG in cooperation with the Fondazione Italiana Linfomi and the lymphoma Study Association according to Simon's two-stage method. The primary endpoint was complete response rate. Fifty-six patients with SMZL diagnosis confirmed on central revision were treated with bendamustine (90 mg/m2 days 1, 2) and rituximab (375 mg/m2 day 1) every 28 days for six cycles (B-R). The overall response and CR rates were 91% and 73%, respectively. Duration of response, progression-free survival and overall survival at 3 years were 93% (95% confidence interval [CI] 81–98), 90% (95% CI 77–96) and 96% (95% CI 84–98), respectively. Toxicity was mostly haematological. Neutropenia grade ≥3 was recorded in 43% of patients; infections and febrile neutropenia in 5·4% and 3·6%. Overall, 14 patients (25%) experienced serious adverse events. Five patients (9%) went off-study because of toxicity and one patient died from infection. In conclusion, B-R resulted in a very effective first-line regimen for SMZL. Based on the results achieved in the BRISMA trial, B-R should be considered when a chemotherapy combination with rituximab is deemed necessary for symptomatic SMZL patients. © 2018 British Society for Haematology and John Wiley & Sons Ltd

AB - Splenectomy in addition to immunotherapy with rituximab can provide quick and sometimes durable disease control in patients with splenic marginal zone lymphoma (SMZL). However, systemic chemotherapy is ultimately required in many cases. The BRISMA (Bendamustine-rituximab as first-line treatment of splenic marginal zone lymphoma)/IELSG (International Extranodal Lymphoma Study Group)36 trial is an open-label, single arm phase II study designed by the IELSG in cooperation with the Fondazione Italiana Linfomi and the lymphoma Study Association according to Simon's two-stage method. The primary endpoint was complete response rate. Fifty-six patients with SMZL diagnosis confirmed on central revision were treated with bendamustine (90 mg/m2 days 1, 2) and rituximab (375 mg/m2 day 1) every 28 days for six cycles (B-R). The overall response and CR rates were 91% and 73%, respectively. Duration of response, progression-free survival and overall survival at 3 years were 93% (95% confidence interval [CI] 81–98), 90% (95% CI 77–96) and 96% (95% CI 84–98), respectively. Toxicity was mostly haematological. Neutropenia grade ≥3 was recorded in 43% of patients; infections and febrile neutropenia in 5·4% and 3·6%. Overall, 14 patients (25%) experienced serious adverse events. Five patients (9%) went off-study because of toxicity and one patient died from infection. In conclusion, B-R resulted in a very effective first-line regimen for SMZL. Based on the results achieved in the BRISMA trial, B-R should be considered when a chemotherapy combination with rituximab is deemed necessary for symptomatic SMZL patients. © 2018 British Society for Haematology and John Wiley & Sons Ltd

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DO - 10.1111/bjh.15641

M3 - Article

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EP - 765

JO - British Journal of Haematology

JF - British Journal of Haematology

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