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.
| Original language | English |
|---|---|
| Pages (from-to) | 755-765 |
| Number of pages | 11 |
| Journal | British Journal of Haematology |
| Volume | 183 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Dec 2018 |
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Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma : results from the phase II BRISMA/IELSG36 study. / Iannitto, Emilio; Bellei, Monica; Amorim, Sandy; Ferreri, Andrés J M; Marcheselli, Luigi; Cesaretti, Marina; Haioun, Corinne; Mancuso, Salvatrice; Bouabdallah, Krimo; Gressin, Remy; Tripodo, Claudio; Traverse-Glehen, Alexandra; Baseggio, Lucile; Zupo, Simonetta; Stelitano, Caterina; Castagnari, Barbara; Patti, Caterina; Alvarez, Isabel; Liberati, Anna Marina; Merli, Michele; Gini, Guido; Cabras, Maria Giuseppina; Dupuis, Jean; Tessoulin, Benoit; Perrot, Aurore; Re, Francesca; Palombi, Francesca; Gulino, Alessandro; Zucca, Emanuele; Federico, Massimo; Thieblemont, Catherine.
In: British Journal of Haematology, Vol. 183, No. 5, 12.2018, p. 755-765.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma
T2 - results from the phase II BRISMA/IELSG36 study
AU - Iannitto, Emilio
AU - Bellei, Monica
AU - Amorim, Sandy
AU - Ferreri, Andrés J M
AU - Marcheselli, Luigi
AU - Cesaretti, Marina
AU - Haioun, Corinne
AU - Mancuso, Salvatrice
AU - Bouabdallah, Krimo
AU - Gressin, Remy
AU - Tripodo, Claudio
AU - Traverse-Glehen, Alexandra
AU - Baseggio, Lucile
AU - Zupo, Simonetta
AU - Stelitano, Caterina
AU - Castagnari, Barbara
AU - Patti, Caterina
AU - Alvarez, Isabel
AU - Liberati, Anna Marina
AU - Merli, Michele
AU - Gini, Guido
AU - Cabras, Maria Giuseppina
AU - Dupuis, Jean
AU - Tessoulin, Benoit
AU - Perrot, Aurore
AU - Re, Francesca
AU - Palombi, Francesca
AU - Gulino, Alessandro
AU - Zucca, Emanuele
AU - Federico, Massimo
AU - Thieblemont, Catherine
N1 - © 2018 British Society for Haematology and John Wiley & Sons Ltd.
PY - 2018/12
Y1 - 2018/12
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.
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.
U2 - 10.1111/bjh.15641
DO - 10.1111/bjh.15641
M3 - Article
C2 - 30407629
VL - 183
SP - 755
EP - 765
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
IS - 5
ER -