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

  • Iannitto E Department of Oncology - Haematology Unit, AOU Policlinico P. Giaccone, Palermo, Italy.
  • Bellei M Fondazione Italiana Linfomi (FIL) c/o Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
  • Amorim S APHP, Saint-Louis Hospital, Haemato-Oncology, Paris, France.
  • Ferreri AJM Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy.
  • Marcheselli L Fondazione Italiana Linfomi (FIL) c/o Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
  • Cesaretti M Fondazione Italiana Linfomi (FIL) c/o Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
  • Haioun C Lymphoid Malignancies Unit, University Hospital Henri Mondor, Creteil, France.
  • Mancuso S Department of Oncology - Haematology Unit, AOU Policlinico P. Giaccone, Palermo, Italy.
  • Bouabdallah K Service d'hématologie, CHU Bordeaux, Bordeaux, France.
  • Gressin R Onco-Haematology Department, University Hospital Grenoble, Grenoble, France.
  • Tripodo C Tumour Immunology Unit, Human Pathology Section, Department of Health Science, University of Palermo, Palermo, Italy.
  • Traverse-Glehen A Centre Hospitalier Lyon sud service d'anatomie pathologique, Université Lyon 1, Pierre Benite, France.
  • Baseggio L Centre Hospitalier Lyon Sud Laboratoire d'Hématologie cellulaire, Université Lyon 1, Pierre Benite, France.
  • Zupo S Molecular Diagnostic Unit, Policlinico San Martino, Genova, Italy.
  • Stelitano C Division of Haematology, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.
  • Castagnari B Hospital Santa Maria delle Croci, UOC of Haematology, Ravenna, Italy.
  • Patti C Division of Haematology, Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
  • Alvarez I Arcispedale Santa Maria Nuova, UOC of Haematology, AUSL Reggio Emilia/IRCCS, Reggio Emilia, Italy.
  • Liberati AM Santa Maria Hospital, Oncology-Haematology Perugia, University of Perugia, Perugia, Italy.
  • Merli M University Hospital Ospedale di Circolo e Fondazione Macchi, ASST Settelaghi, Varese, Italy.
  • Gini G Division of Haematology, Ospedali Riuniti, Ancona, Italy.
  • Cabras MG Division of Haematology, Ospedale Businco, Cagliari, Italy.
  • Dupuis J Lymphoid Malignancies Unit, Henri Mondor Hospital, Creteil, France.
  • Tessoulin B Department of Clinical Haematology, Nantes University Hospital, Nantes, France.
  • Perrot A Haematology Department, University Hospital, Vandoeuvre Les Nancy, France.
  • Re F Azienda Ospedaliero-Universitaria di Parma, UO Ematologia e CTMO, Parma, Italy.
  • Palombi F Haematology and Stem Cell Transplant, Regina Elena National Cancer Institute, Rome, Italy.
  • Gulino A Tumour Immunology Unit, Human Pathology Section, Department of Health Science, University of Palermo, Palermo, Italy.
  • Zucca E IOSI, Oncology Institute of Southern Switzerland and IOR, Institute of Oncology Research, Università della Svizzera Italiana (USI), Bellinzona, Switzerland.
  • Federico M Department of Diagnostic, Clinical, and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy.
  • Thieblemont C APHP, Saint-Louis Hospital, Haemato-oncology- Paris Diderot University, Paris, France.
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  • 2018-11-09
Published in:
  • British journal of haematology. - 2018
Splenic Marginal Zone Lymphoma
bendamustine
first-line therapy
immunochemotherapy
rituximab
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
Bendamustine Hydrochloride
Disease-Free Survival
Drug Administration Schedule
Female
Humans
Lymphoma, B-Cell, Marginal Zone
Male
Middle Aged
Neoplasm Recurrence, Local
Rituximab
Splenectomy
Splenic Neoplasms
Treatment Outcome
English 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.
Language
  • English
Open access status
bronze
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https://sonar.ch/global/documents/92987
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