title: Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma.
abstract: OBJECTIVE
  The aim of this multicenter-study was to evaluate the progression-free survival, response rate and toxicity of the combination of bendamustine and rituximab (BR) in patients with mantle cell or low-grade lymphomas in first to third relapse or refractory to previous treatment.
  
  
  METHODS
  A total of 245 courses (median, four courses per patient) were administered to 63 patients. Bendamustine was given at a dose of 90 mg/m2 as a 30-minute infusion on days 1 and 2, combined with 375 mg/m2 rituximab on day 1, for a maximum of four cycles every 4 weeks. Histologies were 24 follicular, 16 mantle cell, 17 lymphoplasmacytoid, and six marginal zone lymphoma.
  
  
  RESULTS
  Fifty-seven of 63 patients responded to BR, corresponding to an overall response rate of 90% (95% CI, 80% to 96%) with a complete remission rate (CR) of 60% (95% CI, 47% to 72%). The median time of progression-free survival was 24 months (range, 5 to 44+ months), and the median duration of overall survival has not yet been reached. In mantle cell lymphomas, BR showed a considerable activity, achieving a response rate of 75% (95% CI, 48% to 93%) with a CR rate of 50%. Myelosuppression was the major toxicity, with 16% grade 3 and 4 leukocytopenia. Thrombocytopenia was rare, with only 3% grade 3 and 4.
  
  
  CONCLUSIONS
  These results demonstrate that the BR combination is a highly active regimen in the treatment of low-grade lymphomas and mantle cell lymphomas.
authors.affiliation: Med. Klinik II, Johann Wolfgang Goethe-Universitätsklinik, Frankfurt/Main, Germany. rummel@em.uni-frankfurt.de
authors.forename: Mathias J
authors.initials: MJ
authors.lastname: Rummel
authors.forename: Salah E
authors.initials: SE
authors.lastname: Al-Batran
authors.forename: Soo-Z
authors.initials: SZ
authors.lastname: Kim
authors.forename: Manfred
authors.initials: M
authors.lastname: Welslau
authors.forename: Ralf
authors.initials: R
authors.lastname: Hecker
authors.forename: Dorothea
authors.initials: D
authors.lastname: Kofahl-Krause
authors.forename: Klaus-M
authors.initials: KM
authors.lastname: Josten
authors.forename: Heinz
authors.initials: H
authors.lastname: Dürk
authors.forename: Andreas
authors.initials: A
authors.lastname: Rost
authors.forename: Michael
authors.initials: M
authors.lastname: Neise
authors.forename: Ulrich
authors.initials: U
authors.lastname: von Grünhagen
authors.forename: Kai U
authors.initials: KU
authors.lastname: Chow
authors.forename: Martin-L
authors.initials: ML
authors.lastname: Hansmann
authors.forename: Dieter
authors.initials: D
authors.lastname: Hoelzer
authors.forename: Paris S
authors.initials: PS
authors.lastname: Mitrou
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D000069461:Bendamustine Hydrochloride; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects; D018570:Risk Assessment; D000069283:Rituximab; D016037:Single-Blind Method; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride