title: Multicenter phase II study of bendamustine plus rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma.
abstract: OBJECTIVE
  Effective and less aggressive therapies are required for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for or have undergone autologous stem-cell transplantation (ASCT). The present phase II study assessed the efficacy and safety of bendamustine plus rituximab (BR) in this population.
  
  
  METHODS
  Patients with relapsed or refractory DLBCL treated with one to three prior chemotherapy regimens received rituximab 375 mg/m(2) intravenous (IV) infusion on day 1 and bendamustine 120 mg/m(2) by IV infusion on days 2 and 3 of each 21-day cycle for up to six cycles. The primary end point was overall response rate (ORR), and the secondary end points were complete response (CR) rate, progression-free survival (PFS), and safety.
  
  
  RESULTS
  Sixty-three patients were enrolled, and 59 received BR. The median age was 67 years (range, 36 to 75 years), and 62.7% of patients were 65 years of age or older. Fifty-seven patients (96.6%) were previously treated with rituximab-containing chemotherapy. The ORR was 62.7% (95% CI, 49.1% to 75.0%), with a CR rate of 37.3% (95% CI, 25.0% to 50.9%). The ORRs were comparable between patients ≥ 65 years of age and less than 65 years (62.2% and 63.6%, respectively). The median PFS was 6.7 months (95% CI, 3.6 to 13.7 months). The most frequently observed grade 3 or 4 adverse events were hematologic: lymphopenia (78.0%), neutropenia (76.3%), leukopenia (72.9%), CD4 lymphopenia (66.1%), and thrombocytopenia (22.0%).
  
  
  CONCLUSIONS
  BR is a promising salvage regimen for patients with relapsed or refractory DLBCL after rituximab-containing chemotherapy, warranting further investigation.
authors: Yokohama City University Hospital, Kanagawa, Japan.
authors: Ken
authors: K
authors: Ohmachi
authors: Nozomi
authors: N
authors: Niitsu
authors: Toshiki
authors: T
authors: Uchida
authors: Seok Jin
authors: SJ
authors: Kim
authors: Kiyoshi
authors: K
authors: Ando
authors: Naoki
authors: N
authors: Takahashi
authors: Naoto
authors: N
authors: Takahashi
authors: Naokuni
authors: N
authors: Uike
authors: Hyeon Seok
authors: HS
authors: Eom
authors: Yee Soo
authors: YS
authors: Chae
authors: Takashi
authors: T
authors: Terauchi
authors: Ukihide
authors: U
authors: Tateishi
authors: Mitsuaki
authors: M
authors: Tatsumi
authors: Won Seog
authors: WS
authors: Kim
authors: Kensei
authors: K
authors: Tobinai
authors: Cheolwon
authors: C
authors: Suh
authors: Michinori
authors: M
authors: Ogura
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D012074:Remission Induction; D000069283:Rituximab; D033581:Stem Cell Transplantation
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride