title: A phase II trial of bendamustine in combination with rituximab in older patients with previously untreated diffuse large B-cell lymphoma.
abstract: Bendamustine in combination with rituximab (BR) has been associated with high response rates and acceptable toxicity in older patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Evaluation of BR is warranted in the front-line setting for DLBCL patients not eligible for anthracyclines or for the elderly. In this phase II study, we enrolled DLBCL patients aged ≥65 years who were poor candidates for R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) to determine the efficacy and safety of BR in previously untreated stage II-IV DLBCL. Twenty-three patients were enrolled with a median age of 80 years. 52% of patients presented with poor functional status (Eastern Cooperative Oncology Group performance score of ≥2). The overall response rate was 78% with 12 complete responses (52%). At a median follow up of 29 months, the median overall survival was 10·2 months and the median progression-free survival was 5·4 months. The most common grade 3/4 adverse events were haematological. Combination therapy with BR demonstrates high response rates as front-line therapy in frail older patients with DLBCL, but survival rates were low. BR should be used with caution in future clinical trials involving older DLBCL patients with poor functional status.
authors.affiliation: Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC, USA. sipark@med.unc.edu.
authors.forename: Steven I
authors.initials: SI
authors.lastname: Park
authors.affiliation: Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Natalie S
authors.initials: NS
authors.lastname: Grover
authors.affiliation: Rex Hematology Oncology Associates, Raleigh, NC, USA.
authors.forename: Oludamilola
authors.initials: O
authors.lastname: Olajide
authors.affiliation: Division of Hematology/Oncology, University of Oklahoma College of Medicine, Oklahoma City, OK, USA.
authors.forename: Adam S
authors.initials: AS
authors.lastname: Asch
authors.affiliation: Levine Cancer Institute, Concord, NC, USA.
authors.forename: James G
authors.initials: JG
authors.lastname: Wall
authors.affiliation: Division of Hematology/Oncology, Weill Cornell Medical College, New York, NY, USA.
authors.forename: Kristy L
authors.initials: KL
authors.lastname: Richards
authors.affiliation: Seby B. Jones Regional Cancer Center, Boone, NC, USA.
authors.forename: Anna L
authors.initials: AL
authors.lastname: Sobol
authors.affiliation: Division of Biostatistics and Data Management, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Allison M
authors.initials: AM
authors.lastname: Deal
authors.affiliation: Division of Biostatistics and Data Management, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
authors.affiliation: Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Foster
authors.affiliation: Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Hyman B
authors.initials: HB
authors.lastname: Muss
authors.affiliation: Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Shea
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage; D015415:Biomarkers; D002423:Cause of Death; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016403:Lymphoma, Large B-Cell, Diffuse / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D009367:Neoplasm Staging; D011379:Prognosis; D000069283:Rituximab / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride
keywords: 
  DLBCL
  ; bendamustine; elderly patients; lymphoma; rituximab