title: Routine use of bendamustine and rituximab combination therapy in consecutive patients with lymphoproliferative diseases: a survey from Tyrolean hospitals.
abstract: BACKGROUND
  The objective was to demonstrate feasibility and therapeutic efficacy of routine clinical use of the bendamustine/rituximab combination in lymphoproliferative diseases.
  
  
  METHODS
  Data were collected retrospectively from 71 patients treated with bendamustine/rituximab combination in Tyrol/Austria. Toxicities, therapeutic response, and survival outcome in the various lymphoma entities were analyzed.
  
  
  RESULTS
  There was considerable hematotoxicity, with neutropenia and thrombocytopenia of grade 3 or 4 in 33% and 18%, respectively. Interestingly, severe infection of grade 3 or 4 was observed in a remarkable percentage of patients with aggressive lymphoma and CLL (21% and 28%, respectively) but not in indolent lymphoma (p = 0.027). Overall, the therapeutic efficacy of bendamustine/rituximab was encouraging. In CLL, an overall response rate (ORR) of 65% was achieved. Notably, in the seven previously untreated CLL patients, ORR was 86%. The therapy was effective across all FISH-cytogenetic subgroups, except for the five patients harboring 17p deletion with unfavorable prognosis (PFS 2.7 months, OS 9.3 months). In indolent lymphoma (n = 25), the bendamustine-rituximab combination induced a remarkable therapeutic effect (ORR 96%, median PFS and OS not reached). In aggressive lymphoma (n = 20), ORR was 50%; in International Prognostic Index high-risk patients (4 or 5 risk factors, n = 10), ORR was only 20%, significantly inferior than in low/intermediate risk patients (ORR 70%; p = 0.025).
  
  
  CONCLUSIONS
  In the routine setting aside clinical studies, bendamustine/rituximab therapy resulted in marked clinical responses, especially in CLL and indolent lymphoma. In aggressive lymphoma, the combination of bendamustine and rituximab was effective in favorable risk patients.
authors.affiliation: Department of Internal Medicine V, Hematology & Oncology, Innsbruck Medical University, Innsbruck, Austria. Christian.Waldthaler@student.i-med.ac.at
authors.forename: Christian
authors.initials: C
authors.lastname: Waldthaler
authors.forename: Reinhard
authors.initials: R
authors.lastname: Stauder
authors.forename: Michael
authors.initials: M
authors.lastname: Schnallinger
authors.forename: Stephan
authors.initials: S
authors.lastname: Schreieck
authors.forename: Judith
authors.initials: J
authors.lastname: Hager
authors.forename: Horst
authors.initials: H
authors.lastname: Oexle
authors.forename: Günther
authors.initials: G
authors.lastname: Zangerl
authors.forename: Irmgard
authors.initials: I
authors.lastname: Verdorfer
authors.forename: August
authors.initials: A
authors.lastname: Zabernigg
authors.forename: Günther
authors.initials: G
authors.lastname: Gastl
authors.forename: Michael
authors.initials: M
authors.lastname: Fiegl
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001317:Austria; D000069461:Bendamustine Hydrochloride; D002648:Child; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007223:Infant; D053208:Kaplan-Meier Estimate; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy / Q000401:mortality; D008223:Lymphoma / Q000188:drug therapy / Q000401:mortality; D008232:Lymphoproliferative Disorders / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D009894:Opportunistic Infections / Q000139:chemically induced / Q000401:mortality; D010198:Pancytopenia / Q000139:chemically induced / Q000401:mortality; D012189:Retrospective Studies; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride