title: Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group.
abstract: OBJECTIVE
  We investigated the safety and efficacy of bendamustine and rituximab (BR) in previously untreated patients with chronic lymphocytic leukemia (CLL).
  
  
  METHODS
  In all, 117 patients, age 34 to 78 years, 46.2% of patients at Binet stage C, and 25.6% of patients age 70 years or older received BR chemoimmunotherapy for first-line treatment of CLL. Bendamustine was administered at a dose of 90 mg/m(2) on days 1 and 2 combined with 375 mg/m(2) rituximab on day 0 of the first course and 500 mg/m(2) on day 1 during subsequent courses for up to six courses.
  
  
  RESULTS
  Overall response rate was 88.0% (95% CI, 80.7% to 100.0%) with a complete response rate of 23.1% and a partial response rate of 64.9%. Ninety percent of patients with del(11q), 94.7% with trisomy 12, 37.5% with del(17p), and 89.4% with unmutated IGHV status responded to treatment. After a median observation time of 27.0 months, median event-free survival was 33.9 months, and 90.5% of patients were alive. Grade 3 or 4 severe infections occurred in 7.7% of patients. Grade 3 or 4 adverse events for neutropenia, thrombocytopenia, and anemia were documented in 19.7%, 22.2%, and 19.7% of patients, respectively.
  
  
  CONCLUSIONS
  Chemoimmunotherapy with BR is effective and safe in patients with previously untreated CLL.
authors.affiliation: Clemens-Martin Wendtner, University of Cologne, Cologne, Germany.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Fischer
authors.forename: Paula
authors.initials: P
authors.lastname: Cramer
authors.forename: Raymonde
authors.initials: R
authors.lastname: Busch
authors.forename: Sebastian
authors.initials: S
authors.lastname: Böttcher
authors.forename: Jasmin
authors.initials: J
authors.lastname: Bahlo
authors.forename: Jöerg
authors.initials: J
authors.lastname: Schubert
authors.forename: Karl H
authors.initials: KH
authors.lastname: Pflüger
authors.forename: Silke
authors.initials: S
authors.lastname: Schott
authors.forename: Valentin
authors.initials: V
authors.lastname: Goede
authors.forename: Susanne
authors.initials: S
authors.lastname: Isfort
authors.forename: Julia
authors.initials: J
authors.lastname: von Tresckow
authors.forename: Anna-Maria
authors.initials: AM
authors.lastname: Fink
authors.forename: Andreas
authors.initials: A
authors.lastname: Bühler
authors.forename: Dirk
authors.initials: D
authors.lastname: Winkler
authors.forename: Karl-Anton
authors.initials: KA
authors.lastname: Kreuzer
authors.forename: Peter
authors.initials: P
authors.lastname: Staib
authors.forename: Matthias
authors.initials: M
authors.lastname: Ritgen
authors.forename: Michael
authors.initials: M
authors.lastname: Kneba
authors.forename: Hartmut
authors.initials: H
authors.lastname: Döhner
authors.forename: Barbara F
authors.initials: BF
authors.lastname: Eichhorst
authors.forename: Michael
authors.initials: M
authors.lastname: Hallek
authors.forename: Stephan
authors.initials: S
authors.lastname: Stilgenbauer
authors.forename: Clemens-Martin
authors.initials: CM
authors.lastname: Wendtner
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000032:analysis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000069283:Rituximab
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride