title: Phase II STUdy with 3rd- or 4th-line bendamustine (flat dose) therapy in patients with metastatic breast cancer.
abstract: BACKGROUND
  Bendamustine is a drug with a favorable side effect spectrum and it offers a chance to overcome tumor resistance in pretreated patients with metastatic breast cancer (MBC).
  
  
  METHODS
  Bendamustine was given as flat dose with 200 mg at days 1 + 2 in MBC patients pretreated with 2-3 different chemotherapies. Therapy was repeated at day 28 or fully recovered neutrophils. After 2 treatment cycles, a tumor response evaluation was performed. Toxicity was graded according to the National Cancer Institute common toxicity criteria (NCI-CTC) catalogue.
  
  
  RESULTS
  22 patients were evaluated for toxicity. 4 patients dropped out before the first tumor response evaluation; thus, 18 patients were evaluable for anticancer efficacy evaluation. 3/18 patients reached a partial remission (PR), 4 stable disease and 11 showed progression after 2 treatment cycles. The time to progression (TTP) was 5 months in patients with PR and 4 months in patients with no change (NC). In patients with progressive disease (PD), TTP was < 2 months. The main toxicities were nausea, weight loss and fatigue.
  
  
  CONCLUSIONS
  Bendamustine can be given with a fixed flat dose, which simplifies the drug preparation. 2/5th of all treated patients responded to this therapy whereas bendamustine showed no anticancer effect in 3/5th of all patients. Bendamustine is definitely a drug with anticancer potential.
authors.affiliation: Tumor Biology Center at the Albert-Ludwigs-University Freiburg, Freiburg, Germany.
authors.forename: Simone
authors.initials: S
authors.lastname: Steinbild
authors.forename: Annette
authors.initials: A
authors.lastname: Frost
authors.forename: Brigitte
authors.initials: B
authors.lastname: Häring
authors.forename: Clemens
authors.initials: C
authors.lastname: Unger
authors.forename: Klaus
authors.initials: K
authors.lastname: Mross
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000069461:Bendamustine Hydrochloride; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005858:Germany; D006801:Humans; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride