Phase II STUdy with 3rd- or 4th-line bendamustine (flat dose) therapy in patients with metastatic breast cancer

Onkologie. 2009 Sep;32(8-9):488-92. doi: 10.1159/000226137. Epub 2009 Jul 23.

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).

Patients and 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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Bendamustine Hydrochloride
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / secondary*
  • Dose-Response Relationship, Drug
  • Female
  • Germany
  • Humans
  • Middle Aged
  • Nitrogen Mustard Compounds / administration & dosage*
  • Nitrogen Mustard Compounds / adverse effects
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Nitrogen Mustard Compounds
  • Bendamustine Hydrochloride