XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

BMC Cancer. 2008 Nov 12;8:332. doi: 10.1186/1471-2407-8-332.

Abstract

Background: Recombinant granulocyte colony-stimulating factors (G-CSFs) such as Filgrastim are used to treat chemotherapy-induced neutropenia. We investigated a new G-CSF, XM02, and compared it to Neupogen after myelotoxic chemotherapy in breast cancer (BC) patients.

Methods: A total of 348 patients with BC receiving docetaxel/doxorubicin chemotherapy were randomised to treatment with daily injections (subcutaneous 5 microg/kg/day) for at least 5 days and a maximum of 14 days in each cycle of XM02 (n = 140), Neupogen (n = 136) or placebo (n = 72). The primary endpoint was the duration of severe neutropenia (DSN) in cycle 1.

Results: The mean DSN in cycle 1 was 1.1, 1.1, and 3.9 days in the XM02, Neupogen, and placebo group, respectively. Superiority of XM02 over placebo and equivalence of XM02 with Neupogen could be demonstrated. Toxicities were similar between XM02 and Neupogen.

Conclusion: XM02 was superior to placebo and equivalent to Neupogen in reducing DSN after myelotoxic chemotherapy.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Analysis of Variance
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Breast Neoplasms, Male / drug therapy*
  • Breast Neoplasms, Male / pathology
  • Docetaxel
  • Double-Blind Method
  • Doxorubicin / adverse effects
  • Doxorubicin / therapeutic use
  • Female
  • Filgrastim
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Granulocyte Colony-Stimulating Factor / pharmacokinetics
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Neutropenia / chemically induced
  • Neutropenia / drug therapy*
  • Neutrophils / drug effects
  • Recombinant Proteins
  • Taxoids / adverse effects
  • Taxoids / therapeutic use
  • Treatment Outcome

Substances

  • Recombinant Proteins
  • Taxoids
  • Granulocyte Colony-Stimulating Factor
  • Docetaxel
  • Doxorubicin
  • Filgrastim