Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy.

Abstract

BACKGROUND:

Lipegfilgrastim is a novel glyco-pegylated granulocyte-colony stimulating factor in development for neutropenia prophylaxis in cancer patients receiving chemotherapy. This phase III, double-blind, randomized, active-controlled, noninferiority trial compared the efficacy and safety of lipegfilgrastim versus pegfilgrastim in chemotherapy-naïve breast cancer patients receiving doxorubicin/docetaxel chemotherapy.

METHODS:

Patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5 × 109 cells/L were randomized to a single 6-mg subcutaneous injection of lipegfilgrastim (n = 101) or pegfilgrastim (n = 101) on day 2 of each 21-day chemotherapy cycle (4 cycles maximum). The primary efficacy endpoint was the duration of severe neutropenia during cycle 1.

RESULTS:

Cycle 1: The mean duration of severe neutropenia for the lipegfilgrastim and pegfilgrastim groups was 0.7 and 0.8 days, respectively (λ = -0.218 [95% confidence interval: -0.498%, 0.062%], p = 0.126), and no severe neutropenia was observed in 56% and 49% of patients in the lipegfilgrastim and pegfilgrastim groups, respectively. All cycles: In the efficacy population, febrile neutropenia occurred in three pegfilgrastim-treated patients (all in cycle 1) and zero lipegfilgrastim-treated patients. Drug-related adverse events in the safety population were reported in 28% and 26% of patients in the lipegfilgrastim and pegfilgrastim groups, respectively.

CONCLUSION:

This study demonstrates that lipegfilgrastim 6 mg is as effective as pegfilgrastim in reducing neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

TRIAL REGISTRATION:

Eudra EEACTA200901599910.

• Authors: Igor Bondarenko, Oleg A Gladkov, Reiner Elsaesser, Anton Buchner, Peter Bias
• Journal: BMC cancer (BMC Cancer) Vol. 13 Pg. 386 (Aug 14 2013) ISSN: 1471-2407 [Electronic] England
• PMID: 23945072 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Docetaxel
• Double-Blind Method
• Doxorubicin (administration & dosage)
• Female
• Filgrastim
• Follow-Up Studies
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Male
• Middle Aged
• Neoplasm Staging
• Neutropenia (chemically induced)
• Polyethylene Glycols
• Prognosis
• Recombinant Proteins (therapeutic use)
• Taxoids (administration & dosage)