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

BMC Cancer

Peter Bias³  Anton Buchner³  Reiner Elsaesser³  Oleg A Gladkov¹  Igor Bondarenko² 

[1]Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk, Russia

[2]Dnipropetrovsk, State Medical Academy, 9, Dzerzhinsky Street, Dnipropetrovsk, 49044, Ukraine

[3]Teva Ratiopharm, Ulm, Germany

关键词: Pegfilgrastim;    Lipegfilgrastim;    Recombinant granulocyte-colony stimulating factor;    Breast cancer;    Febrile neutropenia;    Neutropenia;   

Others  :  1079604
DOI  :  10.1186/1471-2407-13-386

 received in 2012-12-06, accepted in 2013-06-21,  发布年份 2013

【 摘 要 】

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

The study protocol, two global amendments (Nos. 1 and 2), informed consent documents, and other appropriate study-related documents were reviewed and approved by the Ministry of Health of Ukraine Central Ethics Committee and local independent ethics committees (IECs).

【 授权许可】

   
2013 Bondarenko et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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