Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy
| Autor: | Igor Bondarenko, Reiner Elsaesser, Oleg Gladkov, Peter Bias, Anton Buchner |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
Oncology
Male medicine.medical_specialty Cancer Research Neutropenia Filgrastim Population Febrile neutropenia Breast Neoplasms Docetaxel Polyethylene Glycols Breast cancer Double-Blind Method Internal medicine Recombinant granulocyte-colony stimulating factor Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor medicine Genetics Humans education Lipegfilgrastim Aged Neoplasm Staging education.field_of_study business.industry Middle Aged medicine.disease Prognosis Pegfilgrastim Recombinant Proteins Surgery Doxorubicin Absolute neutrophil count Female Taxoids business medicine.drug Research Article Follow-Up Studies |
| Zdroj: | BMC Cancer |
| ISSN: | 1471-2407 |
| DOI: | 10.1186/1471-2407-13-386 |
| Popis: | 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-naive breast cancer patients receiving doxorubicin/docetaxel chemotherapy. 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. 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. This study demonstrates that lipegfilgrastim 6 mg is as effective as pegfilgrastim in reducing neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. 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). |
| Databáze: | OpenAIRE |
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