A Phase III Study of Balugrastim Versus Pegfilgrastim in Breast Cancer Patients Receiving Chemotherapy With Doxorubicin and Docetaxel

Autor: Liat Adar, Vladimir Moiseyenko, Yaroslav Shparyk, Steve Barash, Igor Bondarenko, Oleg Gladkov, Noa Avisar
Rok vydání: 2015
Předmět:
Adult
0301 basic medicine
Oncology
Cancer Research
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions
Filgrastim
Neutrophils
Recombinant Fusion Proteins
medicine.medical_treatment
Breast Neoplasms
Serum Albumin
Human
Docetaxel
Neutropenia
Polyethylene Glycols
03 medical and health sciences
0302 clinical medicine
Breast cancer
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
medicine
Humans
Serum Albumin
Academia-Pharma Intersect:Breast Cancer
Myelosuppressive Chemotherapy
Chemotherapy
Dose-Response Relationship
Drug
business.industry
Middle Aged
medicine.disease
Recombinant Proteins
Blood Cell Count
030104 developmental biology
Doxorubicin
030220 oncology & carcinogenesis
Absolute neutrophil count
Female
Taxoids
business
Febrile neutropenia
Pegfilgrastim
medicine.drug
Zdroj: The Oncologist. 21:7-15
ISSN: 1549-490X
1083-7159
DOI: 10.1634/theoncologist.2015-0152
Popis: OBJECTIVES This study aimed to evaluate the efficacy and safety of once-per-cycle balugrastim versus pegfilgrastim for neutrophil support in breast cancer patients receiving myelosuppressive chemotherapy. METHODS Breast cancer patients (n = 256) were randomized to 40 or 50 mg of subcutaneous balugrastim or 6 mg of pegfilgrastim ≈24 hours after chemotherapy (60 mg/m(2) doxorubicin and 75 mg/m(2) docetaxel, every 21 days for up to 4 cycles). The primary efficacy parameter was the duration of severe neutropenia (DSN) in cycle 1. Secondary parameters included DSN (cycles 2-4), absolute neutrophil count (ANC) nadir, febrile neutropenia rates, and time to ANC recovery (cycles 1-4). Safety, pharmacokinetics, and immunogenicity were assessed. RESULTS Mean cycle 1 DSN was 1.0 day with 40 mg of balugrastim, 1.3 with 50 mg of balugrastim, and 1.2 with pegfilgrastim (upper limit of 95% confidence intervals for between-group DSN differences was
Databáze: OpenAIRE
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