Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study
| Autor: | De Yun Luo, Yuan Kai Shi, Yiping Zhang, Wei Jing Zhang, Xiao Hui He, Yunpeng Liu, Qiang Chen, X Y Ke, Jianmin Wang, Xiao Qing Liu, Yun Zhong Zhu, Jian Hua Chang, An Lan Wang, Yang Zhang, Wei Lian Li, Xiu Wen Wang, Hua Qing Wang, Ze Fei Jiang |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Neutropenia Filgrastim medicine.medical_treatment Injections Subcutaneous Phases of clinical research Gastroenterology Polyethylene Glycols Internal medicine Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor Medicine Humans Pharmacology (medical) Aged Pharmacology Myelosuppressive Chemotherapy Chemotherapy Cross-Over Studies business.industry Middle Aged medicine.disease Crossover study Recombinant Proteins Surgery Oncology Absolute neutrophil count Female business Febrile neutropenia medicine.drug |
| Zdroj: | Anti-cancer drugs. 24(6) |
| ISSN: | 1473-5741 |
| Popis: | The purpose of this study was to compare the efficacy and safety of a single subcutaneous injection of pegylated filgrastim with daily filgrastim as a prophylaxis for neutropenia induced by commonly used chemotherapy regimens. Fifteen centers enrolled 337 chemotherapy-naive cancer patients with normal bone marrow function. All patients randomized into AOB and BOA arms received two cycles of chemotherapy. Patients received a single dose of pegylated filgrastim 100 µg/kg in cycle 1 (AOB) or cycle 2 (BOA) and daily doses of filgrastim 5 µg/kg/day in cycle 1 (BOA) or cycle 2 (AOB). Efficacy and safety parameters were recorded. The primary end point was the rate of protection against grade 4 neutropenia after chemotherapy [defined as the rate at which the absolute neutrophil count (ANC) remained >0.5×10(9)/l throughout the entire cycle]. Ninety-four percent of patients receiving pegylated filgrastim or filgrastim did not develop grade 4 neutropenia. The incidence of ANC |
| Databáze: | OpenAIRE |
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