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REaCT-5G: a randomized trial of bone pain with 5-day-filgrastim vs. pegfilgrastim for neutropenia in breast cancer.
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Division of Medical Oncology, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
Introduction: Granulocyte colony stimulating factors (G-CSF), including filgrastim and pegfilgrastim, are associated with bone pain, potentially impacting treatment adherence. This study hypothesized that a 5-day regimen of filgrastim (5-day-FIL) would result in less bone pain than single-dose pegfilgrastim (PEG) in patients receiving chemotherapy for early breast cancer.
Methods: In this multicenter, open-label, randomized controlled trial, patients requiring prophylactic G-CSF during chemotherapy were randomized 1:1 to receive either 5-day FIL or PEG.
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Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address:
Human granulocyte colony-stimulating factor (G-CSF) is the primary cytokine promoting the development and function of neutrophils. More than a dozen recombinant human G-CSF (rhG-CSF) therapeutic originator or biosimilar products (e.g.
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Department of Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Background: Febrile neutropenia (FN), a major hematologic adverse event in perioperative chemotherapy for breast cancer, is more prevalent among Asian populations than Caucasians. Hematopoietic growth factor guidelines recommend pegfilgrastim for primary prophylaxis based on chemotherapy regimen and patient risk factors. We verified the appropriateness of these guidelines for patient selection.
View Article and Find Full Text PDFEfficacy and Safety of Pegylated Filgrastim as Primary Prophylaxis Following Pediatric Dose-intensive Chemotherapy: A Randomized Controlled Trial.
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Division of Pediatric Oncology, Department of Pediatrics.
Objectives: Large trials and meta-analyses in adults suggest a similar efficacy and safety of a single dose of peg-filgrastim compared with daily filgrastim in the prevention of chemotherapy-induced neutropenia. However, there is no large prospective data in the pediatric population. This trial was designed to demonstrate the efficacy and safety of peg-filgrastim in children.
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