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Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy.


ABSTRACT: BACKGROUND:Treatment with recombinant human granulocyte-colony stimulating factor (G-CSF) is accepted standard for prevention of chemotherapy-induced neutropenia. RGB-02 (Gedeon Richter) is a proposed biosimilar to pegylated G-CSF (Neulasta®, Amgen) with sustained release properties. This is a randomized, comparative, double-blind, multicenter study to evaluate efficacy and safety of RGB-02 in breast cancer patients receiving cytotoxic regimen. METHODS:Two hundred thirty-nine women presenting with breast cancer were randomized to RGB-02 (n?=?121) and the reference product (n?=?118). All patients received up to 6?cycles of docetaxel/doxorubicin chemotherapy combination and a once-per-cycle injection of a fixed 6?mg dose of pegfilgrastim. Primary endpoint was the duration of severe neutropenia (ANC?

SUBMITTER: Kahan Z 

PROVIDER: S-EPMC6364429 | BioStudies | 2019-01-01

REPOSITORIES: biostudies

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