Efficacy and safety of pegfilgrastim biosimilar MD-110 in patients with breast cancer receiving chemotherapy: Single-arm phase III.

ABSTRACT:

Introduction

Pegfilgrastim is indicated to decrease the incidence of chemotherapy-induced febrile neutropenia. It is the first granulocyte-colony stimulating factor approved for prophylactic use regardless of carcinoma type and is marketed in Japan as G-LASTA (Kyowa Kirin Co., Ltd., Tokyo, Japan). MD-110 is a biosimilar of pegfilgrastim. This phase III, multicenter, open-label, single-arm study investigated the efficacy and safety of MD-110 in early-stage breast cancer patients receiving neoadjuvant or adjuvant myelosuppressive chemotherapy.

Methods

A total of 101 patients received the study drug. Each patient received docetaxel 75 mg/m² and cyclophosphamide 600 mg/m² (TC) for four cycles on day 1 of each cycle. MD-110 (3.6 mg) was administered subcutan

SUBMITTER: Takano T 

PROVIDER: S-EPMC10652341 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature