Telpegfilgrastim for chemotherapy-induced neutropenia in patients with non-small cell lung cancer: a multicentre, randomized, phase 3 study

作者：Yuankai Shi, Xinshuai Wang, Zhidong Pei, Huaqiu Shi, Yanjun Zhang, Tienan Yi, Jiazhuan Mei, Yanzhen Guo, Youhong Dong, Tianjiang Ma, Qingyuan Zhang, Xiaojing Jia, Zhengqiu Zhu, Xu Shen, Yanyan Liu, Hongrui Niu, Weimei Jiang, Xiaodong Jiang, Shengyu Zhou, Li Sun · 发表于：BMC Cancer · 年份：2025 · DOI：10.1186/s12885-025-13736-6 · 被引用次数：3 · 研究领域：Neutropenia and Cancer Infections、Blood disorders and treatments、Immune Response and Inflammation

BACKGROUND: Chemotherapy-induced neutropenia (CIN) is usually managed by recombinant human granulocyte colony stimulating factor (rhG-CSF) and pegylated rhG-CSF (PEG-rhG-CSF). This study evaluated the efficacy and safety of telpegfilgrastim, a novel Y-shaped PEG-rhG-CSF, for CIN prophylaxis in patients with non-small cell lung cancer (NSCLC). METHODS: This was a multicentre, randomized, open-label, active-controlled non-inferiority study. Patients with NSCLC who received 1-4 chemotherapy cycles of docetaxel plus carboplatin were randomized 1:1:1 to receive telpegfilgrastim 2 mg, 33 µg/kg or control drug (rhG-CSF [Topneuter®] in cycle 1 of chemotherapy, rhG-CSF [Topneuter®] or PEG-rhG-CSF [Xinruibai®] per patients' choice in cycles 2-4 of chemotherapy). The primary endpoint was duration of grade 4 neutropenia in cycle 1 of chemotherapy. Secondary endpoints included duration of grade 4 neutropenia in cycles 2-4 of chemotherapy, incidence of febrile neutropenia (FN), duration and incidence of ≥ grade 3 neutropenia, dynamic change of absolute neutrophil count from baseline and safety. RESULTS: From October 16, 2020, to September 1, 2021, 133 patients were randomized to telpegfilgrastim 2 mg (n = 44), 33 µg/kg (n = 45) and control group (n = 44). In cycle 1 of chemotherapy, the mean duration of grade 4 neutropenia in telpegfilgrastim 2 mg, 33 µg/kg groups and control group were 0.02 day, 0.09 day and 0.16 day, respectively. The least square mean differences versus control group we...