BMC cancer · 2025
Telpegfilgrastim for chemotherapy-induced neutropenia in patients with non-small cell lung cancer: a multicentre, randomized, phase 3 study.
Клиническое исследование III фазыEquivalence TrialСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Shi Yuankai, Wang Xinshuai, Pei Zhidong, Shi Huaqiu, Zhang Yanjun, Yi Tienan, Mei Jiazhuan, Guo Yanzhen, Dong Youhong, Ma Tianjiang, Zhang Qingyuan, Jia Xiaojing, Zhu Zhengqiu, Xu Shen, Liu Yanyan, Niu Hongrui, Jiang Weimei, Jiang Xiaodong, Zhou Shengyu, Sun Li
Аннотация
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 were -0.14 day [95% confidence interval [CI]: -0.35, 0.06] for telpegfilgrastim 2 mg group and -0.06 day [95% CI: -0.26, 0.15] for telpegfilgrastim 33 µg/kg group. which met the prespecified non-inferiority margin of 1 day. Incidence of grade 4 neutropenia, incidence of FN and duration of ≥ grade 3 neutropenia in cycles 1-4 of chemotherapy was similar between telpegfilgrastim groups and control group. Telpegfilgrastim was well tolerated, and the incidence of adverse events were comparable with control group.
CONCLUSION: This study demonstrated that telpegfilgrastim 2 mg or 33 μg/kg was non-inferior to rhG-CSF (Topneuter®) and PEG-rhG-CSF (Xinruibai®) for the management of CIN in patients with NSCLC. In particular, a 2 mg fixed dose of telpegfilgrastim presents a more convenient administration option.
TRIAL REGISTRATION: NCT04466137 , July 10, 2020.
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 were -0.14 day [95% confidence interval [CI]: -0.35, 0.06] for telpegfilgrastim 2 mg group and -0.06 day [95% CI: -0.26, 0.15] for telpegfilgrastim 33 µg/kg group. which met the prespecified non-inferiority margin of 1 day. Incidence of grade 4 neutropenia, incidence of FN and duration of ≥ grade 3 neutropenia in cycles 1-4 of chemotherapy was similar between telpegfilgrastim groups and control group. Telpegfilgrastim was well tolerated, and the incidence of adverse events were comparable with control group.
CONCLUSION: This study demonstrated that telpegfilgrastim 2 mg or 33 μg/kg was non-inferior to rhG-CSF (Topneuter®) and PEG-rhG-CSF (Xinruibai®) for the management of CIN in patients with NSCLC. In particular, a 2 mg fixed dose of telpegfilgrastim presents a more convenient administration option.
TRIAL REGISTRATION: NCT04466137 , July 10, 2020.