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Ann Transl Med. 2019 Sep;7(18):482. doi: 10.21037/atm.2019.07.95.

Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial.

Author information

1
Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China.
2
Department of Breast Oncology, Academy of Military Medical Sciences, Beijing 100089, China.
3
Department of Breast Surgery, Liaocheng People's Hospital, Liaocheng 252000, China.
4
Department of Medical Oncology, The First Affiliated Hospital of Xinxiang University, Xinxiang 453100, China.
5
Department of Breast Surgery, Chongqing Cancer Hospital, Chongqing 400030, China.
6
Department of General Surgery, The First Affiliated Hospital of Nanchang University, Nanchang 330006, China.
7
Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China.
8
Department of Breast Surgery, Sichuan Province People's Hospital, Chengdu 610072, China.
9
Department of Medical Oncology, Zhongshan University Cancer Center, Guangzhou 510060, China.
10
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
11
Department of Breast Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
12
Department of Research and Development, Jiangsu Hengrui Medicine Co., Ltd., Shanghai 200120, China.

Abstract

Background:

Neutropenia is a common complication from chemotherapy. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed. This study was to evaluate the efficacy and safety of mecapegfilgrastim for reducing neutropenia compared with filgrastim.

Methods:

This was a randomized, controlled non-inferiority study. A total of 339 breast cancer patients who were eligible for (neo) adjuvant chemotherapy were randomized assigned into three groups to receive mecapegfilgrastim 100 µg/kg, mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day in the first cycle of chemotherapy. The primary endpoint was the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints included the duration of grade ≥3 neutropenia in cycles 2-4, incidence of grade ≥3 neutropenia, and febrile neutropenia (FN). The safety profile was also evaluated.

Results:

The mean duration of grade ≥3 neutropenia was 1.06 [95% confidence interval (CI): 0.65, 1.26] days in mecapegfilgrastim 100 µg/kg group, 1.23 (95% CI: 0.84, 1.88) days in mecapegfilgrastim 6 mg group, and 2.06 (95% CI: 1.66, 2.46) days in the filgrastim group. The mean difference between mecapegfilgrastim 100 µg/kg and filgrastim was -1.00 (95% CI: -1.52, -0.48), the mean difference between mecapegfilgrastim 6 mg and filgrastim was -0.83 (95% CI: -1.36, -0.30). The upper bounds of 95% CI for the difference between mecapegfilgrastim and filgrastim were all <1 day (the predefined non-inferiority margin). For the incidence of grade ≥3 and grade 4 neutropenia, the mean duration of grade 4 neutropenia, mecapegfilgrastim showed better performance compared with filgrastim. For the incidence of FN, there was no difference between patients treated with mecapegfilgrastim and filgrastim. For safety profile, mecapegfilgrastim of two doses groups were all well-tolerated. Fixed 6 mg dose of mecapegfilgrastim exhibited comparable efficacy and safety in comparison with 100 µg/kg during 4 cycles.

Conclusions:

Long-acting mecapegfilgrastim (100 µg/kg and fixed 6 mg) is very effective and well tolerated when administered in the primary prophylaxis of chemotherapy induced neutropenia and in consecutive-cycle treatment. In some clinical parameters, mecafilgrastim is non-inferior and even superior to filgrastim. The fixed 6 mg-dose regimen showed similar efficacy and safety profile compared with 100 µg/kg regimen, and would be the preference in clinical practice, due to the convenient once-per-cycle administration and high-degree treatment compliance for the patients. This study provided new evidence for the novel long-acting rhG-CSF, mecapegfilgrastim, which would be a new alternative for clinical practice for prophylaxis of chemotherapy induced neutropenia.

KEYWORDS:

Breast cancer; filgrastim; long-acting granulocyte colony-stimulating factor (long-acting G-CSF); mecapegfilgrastim

Conflict of interest statement

Conflicts of Interest: The authors have no conflicts of interest to declare.

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