Tao Wang1, Biao Wu2, Xichun Hu3, Jinping Liu4, Tao Zhang5, Funian Li6, Bing Sun1, Li Cai7, Xinzheng Li8, Zhiyue Chen9, Qing Yang9, Zefei Jiang1. 1. Department of Breast Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100071, China. 2. Department of Breast Oncology, The First Affiliated Hospital of Nanchang University, Nanchang 330019, China. 3. Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China. 4. Department of Breast Surgery, Sichuan Province People's Hospital, Chengdu 610072, China. 5. Department of Medical Oncology, Chengdu Military General Hospital, Chengdu 610083, China. 6. Department of Breast Surgery, The Affiliated Hospital of Qingdao University, Qingdao 266003, China. 7. Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China. 8. Department of Breast Surgery, Shanxi Province Cancer Hospital, Taiyuan 30013, China. 9. Department of Research and Development, Jiangsu Hengrui Medicine, Co., Ltd., Shanghai 200120, China.
Abstract
BACKGROUND: This study aimed to evaluate the efficacy and safety of mecapegfilgrastim (HHPG-19K) with different doses compared to granulocyte colony-stimulating growth factor (G-CSF) in treating chemotherapy-induced neutropenia in breast cancer patients. METHODS: A total of 182 breast cancer patients were enrolled in this multi-center, randomized, phase II trial and developed neutropenia after first cycle chemotherapy. Patients were then assigned as 1:1:1 ratio to receive 100 µg/kg HHPG-19K single injection (HHPG-19K-N group), 150 µg/kg HHPG-19Ksingle injection (HHPG-19K-H group) and 5 µg/kg G-CSF daily injection (G-CSF group) at day 3 of the second cycle (cycle 2) chemotherapy. The primary endpoint was incidence of grade ≥3 neutropenia during cycle 2. Study drug-related adverse events during cycle 2 were recorded for safety assessment. RESULTS: During cycle 2 chemotherapy, both HHPG-19K-N and HHPG-19K-H groups exhibited lower incidence of grade ≥3 neutropenia compared with G-CSF group, while no difference was observed between HHPG-19K-N and HHPG-19K-H groups. Also, better outcomes were observed in HHPG-19K-N and HHPG-19K-H groups compared with G-CSF group regarding to grade 4 neutropenia, duration of grade ≥3 neutropenia, duration of grade 4 neutropenia, incidence of febrile neutropenia (FN) and rescue application of G-CSF, time to ANC recovery, while no difference of these outcomes between HHPG-19K-N and HHPG-19K-H groups was observed. For safety analysis, the incidences of hematologic and non-hematologic adverse events were similar among the 3 groups. CONCLUSIONS: HHPG-19K presents with better clinical efficacy as well as equal tolerance compared with G-CSF in treating chemotherapy-induced neutropenia in breast cancer patients.
BACKGROUND: This study aimed to evaluate the efficacy and safety of mecapegfilgrastim (HHPG-19K) with different doses compared to granulocyte colony-stimulating growth factor (G-CSF) in treating chemotherapy-induced neutropenia in breast cancer patients. METHODS: A total of 182 breast cancer patients were enrolled in this multi-center, randomized, phase II trial and developed neutropenia after first cycle chemotherapy. Patients were then assigned as 1:1:1 ratio to receive 100 µg/kg HHPG-19K single injection (HHPG-19K-N group), 150 µg/kg HHPG-19Ksingle injection (HHPG-19K-H group) and 5 µg/kg G-CSF daily injection (G-CSF group) at day 3 of the second cycle (cycle 2) chemotherapy. The primary endpoint was incidence of grade ≥3 neutropenia during cycle 2. Study drug-related adverse events during cycle 2 were recorded for safety assessment. RESULTS: During cycle 2 chemotherapy, both HHPG-19K-N and HHPG-19K-H groups exhibited lower incidence of grade ≥3 neutropenia compared with G-CSF group, while no difference was observed between HHPG-19K-N and HHPG-19K-H groups. Also, better outcomes were observed in HHPG-19K-N and HHPG-19K-H groups compared with G-CSF group regarding to grade 4 neutropenia, duration of grade ≥3 neutropenia, duration of grade 4 neutropenia, incidence of febrile neutropenia (FN) and rescue application of G-CSF, time to ANC recovery, while no difference of these outcomes between HHPG-19K-N and HHPG-19K-H groups was observed. For safety analysis, the incidences of hematologic and non-hematologic adverse events were similar among the 3 groups. CONCLUSIONS: HHPG-19K presents with better clinical efficacy as well as equal tolerance compared with G-CSF in treating chemotherapy-induced neutropenia in breast cancer patients.
Entities:
Keywords:
Mecapegfilgrastim; breast cancer; chemotherapy; efficacy; neutropenia; safety
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