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 mu g/kg HHPG-19K single injection (HHPG-19K-N group), 150 mu g/kg HHPG-19Ksingle injection (HHPG-19K-H group) and 5 mu g/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.
[1]Chinese Peoples Liberat Army Gen Hosp, Med Ctr 5, Dept Breast Oncol, 100 West Fourth Ring Middle Rd, Beijing 100071, Peoples R China;
[2]Nanchang Univ, Dept Breast Oncol, Affiliated Hosp 1, Nanchang 330019, Jiangxi, Peoples R China;
[3]Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, Shanghai 200032, Peoples R China;
[4]Sichuan Prov Peoples Hosp, Dept Breast Surg, Chengdu 610072, Sichuan, Peoples R China;
[5]Chengdu Mil Gen Hosp, Dept Med Oncol, Chengdu 610083, Sichuan, Peoples R China;
[6]Qingdao Univ, Affiliated Hosp, Dept Breast Surg, Qingdao 266003, Shandong, Peoples R China;
[7]Harbin Med Univ, Dept Med Oncol, Canc Hosp, Harbin 150081, Heilongjiang, Peoples R China;
[8]Shanxi Prov Canc Hosp, Dept Breast Surg, Taiyuan 30013, Shanxi, Peoples R China;
[9]Jiangsu Hengrui Med Co Ltd, Dept Res & Dev, Shanghai 200120, Peoples R China
(8.0+极速模式)