Caicun Zhou1, Yunchao Huang2, Donglin Wang3, Changshan An4, Fuxiang Zhou5, Yali Li6, Gongyan Chen7, Changping Wu8, Jianxing He9, Gang Wu10, Xia Song11, Jianfei Gao12, Wei Liu13, Baolan Li14, Jianhua Shi15, Cheng Huang16, Jingrui Yu17, Jueping Feng18, Hongmei Yue19, Meiqi Shi20, Jielai Xia21. 1. Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: zhoucc150602@163.com. 2. Department of Thoracic Surgery, Cancer Hospital of Yunnan Provience, Kunming, China. 3. Department of Oncology, Chongqing Cancer Hospital, Chongqing, China. 4. Department of Respiration Medicine, Yanbian University Hospital, Yanbian, China. 5. Department of Radiotherapy and Chemotherapy, Zhongnan Hospital of Wuhan University, Wuhan, China. 6. Department of Respiration Medicine, The Second Affiliated Hospital of Xi'an Jiaotong University, Xian, China. 7. Department of Respiration Oncology, Harbin Medical University Cancer Hospital, Harbin, China. 8. Department of Oncology, The First People's Hospital of Changzhou, Changzhou, China. 9. Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 10. Department of Oncology, Wuhan Union Hospital, Wuhan, China. 11. Department of Respiration Medicine, Cancer Hospital of Shanxi Provence, Taiyuan, China. 12. Department of Oncology, Wuhan General Hospital of Guangzhou Military, Wuhan, China. 13. Department of Oncology, Tumor Hospital of Hebei Provence, Shijiazhuang, China. 14. Department of General Medicine, Beijing Chest Hospital, Capital Medical University, Beijing, China. 15. Department of Oncology, Linyi Cancer Hospital, Linyi, China. 16. Department of Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China. 17. Department of Oncology, The Second People's Hospital of Sichuan, Chengdu, China. 18. Department of Oncology, Wuhan Puai Hospital, Wuhan, China. 19. Department of Respiration Medicine, The First Hospital of Lanzhou University, Lanzhou, China. 20. Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China. 21. Department of Statistics, The Fourth Military Medical University, Xi'an, China.
Abstract
BACKGROUND:Mecapegfilgrastim (code name HHPG-19K) is a biosimilar to pegylated recombinant human granulocyte-colony stimulating factor (PEG-rhG-CSF). The efficacy and safety of mecapegfilgrastim, using a regimen of once-per-cycle injection of 100-μg/kg or a fixed 6-mg dose, were evaluated for the prophylactic therapy for neutropenia in patients with advanced non-small-cell lung cancer (NSCLC) who were treated withmyelosuppressive chemotherapy. MATERIALS AND METHODS: Patients were randomized (1:1:1) blindly to 3 treatment arms to receive a single injection of mecapegfilgrastim 100 μg/kg, a 6-mg fixed dose of mecapegfilgrastim, or saline (control) in cycle 1. In cycles 2 to 4 following unblinding at the end of cycle 1, patients in the control arm received daily injections of short-acting rhG-CSF at a dose of 5 μg/kg, whereas patients in the 2 mecapegfilgrastim arms continued the same treatment as in cycle 1. All patients received 4 chemotherapy cycles of docetaxel combined with cisplatin or carboplatin every 21 days. The primary endpoint was the incidence of grade ≥ 3 neutropenia in cycle 1. RESULTS: A single dose of 100 μg/kg or a fixed 6-mg dose of mecapegfilgrastim per cycle effectively reduced chemotherapy-induced neutropenia and was comparable to daily rhG-CSF with regard to all efficacy endpoints, including incidence of grade ≥ 3 neutropenia, incidence of febrile neutropenia, duration of grade ≥ 3 neutropenia, and time to neutrophil recovery. No difference in efficacy parameters was observed between the 2-dose regimens of mecapegfilgrastim across all cycles. Mecapegfilgrastim was well-tolerated and was as safe as daily rhG-CSF. CONCLUSION: Once-per-cycle injection of mecapegfilgrastim is as effective and safe as daily rhG-CSF for prophylaxis of chemotherapy-induced neutropenia in patients with NSCLC. Mecapegfilgrastim (fixed 6-mg dose) is recommended in clinical practice for its convenient dose management. Crown
RCT Entities:
BACKGROUND: Mecapegfilgrastim (code name HHPG-19K) is a biosimilar to pegylated recombinant humangranulocyte-colony stimulating factor (PEG-rhG-CSF). The efficacy and safety of mecapegfilgrastim, using a regimen of once-per-cycle injection of 100-μg/kg or a fixed 6-mg dose, were evaluated for the prophylactic therapy for neutropenia in patients with advanced non-small-cell lung cancer (NSCLC) who were treated with myelosuppressive chemotherapy. MATERIALS AND METHODS:Patients were randomized (1:1:1) blindly to 3 treatment arms to receive a single injection of mecapegfilgrastim 100 μg/kg, a 6-mg fixed dose of mecapegfilgrastim, or saline (control) in cycle 1. In cycles 2 to 4 following unblinding at the end of cycle 1, patients in the control arm received daily injections of short-acting rhG-CSF at a dose of 5 μg/kg, whereas patients in the 2 mecapegfilgrastim arms continued the same treatment as in cycle 1. All patients received 4 chemotherapy cycles of docetaxel combined with cisplatin or carboplatin every 21 days. The primary endpoint was the incidence of grade ≥ 3 neutropenia in cycle 1. RESULTS: A single dose of 100 μg/kg or a fixed 6-mg dose of mecapegfilgrastim per cycle effectively reduced chemotherapy-induced neutropenia and was comparable to daily rhG-CSF with regard to all efficacy endpoints, including incidence of grade ≥ 3 neutropenia, incidence of febrile neutropenia, duration of grade ≥ 3 neutropenia, and time to neutrophil recovery. No difference in efficacy parameters was observed between the 2-dose regimens of mecapegfilgrastim across all cycles. Mecapegfilgrastim was well-tolerated and was as safe as daily rhG-CSF. CONCLUSION: Once-per-cycle injection of mecapegfilgrastim is as effective and safe as daily rhG-CSF for prophylaxis of chemotherapy-induced neutropenia in patients with NSCLC. Mecapegfilgrastim (fixed 6-mg dose) is recommended in clinical practice for its convenient dose management. Crown