Mecapegfilgrastim prophylaxis for neutropenia in patients with non-myeloid malignancies: A Chinese nationwide real-world study

• Published in: BMC cancer Vol. 25; no. 1; pp. 742 - 10
• Main Authors: Qin, Shukui, Shi, Yanxia, Fu, Peifen, Xu, Nong, Mao, Chenyu, Chen, Yong, Wang, Yongsheng, Huang, Huiqiang, Huang, Xin, Li, Yongqing, Yan, Haijiao, Yao, Yumin, Cheng, Gang, Yang, Zhe, Zhang, Ningling, Zhang, Guifang, Chen, Minbin, Jiang, Hua, Ren, Zhangxia, Chen, Liang, Ding, Lifang, Xu, Ruihua, Ma, Jun
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 21.04.2025; BioMed Central; BMC
• Subjects: Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Blood; Blood cell count; Breast cancer; Cancer; Chemotherapy; China - epidemiology; Clinical trials; Disease prevention; Drug therapy; East Asian People; Female; Filgrastim - administration & dosage; Filgrastim - adverse effects; Filgrastim - therapeutic use; Granulocyte colony-stimulating factor; Granulocytes; Health aspects; Humans; Incidence; Informed consent; Leukemia; Leukocytes; Lung cancer; Lymphoma; Male; Malignancy; Mecapegfilgrastim; Middle Aged; Mortality; Neoplasms - drug therapy; Neutropenia; Neutropenia - chemically induced; Neutropenia - epidemiology; Neutropenia - prevention & control; Neutrophils; Patient outcomes; Patients; Prevention; Primary prophylaxis; Prophylaxis; Prospective Studies; Real-world study; Risk factors; Tumors; Young Adult; China; Prevention; Primary prophylaxis; Mecapegfilgrastim; Granulocyte colony-stimulating factor; Real-world study; Neutropenia
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-025-14144-6

Mecapegfilgrastim has been previously validated for efficacy and safety in neutropenia prevention during clinical trials. This nationwide, real-world study (RWS) evaluates its role in protecting against moderate to severe chemotherapy-induced neutropenia (CIN) in Chinese patients with non-myeloid malignancies. In this prospective study conducted in the 46 centers across China, the patients with non-myeloid malignancies were enrolled, and received subcutaneous injections of mecapegfilgrastim 24 h after each chemotherapy cycle. Outcomes were monitored over four subsequent chemotherapy cycles. The primary outcome was safety, while secondary outcomes included the incidence of grade 3 or higher neutropenia, grade 4 neutropenia, and febrile neutropenia (FN), etc. RESULTS: From June 2019 to March 2022, 2,859 patients were enrolled, contributing to 7,763 observed chemotherapy cycles. Treatment-related adverse events (TRAEs) were noted in 329 patients (11.5%), with white blood cell count increased being the most common (3.6%). The incidence of grade 3 or higher TRAEs was 1.0%. In the first cycle, 236 (8.3%), 125 (4.4%) and 24 patients (0.8%) reported grade ≥ 3 neutropenia, grade 4 neutropenia, and FN, respectively. Across all cycles, the rates of grade ≥ 3 neutropenia, grade 4 neutropenia and FN were 5.8%, 2.7%, and 0.3%, respectively. Notably, primary prophylaxis was associated with lower incidences of grade ≥ 3 neutropenia (7.9%) and grade 4 neutropenia (4.1%) in the first cycle compared to secondary prophylaxis (11.2% and 6.7%, respectively). This RWS reinforces the safety and effectiveness of mecapegfilgrastim in preventing moderate to severe CIN among the patients with non-myeloid malignancies, with primary prophylaxis showing a lower incidence of neutropenia.