Mecapegfilgrastim prophylaxis for neutropenia in patients with non-myeloid malignancies: A Chinese nationwide real-world study
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 ma...
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| Published in | BMC cancer Vol. 25; no. 1; pp. 742 - 10 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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England
BioMed Central Ltd
21.04.2025
BioMed Central BMC |
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| Abstract | 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. |
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| AbstractList | 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. 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 [greater than or equal to] 3 neutropenia, grade 4 neutropenia, and FN, respectively. Across all cycles, the rates of grade [greater than or equal to] 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 [greater than or equal to] 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. 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. Abstract Background 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. Methods 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). Conclusion 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. Background 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. Methods 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 [greater than or equal to] 3 neutropenia, grade 4 neutropenia, and FN, respectively. Across all cycles, the rates of grade [greater than or equal to] 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 [greater than or equal to] 3 neutropenia (7.9%) and grade 4 neutropenia (4.1%) in the first cycle compared to secondary prophylaxis (11.2% and 6.7%, respectively). Conclusion 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. Keywords: Mecapegfilgrastim, Granulocyte colony-stimulating factor, Neutropenia, Primary prophylaxis, Prevention, Real-world study 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.BACKGROUNDMecapegfilgrastim 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).METHODSIn 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.CONCLUSIONThis 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. BackgroundMecapegfilgrastim 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.MethodsIn 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.ResultsFrom 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).ConclusionThis 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. |
| ArticleNumber | 742 |
| Audience | Academic |
| Author | Shi, Yanxia Yan, Haijiao Wang, Yongsheng Ren, Zhangxia Chen, Liang Fu, Peifen Huang, Huiqiang Yang, Zhe Zhang, Ningling Cheng, Gang Jiang, Hua Xu, Ruihua Huang, Xin Chen, Minbin Ding, Lifang Xu, Nong Qin, Shukui Li, Yongqing Yao, Yumin Zhang, Guifang Ma, Jun Mao, Chenyu Chen, Yong |
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| Keywords | Prevention Primary prophylaxis Mecapegfilgrastim Granulocyte colony-stimulating factor Real-world study Neutropenia |
| Language | English |
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| Snippet | Mecapegfilgrastim has been previously validated for efficacy and safety in neutropenia prevention during clinical trials. This nationwide, real-world study... Background Mecapegfilgrastim has been previously validated for efficacy and safety in neutropenia prevention during clinical trials. This nationwide,... BackgroundMecapegfilgrastim has been previously validated for efficacy and safety in neutropenia prevention during clinical trials. This nationwide, real-world... Abstract Background Mecapegfilgrastim has been previously validated for efficacy and safety in neutropenia prevention during clinical trials. This nationwide,... |
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| SubjectTerms | 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 |
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| Title | Mecapegfilgrastim prophylaxis for neutropenia in patients with non-myeloid malignancies: A Chinese nationwide real-world study |
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