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Background <p>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.</p> Methods <p>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&#xa0;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.</p> Results <p>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).</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月21日

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  • Shukui Qin,
  • Yanxia Shi,
  • Peifen Fu,
  • Nong Xu,
  • Chenyu Mao,
  • Yong Chen,
  • Yongsheng Wang,
  • Huiqiang Huang,
  • Xin Huang,
  • Yongqing Li,
  • Haijiao Yan,
  • Yumin Yao,
  • Gang Cheng,
  • Zhe Yang,
  • Ningling Zhang,
  • Guifang Zhang,
  • Minbin Chen,
  • Hua Jiang,
  • Zhangxia Ren,
  • Liang Chen,
  • Lifang Ding,
  • Ruihua Xu,
  • Jun Ma

摘要

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.