[Clinical expert consensus on the application of long-acting granulocyte colony-stimulating factor in gynecologic malignancies (2025 edition)].

Abstract

Ovarian cancer, cervical cancer, and endometrial cancer are the three major malignant tumors in gynecologic oncology, with an increasing incidence rate in recent years. Chemotherapy, radiotherapy, immunotherapy, and targeted therapy remain the mainstays of treatment; however, all may cause varying degrees of myelosuppression, with neutropenia being the most common adverse effect. Notably, the incidence of grade ≥3 neutropenia among gynecologic oncology patients undergoing antitumor therapy is significantly higher than that in patients with other solid tumors, leading to increased risk of severe infections, prolonged hospitalization, and potentially life-threatening complications. Therefore, effective prevention and management of neutropenia are crucial to ensuring treatment adherence and maintaining patients' quality of life. A growing body of evidence has demonstrated the clinical value of long-acting granulocyte colony-stimulating factor (G-CSF) in the prevention and management of neutropenia. Based on the latest evidence in evidence-based medicine, this expert consensus provides an overview of neutropenia commonly encountered during chemoradiotherapy in patients with gynecologic malignancies and highlights its potential impact on treatment outcomes. It then systematically introduces the long-acting G-CSF currently approved by the U.S. Food and Drug Administration (FDA) and Chinese regulatory authorities. The consensus further elaborates on the clinical applications of long-acting G-CSF in the prevention of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN), and presents corresponding recommendations. Additionally, it outlines the differentiated use of long-acting G-CSF in primary and secondary prophylaxis, along with recommended dosing regimens and administration strategies based on recent literature. Potential adverse effects and corresponding management strategies of long-acting G-CSF are also systematically reviewed. To promote the standardized use of long-acting G-CSF in gynecologic cancer treatment, this 2025 edition of the expert consensus has been jointly developed by leading domestic experts, providing comprehensive guidance and evidence-based recommendations for rational clinical use in this field.

卵巢癌、宫颈癌、子宫内膜癌作为妇科三大恶性肿瘤，近年来，其发病率呈持续上升趋势。化疗、放疗、免疫治疗及靶向治疗是妇科肿瘤主要治疗手段，但均可能导致不同程度的骨髓抑制，而中性粒细胞减少症是常见的不良反应之一。值得注意的是，妇科肿瘤患者在接受抗肿瘤治疗过程中出现≥3级中性粒细胞减少的发生率显著高于其他实体瘤患者，进而可能增加严重感染风险，延长住院时间，甚至危及生命。因此，有效预防和管理中性粒细胞减少症是保障患者治疗依从性和生活质量的关键。目前已有大量研究显示，长效粒细胞集落刺激因子（G-CSF）在预防和治疗中性粒细胞减少症方面显示出良好的临床价值。共识基于循证医学证据，首先对妇科肿瘤患者在放化疗过程中常见的中性粒细胞减少症进行概述，指出其可能影响肿瘤治疗效果，并对长效G-CSF进行了系统介绍，包括目前已获得美国食品药品监督管理局和中国药品监管部门批准的主要药物。随后，对于长效G-CSF在预防化疗导致中性粒细胞减少和发热性中性粒细胞减少中的临床应用价值进行了详细的阐述和分析，形成相应的推荐意见。此外，针对长效G-CSF在一级预防和二级预防中的应用差异，共识分别进行了梳理与建议。对于长效G-CSF的推荐剂量和用法，也结合最新相关文献报道进行了归纳总结，提出了明确的推荐意见。同时，共识还对长效G-CSF可能出现的不良反应及相应的管理策略进行了系统性评估。共识旨在推动妇科肿瘤治疗中长效G-CSF的规范化应用，以期为临床合理用药提供科学依据与实践指导。.