Lipegfilgrastim

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.

Pegylated granulopoesis growth factors (pegylated granulocyte colony-stimulating factors - PGCSF), pegfilgrastim and lipegfilgrastim, have established indications in the prophylaxis of febrile neutropenia (FN) after chemotherapy (CHT). Almost two decades after their introduction into practice, there is an opportunity to analyze their use development.

Retrospective and single centre analysis; patients with at least one and the first in their history application of PGCSF in 2005-2020 (N = 1,794); comparison of characteristics of the Historical group (2005-2010, N = 214) with the numerically comparable Recent group (2019, N = 222).

In the period 2005-2020, there were 1 794 patients with at least one first application of PGCSF. Historical group vs. Recent: age 50 (18-77) vs. 58 (23-84) years; women 79 vs. 66%; breast and gastrointestinal cancer 67 and 3% vs. 29 and 25% respectively; primary FN prophylaxis 45 vs. 62%; CHT curative/neo-adjuvant 75 vs. 61%; CHT Q3W 94 vs. 53%; CHT Q2W 2 vs. 36%; CHT TAC/FEC/AC 57 vs. 25%; FOLFOX/FOLFIRI ± anti-VEGF/-EGFR 0.5 vs. 16% (all P < 0.05); FN incidence 4 vs. 0%; leukopenia as a separate reason leading to postponement of CHT despite prophylactic administration of PGCSF: 2.8 vs. 4.9%; musculoskeletal pain and arthralgia 9 vs. 5%; intolerance/allergy: 2 vs. 1 (all statistically n.s.).

In 2019, compared to 2005-2010, we show an increase in the use of PGCSF with a shift to palliative CHT protocols and generally less risky for the development of FN. The efficacy and safety of PGCSF were consistent with the conclusions of published studies. More detailed analyses of indications for Q2W protocols, generally low-risk or infrequent non-standard situations can bring other important insights and are topics for ideally multicenter cooperation.