ArticleEClinicalMedicine2026
Comparative efficacy and safety of four long-acting granulocyte colony-stimulating factors for primary prophylaxis in patients with breast cancer: a prospective observational cohort study in China.
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Long-acting granulocyte colony-stimulating factors (G-CSFs) are the standard of care for primary prophylaxis against chemotherapy-induced neutropenia in breast cancer, but comparative data remain limited. Methods: This prospective observational cohort study was conducted at a single center in Shanghai, China. Patients with breast cancer scheduled for high-febrile-neutropenia-risk chemotherapy and planned for long-acting G-CSF primary prophylaxis were eligible. Patients received subcutaneous pegfilgrastim, mecapegfilgrastim, telpegfilgrastim, or efbemalenograstim alfa once per cycle per clinical practice. The primary outcome was the incidence of grade 3/4 neutropenia (leukopenia), assessed during chemotherapy cycles and at follow-up visits. Safety was assessed via bone pain-related treatment-emergent adverse events (BPR TEAEs). Findings: Between March 25 and September 30, 2025, 407 patients were analyzed. Grade 3/4 neutropenia (leukopenia) occurred in 24.1%, varying numerically across agents (telpegfilgrastim 30.2%, mecapegfilgrastim 16.4%; overall P = 0.061). After multivariable adjustment, telpegfilgrastim was associated with a higher risk of grade 3/4 neutropenia (leukopenia) versus mecapegfilgrastim (OR = 2.46, P = 0.011). BPR TEAEs occurred in 62.4%, with similar incidence across groups (P = 0.32). Lower BPR TEAE risk was associated with ddEC chemotherapy (OR = 0.32, P = 0.0010) and postmenopausal status (OR = 0.53, P = 0.031). In exploratory analyses, administration at 24-48 h (versus <24 h) was associated with lower grade 4 neutropenia (leukopenia) (9.9% versus 27.3%, P = 0.011) and severe BPR TEAEs (0.5% versus 4.5%, P = 0.032), and a 3 mg pegfilgrastim dose was associated with comparable myeloprotection to 6 mg (29.4% versus 26.5%, P = 0.81) but fewer BPR TEAEs (29.4% versus 60.3%, P = 0.022). Interpretation: All four long-acting G-CSFs demonstrated clinical efficacy. Numerical variations and adjusted analyses indicated distinct clinical profiles, supporting tailored prophylaxis. Optimizing administration timing and considering dose reduction could improve benefit-risk balance. Larger prospective studies are needed to confirm these exploratory findings. Funding: None.
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