Presentation (CTI)

OBJECTIVES: Despite the gradual yet increasing adoption of biosimilars, a paucity of real-world evidence exists concerning the comparative utilization of reference and biosimilar granulocyte colony-stimulating factors (G-CSF) in Asia. This retrospective cohort study aimed to compare the clinical effectiveness and safety of G-CSF as primary prophylaxis in diffuse large B-cell lymphoma (DLBCL).
METHODS: We evaluated patients with previously untreated DLBCL who received chemotherapy followed by primary prophylactic G-CSF at a single medical center in Taiwan between 2015 and 2022. The incidence of febrile neutropenia, infection, and adverse events (AEs) leading to treatment discontinuation or death were assessed. Inverse probability of treatment weighting was used to minimize baseline imbalances, and logistic regression analysis was performed.
RESULTS: This study included 146 patients (mean age 65 years, 58% female), of whom 92% received a short-acting G-CSF. Among all patients, 24% received a biosimilar product. There was no significant difference between the biosimilar and reference G-CSF in the incidence of febrile neutropenia (adjusted odds ratio [aOR]: 0.31, 95% confidence interval [CI]: 0.06, 1.61) or infection (aOR: 0.79, 95% CI: 0.23, 2.77). No patients experienced an AE leading to treatment discontinuation or death.
CONCLUSIONS: This comparative analysis of the incidence of febrile neutropenia and infection revealed no statistically significant differences between biosimilar and reference G-CSF products. Moreover, the study found that no patients experienced AEs that necessitated treatment discontinuation or death, regardless of the G-CSF type (reference or biosimilar). These findings provide evidence to support the utilization of biosimilar G-CSF as a safe and effective alternative to the reference product.