Maculopathy in Paclitaxel Users: Nationwide Drug Use, Incidence, and Risk Factors
Menée en Corée à partir de données portant sur 98 246 patients atteints d'un cancer traité par paclitaxel, cette étude de cohorte rétrospective identifie les facteurs liés au risque d'oedème maculaire et/ou de maculopathie kystique
Purpose: To determine the real-world incidence and risk factors for maculopathy among new paclitaxel users in South Korea.
Design: Retrospective, nationwide cohort study.
Participants: Adults who initiated paclitaxel therapy between 2015 and 2023 without a prior diagnosis of maculopathy, as recorded in the Health Insurance Review and Assessment database.
Methods: Incidence rate ratios (IRRs) were calculated by comparing pre- and post-treatment periods, while cumulative incidence was assessed using Kaplan-Meier analysis. Multivariable Cox regression models were applied to estimate adjusted hazard ratios (HRs) for demographic and clinical risk factors, including a dose-response analysis.
Main Outcome Measures: (1) Cumulative incidence of macular edema and associated cystic maculopathy, (2) IRRs comparing post-treatment with pre-treatment periods, and (3) adjusted HRs for demographic and clinical predictors.
Results: The number of annual paclitaxel users gradually increased during the study period, rising from 7,375 in 2015 to 18,337 in 2023. Among 98,246 patients treated with paclitaxel, the cumulative incidence of macular edema and/or associated cystic maculopathy was 1.4% by the study end. The IRR for the post-treatment versus pre-treatment period was 4.08 (95% confidence interval [CI]: 3.64-4.56) for macular edema and 4.11 (95% CI: 3.72-4.55) for macular edema and/or cystic (toxic) maculopathy. Independent risk factors for maculopathy included duration of use (HR, 1.01; 95% CI: 1.00-1.01), age (HR, 1.01; 95% CI: 1.01-1.02), female sex (HR, 1.47; 95% CI: 1.22-1.77), dyslipidemia (HR, 1.47; 95% CI: 1.24-1.74), and liver disease (HR, 1.32; 95% CI: 1.11-1.57). Patients in the highest tertile of cumulative dose had a higher risk compared with those in the lowest tertile (HR, 1.30; 95% CI: 1.18–1.44 for overall maculopathy and HR, 1.28; 95% CI: 1.03–1.59 for macular edema).
Conclusions: Paclitaxel therapy is associated with a measurable increase in the risk of macular edema and/or associated cystic maculopathy. Older age, female sex, dyslipidemia, liver disease, and greater cumulative dose further amplified this risk.
Ophthalmology Retina , résumé, 2026