Maculopathy in Paclitaxel Users: Nationwide Drug Use, Incidence, and Risk Factors.

PURPOSE: To determine the 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 pretreatment and posttreatment periods, whereas 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: The main outcome measures were as follows: (1) cumulative incidence of macular edema and associated cystic maculopathy, (2) IRRs comparing posttreatment with pretreatment 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 7375 in 2015 to 18 337 in 2023. Among 98 246 patients treated with paclitaxel, the cumulative incidence of macular edema or associated cystic maculopathy was 1.4% by the end of the study period. The IRR for the posttreatment versus pretreatment 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 or associated cystic 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, 1.33; 95% CI, 1.08-1.65 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 or associated cystic maculopathy. Older age, female sex, dyslipidemia, liver disease, and greater cumulative dose further amplified this risk.

FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.