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Paclitaxel use increases the risk of maculopathy, including macular edema. Risk factors like older age, female sex, and higher cumulative doses amplify this effect.

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Area of Science:

  • Ophthalmology
  • Oncology
  • Pharmacovigilance

Background:

  • Paclitaxel is a widely used chemotherapy agent.
  • Maculopathy, including macular edema and cystic changes, is a potential ocular side effect.
  • Real-world data on paclitaxel-induced maculopathy incidence and risk factors are limited.

Purpose of the Study:

  • To determine the incidence and risk factors of maculopathy in new paclitaxel users in South Korea.
  • To assess the association between paclitaxel therapy and the development of macular edema and/or cystic maculopathy.
  • To identify demographic and clinical predictors of paclitaxel-induced maculopathy.

Main Methods:

  • Retrospective, nationwide cohort study using the Health Insurance Review and Assessment database.
  • Included adults initiating paclitaxel between 2015-2023 without prior maculopathy.
  • Analyzed cumulative incidence, incidence rate ratios (IRRs), and multivariable Cox regression models for risk factors.

Main Results:

  • The cumulative incidence of macular edema and/or cystic maculopathy was 1.4% among 98,246 paclitaxel users.
  • The post-treatment vs. pre-treatment IRR for maculopathy was over 4.0.
  • Independent risk factors included longer duration of use, older age, female sex, dyslipidemia, liver disease, and higher cumulative paclitaxel dose.

Conclusions:

  • Paclitaxel therapy is linked to a significant increase in maculopathy risk.
  • Older age, female sex, dyslipidemia, liver disease, and higher cumulative doses are associated with amplified risk.
  • These findings highlight the importance of monitoring for ocular toxicity in paclitaxel recipients.