​​Cancer Drug Linked to Low but Unexpected Increase in Maculopathy Incidence

The research team identified risk factors such as old age, female sex, dyslipidemia and liver disease—suggesting that clinicians may consider closer ophthalmic attention for patients with these characteristics, particularly if visual symptoms arise. Click image to enlarge. In recent years, paclitaxel has grown to become a common drug used in chemotherapy. However, despite how frequently these drugs are used today, few studies have been done on the incidence of ocular adverse events in treated patients. To address this gap in research, a new study analyzed records from a South Korean health claims database over an eight-year period and found that these therapeutic agents may increase the risk of various ophthalmic conditions. The researchers found that, compared with the pre-treatment period, initiation of paclitaxel was associated with approximately a four-fold higher incidence of macular edema and associated cystic maculopathy. Although the relative risk was increased, the cumulative incidence remained low (less than 2%), indicating that the absolute likelihood of maculopathy is modest. However, the cumulative incidence of 1.0% to 1.4% during follow-up was higher than what was expected.Over this study period, 2015 to 2023, the number of annual paclitaxel users gradually increased, 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 mean age of participants was 58.6 years, and 63.6% were women. At the time of paclitaxel initiation, the prevalence of pre-existing comorbidities was 41.3% for diabetes, 49.1% for hypertension and 41.4% for dyslipidemia. Concurrent tamoxifen use was observed in 8.8% of the cohort. The mean duration of paclitaxel therapy was 5.2 months, and the mean cumulative dose was 1.4g. Paclitaxel was most frequently prescribed for lung cancer (23.8%), breast cancer (23.5%) and ovarian cancer (15.9%), with other solid tumors or off-label indications accounting for the remaining 36.8%.The incidence rate ratios for the post-treatment vs. pre-treatment period were 4.08 for macular edema and 4.11 for macular edema and/or cystic (toxic) maculopathy. Independent risk factors for maculopathy included duration of use (hazard ratio; HR: 1.01), age (HR: 1.01), female sex (HR: 1.47), dyslipidemia (HR: 1.47) and liver disease (HR: 1.32). Patients in the highest tertile of cumulative dose had a higher risk compared with those in the lowest tertile (HR: 1.30 for overall maculopathy and HR: 1.28 for macular edema).“This sharp upward trend, reflecting the expanding adoption of paclitaxel across multiple cancer types, highlights that even a low incidence of drug-related maculopathy translates into a potentially substantial number of affected patients at the population level,” the study authors wrote in their paper, which was published in Ophthalmology Retina.“The cumulative maculopathy incidence may represent a potential public health concern given that paclitaxel is an essential therapy for several common malignancies, including breast and lung cancer,” they added. “However, this adverse event is relatively rare and typically symptomatic with relatively good vision and potential reversibility, which limits the justification for implementing routine surveillance among paclitaxel users.”Because the database the study used was fully anonymized, the research team could not link cohort members to OCT images for formal validation of the claims-based outcome definition. During follow-up, approximately 22.9% of patients underwent fundus examination and only 11.1% received OCT. Because paclitaxel-associated maculopathy may initially be mild or asymptomatic, cases that did not undergo evaluation may have remained undetected, potentially leading to under-ascertainment and underestimation of the true incidence.The researchers concluded that they believe that patient education is key—particularly for those with higher-risk characteristics—to ensure prompt reporting and timely evaluation if visual symptoms occur. They suggested that future studies assessing the cost-effectiveness and clinical value of targeted monitoring in high-risk groups may help refine practical guidance. Click here for the journal source. Hwang S, Kim J, Chung JE, Ahn SJ. Maculopathy in paclitaxel users: nationwide drug use, incidence and risk factors. Ophthalmol Retina. March 29, 2026. [Epub ahead of print].  This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.