Purpose: To determine the prevalence rates and associated characteristics of patients who have ocular surface, ocular adnexal, and lacrimal complications associated with the systemic use of the cancer chemotherapeutic agent 5-Fluorouracil (5-FU).
Methods: An exposure-based cohort study was designed. Adult patients who had completed at least 3 months of systemic 5-FU therapy within the past 5 years were eligible for enrollment. Study subjects had a detailed medical history taken with emphasis on preexisting conditions known to be associated with the development of ocular surface, ocular adnexal, and lacrimal complications. An ocular examination was then performed. A complete nasolacrimal system evaluation was performed if symptoms or findings were identified. The prevalence was then determined for each ocular symptom and each ocular finding identified that was not present pretreatment. An exploratory analysis was then performed to identify patient characteristics that might influence the likelihood of developing any of the above complications.
Results: Fifty-two patients were enrolled in the study. The prevalence rates of the following ocular abnormalities were calculated: ocular irritation, 5.8%; blepharitis, 3.8%; conjunctivitis, 3.8%; keratitis, 3.8%; eyelid dermatitis, 5.8%; cicatricial ectropion, 1.9%; tearing, 26.9%; punctal-canalicular stenosis, 5.8%; and blurred vision, 11.5%. Blacks had tearing at a significantly higher rate when compared with whites (P = 0.022, 2-sided Fisher exact test). Three patients had permanent complications that will require surgery for correction. Of the 7 patients who had a single abnormality, 6 had tearing and one had eyelid dermatitis. All of the 8 patients who had multiple findings had tearing as one of their abnormalities.
Conclusions: Ninety-three percent of the patients who had an ocular abnormality had tearing as one of the complications. Patients who are receiving systemic 5-FU and begin to tear should have an ocular examination, looking for ocular surface, ocular adnexal, and lacrimal complications.