Topical 1% 5-Fluoruracil in Ocular Surface Squamous Neoplasia: a Long-term Safety Study

Overview & Synopsis

Background/aims: The aim of this study was to evaluate long-term corneal toxicity of topical chemotherapy with 1% 5-Fluoruracil (5-FU) as a sole or adjuvant treatment of ocular surface squamous neoplasia (OSSN). Methods: Forty-one consecutive cases of OSSN were included in this prospective study. Patients underwent topical chemotherapy with 1% 5-FU four times/day for 4 weeks (one course). Adjunctive courses were repeated until clinical and cytological tumor regression. Clinical confocal microscopy (CCM) (Confoscan 4.0, Nidek Co Ltd, Gamagori, Japan) was used to check for 5-FU long-term corneal toxicity. Results: Mean follow-up was 89.7±14.4 months (range, 63-122 months). Twenty-two patients (53.7%) underwent topical 5-FU as a sole treatment, whereas nineteen patients (46.3%) as adjuvant and/or debulking therapy. Mean number of 5-FU cycles was 1.9 (range, 1-5 cycles). Three tumors (7,3%) treated with 5-FU alone recurred during follow-up. Recurrences were successfully treated with additional 5-FU courses. CCM showed no long-term difference between treated eye and fellow (control) eye in: endothelial cells count, pleomorphism and polymegatism, anterior stromal keratocyte density, sub-basal nerve plexus fibre number, density, and beadings and central cornea epithelium thickness (p=n.s.). Conclusion: Topical 5-FU, as a sole or combined therapy, must be considered a long-term safe and effective treatment for patients affected by OSSN.