Topical 1% 5-fluorouracil in ocular surface squamous neoplasia: a long-term safety study

• Published in: British journal of ophthalmology Vol. 95; no. 3; pp. 355 - 359
• Main Authors: Parrozzani, Raffaele, Lazzarini, Daniela, Alemany-Rubio, Ernesto, Urban, Francesca, Midena, Edoardo
• Format: Journal Article
• Language: English
• Published: BMA House, Tavistock Square, London, WC1H 9JR BMJ Publishing Group Ltd 01.03.2011; BMJ Publishing Group; BMJ Publishing Group LTD
• Subjects: Administration, Topical; Adult; Aged; Aged, 80 and over; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Aqueous solutions; Biological and medical sciences; Chemotherapy; conjunctiva; Conjunctival Neoplasms - drug therapy; Conjunctival Neoplasms - pathology; cornea; Disease; drugs; Endothelium; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Humans; Male; Medical sciences; Microscopy; Microscopy, Confocal; Middle Aged; Miscellaneous; neoplasia; Neoplasm Recurrence, Local - drug therapy; Neoplasms, Squamous Cell - drug therapy; Neoplasms, Squamous Cell - pathology; Ocular surface; Ophthalmology; Patients; Prospective Studies; Skin; Surgery; Treatment Outcome; Tumors; Antineoplastic agent; Ocular; Enzyme; Toxicity; Fluoropyrimidine derivatives; Transferases; Enzyme inhibitor; Malignant tumor; Thymidylate synthase; Long term; Surface; Eye; Local administration; Antimetabolic; Methyltransferases; Pyrimidine derivatives; Ophthalmology; Safety; Cancer; Fluorouracil
• ISSN: 0007-1161; 1468-2079
• DOI: 10.1136/bjo.2010.183244

Background/aimsThe aim of this study was to evaluate the long-term corneal toxicity of topical chemotherapy with 1% 5-fluorouracil (5-FU) as a sole or adjuvant treatment of ocular surface squamous neoplasia (OSSN).MethodsForty-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 tumour regression. Clinical confocal microscopy was used to check for 5-FU long-term corneal toxicity.ResultsMean 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, and 19 patients (46.3%) as adjuvant and/or debulking therapy. The mean number of 5-FU cycles was 1.9 (range 1–5 cycles). Three tumours (7.3%) treated with 5-FU alone recurred during follow-up. Recurrences were successfully treated with additional 5-FU courses. Clinical confocal microscopy showed no long-term difference between the 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=NS).ConclusionTopical 5-FU, as a sole or combined therapy, must be considered a long-term safe and effective treatment for patients affected by OSSN.