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Topical 1% 5-fluorouracil in ocular surface squamous neoplasia: a long-term safety study
  1. Raffaele Parrozzani1,
  2. Daniela Lazzarini1,
  3. Ernesto Alemany-Rubio2,3,
  4. Francesca Urban2,
  5. Edoardo Midena1,2
  1. 1Fondazione GB Bietti per l'Oftalmologia, IRCCS, Rome, Italy
  2. 2Department of Ophthalmology, University of Padua, Padua, Italy
  3. 3Cuban Eye Institute, ‘Ramon Pando Ferrer,’ University of Habana, Habana, Cuba
  1. Correspondence to Professor Edoardo Midena, Department of Ophthalmology, University of Padua, Via Giustiniani 2, Padua 35128, Italy; edoardo.midena{at}


Background/aims The 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).

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 tumour regression. Clinical confocal microscopy 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, 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).

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.

  • Ocular surface
  • neoplasia
  • drugs
  • cornea
  • conjunctiva

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  • This paper was partially presented at the International Congress of Ocular Oncology, 8–12 September 2009, Cambridge, UK.

  • Competing interests None.

  • Ethics approval Ethics approval was provided by the University of Padova, Padova, Italy.

  • Provenance and peer review Not commissioned; externally peer reviewed.