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      Topical fluorouracil after surgery for ocular surface squamous neoplasia in Kenya: a randomised, double-blind, placebo-controlled trial

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          Summary

          Background

          Ocular surface squamous neoplasia (OSSN) is an aggressive eye tumour particularly affecting people with HIV in Africa. Primary treatment is surgical excision; however, tumour recurrence is common. We assessed the effect of fluorouracil 1% eye drops after surgery on recurrence.

          Methods

          We did this multicentre, randomised, placebo-controlled trial in four centres in Kenya. We enrolled patients with histologically proven OSSN aged at least 18 years. After standard surgical excision, participants were randomly allocated to receive either topical fluorouracil 1% or placebo four times a day for 4 weeks. Randomisation was stratified by surgeon, and participants and trial personnel were masked to assignment. Patients were followed up at 1 month, 3 months, 6 months, and 12 months. The primary outcome was clinical recurrence (supported by histological assessment where available) by 1 year, and analysed by intention to treat. The sample size was recalculated because events were more common than anticipated, and trial enrolment was stopped early. The trial was registered with Pan-African Clinical Trials Registry (PACTR201207000396219).

          Findings

          Between August, 2012, and July, 2014, we assigned 49 participants to fluorouracil and 49 to placebo. Four participants were lost to follow-up. Recurrences occurred in five (11%) of 47 patients in the fluorouracil group and 17 (36%) of 47 in the placebo group (odds ratio 0·21, 95% CI 0·07–0·63; p=0·01). Adjusting for passive smoking and antiretroviral therapy had little effect (odds ratio 0·23; 95% CI 0·07–0·75; p=0·02). Adverse effects occurred more commonly in the fluorouracil group, although they were transient and mild. Ocular discomfort occurred in 43 of 49 patients in the fluorouracil group versus 36 of 49 in the placebo group, epiphora occurred in 24 versus five, and eyelid skin inflammation occurred in seven versus none.

          Interpretation

          Topical fluorouracil after surgery substantially reduced recurrence of OSSN, was well-tolerated, and its use recommended.

          Funding

          British Council for Prevention of Blindness and the Wellcome Trust.

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          Most cited references 31

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          5-fluorouracil: mechanisms of action and clinical strategies.

          5-fluorouracil (5-FU) is widely used in the treatment of cancer. Over the past 20 years, increased understanding of the mechanism of action of 5-FU has led to the development of strategies that increase its anticancer activity. Despite these advances, drug resistance remains a significant limitation to the clinical use of 5-FU. Emerging technologies, such as DNA microarray profiling, have the potential to identify novel genes that are involved in mediating resistance to 5-FU. Such target genes might prove to be therapeutically valuable as new targets for chemotherapy, or as predictive biomarkers of response to 5-FU-based chemotherapy.
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            Tumors of the conjunctiva and cornea.

            Tumors of the conjunctiva and cornea comprise a large and varied spectrum of conditions. These tumors are grouped into two major categories of congenital and acquired lesions. The acquired lesions are further subdivided based on origin of the mass into surface epithelial, melanocytic, vascular, fibrous, neural, histiocytic, myxoid, myogenic, lipomatous, lymphoid, leukemic, metastatic and secondary tumors. Melanocytic lesions include nevus, racial melanosis, primary acquired melanosis, melanoma, and other ocular surface conditions like ocular melanocytosis and secondary pigmentary deposition. The most frequent nonmelanocytic neoplastic lesions include squamous cell carcinoma and lymphoma, both of which have typical features appreciated on clinical examination. The caruncle displays a slightly different array of tumors compared to those elsewhere on the conjunctiva, as nevus and papilloma are most common, but oncocytoma and sebaceous gland hyperplasia, adenoma, and carcinoma can be found. In this report, we provide clinical description and illustration of the many conjunctival and corneal tumors and we discuss tumor management.
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              Ocular surface squamous neoplasia.

               G A Lee,  L Hirst (2016)
              Ocular surface squamous neoplasia presents as a spectrum from simple dysplasia to carcinoma in situ to invasive squamous cell carcinoma involving the conjunctiva as well as the cornea. It is a distinct clinical entity, although it has been known by a variety of different names throughout the literature. Most commonly it arises in the limbal region, occurring particularly in elderly males who have lived in geographic areas exposed to high levels of ultraviolet-B radiation. Symptoms range from none to severe pain and visual loss. The development of preoperative diagnostic techniques, such as impression cytology, are of value in clinical decision making and follow-up management. Simple excision with adequate margins is currently the best established form of treatment despite trials of other modalities. The course of this disease may be evanescent, but is more frequently slowly progressive and may require exenteration and occasionally may lead to death.
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                Author and article information

                Contributors
                Journal
                Lancet Glob Health
                Lancet Glob Health
                The Lancet. Global Health
                Elsevier Ltd
                2214-109X
                17 May 2016
                June 2016
                17 May 2016
                : 4
                : 6
                : e378-e385
                Affiliations
                [a ]London School of Hygiene & Tropical Medicine, London, UK
                [b ]Department of Ophthalmology, University of Nairobi, Nairobi, Kenya
                [c ]PCEA Kikuyu Eye Unit, Kikuyu, Kenya
                [d ]Kitale District Hospital, Kitale, Kenya
                [e ]Sabatia Eye Hospital, Wodanga, Kenya
                [f ]Kenyatta National Hospital, Nairobi, Kenya
                [g ]UHEAL Foundation, Nairobi, Kenya
                [h ]Department of Pathology, MP Shah Hospital, Nairobi, Kenya
                [i ]UCL Institute of Ophthalmology, University College London, London, UK
                [j ]Moorfields Eye Hospital, London, UK
                [k ]St Bartholomew's Hospital, London, London, UK
                Author notes
                [* ]Correspondence to: Dr Stephen Gichuhi, International Centre for Eye Health, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UKCorrespondence to: Dr Stephen GichuhiInternational Centre for Eye HealthLondon School of Hygiene & Tropical MedicineLondonWC1E 7HTUK stephen.gichuhi@ 123456lshtm.ac.uk
                Article
                S2214-109X(16)30052-3
                10.1016/S2214-109X(16)30052-3
                5081398
                27198842
                © 2016 Gichuhi et al. Open Access article distributed under the terms of CC BY

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

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