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5-Flouorouracil Is an Attractive Medical Treatment in Women With Vaginal Intraepithelial Neoplasia

A Meta-Analysis

Tranoulis, Anastasios, MD, MSc, PhD1; Georgiou, Dimitra, MD, MRCOG2; Laios, Alexandros, MD, PhD1; Theophilou, Georgios, MD, MBBS, MRCOG1; Thangavelu, Amudha, MD, MBBS, MRCOG1; Hutson, Richard Chanellor, MD, MBChB, FRCOG1

Journal of Lower Genital Tract Disease: October 2018 - Volume 22 - Issue 4 - p 375–381
doi: 10.1097/LGT.0000000000000415
Original Research Articles: Vagina and Vulva

Objective In the absence of standard guidelines, the management of vaginal intraepithelial neoplasia (VaIN) remains a field of debate. The aim of this systematic review and meta-analysis was to ascertain the 5-flouorouracil (5-FU) effectiveness in this context.

Materials and Methods A literature search was conducted throughout the PubMed, EMBASE, SCOPUS,, and Cochrane Databases for relevant studies. We computed the summary proportions of women treated for VaIN with 5-FU for the outcomes of complete response and recurrence by random-effects meta-analysis. We also performed a subgroup analysis by computing the summary proportions for complete response among women with high-grade VaIN, persistent disease, and recurrence respectively.

Results Fourteen observational studies reporting on 358 women included in the study. The study quality was moderate. The summary proportions of women who had complete response after the first 5-FU course were 82.18% (95% CI = 69.80%–88.82%). The summary proportions of women who recurred were 16.42% (95% CI = 7.39%–28.14%). The summary proportions of women with complete response in the high-grade VaIN, persistent disease, and recurrence subgroups were 77.53% (95% CI = 59.90%–91.15%), 53.92% (95% CI = 34.62%–72.61%), and 72.32% (95% CI = 48.12%–91.05%), respectively.

Conclusions This is the first meta-analysis to date to provide a convincing overview of 5-FU efficacy on the VaIN treatment. Albeit a medium risk of bias warrants some caution with interpretation of the results, 5-FU can be an attractive alternative to surgery, especially among young women with multifocal and recurrent disease.

1Department of Gynaecological Oncology, St James's University Hospital, Leeds Teaching Hospitals NHS, Leeds, United Kingdom; and

2Department of Obstetrics and Gynaecology, St. James's University Hospital, Leeds Teaching Hospitals NHS, Leeds, United Kindom

Correspondence to: Anastasios Tranoulis, MD, PhD, Department of Gynaecological Oncology, St. James's University Hospital, Leeds Teaching Hospitals, Beckett St, Leeds LS9 7TF, UK. E-mail:

The authors have declared they have no conflicts of interest.

A.T. and D.G. contributed equally to this work.

We certify that no party has a direct interest in the results of the research and that no benefit will be conferred to us or on any organization with which we are associated.

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Copyright © 2018 by the American Society for Colposcopy and Cervical Pathology