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Topical 5-Fluorouracil for Women With High-Grade Vaginal Intraepithelial Neoplasia

Fiascone, Stephen MD; Vitonis, Allison F. ScM; Feldman, Sarah MD, MPH

doi: 10.1097/AOG.0000000000002311
Contents: Dysplasia: Original Research

OBJECTIVE: To examine success rates of 5-fluorouracil, excision, and laser ablation as the initial and secondary management strategies for women with high-grade vaginal intraepithelial neoplasia.

METHODS: We conducted a retrospective case series of women referred to a single center for management of biopsy-proven, high-grade vaginal intraepithelial neoplasia between April 1994 and May 2016. Data including demographic characteristics, human papillomavirus risk factors, antecedent Pap cytology, concurrent or prior cervical and vulvar dysplasia, and treatment outcome including follow-up Pap cytology were recorded. All women were counseled on options of excision, laser ablation, or 5-fluorouracil, which was administered intravaginally according to a standardized regimen. Recurrence was defined as a biopsy showing any vaginal intraepithelial neoplasia diagnosis after primary treatment.

RESULTS: Forty-seven patients were treated initially with 5-fluorouracil, 35 were treated with excision, and 22 were treated with laser ablation. Demographics were similar between groups. No recurrence was noted in 35 women treated with 5-fluorouracil (74%; 95% CI 62–87%), 20 treated with excision (57%; 95% CI 41–74%), and nine treated with laser ablation (41%; 95% CI 20–61%). Among 13 patients treated with 5-fluorouracil for recurrence, eight (62%) did not experience a second recurrence. Nine of 58 (16%) patients ever treated with 5-fluorouracil reported a side effect, most commonly irritation and dyspareunia.

CONCLUSION: 5-fluorouracil was associated with a 74% success rate as the initial treatment modality for high-grade vaginal dysplasia. There is also a role for 5-fluorouracil in the management of recurrent or persistent high-grade vaginal intraepithelial neoplasia.

Intravaginal 5-fluorouracil is associated with a recurrence rate of less than one third in women with high-grade vaginal intraepithelial neoplasia.

Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, and the Obstetrics–Gynecology Epidemiology Center, Brigham and Women’s Hospital, Boston, Massachusetts.

Corresponding author: Stephen Fiascone, MD, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, 75 Francis Street, Boston, MA 02115; email:

Financial Disclosure The authors did not report any potential conflicts of interest.

Presented as a poster at the 48th Annual Meeting of the Society of Gynecologic Oncology, March 12–15, 2017, National Harbor, Maryland; and at the International Federation for Cervical Pathology & Colposcopy World Congress, April 4–7, 2017, Orlando, Florida.

Each author has indicated that he or she has met the journal's requirements for authorship.

© 2017 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.