Ole Mathiesen1, Sanne K Buus, Marie Cramers. 1. Department of Gynaecology, University Hospital of Aarhus, Skejby, DK-8200 Aarhus N, Denmark. OMA@sks.aaa.dk
Abstract
OBJECTIVE: To investigate the effect of topical imiquimod in patients with vulvar intraepithelial neoplasia (VIN). METHODS: We used a prospective, randomised, double-blinded, placebo-controlled study. Women with biopsy verified, visible VIN2 or VIN3, in a biopsy not older than 2 months were considered. RESULTS:Thirty-two patients were included, one was excluded before treatment. Twenty-one received active treatment, 10 received placebo. Seventeen (81%) in the treatment group showed complete response, two (10%) partial response and none responded in the placebo-group when evaluated by a biopsy 2 months after a treatment period of 16 weeks. Fourteen of 21 patients (67%) in the treatment group had to reduce the number of applications due to local side-effects. CONCLUSION: The topical treatment with imiquimod 5% was shown in this setting to be very efficient. Local side effects were a common feature, but tolerable after dose reduction. Long-term results are not known, but a planned cohort study of this population will show the rate of recurrences.
RCT Entities:
OBJECTIVE: To investigate the effect of topical imiquimod in patients with vulvar intraepithelial neoplasia (VIN). METHODS: We used a prospective, randomised, double-blinded, placebo-controlled study. Women with biopsy verified, visible VIN2 or VIN3, in a biopsy not older than 2 months were considered. RESULTS: Thirty-two patients were included, one was excluded before treatment. Twenty-one received active treatment, 10 received placebo. Seventeen (81%) in the treatment group showed complete response, two (10%) partial response and none responded in the placebo-group when evaluated by a biopsy 2 months after a treatment period of 16 weeks. Fourteen of 21 patients (67%) in the treatment group had to reduce the number of applications due to local side-effects. CONCLUSION: The topical treatment with imiquimod 5% was shown in this setting to be very efficient. Local side effects were a common feature, but tolerable after dose reduction. Long-term results are not known, but a planned cohort study of this population will show the rate of recurrences.
Authors: Marc Arbyn; Silvia de Sanjosé; Mona Saraiya; Mario Sideri; Joel Palefsky; Charles Lacey; Maura Gillison; Laia Bruni; Guglielmo Ronco; Nicolas Wentzensen; Julia Brotherton; You-Lin Qiao; Lynnette Denny; Jacob Bornstein; Laurent Abramowitz; Anna Giuliano; Massimo Tommasino; Joseph Monsonego Journal: Int J Cancer Date: 2012-07-02 Impact factor: 7.396
Authors: Bruno O Fonseca; Júlio C Possati-Resende; Mila P Salcedo; Kathleen M Schmeler; Guilherme S Accorsi; José H T G Fregnani; Marcio Antoniazzi; Naitielle P Pantano; Iara V V Santana; Graziela M Matsushita; Ricardo Dos Reis Journal: Obstet Gynecol Date: 2021-06-01 Impact factor: 7.661