RT3VIN

A study demonstrating that imiquimod and cidofovir as topical treatments are active, safe and feasible and can be used as a potential alternative to surgery for the treatment of Vulval Intraepithelial Neoplasia.

Background

Vulval intraepithelial neoplasia (VIN) is a skin condition affecting the vulval skin which, if left untreated, may become cancerous. Symptoms include itching, burning, soreness and discolouration of the vulval skin which may take on a warty appearance. The main treatment options for patients with VIN have been surgery or laser treatment, neither of which guarantee a cure and can be mutilating, causing physical and psychological problems in women of reproductive age.

This research examined a topical treatment (a rub-on treatment, eg a cream or a gel) that women can apply in the privacy of their own homes that is effective in treating VIN, without the need for potentially mutilating surgery. There have been a few, small scale pilot studies that have shown that two topical treatments (called imiquimod and cidofovir) may have the potential to treat VIN. However, these treatments needed to be investigated in a much larger clinical trial before doctors could be confident to use either (or both) of these treatments as routine practice.

Study aim

The study aimed at verifying whether imiquimod and cidofovir as topical treatments are active, safe and feasible and can be used as a potential alternative to surgery for the treatment of VIN.

Study design

RT3VIN was a randomised phase II multi-centre trial of topical treatments (a cream and gel) in women with vulval intraepithelial neoplasia grade 3, who were randomised to receive either imiquimod or cidofovir.

Recruitment

Recruitment target was 204 participants (102 participants into each research arm for a maximum of 24 weeks treatment). At the end of the trial 182 participants were recruited: 89 were allocated cidofovir, 91 were allocated imiquimod.

Results

The findings of the RT3VIN trial showed that both imiquimod and cidofovir are safe, active, and feasible for the treatment of vulval intraepithelial neoplasia grade 3.

Related publications

• Tristram, A. et al. 2014. Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT³VIN): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncology 15 (12), pp.1361-1368. (10.1016/S1470-2045(14)70456-5)