BACKGROUND: @entity5436 is a @entity272 affecting the vulva that, if left untreated, can become cancerous. Currently, the standard treatment for @entity1 with @entity5436 is surgery, but this approach does not guarantee cure and can be disfiguring, causing physical and psychological problems, particularly in @entity1 of reproductive age. We aimed to assess the activity, safety, and feasibility of two topical treatments- @entity7076 and @entity553 -as an alternative to surgery in female @entity1 with @entity5436 . METHODS: We recruited female @entity1 (age 16 years or older) from 32 centres to an open-label, randomised, phase 2 trial. Eligibility criteria were biopsy-proven @entity5436 grade 3 and at least one lesion that could be measured accurately. We randomly allocated @entity1 to topical treatment with either 1% @entity7076 (supplied as a gel in a 10 g tube, to last 6 weeks) or 5% imiquimod (one 250 mg sachet for every application), to be self-applied three times a week for a maximum of 24 weeks. Randomisation (1:1) was done by stratified minimisation via a central computerised system, with stratification by hospital, disease focality, and presentation stage. The primary endpoint was a histologically confirmed complete response at the post-treatment assessment visit 6 weeks after the end of treatment (a maximum of 30 weeks after treatment started). Analysis of the primary endpoint was by intention to treat. Secondary outcomes were toxic effects (to assess safety) and adherence to treatment (to assess feasibility). We present results after all @entity1 had reached the primary endpoint assessment point at 6 weeks; 2-year follow-up of complete responders continues. This trial is registered with Current Controlled Trials, ISRCTN 34420460. FINDINGS: Between Oct 21, 2009, and Jan 11, 2013, 180 @entity1 were enrolled to the study; 89 @entity1 were randomly allocated @entity7076 and 91 were assigned imiquimod. At the post-treatment assessment visit, a complete response had been achieved by 41 (46%; 90% CI 37  0-55  3) @entity1 allocated @entity7076 and by 42 (46%; 37  2-55  3) @entity1 assigned imiquimod. After 6 weeks of treatment, 156 (87%) @entity1 (78 in each group) had adhered to the treatment regimen. Five @entity1 in the @entity7076 group and seven in the imiquimod group either withdrew or were lost to follow-up before the first 6-week safety assessment. Adverse events of grade 3 or higher were reported in 31 (37%) of 84 @entity1 allocated @entity7076 and 39 (46%) of 84 @entity1 assigned imiquimod; the most frequent grade 3 and 4 events were @entity158 in the vulva, @entity111 , fatigue, and @entity10 . INTERPRETATION: @entity7076 and imiquimod were active, safe, and feasible for treatment of @entity5436 and warrant further investigation in a phase 3 setting. Both drugs are effective alternatives to surgery for female @entity1 with @entity5436 after exclusion of occult invasive disease. FUNDING: Cancer Research UK.

Activity, safety, and feasibility of @entity7076 and imiquimod for treatment of XXXX (RT(3)VIN): a multicentre, open-label, randomised, phase 2 trial.

@entity1 :: ('9606', 'Species') :: ['participants', 'women', 'patients'] @entity272 :: ('MESH:D012871', 'Disease') :: ['skin disorder'] @entity111 :: ('MESH:D011537', 'Disease') :: ['pruritus'] @entity553 :: ('MESH:C056493', 'Chemical') :: ['imiquimod'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity7076 :: ('MESH:C059262', 'Chemical') :: ['cidofovir', 'Cidofovir'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity5436 :: ('MESH:D019048', 'Disease') :: ['vulval intraepithelial neoplasia', 'Vulval intraepithelial neoplasia']
@entity5436 :: (MESH:D019048,Disease) :: ['vulval intraepithelial neoplasia']
