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Treatment of vulvar intraepithelial neoplasia with topical imiquimod: Seven years median follow-up of a randomized clinical trial.
MedLine Citation:
PMID:  21239049     Owner:  NLM     Status:  Publisher    
OBJECTIVE: Recently we reported on the efficacy of imiquimod for treating vulvar intraepithelial neoplasia (VIN) in a placebo-controlled, double-blinded randomized clinical trial (RCT). Four weeks after treatment, a complete response was observed in 35% of patients and a partial response in 46%. All complete responders remained disease-free at 12months follow-up. In the current investigations, we assessed long-term follow-up at least 5years after the initial RCT. METHODS: Twenty-four of 26 imiquimod-treated patients who had participated in the initial RCT were seen for follow-up. Primary endpoint was durability of clinical response to imiquimod assessed by naked eye vulvar examination and histology. Long-term clinical response was correlated to lesion size before start of the initial RCT. Secondary endpoints were mental health, global quality of life, body image and sexual function in relation with long-term clinical response. RESULTS: Median follow-up period was 7.2years (range 5.6-8.3years). VIN recurred in one of nine complete responders. Of the initial partial responders, two became disease-free after additional imiquimod treatment. In the other partial responders, VIN recurred at least once after the initial RCT. In long-term complete responders, lesion size at study entry was smaller and these patients had a significantly better global quality of life at follow-up than patients with residual disease and/or recurrence after imiquimod treatment. CONCLUSIONS: In case of a complete response, imiquimod is effective in the long-term. Furthermore, patients with a long-term complete response had a significantly better global quality of life than patients who recurred after imiquimod treatment.
Annelinde Terlou; Manon van Seters; Patricia C Ewing; Neil K Aaronson; Chad M Gundy; Claudia Heijmans-Antonissen; Wim G V Quint; Leen J Blok; Marc van Beurden; Theo J M Helmerhorst
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-1-14
Journal Detail:
Title:  Gynecologic oncology     Volume:  -     ISSN:  1095-6859     ISO Abbreviation:  -     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-1-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0365304     Medline TA:  Gynecol Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2010 Elsevier Inc. All rights reserved.
Department of Obstetrics and Gynecology, Erasmus MC University Medical Centre, P.O. Box 2040, 3000 CA, Rotterdam, the Netherlands.
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