Treatment of vulvar intraepithelial neoplasia with topical imiquimod: seven years
median follow-up of a randomized clinical trial.
Author(s): Terlou A, van Seters M, Ewing PC, Aaronson NK, Gundy CM, Heijmans-Antonissen C,
Quint WG, Blok LJ, van Beurden M, Helmerhorst TJ.
Affiliation(s): Department of Obstetrics and Gynecology, Erasmus MC University Medical Centre,
Rotterdam, The Netherlands. a.terlou@erasmusmc.nl
Publication date & source: 2011, Gynecol Oncol. , 121(1):157-62
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 12 months follow-up. In the current
investigations, we assessed long-term follow-up at least 5 years 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 7.2 years (range 5.6-8.3 years). 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.
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