Treatment of vulvar intraepithelial neoplasia with topical imiquimod: seven years median follow-up of a randomized clinical trial.
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.
Department of Obstetrics and Gynecology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands. a.terlou@erasmusmc.nl
Annelinde
A
Terlou
Manon
M
van Seters
Patricia C
PC
Ewing
Neil K
NK
Aaronson
Chad M
CM
Gundy
Claudia
C
Heijmans-Antonissen
Wim G V
WG
Quint
Leen J
LJ
Blok
Marc
M
van Beurden
Theo J M
TJ
Helmerhorst
D000328:Adult; D000634:Aminoquinolines / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001828:Body Image; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000523:psychology; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D011788:Quality of Life; D019529:Sexuality; D014846:Vulvar Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod