Imiquimod noninferior to surgery in management of vulvar high-grade squamous intraepithelial lesions

1. Complete clinical response at 6 months was similar in both the topical imiquimod and surgery group.

2. Invasive disease was reported in five patients in the surgery group, and none were found in the imiquimod group.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Vulvar high-grade intraepithelial lesion (vHSIL) is often caused by transmission of the human papillomavirus (HPV), specifically HPV 16, during sexual intercourse. Current management of vHSIL includes surgical excision and laser vaporization, although this is linked with a larger portion of recurrences and psychosexual distress. Imiquimod is an immune modulator that may play a role in mitigating active HPV infection, although current evidence is limited. This randomized controlled trial aimed to compare the safety and clinical efficacy of imiquimod versus the current standard of treatment, surgery, in women with vHSIL. The primary outcome was complete clinical response (CCR) at 6 months post imiquimod treatment or surgical intervention, while key secondary outcomes include HIV status, recurrent disease, and patient satisfaction. According to study results, the proportion of patients achieving CCR was similar in both groups, achieving noninferiority for imiquimod. Although this study was well done, it included a relatively small sample size with strict exclusion criteria, therefore limiting its generalizability.

Click to read the study in The Lancet

Relevant Reading: Treatment of Vulvar Intraepithelial Neoplasia with Topical Imiquimod

In-depth [randomized-controlled trial]: Between Jun 7, 2013, and Jan 8, 2020, 146 women were assessed for eligibility across six hospitals in Austria. Included were those between the 18-90 years of age with histologically confirmed vHSIL. Women who were immunocompromised, pregnant, post-partum, or undergoing active treatment for vHSIL were excluded. Altogether, 107 patients (54 in imiquimod and 53 in surgery) were included in the final analysis. The primary outcome of CCR at 6 months was comparable in both groups (80% in imiquimod vs. 79% in surgery, difference -0.016, 95% confidence interval [CI] -0.15 to -0.18, p=0.0056). There was no significant difference concerning secondary outcomes of HPV-positive status (33% in imiquimod vs. 26% in surgery, p=0.43), recurrent disease or partial response (20% in imiquimod vs. 21% in surgery), and patient-reported treatment satisfaction. Moreover, fewer patients in the imiquimod group (n=0, 0%) experienced invasive disease compared to those in the surgery group (n=4, 8%). Overall, findings from this study suggest that imiquimod may be as safe and effective as surgery in women with vHSIL.

Image: PD

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