Imiquimod cream is a safe, effective, first-line alternative to surgery for the treatment of vulvar high-grade squamous intraepithelial lesions (vHSILs), suggest the results from the first randomized trial to compare the two approaches directly.
The findings provide women with human papillomavirus (HPV)–related precancerous lesions with a new treatment option that can circumvent drawbacks of surgery, according to first author Gerda Trutnovsky, MD, deputy head of the Division of Gynecology at the Medical University of Graz, Austria.
“Surgical removal of [vulvar intraepithelial neoplasia] can cause wound healing disorders, scarring, and even sexual complaints later on,” she explained in a press statement. Further, recurrences are common, and repeat surgeries are often necessary, she said.
The results from the trial show that “imiquimod cream was effective and well tolerated, and the rate of success of this treatment equaled that of surgery,” Dr. Trutnovsky said.
The study was published online in The Lancet.
The findings are of note because HPV vaccination rates remain low, and the incidence of both cervical and vulvar intraepithelial neoplasia has increased in recent years, particularly among younger women, the authors comment.
First head-to-head trial
For the trial, Dr. Trutnovsky and her colleagues randomly assigned 110 women with vHSIL to receive either imiquimod treatment or surgery between June 2013 and January 2020. Of these patients, 78% had unifocal lesions, and 22% had multifocal lesions.
The participants (aged 18-90 years) were recruited from six hospitals in Austria. All had histologically confirmed vHSIL with visible unifocal or multifocal lesions. Those with suspected invasive disease, a history of vulvar cancer or severe inflammatory dermatosis of the vulva, or who had undergone active treatment for vHSIL in the prior 3 months were excluded.
Imiquimod treatment was self-administered. The dose was slowly escalated to no more than three times per week for 4-6 months. Surgery involved either excision or ablation.
The team reports that 98 patients (of the 110 who were randomly assigned) completed the study: 46 in the imiquinod arm and 52 in the surgery arm.
Complete clinical response rates at 6 months were 80% with imiquimod versus 79% with surgery. No significant difference was observed between the groups with respect to HPV clearance, adverse events, and treatment satisfaction, the authors report.
“Long-term follow-up ... is ongoing and will assess the effect of treatment modality on recurrence rates,” the team comments.
Dr. Trutnovsky and colleagues recommend that patients with vHSIL be counseled regarding the potential benefits and risks of treatment options. “On the basis of our results, the oncological safety of imiquimod treatment can be assumed as long as regular clinical check-ups are carried out,” they write.
They also note that good patient compliance is important for treatment with imiquimod to be successful and that surgery might remain the treatment of choice for patients who may not be adherent to treatment.
“In all other women with vHSIL, imiquimod can be considered a first-line treatment option,” the authors conclude.
The study was funded by the Austrian Science Fund and Austrian Gynaecological Oncology group. The authors have disclosed no relevant financial relationships.
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