NEW YORK (Reuters Health) - Topical imiquimod works just as well as surgery for the first-line treatment of women with vulvar high-grade squamous intraepithelial lesions (vHSILs) — a precancerous lesion commonly caused by human papillomavirus (HPV).
That's according to results of the first randomized, non-inferiority trial comparing the two treatment approaches.
The study, conducted at six Austrian hospitals, included 110 patients with histologically confirmed p16 positive vHSIL, with 54 treated with imiquimod self-administered in escalating doses up to three times per week for four to six months and 53 to surgery (excision or ablation).
"We found that per-protocol treatment with imiquimod resulted in a complete clinical response rate of 80% at six months, compared with 79% after one surgical intervention," Dr. Gerda Trutnovsky of the Medical University of Graz, Austria, and colleagues report in The Lancet.
"Adverse events differed, with local pain being more intense after surgical treatment, and local pruritus and erythema being more common during imiquimod application," they note.
There were no between-group differences in health-related quality of life or treatment satisfaction. Invasive vulvar cancer was diagnosed in four patients at primary surgery and in no patients after complete imiquimod treatment.
For women with vHSIL, discussion of potential benefits and risks of treatment options is essential, the authors say.
