AT WCD 2015

VANCOUVER, B.C. (FRONTLINE MEDICAL NEWS) – Women with vulvar lichen sclerosus (VLS) who consistently used topical corticosteroids that had been titrated to normalize skin color and texture had significantly better outcomes than patients who sometimes skipped treatment, a prospective single-center cohort study found.

Most notably, none of the treatment-compliant patients developed vulvar carcinoma during an average of almost 5 years of follow-up, compared with 4.7% of the partially compliant group (P < .001), reported Dr. Jason Lee, a dermatologist with the University of Sydney, Australia.

“We are proposing a paradigm shift to change the way we manage this condition,” Dr. Lee said at the World Congress of Dermatology. “Clinicians should aim for individual regular treatment of patients with vulvar lichen sclerosus. The treatment is safe, and the course of the disease can be altered by treatment.”

The report appeared simultaneously in JAMA Dermatology (2015 June 12 [ doi:10.1001/jamadermatol.2015.0643 ]).

Vulvar lichen sclerosus is an uncommon disease that causes vulvar itching, pain, and sexual dysfunction, and can significantly alter the vulvar architecture. Before clinicians began treating VLS with superpotent topical corticosteroids, about 5% of cases were thought to progress to vulvar intraepithelial neoplasia or invasive squamous cell carcinoma.

Furthermore, even fairly mild cases can become cancerous, Dr. Lee noted. “Until now, it was thought that cancer was inevitable in some women with VLS,” he added. “Short-term control is easy, but long-term management lacks data, and research has not addressed whether treatment can prevent scarring or cancer.”

To assess the impact of individualized topical corticosteroid therapy with regular follow-up, Dr. Lee and his associates studied 507 women with biopsy-proven VLS during 2008-2014. Patients averaged 55 years of age at presentation and had an average symptom history of 5 years.

The investigators graded cases as mild, moderate, severe, or very severe depending on degree of hyperkeratosis, and titrated treatment with the goal of normalizing skin color and texture. They classified patients as treatment-compliant if they said they followed treatment directions most or all of the time, and as partially compliant if they said they followed directions some, little, or none of the time. They saw patients at least once a year for follow-up.

Most patients initially needed superpotent or ultrapotent topical corticosteroids to control their disease and then switched to moderate or mild strength formulations to maintain results, Dr. Lee and his associates reported.

About 30% of patients were only partially compliant with treatment. These patients were significantly less likely to achieve symptom resolution (58% vs. 93%) and resolution of dyspareunia (66% vs. 94%), and were more likely to develop adhesions and scars during follow-up (40% vs. 3%), compared with fully compliant patients (P < .001 for all), the researchers said. Rates of steroid dermatitis and reversible steroid-induced cutaneous atrophy were similar between the fully and partially compliant groups (2.2% vs. 4%, and 1.1% vs. 2%, respectively).

Based on the findings, clinicians would need to treat 21 cases of VLS to prevent 1 case of vulvar cancer and 2.7 cases to prevent scarring, said Dr. Lee.

“This is the first study adequately powered to demonstrate that cancer and scarring can be prevented by regular treatment according to clinical outcome, not symptoms,” he added.

But Dr. Lee acknowledged that selection bias could have affected the results. “We did find that patients who were not complying with treatment were more likely to have severe disease at the start of the study,” he said. “They probably were at increased risk of cancer to start with.”

The dermatology department of Royal North Shore Hospital partially funded the work. The investigators reported having no relevant conflicts of interest.