April 11, 2008

Aldara™ Effective Alternative to Surgery for Precancerous Changes to Vulva


Aldara™ Effective Alternative to Surgery for Precancerous Changes to Vulva

A recently published study in the New England Journal of Medicine reports that topical Aldara™ (imiquimod) may be an effective alternative to surgery for the treatment of precancerous changes to the vulva called vulvar intraepithelial neoplasia.

The vulva consists of the inner and outer lips of the vagina, the clitoris, and the opening of the vagina. Cancer of the vulva may be preceded by precancerous changes to the vulva known as vulvar intraepithelial neoplasia (VIN). The severity of VIN is graded on a scale of 1 to 3, with grades 2 and 3 considered “high-grade.” Because high-grade VIN can progress to cancer, effective treatment of these lesions is important. Treatment of high-grade VIN may include laser treatment or surgical removal of the abnormal areas.

In an effort to find alternatives to surgery for VIN, researchers with the current study investigated the use of Aldara cream, a topical treatment used to stimulate the immune system to destroy the cancerous cells. Study participants included women with either grade 2 or 3 VIN, who was assigned to receive either Aldara or a placebo twice weekly for 16 weeks. Researchers were looking for a 25% reduction of the lesion at 20 weeks. Other areas of focus included reduction in tissue changes, reduction of the human papillomavirus virus from the lesion, symptom relief, improvement in quality of life, and length of response. The follow-up period was 12 months.

Results of the study were as follows:

  • Lesion size was decreased by 25% at 20 weeks in 21 of the 26 patients (81%) compared with no decrease in the placebo group.
  • At the start of the trial, 96% of patients tested positive for HPV. After treatment with Aldara, 58% had cleared the HPV from the lesion compared with 8% among the placebo group.
  • Tissue samples demonstrated a significant increase in the number of immune cells at the site after treatment with Aldara compared with the placebo group.
  • Symptoms such as itching and pain were significantly improved at 20 weeks and at 12 months after treatment with Aldara.
  • After 20 weeks nine patients in the Aldara group had a complete response and were still free from disease at 12 months. However, in 6% (3) of the patients followed for 12 months, lesions progressed to a depth of less than1mm. One of these patients had received treatment with Aldara, while the other two had been part of the placebo group.

Researchers concluded that Aldara was a safe and effective alternative to surgery for the treatment of VIN. Effective treatment of VIN is critical as it can progress to cancer.

Reference: Van Seters, M., Van Beurden, M., Fiebo, J., et al. Treatment of intraepithelial neoplasia with topical imiquimod. New England Journal of Medicine. 2008; 358:1465-1473.

Related News: Aldara™ Effective Against Precancerous Changes to the Vulva (3/7/2006)

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