Vismodegib effective as adjuvant therapy before Mohs surgery for BCC

MIAMI BEACH, Fla. — Vismodegib, an oral hedgehog-pathway inhibitor, was effective as an adjuvant treatment in shrinking basal cell carcinomas before excision and reducing surgical defects, according to late-breaking research presented at the American Academy of Dermatology Annual Meeting.

“We have now reported the success of vismodegib as an adjuvant treatment for [basal cell carcinomas] prior to surgery of any histological subtype,” researcher Mina Ally, MBBS, postdoctoral research fellow at Stanford University, said during her presentation.

In an open-label, single-arm intervention trial, researchers determined the safety and efficacy of vismodegib, which is FDA approved for treating advanced and metastatic basal cell carcinomas (BCCs), as an adjuvant therapy before Mohs micrographic surgery for BCCs. The researchers studied five patients with seven BCCs, six located on the face, treated with 150 mg vismodegib daily for at least 3 months. Mean baseline tumor size was 3 cm2. Surgical defects size reduction was the primary endpoint.

There was a 38% reduction in surgical defect size (–1.1 cm2; 95% CI, –0.19 to –2) and a 46% reduction in tumor area from baseline (–1.4 cm2 ; 95% CI, –0.19 to –2). There were no BCCs in three tumors, residual BCC in one tumor and equivocal diagnoses in three tumors that resembled infundibular cysts and stained positive for Ber-EP4 and BCL-2, according to histology. During a mean follow-up of 3 months, no tumors recurred.

“We found that [vismodegib] reduced BCC area by approximately 50% from baseline; however, it was more effective in some cases than others,” Ally said. “We feel that at least 3 months of therapy prior to surgery is required for efficacy.”

All patients experienced Grade 1 taste loss, muscle cramps and hair loss, which resided with drug discontinuation.

For more information:

Ally M. S018 – Late-breaking research: Vismodegib as an Adjuvant to Surgery for Basal Cell Carcinomas. Presented at: American Academy of Dermatology 2013 Annual Meeting; March 1-5, Miami Beach, Fla.