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Hedgehog inhibitor effective in advanced basal cell carcinomas
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Patients with locally advanced or metastatic basal cell carcinoma experienced high levels of tumor response when treated with the hedgehog pathway inhibitor vismodegib, according to the results of a multicenter, nonrandomized study.
Prior studies of vismodegib (Erivedge, Genentech) indicated that treatment with the hedgehog inhibitor resulted in a 58% response rate among patients with basal cell carcinoma. This result was especially encouraging given that the standard treatment for basal cell carcinoma is surgery, and few treatments exist for patients who present with advanced disease.
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In this study, the researchers enrolled patients with metastatic (n=33) or locally advanced inoperable (n=63) basal cell carcinoma and assigned them to treatment with 150 mg oral vismodegib daily. Researchers hoped that treatment with the first-in-class drug would result in response rates of greater than 20% for locally advanced disease and 10% for metastatic disease.
All treated patients had a median duration of response of 7.6 months. Those patients with metastatic disease had a better-than-expected response rate of 30% (95% CI, 16-48). Patients with locally advanced disease had a response rate of 43% (95% CI, 31-56). Thirteen patients with locally advanced disease experienced a complete response.
“Our findings confirm the essential role of the hedgehog pathway in basal cell carcinomas and indicate that vismodegib is efficacious in preventing and treating basal cell carcinomas in patients with the basal cell nevus syndrome,” the researchers wrote.
Frequently occurring adverse events included muscle spasms, alopecia, dysgeusia, weight loss and fatigue. One-fourth of patients reported serious adverse events, and seven deaths occurred due to adverse events, according to researchers.
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