Treatment with vismodegib, a Hedgehog pathway inhibitor, may substantially benefit patients with advanced basal cell carcinoma, a recent study published online first in the journal The Lancet Oncology has shown.
For the multicenter, open-label STEVIE trial, researchers sought to evaluate the safety of vismodegib in a situation representative of routine practice, with a long follow-up. Researchers enrolled 1,227 patients with locally advanced or metastatic basal cell carcinoma. Of those, 499 had received vismodegib 150mg orally once daily in 28-day cycles at clinical cutoff.
Results showed that 98% of patients experienced adverse events. The most common adverse events were muscle spasms, alopecia, dysgeusia, diarrhea, nausea, and fatigue. Twenty-one patients died as a result of adverse events.
Researchers found that 66.7% (95% CI: 62.1-71.0) of those with locally advanced disease and 37.9% (95% CI: 20.7-57.7) of those with metastatic disease achieved an overall response.
Vismodegib (Erivedge) was initially approved by the U.S. Food and Drug Administration (FDA) in 2012 for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
Vismodegib has shown clinical benefit in patients with advanced basal cell carcinoma and is approved for treatment of patients with advanced basal cell carcinoma for whom surgery is inappropriate. STEVIE was designed to assess the safety of vismodegib in a situation similar to routine practice, with a long follow-up.