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Vismodegib safety, efficacy confirmed in advanced BCC patients
The safety and efficacy of vismodegib in treating patients with advanced basal cell carcinoma was confirmed in recent study results.
Researchers studied 119 patients with advanced basal cell carcinoma (BCC; median age, 62 years; 73.9% women) inappropriate for radiotherapy or surgery who had at least one histologically confirmed lesion 10 mm or larger. Patients received 150 mg vismodegib, the first FDA-approved oral, small-molecule, hedgehog pathway inhibitor effective in advanced BCC, daily until disease progression or intolerable toxicity was reached (median, 5.5 months). The FDA approved vismodegib in January 2012 after one phase 2 clinical trial.
Sixty-two patients had locally advanced BCC, while 57 had metastatic BCC. In the locally advanced BCC cohort, 46.4% experienced objective response, compared with 30.8% of patients with metastatic BCC. Patients with locally advanced BCC had a negative response association with prior systemic therapy (P=.002).
One hundred sixteen patients experienced a treatment-emergent adverse event (TEAE) during a median safety follow-up for 6.5 months, which included muscle spasms (70.6%), dysgeusia (70.6%), alopecia (58%) and diarrhea (25.2%).
“In light of priority review and approval of vismodegib by the FDA based on a single phase 2 study, this study contributes important additional data confirming the safety and efficacy of vismodegib for advanced BCCs,” the researchers wrote. “Given the complexity of many of these patients, and the recent availability of vismodegib for commercial use, multidisciplinary efforts among dermatologists, medical oncologists, radiation oncologists, otolaryngologists, and surgical oncologists may be needed to optimize patient outcomes.”
Disclosure: See the study for a full list of relevant financial disclosures.