Abstract
Aim: To assess safety and efficacy of vismodegib in the Italian cohort from the SafeTy Events in VIsmodEgib study. Materials & methods: Data from Italian patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC were analyzed. Results: Among 182 Italian patients, adverse events occurred with similar incidence to the overall population. Overall response rate was 67.1% in laBCC, 20% in metastatic BCC; complete response rate was 33.1% overall and 37.4% in laBCC. Median time to response was 2 months in complete responders versus 3.6 months overall. Quality of life improved from baseline. Conclusion: In the Italian cohort of STEVIE, vismodegib showed a safety profile consistent with the whole population; older age did not affect safety or efficacy. ClinicalTrials.gov registration: NCT01367665.
Keywords:
Gorlin syndrome; HhAntag691; basal cell; carcinoma; vismodegib.
Publication types
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Clinical Trial, Phase II
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Multicenter Study
MeSH terms
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ATP-Binding Cassette Transporters / antagonists & inhibitors
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ATP-Binding Cassette Transporters / metabolism
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Adult
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Aged
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Aged, 80 and over
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Anilides / adverse effects
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Anilides / therapeutic use*
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Animals
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use
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Carcinoma, Basal Cell / drug therapy*
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Carcinoma, Basal Cell / epidemiology
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Carcinoma, Basal Cell / metabolism
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Carcinoma, Basal Cell / pathology
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Cohort Studies
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Disease Progression
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Female
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Humans
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Italy / epidemiology
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Male
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Middle Aged
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Pyridines / adverse effects
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Pyridines / therapeutic use*
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Quality of Life
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Skin Neoplasms / drug therapy*
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Skin Neoplasms / epidemiology
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Skin Neoplasms / metabolism
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Skin Neoplasms / pathology
Substances
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ATP-Binding Cassette Transporters
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Anilides
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Antineoplastic Agents
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HhAntag691
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Pyridines
Associated data
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ClinicalTrials.gov/NCT01367665