Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study.
Paolo BossiKetty PerisPiergiacomo Calzavara-PintonPaola QueiroloSalvatore AlfieriMarco PallaMaria Teresa RossiFrancesco SpagnoloSara TamboneCinzia AstolfiPaolo A AsciertoPublished in: Future oncology (London, England) (2020)
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.
Keyphrases
- basal cell carcinoma
- end stage renal disease
- squamous cell carcinoma
- phase ii
- newly diagnosed
- chronic kidney disease
- clinical trial
- locally advanced
- small cell lung cancer
- peritoneal dialysis
- physical activity
- open label
- risk factors
- rectal cancer
- patient reported outcomes
- machine learning
- electronic health record
- community dwelling
- study protocol