Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study: Future Oncology

P. Bossi, K. Peris, P. Calzavara-Pinton, P. Queirolo, S. Alfieri, M. Palla, M.T. Rossi, F. Spagnolo, S. Tambone, C. Astolfi, P.A. Ascierto

Research output: Contribution to journalArticlepeer-review

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: NCT0136766. © 2020 Future Medicine Ltd.
Original languageEnglish
Pages (from-to)1091-1100
Number of pages10
JournalFuture Oncol.
Volume16
Issue number16
DOIs
Publication statusPublished - 2020

Keywords

  • basal cell
  • carcinoma
  • Gorlin syndrome
  • HhAntag691
  • vismodegib
  • adult
  • advanced cancer
  • aged
  • ageusia
  • alopecia
  • Article
  • asthenia
  • basal cell carcinoma
  • body weight loss
  • cancer control
  • cancer growth
  • clinical effectiveness
  • cohort analysis
  • diarrhea
  • drug safety
  • dysgeusia
  • exploratory research
  • female
  • fever
  • human
  • incidence
  • Italian (citizen)
  • loss of appetite
  • major clinical study
  • male
  • multicenter study
  • muscle cramp
  • nausea
  • open study
  • outcome assessment
  • phase 2 clinical trial
  • population research
  • priority journal
  • progression free survival
  • quality of life
  • side effect
  • treatment outcome
  • treatment response
  • treatment response time
  • treatment withdrawal
  • very elderly

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