Assessment of quality of life using Skindex-16 in patients with advanced basal cell carcinoma treated with vismodegib in the STEVIE study

Johan Hansson, Karen Bartley, Thomas Karagiannis, Jean-Jacques Grob, Rainer Kunstfeld, Brigitte Dréno, Laurent Mortier, Paolo A Ascierto, Lisa Licitra, Caroline Dutriaux, Luc Thomas, Nicolas Meyer, Bernard Guillot, Reinhard Dummer, Kate Fife, D Scott Ernst, Yeun Mi Yim, Natalie Dimier, Alberto Fittipaldo, Nicole Basset-SéguinAxel Hauschild

Research output: Contribution to journalArticlepeer-review

Abstract

Health-related quality of life (HRQoL) data are limited in patients with advanced basal cell carcinoma. To report HRQoL outcomes based on STEVIE (NCT01367665), a phase 2 study of vismodegib safety in patients with metastatic BCC or locally advanced BCC that is unsuitable for surgery or radiotherapy. Skindex-16 and MD Anderson Symptom Inventory (MDASI) questionnaires were completed at baseline and at three subsequent visits. Clinically meaningful improvement was defined as a ≥10-point decrease from baseline (Skindex-16) or improvement of at least 3 points from baseline (MDASI). HRQoL-evaluable patients with locally advanced BCC (n = 730) had ≥10-point improvements in Skindex-16 emotion domain scores at all time points. Changes in symptom and function scores in these patients or in any domain scores at any time point in patients with metastatic BCC (n = 10) were not clinically meaningful. Of 10 patients with symptomatic metastatic BCC at baseline, six had ≥3-point improvements in MDASI symptom severity. Skindex-16 and MDASI showed improvement in HRQoL in vismodegib-treated patients with locally advanced or metastatic BCC or BCC.

Original languageEnglish
Pages (from-to)775-783
Number of pages9
JournalEuropean journal of dermatology : EJD
Volume28
Issue number6
DOIs
Publication statusPublished - Dec 1 2018

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