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

  • Investigative report
  • Published:
European Journal of Dermatology

Abstract

Background

Health-related quality of life (HRQoL) data are limited in patients with advanced basal cell carcinoma.

Objectives

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.

Materials and methods

Skindex-16 and MD Anderson Symptom Inventory (MDASI) questionnaires were completed atbaseline and atthree subsequentvisits. Clinically meaningful improvement was defined as a ≥10-point decrease from baseline (Skindex-16) or improvement of at least 3 points from baseline (MDASI).

Results

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 pointin 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.

Conclusions

Skindex-16 and MDASI showed improvement in HRQoL in vismodegib-treated patients with locally advanced or metastatic BCC or BCC.

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Author information

Authors and Affiliations

  1. Karolinska Institutet, Solma, 17176, Stockholm, Sweden

    Johan Hansson

  2. Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA

    Karen Bartley, Thomas Karagiannis & Yeun Mi Yim

  3. Timone Hospital, Aix-Marseille University, 264 rue Saint-Pierre, 13385, Marseille cedex 05, France

    Jean-Jacques Grob

  4. Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria

    Rainer Kunstfeld

  5. Nantes University, place Alexis-Ricordeau, 44093, Nantes cedex 01, France

    Brigitte Dréno

  6. Lille Regional University Hospital, University of Lille 2, 2 avenue Oscar-Lambret, 59037, Lille cedex, France

    Laurent Mortier

  7. Istituto Nazionale Tumori Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy

    Paolo A. Ascierto

  8. Fondazione IRCCS Istituto Tumori, Via Giacomo Venezian 1, 20133, Milan, Italy

    Lisa Licitra

  9. University Hospital of Bordeaux, 1, rue Jean-Burguet, 33075, Bordeaux, France

    Caroline Dutriaux

  10. Centre Hospitalier Lyon Sud, 69495, Pierre-Bénite cedex, France

    Luc Thomas

  11. Paul-Sabatier University and Toulouse Cancer University Institute, 170 avenue de Casselardit, 31059, Toulouse, France

    Nicolas Meyer

  12. University Hospital of Montpellier, 80, avenue Augustin-Fliche, 34090, Montpellier, France

    Bernard Guillot

  13. University Hospital of Zurich, Gloriastr. 31, 8091, Zurich, Switzerland

    Reinhard Dummer

  14. NHS Foundation Trust, Addenbrookes Hospital, Cambridge University Hospitals, Hills Road, Cambridge, CB2 2OQ, UK

    Kate Fife

  15. London Regional Cancer Program, Western University, 790 Commissioners Road, East London, NGA 4L6, Ontario, Canada

    D. Scott Ernst

  16. Roche Products Ltd, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK

    Natalie Dimier & Alberto Fittipaldo

  17. University Paris 7 and Hôpital Saint-Louis, 1 avenue Claude-Vellefaux, 75475, Paris, France

    Nicole Basset-Séguin

  18. University Hospital Schleswig-Holstein and University of Kiel, Rosalind-Franklin-Str. 7, D-24105, Kiel, Germany

    Axel Hauschild

Authors
  1. Johan Hansson
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  2. Karen Bartley
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  3. Thomas Karagiannis
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  4. Jean-Jacques Grob
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  5. Rainer Kunstfeld
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  6. Brigitte Dréno
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  7. Laurent Mortier
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  8. Paolo A. Ascierto
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  9. Lisa Licitra
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  10. Caroline Dutriaux
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  11. Luc Thomas
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  12. Nicolas Meyer
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  13. Bernard Guillot
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  14. Reinhard Dummer
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  15. Kate Fife
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  16. D. Scott Ernst
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  17. Yeun Mi Yim
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  18. Natalie Dimier
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  19. Alberto Fittipaldo
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  20. Nicole Basset-Séguin
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  21. Axel Hauschild
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Corresponding author

Correspondence to Johan Hansson.

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Hansson, J., Bartley, K., Karagiannis, T. et al. Assessment of quality of life using Skindex-16 in patients with advanced basal cell carcinoma treated with vismodegib in the STEVIE study. Eur J Dermatol 28, 775–783 (2018). https://doi.org/10.1684/ejd.2018.3448

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  • DOI: https://doi.org/10.1684/ejd.2018.3448

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