Assaf Gershoni1,2, Alon Tiosano1,2, Meydan Ben Ishai1,2, Edward Barayev1,2, Guy J Ben Simon2,3,4, Iftach Yassur5,6. 1. Ophthalmology Division, Rabin Medical Center-Beilinson Hospital, Petach Tikva, Israel. 2. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 3. Dr. Pinchas Borenstein Talpiot Medical Leadership Program, Ramat Gan, Israel. 4. Department of Ophthalmology, Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel. 5. Ophthalmology Division, Rabin Medical Center-Beilinson Hospital, Petach Tikva, Israel. yassurdoc@gmail.com. 6. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. yassurdoc@gmail.com.
Abstract
OBJECTIVES: To evaluate the effect of locally advanced periocular basal cell carcinoma (POLA-BCC) on health-related quality of life (HRQoL) and the benefit of vismodegib treatment among participants in the Safety Events in Vismodegib (STEVIE) trial between 2011 and 2017. METHODS: The STEVIE trial was conducted in patients with BCC (all anatomic locations) who were treated with vismodegib in 28-day cycles. Patients completed the Skindex-16, a validated questionnaire for the analysis symptoms, emotions, and functioning, at baseline, on day 1 of cycle 2, on day 1 of cycle 7, and at the end-of-study visit. For the present study, data mining techniques were used to construct an ophthalmic database of the STEVIE study. Skindex-16 scores were compared among patients with POLA-BCC between baseline and follow-up and between patients with POLA-BCC and patients with locally advanced BCC on other sites of the head and face (controls). RESULTS: The cohort included 169 patients with POLA-BCC and 428 patients with non-periocular head BCC. Patients with POLA-BCC had a significantly worse overall functioning score at baseline than controls (p = 0.038) and a lower score specifically in activities of daily living (p = 0.001). At the last follow-up, patients with POLA-BCC showed significant improvement in scores for functioning (100%), symptoms (100%), and emotions (75%) relative to baseline. CONCLUSIONS: Secondary analysis of the results of the STEVIE trial showed that the HRQoL of patients with POLA-BCC is significantly impaired and can be greatly improved with vismodegib treatment.
OBJECTIVES: To evaluate the effect of locally advanced periocular basal cell carcinoma (POLA-BCC) on health-related quality of life (HRQoL) and the benefit of vismodegib treatment among participants in the Safety Events in Vismodegib (STEVIE) trial between 2011 and 2017. METHODS: The STEVIE trial was conducted in patients with BCC (all anatomic locations) who were treated with vismodegib in 28-day cycles. Patients completed the Skindex-16, a validated questionnaire for the analysis symptoms, emotions, and functioning, at baseline, on day 1 of cycle 2, on day 1 of cycle 7, and at the end-of-study visit. For the present study, data mining techniques were used to construct an ophthalmic database of the STEVIE study. Skindex-16 scores were compared among patients with POLA-BCC between baseline and follow-up and between patients with POLA-BCC and patients with locally advanced BCC on other sites of the head and face (controls). RESULTS: The cohort included 169 patients with POLA-BCC and 428 patients with non-periocular head BCC. Patients with POLA-BCC had a significantly worse overall functioning score at baseline than controls (p = 0.038) and a lower score specifically in activities of daily living (p = 0.001). At the last follow-up, patients with POLA-BCC showed significant improvement in scores for functioning (100%), symptoms (100%), and emotions (75%) relative to baseline. CONCLUSIONS: Secondary analysis of the results of the STEVIE trial showed that the HRQoL of patients with POLA-BCC is significantly impaired and can be greatly improved with vismodegib treatment.
Authors: 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-Séguin; Axel Hauschild Journal: Eur J Dermatol Date: 2018-12-01 Impact factor: 3.328
Authors: Nicole Basset-Seguin; Axel Hauschild; Jean-Jacques Grob; Rainer Kunstfeld; Brigitte Dréno; Laurent Mortier; Paolo A Ascierto; Lisa Licitra; Caroline Dutriaux; Luc Thomas; Thomas Jouary; Nicolas Meyer; Bernard Guillot; Reinhard Dummer; Kate Fife; D Scott Ernst; Sarah Williams; Alberto Fittipaldo; Ioannis Xynos; Johan Hansson Journal: Lancet Oncol Date: 2015-05-13 Impact factor: 41.316
Authors: N Basset-Séguin; A Hauschild; R Kunstfeld; J Grob; B Dréno; L Mortier; P A Ascierto; L Licitra; C Dutriaux; L Thomas; N Meyer; B Guillot; R Dummer; P Arenberger; K Fife; A Raimundo; E Dika; N Dimier; A Fittipaldo; I Xynos; J Hansson Journal: Eur J Cancer Date: 2017-11-05 Impact factor: 9.162