3342 Assessment of quality of life using Skindex-16 in patients with advanced basal cell carcinoma (BCC) treated with vismodegib in the STEVIE study

Hansson, Johan; Bartley, Karen; Grob, J.J.; Kuntsfeld, R.; Dréno, Brigitte; Mortier, Laurent; Ascierto, Paolo A.; Licitra, Lisa; Dutriaux, Caroline; Jouary, Thomas; Meyer, Nicole; Guillot, B.; Dummer, Richard; Fife, Kate; Ernst, D. Scott; Yim, Yeun Mi; Williams, Sophie; Fittipaldo, A.; Basset-Séguin, Nicole; Hauschild, Axel

doi:10.1016/s0959-8049(16)31860-3

Cited by 8 publications

(27 citation statements)

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“…A phase 2 study of vismodegib safety, STEVIE (NCT01367665), reported the HRQoL outcomes in 730 patients with locally advanced BCCs and metastasizing BCCs. Skindex-16 and MD Anderson Symptom Inventory (MDASI) questionnaires were completed at baseline and at three subsequent visits, and the results pointed to an improvement in HRQoL in all vismodegib-treated patients [16]. Furthermore, in a recent study,…”

Section: Discussionmentioning

confidence: 90%

Real-Life Effectiveness of Vismodegib in Patients with Metastatic and Advanced Basal Cell Carcinoma: Characterization of Adverse Events and Assessment of Health-Related Quality of Life using the Dermatology Life Quality Index (DLQI) Test

Villani

Fabbrocini

Cappello

et al. 2019

Dermatol Ther (Heidelb)

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Introduction: Non-melanoma skin cancer (NMSC) is the most common type of human tumor, with an estimated five million new cases each year. NMSC has been described as having a major impact on the health-related quality of life of the patient. Vismodegib is a hedgehog pathway inhibitor therapy for patients who are affected by locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma and are ineligible for surgery and/or radiotherapy. The objective of this study was to assess treatment-emergent adverse events reported by patients with advanced BCC who were undergoing hedgehog pathway inhibitor therapy with vismodegib, and to quantify their health-related quality of life using the Dermatology Life Quality Index (DLQI) questionnaire.

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Section: Discussionmentioning

confidence: 90%

Real-Life Effectiveness of Vismodegib in Patients with Metastatic and Advanced Basal Cell Carcinoma: Characterization of Adverse Events and Assessment of Health-Related Quality of Life using the Dermatology Life Quality Index (DLQI) Test

Villani

Fabbrocini

Cappello

et al. 2019

Dermatol Ther (Heidelb)

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“…However, these data cannot be compared, as different health‐related QoL scales were used and the assessment frequency also differed. A review of the QoL outcomes from the STEVIE study showed that vismodegib was associated with clinically meaningful improvement in the emotional domain using the Skindex‐16 scale . However, differences in isolated health‐related QoL scale dimensions may result in bias and should not be compared.…”

Section: Further Studies Are Needed To Provide a Conclusive Outcomementioning

confidence: 99%

Sonidegib and vismodegib in the treatment of patients with locally advanced basal cell carcinoma: a joint expert opinion

Dummer

Ascierto

Basset-Séguin

et al. 2020

Acad Dermatol Venereol

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133

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Sonidegib and vismodegib are hedgehog pathway inhibitors (HhIs) approved for the treatment of advanced basal cell carcinoma (BCC). Until recently, vismodegib was the only targeted treatment available for patients with locally advanced BCC (laBCC) in cases where surgery and radiotherapy are inappropriate. Sonidegib has recently been approved and now presents an alternative treatment option. The clinical differences between the two HhIs in patients with laBCC are unclear, as no head‐to‐head randomized controlled trials are or will be initiated. Moreover, there were important differences in the designs of their pivotal studies, BOLT (sonidegib) and ERIVANCE (vismodegib), and these differences complicate evidence‐based analysis of their relative efficacy and safety profiles. In this paper, a group of clinical experts in the management of laBCC summarizes the clinical and pharmacological profiles of sonidegib and vismodegib based on published data and their own clinical experience. One key difference between the two pivotal studies was the criteria used to assess BCC severity. ERIVANCE (a single‐arm phase II trial) used the conventional Response Evaluation Criteria in Solid Tumors (RECIST), while the more recent double‐blind randomized BOLT trial used the stringent modified RECIST. A preplanned analysis adjusted the outcomes from BOLT with RECIST‐like criteria, and this enabled the experts to discuss relative efficacy outcomes for the two treatments. Centrally reviewed objective response rate (ORR) for vismodegib was 47.6% (95% CI: 35.5–60.6) at 21‐month follow‐up using RECIST. After adjusting with RECIST‐like criteria, the ORR for sonidegib according to central review at 18‐month follow‐up was 60.6% (95% CI: 47.8–72.4). Both treatments were associated with similar patterns of adverse events. Sonidegib and vismodegib share the same efficacy and tolerability profiles, but their pharmacokinetic profiles show several differences, such as volume of distribution and half‐life. Further studies are needed to understand how these differences may impact clinical practice.

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“…Skindex-29 responds to change over time and has been used in clinical trials in several diseases. 18,19 This instrument includes 29 questions that assess the physical (7 question), emotional (10 questions), and functional (11 questions) effects of skin conditions; there is one additional question to assess itch. The response to each question on the Skindex was coded (0 = never; 25 = rarely; 50 = sometimes; 75 = often; 100 = all the time).…”

Section: Survey Instrumentmentioning

confidence: 99%

Measuring the Effect of Cutaneous Neurofibromas on Quality of Life in Neurofibromatosis Type 1

et al. 2021

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Objective:In order to explore the use of Skindex scoring in NF1 patients across multiple clinical sites, and inform design of additional quality of life measures, we analysed correlations between skindex, site and clinical parameters for 79 patients with NF1 from specialised clinics in Sydney, NSW Australia (RNS) and Minneapolis Minnesota, USA (UMN).Methods:The relationship between the clinical factors and Skindex scores were explored by clinic site and overall.Results:40 subjects were recruited from RNS and 39 from UMN. Female sex, total number of cNFs, and whether cNFs were present on the face, correlated highly with skindex and not Riccardi scores. The UMN site had lower average scores, but these differences were almost entirely removed after adjusting for age, sex, facial CNFs and total CNF number.Conclusions:The development of cutaneous neurofibromas (cNFs) in adolescence and adulthood in neurofibromatosis, type 1 (NF1) often lead to progressive disfigurement and discomfort, and are among one of the most common reasons for patients to seek medical treatment. Skindex has been used to assess skin related quality of life in NF1 previously but is not specific to NF1. These findings highlight the need for a low threshold for referral to Dermatologists for all patients with Neurofibromatosis Type 1 regardless of the severity of disease. The finding that facial CNFs and higher total number of CNFs correlates with poorer skin related quality of life, may benefit design of more specific NF1 skin related quality of life measures.

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3342 Assessment of quality of life using Skindex-16 in patients with advanced basal cell carcinoma (BCC) treated with vismodegib in the STEVIE study

Cited by 8 publications

References 0 publications

Real-Life Effectiveness of Vismodegib in Patients with Metastatic and Advanced Basal Cell Carcinoma: Characterization of Adverse Events and Assessment of Health-Related Quality of Life using the Dermatology Life Quality Index (DLQI) Test

Real-Life Effectiveness of Vismodegib in Patients with Metastatic and Advanced Basal Cell Carcinoma: Characterization of Adverse Events and Assessment of Health-Related Quality of Life using the Dermatology Life Quality Index (DLQI) Test

Sonidegib and vismodegib in the treatment of patients with locally advanced basal cell carcinoma: a joint expert opinion

Measuring the Effect of Cutaneous Neurofibromas on Quality of Life in Neurofibromatosis Type 1

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