Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial

Basset-Séguin, Nicole; Hauschild, Axel; Kunstfeld, Rainer; Grob, Jean‐Jacques; Dréno, Brigitte; Mortier, Laurent; Ascierto, Paolo A.; Licitra, Lisa; Dutriaux, Caroline; Thomas, Luc; Meyer, Nicolas; Guillot, B.; Dummer, Reinhard; Arenberger, Petr; Fife, Kate; Raimundo, A.; Dika, Emi; Dimier, Natalie; Fittipaldo, A.; Xynos, Ioannis; Hansson, Johan

doi:10.1016/j.ejca.2017.08.022

Cited by 232 publications

(274 citation statements)

References 17 publications

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“…Given the rarity of mBCC (<0.1%) 1 , there are only limited reports of chemotherapy for patients with mBCC with transient or disappointing results or intolerable toxicity . For mBCC, the median progression‐free survival (PFS), with vismodegib at approved dosing, was 9.3 months in the ERIVANCE study and 13.1 months in the STEVIE study , and with sonidegib was 13.1 months in the BOLT study . As HPIs become increasingly incorporated in the clinical practice, dermatologists will face many challenges during the monitoring of treatment of patients with HPI: to optimally schedule clinical follow‐up, to assess efficacy and tumor responses, to monitor for toxicity and tolerability issues, and to inform patients about which adverse events to expect and how to effectively cope.…”

Section: Meeting the Needs Of Advanced Bcc: Treatment With Hedgehog Imentioning

confidence: 99%

“…Imaging includes magnetic resonance imaging (MRI) or computed tomography and evaluates tumor response according to RECIST version 1.1 for solid tumours (Table ) . For the assessment of tumor response with imaging, for measurable target lesions, the RECIST criteria have been consistently used in trials investigating HPI treatment . According to RECIST v1.1, complete response is defined as the disappearance of all target lesions, while any pathological lymph nodes (target or nontarget) needed to have a reduction in short axis to <10 mm.…”

Section: Evaluations For Tumor Response: Clinical Follow‐up and Imagingmentioning

confidence: 99%

“…The most common AEs leading to HPI discontinuation include muscle spasms (8%), weight loss (6%), dysgeusia (4.7%), and alopecia (6%). The majority of these adverse events occur early in the course of HPI treatment, and patients may be reassured that the severity of the AE does not worsen with longer treatment duration, based on data from the ERIVANCE BCC study and the STEVIE study . Patients starting sonidegib should be informed of the risk for muscle‐related AEs, including rhabdomyolysis .…”

Section: Follow‐up Of Patients During Hpi Treatment For Adverse Eventsmentioning

confidence: 99%

“…not worsen with longer treatment duration, based on data from the ERIVANCE BCC study and the STEVIE study [18,40].…”

Section: Stable Diseasementioning

confidence: 99%

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A Practical Guide for the Follow-Up of Patients with Advanced Basal Cell Carcinoma During Treatment with Hedgehog Pathway Inhibitors

et al. 2019

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The Hedgehog pathway inhibitors (HPIs), vismodegib and sonidegib, are increasingly employed in the treatment of patients with advanced basal cell carcinoma (BCC). The aim of this review is to create a synthesis of available information in the literature regarding the follow‐up of patients with advanced BCC treated with HPIs and to provide the treating physician with a structured practical guide to standardize clinical practice. Several challenges during treatment are addressed: to optimally evaluate tumor responses, to differentiate between resistance (HPI rechallenge not possible) and recurrence (HPI rechallenge may be possible) in case of BCC regrowth, to readily assess for toxicity and tolerability issues, to provide patients with practical ways and behaviors to effectively cope with adverse events, and to improve patient adherence and quality of life. Implications for Practice This is a practical guide for clinical practice regarding the monitoring and follow‐up of patients with advanced basal cell carcinoma (BCC) during treatment with the Hedgehog pathway inhibitors (HPIs) vismodegib and sonidegib. This review aims to bridge the gap in knowledge of assessing tumor response for BCC with both an externally visible component and an infiltrating component measurable with imaging. Furthermore, it addresses the follow‐up for adverse events as a challenging multistep process involving practices aiming to readily assess new‐onset symptoms of HPI toxicity, perform total‐body skin examination, and improve patient adherence and quality of life.

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Section: Meeting the Needs Of Advanced Bcc: Treatment With Hedgehog Imentioning

confidence: 99%

Section: Evaluations For Tumor Response: Clinical Follow‐up and Imagingmentioning

confidence: 99%

Section: Follow‐up Of Patients During Hpi Treatment For Adverse Eventsmentioning

confidence: 99%

“…not worsen with longer treatment duration, based on data from the ERIVANCE BCC study and the STEVIE study [18,40].…”

Section: Stable Diseasementioning

confidence: 99%

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A Practical Guide for the Follow-Up of Patients with Advanced Basal Cell Carcinoma During Treatment with Hedgehog Pathway Inhibitors

et al. 2019

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“…1,2 The approval of hedgehog inhibitor (HHI) vismodegib in 2012 opened a novel therapeutic option. [2][3][4][5][6][7][8][9][10] "Drug holidays" have been proposed to increase patients' compliance and adherence which is poor due to the high frequency of adverse effects (AE's) of HHI, [3][4][5] however, up to date, the effect of dose reduction during HHI treatment has not been reported. Herein, we report the data of a single centre's experience in dose adjustment in 13 patients with laBCC treated with vismodegib.…”

mentioning

confidence: 99%

Managing adverse effects by dose reduction during routine treatment of locally advanced basal cell carcinoma with the hedgehog inhibitor vismodegib: a single centre experience

Woltsche

Pichler

Wolf

et al. 2018

Acad Dermatol Venereol

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Outcomes of Vismodegib for Periocular Locally Advanced Basal Cell Carcinoma From an Open-label Trial

et al. 2020

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IMPORTANCEThe outcomes of vismodegib treatment in a relatively large cohort of study participants with periocular locally advanced basal cell carcinoma (POLA-BCC) may guide physicians when considering this treatment.OBJECTIVE To report the outcomes of vismodegib treatment in patients with POLA-BCC in the Safety Events in Vismodegib (STEVIE) study. DESIGN, SETTING, AND PARTICIPANTSThis post hoc subgroup analysis from the STEVIE single-arm, multicenter, open-label cohort study screened all 1215 participants for ocular or periocular involvement and identified 244 participants with POLA-BCC or metastatic BCC. Data for the first STEVIE trial were collected from 167 treatment locations in 36 countries from June 30, 2011, to June 14, 2017. This post hoc analysis was performed from April 1 to August 31, 2019. MAIN OUTCOMES AND MEASURESResponse to treatment and adverse events. RESULTS Ocular or periocular involvement was found in 244 of 1215 STEVIE participants (20.1%), who constituted the analytic sample. The median age of the study participants was 72.0 (interquartile range [IQR], 60.0-82.0]) years, and they included 143 men (58.6%). Locally advanced BCC was diagnosed in 238 of the 244 participants (97.5%) and metastatic BCC, in 6 (2.5%). The median duration of exposure to vismodegib was 40.0 (IQR, 20.0-78.0) weeks, specifically 39.7 (IQR, 19.9-76.0) weeks for POLA-BCC and 92.4 (IQR, 53.2-163.0) weeks for metastatic BCC. Sixty-nine participants (28.3%) sustained serious adverse events (alopecia, muscle spasms, dysgeusia, weight loss, decreased appetite, asthenia, ageusia, nausea, fatigue, and diarrhea). Two hundred thirty-two study participants (95.1%) sustained more than 1 adverse effect. The overall mean (SD) number of drug-related adverse effects per study participant by first adverse event, regardless of the severity, was 5.48 (3.84). Discontinuation of vismodegib treatment owing to an adverse event was recorded in 58 participants (23.8%). During the study, 22 participants (9.0%) died, 70 (28.7%) achieved complete response, and 94 (38.5%) achieved partial response. CONCLUSIONS AND RELEVANCEVismodegib was well tolerated by the study participants with POLA-BCC. The safety of vismodegib treatment according to the STEVIE trial findings is consistent with that reported in previous studies. These data may be helpful when considering vismodegib for patients with POLA-BCC.

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Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial

Cited by 232 publications

References 17 publications

A Practical Guide for the Follow-Up of Patients with Advanced Basal Cell Carcinoma During Treatment with Hedgehog Pathway Inhibitors

A Practical Guide for the Follow-Up of Patients with Advanced Basal Cell Carcinoma During Treatment with Hedgehog Pathway Inhibitors

Managing adverse effects by dose reduction during routine treatment of locally advanced basal cell carcinoma with the hedgehog inhibitor vismodegib: a single centre experience

Outcomes of Vismodegib for Periocular Locally Advanced Basal Cell Carcinoma From an Open-label Trial

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