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Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial
N. Basset-Séguin, A. Hauschild, R. Kunstfeld, J. Grob, B. Dréno, L. Mortier, PA. 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,
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie, práce podpořená grantem
- MeSH
- anilidy aplikace a dávkování škodlivé účinky MeSH
- aplikace orální MeSH
- bazocelulární karcinom farmakoterapie mortalita sekundární MeSH
- časové faktory MeSH
- dospělí MeSH
- Kaplanův-Meierův odhad MeSH
- kreatinkinasa krev MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- přežití bez známek nemoci MeSH
- progrese nemoci MeSH
- protinádorové látky aplikace a dávkování škodlivé účinky MeSH
- pyridiny aplikace a dávkování škodlivé účinky MeSH
- rozvrh dávkování léků MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- spasmus chemicky indukované MeSH
- syndrom bazocelulárního névu farmakoterapie mortalita patologie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
BACKGROUND: The SafeTy Events in VIsmodEgib study (STEVIE, ClinicalTrials.gov, NCT01367665), assessed safety and efficacy of vismodegib-a first-in-class Hedgehog pathway inhibitor demonstrating clinical benefit in advanced basal cell carcinoma (BCC)-in a patient population representative of clinical practice. Primary analysis data are presented. PATIENTS AND METHODS: Patients with locally advanced or metastatic BCC received oral vismodegib 150 mg/d until progressive disease, unacceptable toxicity, or withdrawal. Primary objective was safety. Efficacy variables were assessed as secondary end-points. RESULTS: Evaluable adult patients (N = 1215, 1119 locally advanced; 96 metastatic BCC) from 36 countries were treated; 147 patients (12%) remained on study at time of reporting. Median (range) treatment duration was 8.6 (0-44) months. Most patients (98%) had ≥1 treatment-emergent adverse event (TEAE). The incidence of the most common TEAEs was consistent with reports in previous analyses. No association between creatine phosphokinase (CPK) abnormalities and muscle spasm was observed. Serious TEAEs occurred in 289 patients (23.8%). Exposure ≥12 months did not lead to increased incidence or severity of new TEAEs. The majority of the most common TEAEs ongoing at time of treatment discontinuation resolved by 12 months afterwards, regardless of Gorlin syndrome status. Response rates (investigator-assessed) in patients with histologically confirmed measurable baseline disease were 68.5% (95% confidence interval (CI) 65.7-71.3) in patients with locally advanced BCC and 36.9% (95% CI 26.6-48.1) in patients with metastatic BCC. CONCLUSIONS: The primary analysis of STEVIE demonstrates that vismodegib is tolerable in typical patients in clinical practice; safety profile is consistent with that in previous reports. Long-term exposure was not associated with worsening severity/frequency of TEAEs. Investigator-assessed response rates showed high rate of tumour control. CLINICALTRIALS.GOV: NCT01367665.
Department of Dermatology Hôpital Saint Louis 1 Avenue Claude Vellefaux 75475 Paris France
Department of Dermatology University of Kiel Rosalind Franklin Str 7 D 24105 Kiel Germany
Dermatology Department University Hospital Zurich Gloriastr 31 8091 Zurich Switzerland
Dermatology Service University Hospital of Bordeaux 1 Rue Jean Burguet 33075 Bordeaux France
Oncology Centre Addenbrooke's Hospital Hills Road Cambridge CB2 2OQ UK
Roche Products Ltd 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW UK
Citace poskytuje Crossref.org
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- $a Basset-Séguin, N $u Department of Dermatology, Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75475, Paris, France. Electronic address: nicole.basset-seguin@aphp.fr.
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- $a Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial / $c N. Basset-Séguin, A. Hauschild, R. Kunstfeld, J. Grob, B. Dréno, L. Mortier, PA. 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,
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- $a BACKGROUND: The SafeTy Events in VIsmodEgib study (STEVIE, ClinicalTrials.gov, NCT01367665), assessed safety and efficacy of vismodegib-a first-in-class Hedgehog pathway inhibitor demonstrating clinical benefit in advanced basal cell carcinoma (BCC)-in a patient population representative of clinical practice. Primary analysis data are presented. PATIENTS AND METHODS: Patients with locally advanced or metastatic BCC received oral vismodegib 150 mg/d until progressive disease, unacceptable toxicity, or withdrawal. Primary objective was safety. Efficacy variables were assessed as secondary end-points. RESULTS: Evaluable adult patients (N = 1215, 1119 locally advanced; 96 metastatic BCC) from 36 countries were treated; 147 patients (12%) remained on study at time of reporting. Median (range) treatment duration was 8.6 (0-44) months. Most patients (98%) had ≥1 treatment-emergent adverse event (TEAE). The incidence of the most common TEAEs was consistent with reports in previous analyses. No association between creatine phosphokinase (CPK) abnormalities and muscle spasm was observed. Serious TEAEs occurred in 289 patients (23.8%). Exposure ≥12 months did not lead to increased incidence or severity of new TEAEs. The majority of the most common TEAEs ongoing at time of treatment discontinuation resolved by 12 months afterwards, regardless of Gorlin syndrome status. Response rates (investigator-assessed) in patients with histologically confirmed measurable baseline disease were 68.5% (95% confidence interval (CI) 65.7-71.3) in patients with locally advanced BCC and 36.9% (95% CI 26.6-48.1) in patients with metastatic BCC. CONCLUSIONS: The primary analysis of STEVIE demonstrates that vismodegib is tolerable in typical patients in clinical practice; safety profile is consistent with that in previous reports. Long-term exposure was not associated with worsening severity/frequency of TEAEs. Investigator-assessed response rates showed high rate of tumour control. CLINICALTRIALS.GOV: NCT01367665.
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- $a Hauschild, A $u Department of Dermatology, University of Kiel, Rosalind-Franklin-Str 7, D-24105, Kiel, Germany. Electronic address: ahauschild@dermatology.uni-kiel.de.
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- $a Kunstfeld, R $u University Dermatology Clinic, Medical University of Vienna, Währinger Gürtel 18-20, A-1090, Vienna, Austria. Electronic address: rainer.kunstfeld@meduniwien.ac.at.
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- 700 1_
- $a Dréno, B $u Department of Dermato Oncology, University Hospital Nantes, Hotel Dieu, Place Alexis Ricordeau, 44093, Cedex 01 Nantes, France. Electronic address: brigitte.dreno@wanadoo.fr.
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- $a Ascierto, P A $u Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione Pascale, Via Mariano Semmola, 80131, Naples, Italy. Electronic address: paolo.ascierto@gmail.com.
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