The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.
Identifieur interne : 001B80 ( PubMed/Curation ); précédent : 001B79; suivant : 001B81The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.
Auteurs : Reinhard Dummer [Suisse] ; Alexander Guminski [Australie] ; Ralf Gutzmer [Allemagne] ; Luc Dirix [Belgique] ; Karl D. Lewis [États-Unis] ; Patrick Combemale [France] ; Robert M. Herd [Royaume-Uni] ; Martin Kaatz [Allemagne] ; Carmen Loquai [Allemagne] ; Alexander J. Stratigos [Grèce] ; Hans-Joachim Schulze [Allemagne] ; Ruth Plummer [Royaume-Uni] ; Sven Gogov [Suisse] ; Celine Pallaud [Suisse] ; Tingting Yi [États-Unis] ; Manisha Mone [États-Unis] ; Anne Lynn S. Chang [États-Unis] ; Frank Cornélis [Belgique] ; Ragini Kudchadkar [Géorgie (pays)] ; Uwe Trefzer [Allemagne] ; John T. Lear [Royaume-Uni] ; Dalila Sellami [États-Unis] ; Michael R. Migden [États-Unis]Source :
- Journal of the American Academy of Dermatology [ 1097-6787 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antinéoplasiques (administration et posologie), Antinéoplasiques (effets indésirables), Antinéoplasiques (usage thérapeutique), Carcinome basocellulaire (secondaire), Carcinome basocellulaire (traitement médicamenteux), Dérivés du biphényle (administration et posologie), Dérivés du biphényle (effets indésirables), Dérivés du biphényle (usage thérapeutique), Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Pyridines (administration et posologie), Pyridines (effets indésirables), Pyridines (usage thérapeutique), Récepteur Smoothened (antagonistes et inhibiteurs), Sujet âgé, Sujet âgé de 80 ans ou plus, Taux de survie, Tumeurs cutanées (anatomopathologie), Tumeurs cutanées (traitement médicamenteux), Évolution de la maladie.
- MESH :
- administration et posologie : Antinéoplasiques, Dérivés du biphényle, Pyridines.
- anatomopathologie : Tumeurs cutanées.
- antagonistes et inhibiteurs : Récepteur Smoothened.
- effets indésirables : Antinéoplasiques, Dérivés du biphényle, Pyridines.
- secondaire : Carcinome basocellulaire.
- traitement médicamenteux : Carcinome basocellulaire, Tumeurs cutanées.
- usage thérapeutique : Antinéoplasiques, Dérivés du biphényle, Pyridines.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Sujet âgé, Sujet âgé de 80 ans ou plus, Taux de survie, Évolution de la maladie.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Agents (administration & dosage), Antineoplastic Agents (adverse effects), Antineoplastic Agents (therapeutic use), Biphenyl Compounds (administration & dosage), Biphenyl Compounds (adverse effects), Biphenyl Compounds (therapeutic use), Carcinoma, Basal Cell (drug therapy), Carcinoma, Basal Cell (secondary), Disease Progression, Double-Blind Method, Female, Humans, Male, Middle Aged, Pyridines (administration & dosage), Pyridines (adverse effects), Pyridines (therapeutic use), Skin Neoplasms (drug therapy), Skin Neoplasms (pathology), Smoothened Receptor (antagonists & inhibitors), Survival Rate, Young Adult.
- MESH :
- chemical , administration & dosage : Antineoplastic Agents, Biphenyl Compounds, Pyridines.
- chemical , adverse effects : Antineoplastic Agents, Biphenyl Compounds, Pyridines.
- chemical , antagonists & inhibitors : Smoothened Receptor.
- chemical , therapeutic use : Antineoplastic Agents, Biphenyl Compounds, Pyridines.
- drug therapy : Carcinoma, Basal Cell, Skin Neoplasms.
- pathology : Skin Neoplasms.
- secondary : Carcinoma, Basal Cell.
- Adult, Aged, Aged, 80 and over, Disease Progression, Double-Blind Method, Female, Humans, Male, Middle Aged, Survival Rate, Young Adult.
Abstract
The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study.
DOI: 10.1016/j.jaad.2016.02.1226
PubMed: 27067394
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pubmed:27067394Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en">The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.</title>
<author><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
<affiliation wicri:level="1"><nlm:affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland. Electronic address: reinhard.dummer@usz.ch.</nlm:affiliation>
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</affiliation>
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<author><name sortKey="Guminski, Alexander" sort="Guminski, Alexander" uniqKey="Guminski A" first="Alexander" last="Guminski">Alexander Guminski</name>
<affiliation wicri:level="1"><nlm:affiliation>Royal North Shore Hospital, Sydney, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
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<author><name sortKey="Gutzmer, Ralf" sort="Gutzmer, Ralf" uniqKey="Gutzmer R" first="Ralf" last="Gutzmer">Ralf Gutzmer</name>
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<author><name sortKey="Lewis, Karl D" sort="Lewis, Karl D" uniqKey="Lewis K" first="Karl D" last="Lewis">Karl D. Lewis</name>
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<country xml:lang="fr">France</country>
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</affiliation>
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<author><name sortKey="Herd, Robert M" sort="Herd, Robert M" uniqKey="Herd R" first="Robert M" last="Herd">Robert M. Herd</name>
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<country xml:lang="fr">Royaume-Uni</country>
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<author><name sortKey="Kaatz, Martin" sort="Kaatz, Martin" uniqKey="Kaatz M" first="Martin" last="Kaatz">Martin Kaatz</name>
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<author><name sortKey="Stratigos, Alexander J" sort="Stratigos, Alexander J" uniqKey="Stratigos A" first="Alexander J" last="Stratigos">Alexander J. Stratigos</name>
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<author><name sortKey="Yi, Tingting" sort="Yi, Tingting" uniqKey="Yi T" first="Tingting" last="Yi">Tingting Yi</name>
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<author><name sortKey="Mone, Manisha" sort="Mone, Manisha" uniqKey="Mone M" first="Manisha" last="Mone">Manisha Mone</name>
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<author><name sortKey="Chang, Anne Lynn S" sort="Chang, Anne Lynn S" uniqKey="Chang A" first="Anne Lynn S" last="Chang">Anne Lynn S. Chang</name>
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<author><name sortKey="Cornelis, Frank" sort="Cornelis, Frank" uniqKey="Cornelis F" first="Frank" last="Cornélis">Frank Cornélis</name>
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<front><div type="abstract" xml:lang="en">The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study.</div>
</front>
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<DateCreated><Year>2016</Year>
<Month>06</Month>
<Day>18</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>04</Month>
<Day>12</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>08</Month>
<Day>17</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1097-6787</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>75</Volume>
<Issue>1</Issue>
<PubDate><Year>2016</Year>
<Month>Jul</Month>
</PubDate>
</JournalIssue>
<Title>Journal of the American Academy of Dermatology</Title>
<ISOAbbreviation>J. Am. Acad. Dermatol.</ISOAbbreviation>
</Journal>
<ArticleTitle>The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.</ArticleTitle>
<Pagination><MedlinePgn>113-125.e5</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jaad.2016.02.1226</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0190-9622(16)01491-2</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">This report provides long-term follow-up data collected up to 12 months after the last patient was randomized.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In this multicenter, randomized, double-blind phase II study, patients were randomized 1:2 to sonidegib 200 or 800 mg. The primary end point was objective response rate assessed by central review.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Objective response rates in the 200- and 800-mg arms were 57.6% and 43.8% in locally advanced BCC and 7.7% and 17.4% in metastatic BCC, respectively. Among the 94 patients with locally advanced BCC who responded, only 18 progressed or died and more than 50% had responses lasting longer than 6 months. In addition, 4 of 5 responders with metastatic BCC maintained an objective response. Grade 3/4 adverse events and those leading to discontinuation were less frequent with sonidegib 200 versus 800 mg (38.0% vs 59.3%; 27.8% vs 37.3%, respectively).</AbstractText>
<AbstractText Label="LIMITATIONS" NlmCategory="CONCLUSIONS">No placebo or comparator arms were used because sonidegib demonstrated efficacy in advanced BCC in a phase I study, and the hedgehog pathway inhibitor vismodegib was not yet approved.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">With longer follow-up, sonidegib demonstrated sustained tumor responses in patients with advanced BCC.</AbstractText>
<CopyrightInformation>Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
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<ForeName>Reinhard</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland. Electronic address: reinhard.dummer@usz.ch.</Affiliation>
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<Initials>A</Initials>
<AffiliationInfo><Affiliation>Royal North Shore Hospital, Sydney, Australia.</Affiliation>
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<ForeName>Ralf</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</Affiliation>
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<AffiliationInfo><Affiliation>Glasgow Royal Infirmary, Glasgow, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Martin</ForeName>
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<AffiliationInfo><Affiliation>University Hospital Jena, Jena, Germany; SRH Wald-Klinikum Gera GmbH, Gera, Germany.</Affiliation>
</AffiliationInfo>
</Author>
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<Initials>C</Initials>
<AffiliationInfo><Affiliation>University Medical Center Mainz, Mainz, Germany.</Affiliation>
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</Author>
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<AffiliationInfo><Affiliation>Department of Dermatology, Andreas Sygros Hospital, University of Athens, Athens, Greece.</Affiliation>
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<Initials>R</Initials>
<AffiliationInfo><Affiliation>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom.</Affiliation>
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<Initials>S</Initials>
<AffiliationInfo><Affiliation>Novartis Pharma AG, Oncology Global Development, Basel, Switzerland.</Affiliation>
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<ForeName>Frank</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.</Affiliation>
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<AffiliationInfo><Affiliation>Winship Cancer Institute at Emory University, Atlanta, Georgia.</Affiliation>
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<ForeName>Uwe</ForeName>
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<ForeName>John T</ForeName>
<Initials>JT</Initials>
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<AffiliationInfo><Affiliation>Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas.</Affiliation>
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