Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study.
Identifieur interne : 000877 ( PubMed/Checkpoint ); précédent : 000876; suivant : 000878Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study.
Auteurs : J T Lear [Royaume-Uni] ; M R Migden [États-Unis] ; K D Lewis [États-Unis] ; A L S. Chang [États-Unis] ; A. Guminski [Australie] ; R. Gutzmer [Allemagne] ; L. Dirix [Belgique] ; P. Combemale [France] ; A. Stratigos [Grèce] ; R. Plummer [Royaume-Uni] ; H. Castro [Suisse] ; T. Yi [États-Unis] ; M. Mone [États-Unis] ; J. Zhou [États-Unis] ; U. Trefzer [Allemagne] ; M. Kaatz [Allemagne] ; C. Loquai [Allemagne] ; R. Kudchadkar [États-Unis] ; D. Sellami [États-Unis] ; R. Dummer [Suisse]Source :
- Journal of the European Academy of Dermatology and Venereology : JEADV [ 1468-3083 ] ; 2017.
Abstract
Patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC), two difficult-to-treat populations, have had limited treatment options. Sonidegib, a hedgehog pathway inhibitor (HPI), was approved in laBCC based on results from the BOLT trial.
DOI: 10.1111/jdv.14542
PubMed: 28846163
Affiliations:
- Allemagne, Australie, Belgique, France, Grèce, Royaume-Uni, Suisse, États-Unis
- Angleterre, Attique (région), Auvergne-Rhône-Alpes, Basse-Saxe, Berlin, Californie, Canton de Zurich, Colorado, Grand Manchester, Géorgie (États-Unis), New Jersey, Rhénanie-Palatinat, Rhône-Alpes, Texas
- Athènes, Berlin, Hanovre, Lyon, Manchester, Mayence, Zurich
- Université de Manchester
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study.</title><author><name sortKey="Lear, J T" sort="Lear, J T" uniqKey="Lear J" first="J T" last="Lear">J T Lear</name><affiliation wicri:level="4"><nlm:affiliation>Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Manchester Academic Health Science Centre, University of Manchester, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region><settlement type="city">Manchester</settlement></placeName><orgName type="university">Université de Manchester</orgName></affiliation></author><author><name sortKey="Migden, M R" sort="Migden, M R" uniqKey="Migden M" first="M R" last="Migden">M R Migden</name><affiliation wicri:level="2"><nlm:affiliation>Departments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Lewis, K D" sort="Lewis, K D" uniqKey="Lewis K" first="K D" last="Lewis">K D Lewis</name><affiliation wicri:level="2"><nlm:affiliation>Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Chang, A L S" sort="Chang, A L S" uniqKey="Chang A" first="A L S" last="Chang">A L S. Chang</name><affiliation wicri:level="2"><nlm:affiliation>Stanford University School of Medicine, Redwood City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stanford University School of Medicine, Redwood City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Guminski, A" sort="Guminski, A" uniqKey="Guminski A" first="A" last="Guminski">A. Guminski</name><affiliation wicri:level="1"><nlm:affiliation>Royal North Shore Hospital, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Royal North Shore Hospital, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Gutzmer, R" sort="Gutzmer, R" uniqKey="Gutzmer R" first="R" last="Gutzmer">R. Gutzmer</name><affiliation wicri:level="3"><nlm:affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medizinische Hochschule Hannover, Hannover</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Dirix, L" sort="Dirix, L" uniqKey="Dirix L" first="L" last="Dirix">L. Dirix</name><affiliation wicri:level="1"><nlm:affiliation>Sint-Augustinus Ziekenhuis, Antwerp, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Sint-Augustinus Ziekenhuis, Antwerp</wicri:regionArea><wicri:noRegion>Antwerp</wicri:noRegion></affiliation></author><author><name sortKey="Combemale, P" sort="Combemale, P" uniqKey="Combemale P" first="P" last="Combemale">P. Combemale</name><affiliation wicri:level="3"><nlm:affiliation>Anti Cancer Institute, Léon Bérard, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Anti Cancer Institute, Léon Bérard, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Stratigos, A" sort="Stratigos, A" uniqKey="Stratigos A" first="A" last="Stratigos">A. Stratigos</name><affiliation wicri:level="3"><nlm:affiliation>Andreas Syggros Hospital, University of Athens, Athens, Greece.</nlm:affiliation><country xml:lang="fr">Grèce</country><wicri:regionArea>Andreas Syggros Hospital, University of Athens, Athens</wicri:regionArea><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Plummer, R" sort="Plummer, R" uniqKey="Plummer R" first="R" last="Plummer">R. Plummer</name><affiliation wicri:level="1"><nlm:affiliation>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne</wicri:regionArea><wicri:noRegion>Newcastle upon Tyne</wicri:noRegion></affiliation></author><author><name sortKey="Castro, H" sort="Castro, H" uniqKey="Castro H" first="H" last="Castro">H. Castro</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Yi, T" sort="Yi, T" uniqKey="Yi T" first="T" last="Yi">T. Yi</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Mone, M" sort="Mone, M" uniqKey="Mone M" first="M" last="Mone">M. Mone</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Zhou, J" sort="Zhou, J" uniqKey="Zhou J" first="J" last="Zhou">J. Zhou</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Trefzer, U" sort="Trefzer, U" uniqKey="Trefzer U" first="U" last="Trefzer">U. Trefzer</name><affiliation wicri:level="3"><nlm:affiliation>Dermatologikum Berlin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Dermatologikum Berlin, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Kaatz, M" sort="Kaatz, M" uniqKey="Kaatz M" first="M" last="Kaatz">M. Kaatz</name><affiliation wicri:level="1"><nlm:affiliation>University Hospital Jena, Jena, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>University Hospital Jena, Jena</wicri:regionArea><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion></affiliation></author><author><name sortKey="Loquai, C" sort="Loquai, C" uniqKey="Loquai C" first="C" last="Loquai">C. Loquai</name><affiliation wicri:level="3"><nlm:affiliation>University Medical Center Mainz, Mainz, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>University Medical Center Mainz, Mainz</wicri:regionArea><placeName><region type="land" nuts="2">Rhénanie-Palatinat</region><settlement type="city">Mayence</settlement></placeName></affiliation></author><author><name sortKey="Kudchadkar, R" sort="Kudchadkar, R" uniqKey="Kudchadkar R" first="R" last="Kudchadkar">R. Kudchadkar</name><affiliation wicri:level="2"><nlm:affiliation>Winship Cancer Institute of Emory University, Atlanta, GA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Winship Cancer Institute of Emory University, Atlanta, GA</wicri:regionArea><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Sellami, D" sort="Sellami, D" uniqKey="Sellami D" first="D" last="Sellami">D. Sellami</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dummer, R" sort="Dummer, R" uniqKey="Dummer R" first="R" last="Dummer">R. Dummer</name><affiliation wicri:level="3"><nlm:affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich</wicri:regionArea><placeName><settlement type="city">Zurich</settlement><region nuts="3" type="region">Canton de Zurich</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28846163</idno><idno type="pmid">28846163</idno><idno type="doi">10.1111/jdv.14542</idno><idno type="wicri:Area/PubMed/Corpus">000774</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000774</idno><idno type="wicri:Area/PubMed/Curation">000771</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000771</idno><idno type="wicri:Area/PubMed/Checkpoint">000771</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000771</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study.</title><author><name sortKey="Lear, J T" sort="Lear, J T" uniqKey="Lear J" first="J T" last="Lear">J T Lear</name><affiliation wicri:level="4"><nlm:affiliation>Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Manchester Academic Health Science Centre, University of Manchester, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region><settlement type="city">Manchester</settlement></placeName><orgName type="university">Université de Manchester</orgName></affiliation></author><author><name sortKey="Migden, M R" sort="Migden, M R" uniqKey="Migden M" first="M R" last="Migden">M R Migden</name><affiliation wicri:level="2"><nlm:affiliation>Departments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Lewis, K D" sort="Lewis, K D" uniqKey="Lewis K" first="K D" last="Lewis">K D Lewis</name><affiliation wicri:level="2"><nlm:affiliation>Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Chang, A L S" sort="Chang, A L S" uniqKey="Chang A" first="A L S" last="Chang">A L S. Chang</name><affiliation wicri:level="2"><nlm:affiliation>Stanford University School of Medicine, Redwood City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stanford University School of Medicine, Redwood City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Guminski, A" sort="Guminski, A" uniqKey="Guminski A" first="A" last="Guminski">A. Guminski</name><affiliation wicri:level="1"><nlm:affiliation>Royal North Shore Hospital, St Leonards, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Royal North Shore Hospital, St Leonards, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author><author><name sortKey="Gutzmer, R" sort="Gutzmer, R" uniqKey="Gutzmer R" first="R" last="Gutzmer">R. Gutzmer</name><affiliation wicri:level="3"><nlm:affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medizinische Hochschule Hannover, Hannover</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Dirix, L" sort="Dirix, L" uniqKey="Dirix L" first="L" last="Dirix">L. Dirix</name><affiliation wicri:level="1"><nlm:affiliation>Sint-Augustinus Ziekenhuis, Antwerp, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Sint-Augustinus Ziekenhuis, Antwerp</wicri:regionArea><wicri:noRegion>Antwerp</wicri:noRegion></affiliation></author><author><name sortKey="Combemale, P" sort="Combemale, P" uniqKey="Combemale P" first="P" last="Combemale">P. Combemale</name><affiliation wicri:level="3"><nlm:affiliation>Anti Cancer Institute, Léon Bérard, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Anti Cancer Institute, Léon Bérard, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Stratigos, A" sort="Stratigos, A" uniqKey="Stratigos A" first="A" last="Stratigos">A. Stratigos</name><affiliation wicri:level="3"><nlm:affiliation>Andreas Syggros Hospital, University of Athens, Athens, Greece.</nlm:affiliation><country xml:lang="fr">Grèce</country><wicri:regionArea>Andreas Syggros Hospital, University of Athens, Athens</wicri:regionArea><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Plummer, R" sort="Plummer, R" uniqKey="Plummer R" first="R" last="Plummer">R. Plummer</name><affiliation wicri:level="1"><nlm:affiliation>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne</wicri:regionArea><wicri:noRegion>Newcastle upon Tyne</wicri:noRegion></affiliation></author><author><name sortKey="Castro, H" sort="Castro, H" uniqKey="Castro H" first="H" last="Castro">H. Castro</name><affiliation wicri:level="1"><nlm:affiliation>Novartis Pharma AG, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Yi, T" sort="Yi, T" uniqKey="Yi T" first="T" last="Yi">T. Yi</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Mone, M" sort="Mone, M" uniqKey="Mone M" first="M" last="Mone">M. Mone</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Zhou, J" sort="Zhou, J" uniqKey="Zhou J" first="J" last="Zhou">J. Zhou</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Trefzer, U" sort="Trefzer, U" uniqKey="Trefzer U" first="U" last="Trefzer">U. Trefzer</name><affiliation wicri:level="3"><nlm:affiliation>Dermatologikum Berlin, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Dermatologikum Berlin, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Kaatz, M" sort="Kaatz, M" uniqKey="Kaatz M" first="M" last="Kaatz">M. Kaatz</name><affiliation wicri:level="1"><nlm:affiliation>University Hospital Jena, Jena, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>University Hospital Jena, Jena</wicri:regionArea><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion><wicri:noRegion>Jena</wicri:noRegion></affiliation></author><author><name sortKey="Loquai, C" sort="Loquai, C" uniqKey="Loquai C" first="C" last="Loquai">C. Loquai</name><affiliation wicri:level="3"><nlm:affiliation>University Medical Center Mainz, Mainz, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>University Medical Center Mainz, Mainz</wicri:regionArea><placeName><region type="land" nuts="2">Rhénanie-Palatinat</region><settlement type="city">Mayence</settlement></placeName></affiliation></author><author><name sortKey="Kudchadkar, R" sort="Kudchadkar, R" uniqKey="Kudchadkar R" first="R" last="Kudchadkar">R. Kudchadkar</name><affiliation wicri:level="2"><nlm:affiliation>Winship Cancer Institute of Emory University, Atlanta, GA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Winship Cancer Institute of Emory University, Atlanta, GA</wicri:regionArea><placeName><region type="state">Géorgie (États-Unis)</region></placeName></affiliation></author><author><name sortKey="Sellami, D" sort="Sellami, D" uniqKey="Sellami D" first="D" last="Sellami">D. Sellami</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals Corporation, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dummer, R" sort="Dummer, R" uniqKey="Dummer R" first="R" last="Dummer">R. Dummer</name><affiliation wicri:level="3"><nlm:affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich</wicri:regionArea><placeName><settlement type="city">Zurich</settlement><region nuts="3" type="region">Canton de Zurich</region></placeName></affiliation></author></analytic><series><title level="j">Journal of the European Academy of Dermatology and Venereology : JEADV</title><idno type="eISSN">1468-3083</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC), two difficult-to-treat populations, have had limited treatment options. Sonidegib, a hedgehog pathway inhibitor (HPI), was approved in laBCC based on results from the BOLT trial.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">28846163</PMID><DateCreated><Year>2017</Year><Month>08</Month><Day>28</Day></DateCreated><DateRevised><Year>2017</Year><Month>11</Month><Day>06</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1468-3083</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year><Month>Aug</Month><Day>28</Day></PubDate></JournalIssue><Title>Journal of the European Academy of Dermatology and Venereology : JEADV</Title><ISOAbbreviation>J Eur Acad Dermatol Venereol</ISOAbbreviation></Journal><ArticleTitle>Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study.</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.1111/jdv.14542</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Patients with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC), two difficult-to-treat populations, have had limited treatment options. Sonidegib, a hedgehog pathway inhibitor (HPI), was approved in laBCC based on results from the BOLT trial.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate long-term efficacy and safety of sonidegib in laBCC and mBCC in the BOLT 18- and 30-month analyses.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">BOLT (NCT01327053, ClinicalTrials.gov), a double-blind phase 2 study, enrolled patients from July 2011 until January 2013. Eligible HPI-treatment-naïve patients with laBCC not amenable to curative surgery/radiotherapy or mBCC were randomized 1 : 2 to sonidegib 200 mg (laBCC, n = 66; mBCC, n = 13) or 800 mg (laBCC, n = 128; mBCC, n = 23). Tumour response was assessed per central and investigator review.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">With 30 months of follow-up, among patients treated with sonidegib 200 mg (approved dose), objective response rates were 56.1% (central) and 71.2% (investigator) in laBCC and 7.7% (central) and 23.1% (investigator) in mBCC. Tumour responses were durable as follows: median duration of response was 26.1 months (central) and 15.7 months (investigator) in laBCC and 24.0 months (central) and 18.1 months (investigator) in mBCC. Five patients with laBCC and three with mBCC in the 200-mg arm died. Median overall survival was not reached in either population; 2-year overall survival rates were 93.2% (laBCC) and 69.3% (mBCC). In laBCC, efficacy was similar regardless of aggressive or non-aggressive histology. Sonidegib 200 mg continued to have a better safety profile than 800 mg, with lower rates of grade 3/4 adverse events (43.0% vs. 64.0%) and adverse events leading to discontinuation (30.4% vs. 40.0%).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Sonidegib continued to demonstrate long-term efficacy and safety in these populations. These data support the use of sonidegib 200 mg per local treatment guidelines.</AbstractText><CopyrightInformation>© 2017 European Academy of Dermatology and Venereology.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lear</LastName><ForeName>J T</ForeName><Initials>JT</Initials><AffiliationInfo><Affiliation>Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Migden</LastName><ForeName>M R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Departments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lewis</LastName><ForeName>K D</ForeName><Initials>KD</Initials><AffiliationInfo><Affiliation>Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chang</LastName><ForeName>A L S</ForeName><Initials>ALS</Initials><AffiliationInfo><Affiliation>Stanford University School of Medicine, Redwood City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guminski</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Royal North Shore Hospital, St Leonards, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gutzmer</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dirix</LastName><ForeName>L</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Sint-Augustinus Ziekenhuis, Antwerp, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Combemale</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Anti Cancer Institute, Léon Bérard, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stratigos</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Andreas Syggros Hospital, University of Athens, Athens, Greece.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Plummer</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Castro</LastName><ForeName>H</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Novartis Pharma AG, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yi</LastName><ForeName>T</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mone</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhou</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Trefzer</LastName><ForeName>U</ForeName><Initials>U</Initials><AffiliationInfo><Affiliation>Dermatologikum Berlin, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaatz</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>University Hospital Jena, Jena, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Loquai</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>University Medical Center Mainz, Mainz, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kudchadkar</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Winship Cancer Institute of Emory University, Atlanta, GA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sellami</LastName><ForeName>D</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dummer</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>08</Month><Day>28</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Eur Acad Dermatol Venereol</MedlineTA><NlmUniqueID>9216037</NlmUniqueID><ISSNLinking>0926-9959</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>03</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>08</Month><Day>07</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>8</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>8</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>8</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28846163</ArticleId><ArticleId IdType="doi">10.1111/jdv.14542</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>France</li><li>Grèce</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Attique (région)</li><li>Auvergne-Rhône-Alpes</li><li>Basse-Saxe</li><li>Berlin</li><li>Californie</li><li>Canton de Zurich</li><li>Colorado</li><li>Grand Manchester</li><li>Géorgie (États-Unis)</li><li>New Jersey</li><li>Rhénanie-Palatinat</li><li>Rhône-Alpes</li><li>Texas</li></region><settlement><li>Athènes</li><li>Berlin</li><li>Hanovre</li><li>Lyon</li><li>Manchester</li><li>Mayence</li><li>Zurich</li></settlement><orgName><li>Université de Manchester</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lear, J T" sort="Lear, J T" uniqKey="Lear J" first="J T" last="Lear">J T Lear</name></region><name sortKey="Plummer, R" sort="Plummer, R" uniqKey="Plummer R" first="R" last="Plummer">R. Plummer</name></country><country name="États-Unis"><region name="Texas"><name sortKey="Migden, M R" sort="Migden, M R" uniqKey="Migden M" first="M R" last="Migden">M R Migden</name></region><name sortKey="Chang, A L S" sort="Chang, A L S" uniqKey="Chang A" first="A L S" last="Chang">A L S. Chang</name><name sortKey="Kudchadkar, R" sort="Kudchadkar, R" uniqKey="Kudchadkar R" first="R" last="Kudchadkar">R. Kudchadkar</name><name sortKey="Lewis, K D" sort="Lewis, K D" uniqKey="Lewis K" first="K D" last="Lewis">K D Lewis</name><name sortKey="Mone, M" sort="Mone, M" uniqKey="Mone M" first="M" last="Mone">M. Mone</name><name sortKey="Sellami, D" sort="Sellami, D" uniqKey="Sellami D" first="D" last="Sellami">D. Sellami</name><name sortKey="Yi, T" sort="Yi, T" uniqKey="Yi T" first="T" last="Yi">T. Yi</name><name sortKey="Zhou, J" sort="Zhou, J" uniqKey="Zhou J" first="J" last="Zhou">J. Zhou</name></country><country name="Australie"><noRegion><name sortKey="Guminski, A" sort="Guminski, A" uniqKey="Guminski A" first="A" last="Guminski">A. Guminski</name></noRegion></country><country name="Allemagne"><region name="Basse-Saxe"><name sortKey="Gutzmer, R" sort="Gutzmer, R" uniqKey="Gutzmer R" first="R" last="Gutzmer">R. Gutzmer</name></region><name sortKey="Kaatz, M" sort="Kaatz, M" uniqKey="Kaatz M" first="M" last="Kaatz">M. Kaatz</name><name sortKey="Loquai, C" sort="Loquai, C" uniqKey="Loquai C" first="C" last="Loquai">C. Loquai</name><name sortKey="Trefzer, U" sort="Trefzer, U" uniqKey="Trefzer U" first="U" last="Trefzer">U. Trefzer</name></country><country name="Belgique"><noRegion><name sortKey="Dirix, L" sort="Dirix, L" uniqKey="Dirix L" first="L" last="Dirix">L. Dirix</name></noRegion></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Combemale, P" sort="Combemale, P" uniqKey="Combemale P" first="P" last="Combemale">P. 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