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 : 001C04 ( PubMed/Corpus ); précédent : 001C03; suivant : 001C05The 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 ; Alexander Guminski ; Ralf Gutzmer ; Luc Dirix ; Karl D. Lewis ; Patrick Combemale ; Robert M. Herd ; Martin Kaatz ; Carmen Loquai ; Alexander J. Stratigos ; Hans-Joachim Schulze ; Ruth Plummer ; Sven Gogov ; Celine Pallaud ; Tingting Yi ; Manisha Mone ; Anne Lynn S. Chang ; Frank Cornélis ; Ragini Kudchadkar ; Uwe Trefzer ; John T. Lear ; Dalila Sellami ; Michael R. MigdenSource :
- Journal of the American Academy of Dermatology [ 1097-6787 ] ; 2016.
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
Links to Exploration step
pubmed:27067394Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><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><nlm:affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland. Electronic address: reinhard.dummer@usz.ch.</nlm:affiliation></affiliation></author><author><name sortKey="Guminski, Alexander" sort="Guminski, Alexander" uniqKey="Guminski A" first="Alexander" last="Guminski">Alexander Guminski</name><affiliation><nlm:affiliation>Royal North Shore Hospital, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Gutzmer, Ralf" sort="Gutzmer, Ralf" uniqKey="Gutzmer R" first="Ralf" last="Gutzmer">Ralf Gutzmer</name><affiliation><nlm:affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Dirix, Luc" sort="Dirix, Luc" uniqKey="Dirix L" first="Luc" last="Dirix">Luc Dirix</name><affiliation><nlm:affiliation>Sint-Augustinus Ziekenhuis, Antwerp, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Lewis, Karl D" sort="Lewis, Karl D" uniqKey="Lewis K" first="Karl D" last="Lewis">Karl D. Lewis</name><affiliation><nlm:affiliation>Division of Medical Oncology, School of Medicine, University of Colorado, Aurora, Colorado.</nlm:affiliation></affiliation></author><author><name sortKey="Combemale, Patrick" sort="Combemale, Patrick" uniqKey="Combemale P" first="Patrick" last="Combemale">Patrick Combemale</name><affiliation><nlm:affiliation>Anti Cancer Institute, Léon Bérard, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Herd, Robert M" sort="Herd, Robert M" uniqKey="Herd R" first="Robert M" last="Herd">Robert M. Herd</name><affiliation><nlm:affiliation>Glasgow Royal Infirmary, Glasgow, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Kaatz, Martin" sort="Kaatz, Martin" uniqKey="Kaatz M" first="Martin" last="Kaatz">Martin Kaatz</name><affiliation><nlm:affiliation>University Hospital Jena, Jena, Germany; SRH Wald-Klinikum Gera GmbH, Gera, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Loquai, Carmen" sort="Loquai, Carmen" uniqKey="Loquai C" first="Carmen" last="Loquai">Carmen Loquai</name><affiliation><nlm:affiliation>University Medical Center Mainz, Mainz, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Stratigos, Alexander J" sort="Stratigos, Alexander J" uniqKey="Stratigos A" first="Alexander J" last="Stratigos">Alexander J. Stratigos</name><affiliation><nlm:affiliation>Department of Dermatology, Andreas Sygros Hospital, University of Athens, Athens, Greece.</nlm:affiliation></affiliation></author><author><name sortKey="Schulze, Hans Joachim" sort="Schulze, Hans Joachim" uniqKey="Schulze H" first="Hans-Joachim" last="Schulze">Hans-Joachim Schulze</name><affiliation><nlm:affiliation>Fachklinik Hornheide, Münster, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Plummer, Ruth" sort="Plummer, Ruth" uniqKey="Plummer R" first="Ruth" last="Plummer">Ruth Plummer</name><affiliation><nlm:affiliation>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Gogov, Sven" sort="Gogov, Sven" uniqKey="Gogov S" first="Sven" last="Gogov">Sven Gogov</name><affiliation><nlm:affiliation>Novartis Pharma AG, Oncology Global Development, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Pallaud, Celine" sort="Pallaud, Celine" uniqKey="Pallaud C" first="Celine" last="Pallaud">Celine Pallaud</name><affiliation><nlm:affiliation>Novartis Pharma AG, Oncology Global Development, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Yi, Tingting" sort="Yi, Tingting" uniqKey="Yi T" first="Tingting" last="Yi">Tingting Yi</name><affiliation><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</nlm:affiliation></affiliation></author><author><name sortKey="Mone, Manisha" sort="Mone, Manisha" uniqKey="Mone M" first="Manisha" last="Mone">Manisha Mone</name><affiliation><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</nlm:affiliation></affiliation></author><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><affiliation><nlm:affiliation>Stanford University School of Medicine, Redwood City, California.</nlm:affiliation></affiliation></author><author><name sortKey="Cornelis, Frank" sort="Cornelis, Frank" uniqKey="Cornelis F" first="Frank" last="Cornélis">Frank Cornélis</name><affiliation><nlm:affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Kudchadkar, Ragini" sort="Kudchadkar, Ragini" uniqKey="Kudchadkar R" first="Ragini" last="Kudchadkar">Ragini Kudchadkar</name><affiliation><nlm:affiliation>Winship Cancer Institute at Emory University, Atlanta, Georgia.</nlm:affiliation></affiliation></author><author><name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name><affiliation><nlm:affiliation>Dermatologikum Berlin, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Lear, John T" sort="Lear, John T" uniqKey="Lear J" first="John T" last="Lear">John T. Lear</name><affiliation><nlm:affiliation>Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Sellami, Dalila" sort="Sellami, Dalila" uniqKey="Sellami D" first="Dalila" last="Sellami">Dalila Sellami</name><affiliation><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</nlm:affiliation></affiliation></author><author><name sortKey="Migden, Michael R" sort="Migden, Michael R" uniqKey="Migden M" first="Michael R" last="Migden">Michael R. Migden</name><affiliation><nlm:affiliation>Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27067394</idno><idno type="pmid">27067394</idno><idno type="doi">10.1016/j.jaad.2016.02.1226</idno><idno type="wicri:Area/PubMed/Corpus">001C04</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001C04</idno></publicationStmt><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><nlm:affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland. Electronic address: reinhard.dummer@usz.ch.</nlm:affiliation></affiliation></author><author><name sortKey="Guminski, Alexander" sort="Guminski, Alexander" uniqKey="Guminski A" first="Alexander" last="Guminski">Alexander Guminski</name><affiliation><nlm:affiliation>Royal North Shore Hospital, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Gutzmer, Ralf" sort="Gutzmer, Ralf" uniqKey="Gutzmer R" first="Ralf" last="Gutzmer">Ralf Gutzmer</name><affiliation><nlm:affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Dirix, Luc" sort="Dirix, Luc" uniqKey="Dirix L" first="Luc" last="Dirix">Luc Dirix</name><affiliation><nlm:affiliation>Sint-Augustinus Ziekenhuis, Antwerp, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Lewis, Karl D" sort="Lewis, Karl D" uniqKey="Lewis K" first="Karl D" last="Lewis">Karl D. Lewis</name><affiliation><nlm:affiliation>Division of Medical Oncology, School of Medicine, University of Colorado, Aurora, Colorado.</nlm:affiliation></affiliation></author><author><name sortKey="Combemale, Patrick" sort="Combemale, Patrick" uniqKey="Combemale P" first="Patrick" last="Combemale">Patrick Combemale</name><affiliation><nlm:affiliation>Anti Cancer Institute, Léon Bérard, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Herd, Robert M" sort="Herd, Robert M" uniqKey="Herd R" first="Robert M" last="Herd">Robert M. Herd</name><affiliation><nlm:affiliation>Glasgow Royal Infirmary, Glasgow, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Kaatz, Martin" sort="Kaatz, Martin" uniqKey="Kaatz M" first="Martin" last="Kaatz">Martin Kaatz</name><affiliation><nlm:affiliation>University Hospital Jena, Jena, Germany; SRH Wald-Klinikum Gera GmbH, Gera, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Loquai, Carmen" sort="Loquai, Carmen" uniqKey="Loquai C" first="Carmen" last="Loquai">Carmen Loquai</name><affiliation><nlm:affiliation>University Medical Center Mainz, Mainz, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Stratigos, Alexander J" sort="Stratigos, Alexander J" uniqKey="Stratigos A" first="Alexander J" last="Stratigos">Alexander J. Stratigos</name><affiliation><nlm:affiliation>Department of Dermatology, Andreas Sygros Hospital, University of Athens, Athens, Greece.</nlm:affiliation></affiliation></author><author><name sortKey="Schulze, Hans Joachim" sort="Schulze, Hans Joachim" uniqKey="Schulze H" first="Hans-Joachim" last="Schulze">Hans-Joachim Schulze</name><affiliation><nlm:affiliation>Fachklinik Hornheide, Münster, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Plummer, Ruth" sort="Plummer, Ruth" uniqKey="Plummer R" first="Ruth" last="Plummer">Ruth Plummer</name><affiliation><nlm:affiliation>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Gogov, Sven" sort="Gogov, Sven" uniqKey="Gogov S" first="Sven" last="Gogov">Sven Gogov</name><affiliation><nlm:affiliation>Novartis Pharma AG, Oncology Global Development, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Pallaud, Celine" sort="Pallaud, Celine" uniqKey="Pallaud C" first="Celine" last="Pallaud">Celine Pallaud</name><affiliation><nlm:affiliation>Novartis Pharma AG, Oncology Global Development, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Yi, Tingting" sort="Yi, Tingting" uniqKey="Yi T" first="Tingting" last="Yi">Tingting Yi</name><affiliation><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</nlm:affiliation></affiliation></author><author><name sortKey="Mone, Manisha" sort="Mone, Manisha" uniqKey="Mone M" first="Manisha" last="Mone">Manisha Mone</name><affiliation><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</nlm:affiliation></affiliation></author><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><affiliation><nlm:affiliation>Stanford University School of Medicine, Redwood City, California.</nlm:affiliation></affiliation></author><author><name sortKey="Cornelis, Frank" sort="Cornelis, Frank" uniqKey="Cornelis F" first="Frank" last="Cornélis">Frank Cornélis</name><affiliation><nlm:affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Kudchadkar, Ragini" sort="Kudchadkar, Ragini" uniqKey="Kudchadkar R" first="Ragini" last="Kudchadkar">Ragini Kudchadkar</name><affiliation><nlm:affiliation>Winship Cancer Institute at Emory University, Atlanta, Georgia.</nlm:affiliation></affiliation></author><author><name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name><affiliation><nlm:affiliation>Dermatologikum Berlin, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Lear, John T" sort="Lear, John T" uniqKey="Lear J" first="John T" last="Lear">John T. Lear</name><affiliation><nlm:affiliation>Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Sellami, Dalila" sort="Sellami, Dalila" uniqKey="Sellami D" first="Dalila" last="Sellami">Dalila Sellami</name><affiliation><nlm:affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</nlm:affiliation></affiliation></author><author><name sortKey="Migden, Michael R" sort="Migden, Michael R" uniqKey="Migden M" first="Michael R" last="Migden">Michael R. Migden</name><affiliation><nlm:affiliation>Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of the American Academy of Dermatology</title><idno type="eISSN">1097-6787</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Agents (administration & dosage)</term><term>Antineoplastic Agents (adverse effects)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Biphenyl Compounds (administration & dosage)</term><term>Biphenyl Compounds (adverse effects)</term><term>Biphenyl Compounds (therapeutic use)</term><term>Carcinoma, Basal Cell (drug therapy)</term><term>Carcinoma, Basal Cell (secondary)</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pyridines (administration & dosage)</term><term>Pyridines (adverse effects)</term><term>Pyridines (therapeutic use)</term><term>Skin Neoplasms (drug therapy)</term><term>Skin Neoplasms (pathology)</term><term>Smoothened Receptor (antagonists & inhibitors)</term><term>Survival Rate</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Agents</term><term>Biphenyl Compounds</term><term>Pyridines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Agents</term><term>Biphenyl Compounds</term><term>Pyridines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Smoothened Receptor</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents</term><term>Biphenyl Compounds</term><term>Pyridines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Carcinoma, Basal Cell</term><term>Skin Neoplasms</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Skin Neoplasms</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Carcinoma, Basal Cell</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Survival Rate</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27067394</PMID><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><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Dummer</LastName><ForeName>Reinhard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>UniversitätsSpital Zürich-Skin Cancer Center, University Hospital, Zürich, Switzerland. Electronic address: reinhard.dummer@usz.ch.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guminski</LastName><ForeName>Alexander</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Royal North Shore Hospital, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gutzmer</LastName><ForeName>Ralf</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Medizinische Hochschule Hannover, Hannover, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dirix</LastName><ForeName>Luc</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Sint-Augustinus Ziekenhuis, Antwerp, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lewis</LastName><ForeName>Karl D</ForeName><Initials>KD</Initials><AffiliationInfo><Affiliation>Division of Medical Oncology, School of Medicine, University of Colorado, Aurora, Colorado.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Combemale</LastName><ForeName>Patrick</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Anti Cancer Institute, Léon Bérard, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Herd</LastName><ForeName>Robert M</ForeName><Initials>RM</Initials><AffiliationInfo><Affiliation>Glasgow Royal Infirmary, Glasgow, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaatz</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>University Hospital Jena, Jena, Germany; SRH Wald-Klinikum Gera GmbH, Gera, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Loquai</LastName><ForeName>Carmen</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>University Medical Center Mainz, Mainz, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stratigos</LastName><ForeName>Alexander J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Department of Dermatology, Andreas Sygros Hospital, University of Athens, Athens, Greece.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schulze</LastName><ForeName>Hans-Joachim</ForeName><Initials>HJ</Initials><AffiliationInfo><Affiliation>Fachklinik Hornheide, Münster, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Plummer</LastName><ForeName>Ruth</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gogov</LastName><ForeName>Sven</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Novartis Pharma AG, Oncology Global Development, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pallaud</LastName><ForeName>Celine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Novartis Pharma AG, Oncology Global Development, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yi</LastName><ForeName>Tingting</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mone</LastName><ForeName>Manisha</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chang</LastName><ForeName>Anne Lynn S</ForeName><Initials>AL</Initials><AffiliationInfo><Affiliation>Stanford University School of Medicine, Redwood City, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cornélis</LastName><ForeName>Frank</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kudchadkar</LastName><ForeName>Ragini</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Winship Cancer Institute at Emory University, Atlanta, Georgia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Trefzer</LastName><ForeName>Uwe</ForeName><Initials>U</Initials><AffiliationInfo><Affiliation>Dermatologikum Berlin, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lear</LastName><ForeName>John T</ForeName><Initials>JT</Initials><AffiliationInfo><Affiliation>Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sellami</LastName><ForeName>Dalila</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Migden</LastName><ForeName>Michael R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>04</Month><Day>07</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Am Acad Dermatol</MedlineTA><NlmUniqueID>7907132</NlmUniqueID><ISSNLinking>0190-9622</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001713">Biphenyl Compounds</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C561435">LDE225</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011725">Pyridines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000072086">Smoothened Receptor</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001713" MajorTopicYN="N">Biphenyl Compounds</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002280" MajorTopicYN="N">Carcinoma, Basal Cell</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000556" MajorTopicYN="N">secondary</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018450" MajorTopicYN="N">Disease Progression</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011725" MajorTopicYN="N">Pyridines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012878" MajorTopicYN="N">Skin Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000072086" MajorTopicYN="N">Smoothened Receptor</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="N">antagonists & inhibitors</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Basal Cell Carcinoma Outcomes with LDE225 Treatment study</Keyword><Keyword MajorTopicYN="Y">advanced basal cell carcinoma</Keyword><Keyword MajorTopicYN="Y">hedgehog pathway inhibitor</Keyword><Keyword MajorTopicYN="Y">locally advanced basal cell carcinoma</Keyword><Keyword MajorTopicYN="Y">metastatic basal cell carcinoma</Keyword><Keyword MajorTopicYN="Y">sonidegib</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>08</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>02</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>02</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>4</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>4</Month><Day>14</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>4</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27067394</ArticleId><ArticleId IdType="pii">S0190-9622(16)01491-2</ArticleId><ArticleId IdType="doi">10.1016/j.jaad.2016.02.1226</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= 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.
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