Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.
Identifieur interne : 000872 ( PubMed/Checkpoint ); précédent : 000871; suivant : 000873Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.
Auteurs : Aleksandar Sekulic [États-Unis] ; Michael R. Migden [États-Unis] ; Nicole Basset-Seguin [France] ; Claus Garbe [Allemagne] ; Anja Gesierich [Allemagne] ; Christopher D. Lao [États-Unis] ; Chris Miller [États-Unis] ; Laurent Mortier [France] ; Dedee F. Murrell [Australie] ; Omid Hamid [États-Unis] ; Jorge F. Quevedo [États-Unis] ; Jeannie Hou [États-Unis] ; Edward Mckenna [États-Unis] ; Natalie Dimier [Royaume-Uni] ; Sarah Williams [Royaume-Uni] ; Dirk Schadendorf [Allemagne] ; Axel Hauschild [Allemagne]Source :
- BMC cancer [ 1471-2407 ] ; 2017.
Abstract
In the primary analysis of the ERIVANCE BCC trial, vismodegib, the first US Food and Drug Administration-approved Hedgehog pathway inhibitor, showed objective response rates (ORRs) by independent review facility (IRF) of 30% and 43% in metastatic basal cell carcinoma (mBCC) and locally advanced BCC (laBCC), respectively. ORRs by investigator review were 45% (mBCC) and 60% (laBCC). Herein, we present long-term safety and final investigator-assessed efficacy results in patients with mBCC or laBCC.
DOI: 10.1186/s12885-017-3286-5
PubMed: 28511673
Affiliations:
- Allemagne, Australie, France, Royaume-Uni, États-Unis
- Bade-Wurtemberg, Bavière, Californie, District de Basse-Franconie, District de Tübingen, Hauts-de-France, Nord-Pas-de-Calais, Schleswig-Holstein, Île-de-France
- Kiel, Lille, Paris, Tübingen, Wurtzbourg
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.</title><author><name sortKey="Sekulic, Aleksandar" sort="Sekulic, Aleksandar" uniqKey="Sekulic A" first="Aleksandar" last="Sekulic">Aleksandar Sekulic</name><affiliation wicri:level="1"><nlm:affiliation>Mayo Clinic Scottsdale, 13400 East Shea Boulevard, Scottsdale, AZ, 85259, USA. sekulic.aleksandar@mayo.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic Scottsdale, 13400 East Shea Boulevard, Scottsdale, AZ, 85259</wicri:regionArea><wicri:noRegion>85259</wicri:noRegion></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 wicri:level="1"><nlm:affiliation>Departments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Houston, TX, 77030, 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, 1400 Pressler Street, Houston, TX, 77030</wicri:regionArea><wicri:noRegion>77030</wicri:noRegion></affiliation></author><author><name sortKey="Basset Seguin, Nicole" sort="Basset Seguin, Nicole" uniqKey="Basset Seguin N" first="Nicole" last="Basset-Seguin">Nicole Basset-Seguin</name><affiliation wicri:level="3"><nlm:affiliation>Service de Dermatologie, Hôpital Saint-Louis, 1 av claude Vellefaux, 75010, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Hôpital Saint-Louis, 1 av claude Vellefaux, 75010, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name><affiliation wicri:level="3"><nlm:affiliation>Studienzentrum Dermatologische Onkologie, Universitätsklinikum Tübingen, Liebermeisterstr. 25, 72074, Tübingen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Studienzentrum Dermatologische Onkologie, Universitätsklinikum Tübingen, Liebermeisterstr. 25, 72074, Tübingen</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Tübingen</settlement></placeName></affiliation></author><author><name sortKey="Gesierich, Anja" sort="Gesierich, Anja" uniqKey="Gesierich A" first="Anja" last="Gesierich">Anja Gesierich</name><affiliation wicri:level="3"><nlm:affiliation>Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg, Josef-Schneider-Str. 2, 97080, Würzburg, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg, Josef-Schneider-Str. 2, 97080, Würzburg</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Lao, Christopher D" sort="Lao, Christopher D" uniqKey="Lao C" first="Christopher D" last="Lao">Christopher D. Lao</name><affiliation wicri:level="1"><nlm:affiliation>University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109</wicri:regionArea><wicri:noRegion>48109</wicri:noRegion></affiliation></author><author><name sortKey="Miller, Chris" sort="Miller, Chris" uniqKey="Miller C" first="Chris" last="Miller">Chris Miller</name><affiliation wicri:level="1"><nlm:affiliation>Department of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104</wicri:regionArea><wicri:noRegion>19104</wicri:noRegion></affiliation></author><author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name><affiliation wicri:level="3"><nlm:affiliation>Clinique de Dermatologie, Hôpital Claude Huriez, Inserm U1189, Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinique de Dermatologie, Hôpital Claude Huriez, Inserm U1189, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Murrell, Dedee F" sort="Murrell, Dedee F" uniqKey="Murrell D" first="Dedee F" last="Murrell">Dedee F. Murrell</name><affiliation wicri:level="1"><nlm:affiliation>Dermatology Department, St George Clinical School, University of New South Wales, Grey Street, Sydney, 2217, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Dermatology Department, St George Clinical School, University of New South Wales, Grey Street, Sydney, 2217</wicri:regionArea><wicri:noRegion>2217</wicri:noRegion></affiliation></author><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><affiliation wicri:level="2"><nlm:affiliation>The Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Quevedo, Jorge F" sort="Quevedo, Jorge F" uniqKey="Quevedo J" first="Jorge F" last="Quevedo">Jorge F. Quevedo</name><affiliation wicri:level="1"><nlm:affiliation>Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic, 200 First Street SW, Rochester, MN, 55905</wicri:regionArea><wicri:noRegion>55905</wicri:noRegion></affiliation></author><author><name sortKey="Hou, Jeannie" sort="Hou, Jeannie" uniqKey="Hou J" first="Jeannie" last="Hou">Jeannie Hou</name><affiliation wicri:level="1"><nlm:affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080</wicri:regionArea><wicri:noRegion>94080</wicri:noRegion></affiliation></author><author><name sortKey="Mckenna, Edward" sort="Mckenna, Edward" uniqKey="Mckenna E" first="Edward" last="Mckenna">Edward Mckenna</name><affiliation wicri:level="1"><nlm:affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080</wicri:regionArea><wicri:noRegion>94080</wicri:noRegion></affiliation></author><author><name sortKey="Dimier, Natalie" sort="Dimier, Natalie" uniqKey="Dimier N" first="Natalie" last="Dimier">Natalie Dimier</name><affiliation wicri:level="1"><nlm:affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW</wicri:regionArea><wicri:noRegion>Al7 1TW</wicri:noRegion></affiliation></author><author><name sortKey="Williams, Sarah" sort="Williams, Sarah" uniqKey="Williams S" first="Sarah" last="Williams">Sarah Williams</name><affiliation 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Essen</wicri:noRegion><wicri:noRegion>45147, Essen</wicri:noRegion><wicri:noRegion>Essen</wicri:noRegion></affiliation></author><author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name><affiliation wicri:level="3"><nlm:affiliation>Universitätsklinikum Schleswig-Holstein, Schittenhelmstr, 7, D-24 105, Kiel, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Universitätsklinikum Schleswig-Holstein, Schittenhelmstr, 7, D-24 105, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28511673</idno><idno type="pmid">28511673</idno><idno type="doi">10.1186/s12885-017-3286-5</idno><idno type="wicri:Area/PubMed/Corpus">000C80</idno><idno 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Scottsdale, 13400 East Shea Boulevard, Scottsdale, AZ, 85259</wicri:regionArea><wicri:noRegion>85259</wicri:noRegion></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 wicri:level="1"><nlm:affiliation>Departments of Dermatology and Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Houston, TX, 77030, 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, 1400 Pressler Street, Houston, TX, 77030</wicri:regionArea><wicri:noRegion>77030</wicri:noRegion></affiliation></author><author><name sortKey="Basset Seguin, Nicole" sort="Basset Seguin, Nicole" uniqKey="Basset Seguin N" first="Nicole" last="Basset-Seguin">Nicole Basset-Seguin</name><affiliation wicri:level="3"><nlm:affiliation>Service de Dermatologie, Hôpital Saint-Louis, 1 av claude Vellefaux, 75010, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Dermatologie, Hôpital Saint-Louis, 1 av claude Vellefaux, 75010, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name><affiliation wicri:level="3"><nlm:affiliation>Studienzentrum Dermatologische Onkologie, Universitätsklinikum Tübingen, Liebermeisterstr. 25, 72074, Tübingen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Studienzentrum Dermatologische Onkologie, Universitätsklinikum Tübingen, Liebermeisterstr. 25, 72074, Tübingen</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Tübingen</settlement></placeName></affiliation></author><author><name sortKey="Gesierich, Anja" sort="Gesierich, Anja" uniqKey="Gesierich A" first="Anja" last="Gesierich">Anja Gesierich</name><affiliation wicri:level="3"><nlm:affiliation>Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg, Josef-Schneider-Str. 2, 97080, Würzburg, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg, Josef-Schneider-Str. 2, 97080, Würzburg</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Lao, Christopher D" sort="Lao, Christopher D" uniqKey="Lao C" first="Christopher D" last="Lao">Christopher D. Lao</name><affiliation wicri:level="1"><nlm:affiliation>University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109</wicri:regionArea><wicri:noRegion>48109</wicri:noRegion></affiliation></author><author><name sortKey="Miller, Chris" sort="Miller, Chris" uniqKey="Miller C" first="Chris" last="Miller">Chris Miller</name><affiliation wicri:level="1"><nlm:affiliation>Department of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104</wicri:regionArea><wicri:noRegion>19104</wicri:noRegion></affiliation></author><author><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name><affiliation wicri:level="3"><nlm:affiliation>Clinique de Dermatologie, Hôpital Claude Huriez, Inserm U1189, Lille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinique de Dermatologie, Hôpital Claude Huriez, Inserm U1189, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Murrell, Dedee F" sort="Murrell, Dedee F" uniqKey="Murrell D" first="Dedee F" last="Murrell">Dedee F. Murrell</name><affiliation wicri:level="1"><nlm:affiliation>Dermatology Department, St George Clinical School, University of New South Wales, Grey Street, Sydney, 2217, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Dermatology Department, St George Clinical School, University of New South Wales, Grey Street, Sydney, 2217</wicri:regionArea><wicri:noRegion>2217</wicri:noRegion></affiliation></author><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><affiliation wicri:level="2"><nlm:affiliation>The Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Quevedo, Jorge F" sort="Quevedo, Jorge F" uniqKey="Quevedo J" first="Jorge F" last="Quevedo">Jorge F. Quevedo</name><affiliation wicri:level="1"><nlm:affiliation>Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic, 200 First Street SW, Rochester, MN, 55905</wicri:regionArea><wicri:noRegion>55905</wicri:noRegion></affiliation></author><author><name sortKey="Hou, Jeannie" sort="Hou, Jeannie" uniqKey="Hou J" first="Jeannie" last="Hou">Jeannie Hou</name><affiliation wicri:level="1"><nlm:affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080</wicri:regionArea><wicri:noRegion>94080</wicri:noRegion></affiliation></author><author><name sortKey="Mckenna, Edward" sort="Mckenna, Edward" uniqKey="Mckenna E" first="Edward" last="Mckenna">Edward Mckenna</name><affiliation wicri:level="1"><nlm:affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080</wicri:regionArea><wicri:noRegion>94080</wicri:noRegion></affiliation></author><author><name sortKey="Dimier, Natalie" sort="Dimier, Natalie" uniqKey="Dimier N" first="Natalie" last="Dimier">Natalie Dimier</name><affiliation wicri:level="1"><nlm:affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW</wicri:regionArea><wicri:noRegion>Al7 1TW</wicri:noRegion></affiliation></author><author><name sortKey="Williams, Sarah" sort="Williams, Sarah" uniqKey="Williams S" first="Sarah" last="Williams">Sarah Williams</name><affiliation wicri:level="1"><nlm:affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW</wicri:regionArea><wicri:noRegion>Al7 1TW</wicri:noRegion></affiliation></author><author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name><affiliation wicri:level="1"><nlm:affiliation>Klinikum für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstrabe 55, 45147, Essen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinikum für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstrabe 55, 45147, Essen</wicri:regionArea><wicri:noRegion>45147, Essen</wicri:noRegion><wicri:noRegion>45147, Essen</wicri:noRegion><wicri:noRegion>Essen</wicri:noRegion></affiliation></author><author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name><affiliation wicri:level="3"><nlm:affiliation>Universitätsklinikum Schleswig-Holstein, Schittenhelmstr, 7, D-24 105, Kiel, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Universitätsklinikum Schleswig-Holstein, Schittenhelmstr, 7, D-24 105, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author></analytic><series><title level="j">BMC cancer</title><idno type="eISSN">1471-2407</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">In the primary analysis of the ERIVANCE BCC trial, vismodegib, the first US Food and Drug Administration-approved Hedgehog pathway inhibitor, showed objective response rates (ORRs) by independent review facility (IRF) of 30% and 43% in metastatic basal cell carcinoma (mBCC) and locally advanced BCC (laBCC), respectively. ORRs by investigator review were 45% (mBCC) and 60% (laBCC). Herein, we present long-term safety and final investigator-assessed efficacy results in patients with mBCC or laBCC.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28511673</PMID><DateCreated><Year>2017</Year><Month>05</Month><Day>17</Day></DateCreated><DateRevised><Year>2017</Year><Month>08</Month><Day>30</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1471-2407</ISSN><JournalIssue CitedMedium="Internet"><Volume>17</Volume><Issue>1</Issue><PubDate><Year>2017</Year><Month>May</Month><Day>16</Day></PubDate></JournalIssue><Title>BMC cancer</Title><ISOAbbreviation>BMC Cancer</ISOAbbreviation></Journal><ArticleTitle>Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.</ArticleTitle><Pagination><MedlinePgn>332</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12885-017-3286-5</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In the primary analysis of the ERIVANCE BCC trial, vismodegib, the first US Food and Drug Administration-approved Hedgehog pathway inhibitor, showed objective response rates (ORRs) by independent review facility (IRF) of 30% and 43% in metastatic basal cell carcinoma (mBCC) and locally advanced BCC (laBCC), respectively. ORRs by investigator review were 45% (mBCC) and 60% (laBCC). Herein, we present long-term safety and final investigator-assessed efficacy results in patients with mBCC or laBCC.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">One hundred four patients with measurable advanced BCC received oral vismodegib 150 mg once daily until disease progression or intolerable toxicity. The primary end point was IRF-assessed ORR. Secondary end points included ORR, duration of response (DOR), progression-free survival, overall survival (OS), and safety.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">At data cutoff (39 months after completion of accrual), 8 patients were receiving the study drug (69 patients in survival follow-up). Investigator-assessed ORR was 48.5% in the mBCC group (all partial responses) and 60.3% in the laBCC group (20 patients had complete response and 18 patients had partial response). ORRs were comparable across patient subgroups, including aggressive histologic subtypes (eg, infiltrative BCC). Median DOR was 14.8 months (mBCC) and 26.2 months (laBCC). Median OS was 33.4 months in the mBCC cohort and not estimable in the laBCC cohort. Adverse events remained consistent with clinical experience. Thirty-three deaths (31.7%) were reported; none were related to vismodegib.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This long-term update of the ERIVANCE BCC trial demonstrated durability of response, efficacy across patient subgroups, and manageable long-term safety of vismodegib in patients with advanced BCC.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">This study was registered prospectively with Clinicaltrials.gov , number NCT00833417 on January 30, 2009.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sekulic</LastName><ForeName>Aleksandar</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Mayo Clinic Scottsdale, 13400 East Shea Boulevard, Scottsdale, AZ, 85259, USA. sekulic.aleksandar@mayo.edu.</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, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Houston, TX, 77030, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Basset-Seguin</LastName><ForeName>Nicole</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Service de Dermatologie, Hôpital Saint-Louis, 1 av claude Vellefaux, 75010, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garbe</LastName><ForeName>Claus</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Studienzentrum Dermatologische Onkologie, Universitätsklinikum Tübingen, Liebermeisterstr. 25, 72074, Tübingen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gesierich</LastName><ForeName>Anja</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg, Josef-Schneider-Str. 2, 97080, Würzburg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lao</LastName><ForeName>Christopher D</ForeName><Initials>CD</Initials><AffiliationInfo><Affiliation>University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Miller</LastName><ForeName>Chris</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mortier</LastName><ForeName>Laurent</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Clinique de Dermatologie, Hôpital Claude Huriez, Inserm U1189, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Murrell</LastName><ForeName>Dedee F</ForeName><Initials>DF</Initials><AffiliationInfo><Affiliation>Dermatology Department, St George Clinical School, University of New South Wales, Grey Street, Sydney, 2217, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hamid</LastName><ForeName>Omid</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>The Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Quevedo</LastName><ForeName>Jorge F</ForeName><Initials>JF</Initials><AffiliationInfo><Affiliation>Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hou</LastName><ForeName>Jeannie</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McKenna</LastName><ForeName>Edward</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dimier</LastName><ForeName>Natalie</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Williams</LastName><ForeName>Sarah</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schadendorf</LastName><ForeName>Dirk</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Klinikum für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstrabe 55, 45147, Essen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hauschild</LastName><ForeName>Axel</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Universitätsklinikum Schleswig-Holstein, Schittenhelmstr, 7, D-24 105, Kiel, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>ERIVANCE BCC Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>05</Month><Day>16</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMC Cancer</MedlineTA><NlmUniqueID>100967800</NlmUniqueID><ISSNLinking>1471-2407</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Clin Cancer Res. 2011 Apr 15;17 (8):2502-11</RefSource><PMID 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PubStatus="pubmed"><Year>2017</Year><Month>5</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>5</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28511673</ArticleId><ArticleId IdType="doi">10.1186/s12885-017-3286-5</ArticleId><ArticleId IdType="pii">10.1186/s12885-017-3286-5</ArticleId><ArticleId IdType="pmc">PMC5433030</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Bade-Wurtemberg</li><li>Bavière</li><li>Californie</li><li>District de Basse-Franconie</li><li>District de Tübingen</li><li>Hauts-de-France</li><li>Nord-Pas-de-Calais</li><li>Schleswig-Holstein</li><li>Île-de-France</li></region><settlement><li>Kiel</li><li>Lille</li><li>Paris</li><li>Tübingen</li><li>Wurtzbourg</li></settlement></list><tree><country name="États-Unis"><noRegion><name sortKey="Sekulic, Aleksandar" sort="Sekulic, Aleksandar" uniqKey="Sekulic A" first="Aleksandar" last="Sekulic">Aleksandar Sekulic</name></noRegion><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><name sortKey="Hou, Jeannie" sort="Hou, Jeannie" uniqKey="Hou J" first="Jeannie" last="Hou">Jeannie Hou</name><name sortKey="Lao, Christopher D" sort="Lao, Christopher D" uniqKey="Lao C" first="Christopher D" last="Lao">Christopher D. Lao</name><name sortKey="Mckenna, Edward" sort="Mckenna, Edward" uniqKey="Mckenna E" first="Edward" last="Mckenna">Edward Mckenna</name><name sortKey="Migden, Michael R" sort="Migden, Michael R" uniqKey="Migden M" first="Michael R" last="Migden">Michael R. Migden</name><name sortKey="Miller, Chris" sort="Miller, Chris" uniqKey="Miller C" first="Chris" last="Miller">Chris Miller</name><name sortKey="Quevedo, Jorge F" sort="Quevedo, Jorge F" uniqKey="Quevedo J" first="Jorge F" last="Quevedo">Jorge F. Quevedo</name></country><country name="France"><region name="Île-de-France"><name sortKey="Basset Seguin, Nicole" sort="Basset Seguin, Nicole" uniqKey="Basset Seguin N" first="Nicole" last="Basset-Seguin">Nicole Basset-Seguin</name></region><name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name></country><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name></region><name sortKey="Gesierich, Anja" sort="Gesierich, Anja" uniqKey="Gesierich A" first="Anja" last="Gesierich">Anja Gesierich</name><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name></country><country name="Australie"><noRegion><name sortKey="Murrell, Dedee F" sort="Murrell, Dedee F" uniqKey="Murrell D" first="Dedee F" last="Murrell">Dedee F. Murrell</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Dimier, Natalie" sort="Dimier, Natalie" uniqKey="Dimier N" first="Natalie" last="Dimier">Natalie Dimier</name></noRegion><name sortKey="Williams, Sarah" sort="Williams, Sarah" uniqKey="Williams S" first="Sarah" last="Williams">Sarah Williams</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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