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Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.

Identifieur interne : 000C80 ( PubMed/Corpus ); précédent : 000C79; suivant : 000C81

Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.

Auteurs : Aleksandar Sekulic ; Michael R. Migden ; Nicole Basset-Seguin ; Claus Garbe ; Anja Gesierich ; Christopher D. Lao ; Chris Miller ; Laurent Mortier ; Dedee F. Murrell ; Omid Hamid ; Jorge F. Quevedo ; Jeannie Hou ; Edward Mckenna ; Natalie Dimier ; Sarah Williams ; Dirk Schadendorf ; Axel Hauschild

Source :

RBID : pubmed:28511673

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

Links to Exploration step

pubmed:28511673

Le document en format XML

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<name sortKey="Basset Seguin, Nicole" sort="Basset Seguin, Nicole" uniqKey="Basset Seguin N" first="Nicole" last="Basset-Seguin">Nicole Basset-Seguin</name>
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<name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
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<name sortKey="Lao, Christopher D" sort="Lao, Christopher D" uniqKey="Lao C" first="Christopher D" last="Lao">Christopher D. Lao</name>
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<nlm:affiliation>University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.</nlm:affiliation>
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<name sortKey="Miller, Chris" sort="Miller, Chris" uniqKey="Miller C" first="Chris" last="Miller">Chris Miller</name>
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<nlm:affiliation>Department of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name>
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<nlm:affiliation>Clinique de Dermatologie, Hôpital Claude Huriez, Inserm U1189, Lille, France.</nlm:affiliation>
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<name sortKey="Murrell, Dedee F" sort="Murrell, Dedee F" uniqKey="Murrell D" first="Dedee F" last="Murrell">Dedee F. Murrell</name>
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<nlm:affiliation>Dermatology Department, St George Clinical School, University of New South Wales, Grey Street, Sydney, 2217, Australia.</nlm:affiliation>
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<name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
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<nlm:affiliation>The Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California, USA.</nlm:affiliation>
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<name sortKey="Quevedo, Jorge F" sort="Quevedo, Jorge F" uniqKey="Quevedo J" first="Jorge F" last="Quevedo">Jorge F. Quevedo</name>
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<nlm:affiliation>Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.</nlm:affiliation>
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<name sortKey="Hou, Jeannie" sort="Hou, Jeannie" uniqKey="Hou J" first="Jeannie" last="Hou">Jeannie Hou</name>
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<nlm:affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Mckenna, Edward" sort="Mckenna, Edward" uniqKey="Mckenna E" first="Edward" last="Mckenna">Edward Mckenna</name>
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<nlm:affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</nlm:affiliation>
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<name sortKey="Dimier, Natalie" sort="Dimier, Natalie" uniqKey="Dimier N" first="Natalie" last="Dimier">Natalie Dimier</name>
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<nlm:affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</nlm:affiliation>
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<name sortKey="Williams, Sarah" sort="Williams, Sarah" uniqKey="Williams S" first="Sarah" last="Williams">Sarah Williams</name>
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<nlm:affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</nlm:affiliation>
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<name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
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<nlm:affiliation>Klinikum für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstrabe 55, 45147, Essen, Germany.</nlm:affiliation>
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<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
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<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>
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<Month>May</Month>
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<Title>BMC cancer</Title>
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<ArticleTitle>Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study.</ArticleTitle>
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<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>
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<Affiliation>Department of Dermatology, University of Pennsylvania Medical Center, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA.</Affiliation>
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<LastName>Hamid</LastName>
<ForeName>Omid</ForeName>
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<Affiliation>The Angeles Clinic and Research Institute, 1818 Wilshire Boulevard, Los Angeles, California, USA.</Affiliation>
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<LastName>Quevedo</LastName>
<ForeName>Jorge F</ForeName>
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<Affiliation>Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Hou</LastName>
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<Affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</Affiliation>
</AffiliationInfo>
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<LastName>McKenna</LastName>
<ForeName>Edward</ForeName>
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<Affiliation>Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.</Affiliation>
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<LastName>Dimier</LastName>
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<Initials>N</Initials>
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<Affiliation>Roche Products Limited, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, Al7 1TW, UK.</Affiliation>
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<Affiliation>Klinikum für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Essen, Hufelandstrabe 55, 45147, Essen, Germany.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y">
<LastName>Hauschild</LastName>
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<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Universitätsklinikum Schleswig-Holstein, Schittenhelmstr, 7, D-24 105, Kiel, Germany.</Affiliation>
</AffiliationInfo>
</Author>
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<CollectiveName>ERIVANCE BCC Investigators</CollectiveName>
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<Keyword MajorTopicYN="N">Basal cell carcinoma (BCC)</Keyword>
<Keyword MajorTopicYN="N">Efficacy</Keyword>
<Keyword MajorTopicYN="N">Long-term</Keyword>
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