AustralieFrV1, Main, Exploration, bibRecord, 004C82

Safety and Tumor Responses with Lambrolizumab (Anti-PD-1) in Melanoma

Identifieur interne : 004C82 ( Main/Exploration ); précédent : 004C81; suivant : 004C83

Safety and Tumor Responses with Lambrolizumab (Anti-PD-1) in Melanoma

Auteurs : Omid Hamid [États-Unis] ; Caroline Robert [France] ; Adil Daud [États-Unis] ; F. Stephen Hodi [États-Unis] ; Wen-Jen Hwu [États-Unis] ; Richard Kefford [Australie] ; Jedd D. Wolchok ; Peter Hersey [Australie] ; Richard W. Joseph ; Jeffrey S. Weber ; Roxana Dronca ; Tara C. Gangadhar ; Amita Patnaik ; Hassane Zarour ; Anthony M. Joshua ; Kevin Gergich ; Jeroen Elassaiss-Schaap ; Alain Algazi [États-Unis] ; Christine Mateus [France] ; Peter Boasberg [États-Unis] ; Paul C. Tumeh [États-Unis] ; Bartosz Chmielowski [États-Unis] ; Scot W. Ebbinghaus ; Xiaoyun Nicole Li ; S. Peter Kang ; Antoni Ribas [États-Unis]

Source :

The New England journal of medicine [ 0028-4793 ] ; 2013.

RBID : Pascal:13-0218807

Descripteurs français

Pascal (Inist)
- Mélanome malin, Toxicité, Sécurité, Médecine, Protéine PD 1.
Wicri :
- topic : Médecine.

English descriptors

KwdEn :
- Malignant melanoma, Medicine, Programmed cell death protein 1, Safety, Toxicity.

Abstract

BACKGROUND The programmed death 1 (PD-1) receptor is a negative regulator of T-cell effector mechanisms that limits immune responses against cancer. We tested the anti-PD-1 antibody lambrolizumab (previously known as MK-3475) in patients with advanced melanoma. METHODS We administered lambrolizumab intravenously at a dose of 10 mg per kilogram of body weight every 2 or 3 weeks or 2 mg per kilogram every 3 weeks in patients with advanced melanoma, both those who had received prior treatment with the immune checkpoint inhibitor ipilimumab and those who had not. Tumor responses were assessed every 12 weeks. RESULTS A total of 135 patients with advanced melanoma were treated. Common adverse events attributed to treatment were fatigue, rash, pruritus, and diarrhea; most of the adverse events were low grade. The confirmed response rate across all dose cohorts, evaluated by central radiologic review according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was 38% (95% confidence interval [CI], 25 to 44), with the highest confirmed response rate observed in the cohort that received 10 mg per kilogram every 2 weeks (52%; 95% CI, 38 to 66). The response rate did not differ significantly between patients who had received prior ipilimumab treatment and those who had not (confirmed response rate, 38% [95% CI, 23 to 55] and 37% [95% CI, 26 to 49], respectively). Responses were durable in the majority of patients (median follow-up, 11 months among patients who had a response); 81% of the patients who had a response (42 of 52) were still receiving treatment at the time of analysis in March 2013. The overall median progression-free survival among the 135 patients was longer than 7 months. CONCLUSIONS In patients with advanced melanoma, including those who had had disease progression while they had been receiving ipilimumab, treatment with lambrolizumab resulted in a high rate of sustained tumor regression, with mainly grade 1 or 2 toxic effects.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4126516

Affiliations:

Le document en format XML

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<author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
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<author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name>
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<author><name sortKey="Tumeh, Paul C" sort="Tumeh, Paul C" uniqKey="Tumeh P" first="Paul C." last="Tumeh">Paul C. Tumeh</name>
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</affiliation>
</author>
<author><name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>University of California, Los Angeles</s1>
<s2>Los Angeles</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>26 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ebbinghaus, Scot W" sort="Ebbinghaus, Scot W" uniqKey="Ebbinghaus S" first="Scot W." last="Ebbinghaus">Scot W. Ebbinghaus</name>
</author>
<author><name sortKey="Nicole Li, Xiaoyun" sort="Nicole Li, Xiaoyun" uniqKey="Nicole Li X" first="Xiaoyun" last="Nicole Li">Xiaoyun Nicole Li</name>
</author>
<author><name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S. Peter" last="Kang">S. Peter Kang</name>
</author>
<author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>University of California, Los Angeles</s1>
<s2>Los Angeles</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
<sZ>26 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Los Angeles</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Malignant melanoma</term>
<term>Medicine</term>
<term>Programmed cell death protein 1</term>
<term>Safety</term>
<term>Toxicity</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Mélanome malin</term>
<term>Toxicité</term>
<term>Sécurité</term>
<term>Médecine</term>
<term>Protéine PD 1</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND The programmed death 1 (PD-1) receptor is a negative regulator of T-cell effector mechanisms that limits immune responses against cancer. We tested the anti-PD-1 antibody lambrolizumab (previously known as MK-3475) in patients with advanced melanoma. METHODS We administered lambrolizumab intravenously at a dose of 10 mg per kilogram of body weight every 2 or 3 weeks or 2 mg per kilogram every 3 weeks in patients with advanced melanoma, both those who had received prior treatment with the immune checkpoint inhibitor ipilimumab and those who had not. Tumor responses were assessed every 12 weeks. RESULTS A total of 135 patients with advanced melanoma were treated. Common adverse events attributed to treatment were fatigue, rash, pruritus, and diarrhea; most of the adverse events were low grade. The confirmed response rate across all dose cohorts, evaluated by central radiologic review according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was 38% (95% confidence interval [CI], 25 to 44), with the highest confirmed response rate observed in the cohort that received 10 mg per kilogram every 2 weeks (52%; 95% CI, 38 to 66). The response rate did not differ significantly between patients who had received prior ipilimumab treatment and those who had not (confirmed response rate, 38% [95% CI, 23 to 55] and 37% [95% CI, 26 to 49], respectively). Responses were durable in the majority of patients (median follow-up, 11 months among patients who had a response); 81% of the patients who had a response (42 of 52) were still receiving treatment at the time of analysis in March 2013. The overall median progression-free survival among the 135 patients was longer than 7 months. CONCLUSIONS In patients with advanced melanoma, including those who had had disease progression while they had been receiving ipilimumab, treatment with lambrolizumab resulted in a high rate of sustained tumor regression, with mainly grade 1 or 2 toxic effects.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>France</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Massachusetts</li>
<li>Nouvelle-Galles du Sud</li>
<li>Texas</li>
</region>
<settlement><li>Boston</li>
<li>Houston</li>
<li>Los Angeles</li>
<li>San Francisco</li>
<li>Sydney</li>
</settlement>
<orgName><li>Université de Sydney</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name>
<name sortKey="Ebbinghaus, Scot W" sort="Ebbinghaus, Scot W" uniqKey="Ebbinghaus S" first="Scot W." last="Ebbinghaus">Scot W. Ebbinghaus</name>
<name sortKey="Elassaiss Schaap, Jeroen" sort="Elassaiss Schaap, Jeroen" uniqKey="Elassaiss Schaap J" first="Jeroen" last="Elassaiss-Schaap">Jeroen Elassaiss-Schaap</name>
<name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name>
<name sortKey="Gergich, Kevin" sort="Gergich, Kevin" uniqKey="Gergich K" first="Kevin" last="Gergich">Kevin Gergich</name>
<name sortKey="Joseph, Richard W" sort="Joseph, Richard W" uniqKey="Joseph R" first="Richard W." last="Joseph">Richard W. Joseph</name>
<name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. Joshua</name>
<name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S. Peter" last="Kang">S. Peter Kang</name>
<name sortKey="Nicole Li, Xiaoyun" sort="Nicole Li, Xiaoyun" uniqKey="Nicole Li X" first="Xiaoyun" last="Nicole Li">Xiaoyun Nicole Li</name>
<name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name>
<name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S." last="Weber">Jeffrey S. Weber</name>
<name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D." last="Wolchok">Jedd D. Wolchok</name>
<name sortKey="Zarour, Hassane" sort="Zarour, Hassane" uniqKey="Zarour H" first="Hassane" last="Zarour">Hassane Zarour</name>
</noCountry>
<country name="États-Unis"><noRegion><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
</noRegion>
<name sortKey="Algazi, Alain" sort="Algazi, Alain" uniqKey="Algazi A" first="Alain" last="Algazi">Alain Algazi</name>
<name sortKey="Boasberg, Peter" sort="Boasberg, Peter" uniqKey="Boasberg P" first="Peter" last="Boasberg">Peter Boasberg</name>
<name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name>
<name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name>
<name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F. Stephen" last="Hodi">F. Stephen Hodi</name>
<name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name>
<name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<name sortKey="Tumeh, Paul C" sort="Tumeh, Paul C" uniqKey="Tumeh P" first="Paul C." last="Tumeh">Paul C. Tumeh</name>
</country>
<country name="France"><noRegion><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
</noRegion>
<name sortKey="Mateus, Christine" sort="Mateus, Christine" uniqKey="Mateus C" first="Christine" last="Mateus">Christine Mateus</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name>
</region>
<name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
</country>
</tree>
</affiliations>
</record>

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Safety and Tumor Responses with Lambrolizumab (Anti-PD-1) in Melanoma

Safety and Tumor Responses with Lambrolizumab (Anti-PD-1) in Melanoma

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