Safety and Tumor Responses with Lambrolizumab (Anti–PD-1) in Melanoma
Identifieur interne : 001B38 ( Pmc/Curation ); précédent : 001B37; suivant : 001B39Safety and Tumor Responses with Lambrolizumab (Anti–PD-1) in Melanoma
Auteurs : Omid Hamid ; Caroline Robert ; Adil Daud ; F. Stephen Hodi ; Wen-Jen Hwu ; Richard Kefford ; Jedd D. Wolchok ; Peter Hersey ; 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 ; Christine Mateus ; Peter Boasberg ; Paul C. Tumeh ; Bartosz Chmielowski ; Scot W. Ebbinghaus ; Xiaoyun Nicole Li ; S. Peter Kang ; Antoni RibasSource :
- The New England journal of medicine [ 0028-4793 ] ; 2013.
Abstract
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.
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.
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.
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. (Funded by Merck Sharp and Dohme; ClinicalTrials.gov number, NCT01295827.)
Url:
DOI: 10.1056/NEJMoa1305133
PubMed: 23724846
PubMed Central: 4126516
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Stephen Hodi</name></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name></author><author><name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D." last="Wolchok">Jedd D. Wolchok</name></author><author><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name></author><author><name sortKey="Joseph, Richard W" sort="Joseph, Richard W" uniqKey="Joseph R" first="Richard W." last="Joseph">Richard W. Joseph</name></author><author><name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S." last="Weber">Jeffrey S. Weber</name></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name></author><author><name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name></author><author><name sortKey="Zarour, Hassane" sort="Zarour, Hassane" uniqKey="Zarour H" first="Hassane" last="Zarour">Hassane Zarour</name></author><author><name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. 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Tumeh</name></author><author><name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name></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="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="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></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23724846</idno><idno type="pmc">4126516</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4126516</idno><idno type="RBID">PMC:4126516</idno><idno type="doi">10.1056/NEJMoa1305133</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">001C80</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001C80</idno><idno type="wicri:Area/Pmc/Curation">001B38</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001B38</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Safety and Tumor Responses with Lambrolizumab (Anti–PD-1) in Melanoma</title><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name></author><author><name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F. Stephen" last="Hodi">F. Stephen Hodi</name></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name></author><author><name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D." last="Wolchok">Jedd D. Wolchok</name></author><author><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name></author><author><name sortKey="Joseph, Richard W" sort="Joseph, Richard W" uniqKey="Joseph R" first="Richard W." last="Joseph">Richard W. Joseph</name></author><author><name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S." last="Weber">Jeffrey S. Weber</name></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name></author><author><name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name></author><author><name sortKey="Zarour, Hassane" sort="Zarour, Hassane" uniqKey="Zarour H" first="Hassane" last="Zarour">Hassane Zarour</name></author><author><name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. Joshua</name></author><author><name sortKey="Gergich, Kevin" sort="Gergich, Kevin" uniqKey="Gergich K" first="Kevin" last="Gergich">Kevin Gergich</name></author><author><name sortKey="Elassaiss Schaap, Jeroen" sort="Elassaiss Schaap, Jeroen" uniqKey="Elassaiss Schaap J" first="Jeroen" last="Elassaiss-Schaap">Jeroen Elassaiss-Schaap</name></author><author><name sortKey="Algazi, Alain" sort="Algazi, Alain" uniqKey="Algazi A" first="Alain" last="Algazi">Alain Algazi</name></author><author><name sortKey="Mateus, Christine" sort="Mateus, Christine" uniqKey="Mateus C" first="Christine" last="Mateus">Christine Mateus</name></author><author><name sortKey="Boasberg, Peter" sort="Boasberg, Peter" uniqKey="Boasberg P" first="Peter" last="Boasberg">Peter Boasberg</name></author><author><name sortKey="Tumeh, Paul C" sort="Tumeh, Paul C" uniqKey="Tumeh P" first="Paul C." last="Tumeh">Paul C. Tumeh</name></author><author><name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name></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="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="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></author></analytic><series><title level="j">The New England journal of medicine</title><idno type="ISSN">0028-4793</idno><idno type="eISSN">1533-4406</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>BACKGROUND</title><p id="P1">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.</p></sec><sec id="S2"><title>METHODS</title><p id="P2">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.</p></sec><sec id="S3"><title>RESULTS</title><p id="P3">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.</p></sec><sec id="S4"><title>CONCLUSIONS</title><p id="P4">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. (Funded by Merck Sharp and Dohme; ClinicalTrials.gov number, NCT01295827.)</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">0255562</journal-id><journal-id journal-id-type="pubmed-jr-id">5985</journal-id><journal-id journal-id-type="nlm-ta">N Engl J Med</journal-id><journal-id journal-id-type="iso-abbrev">N. Engl. J. Med.</journal-id><journal-title-group><journal-title>The New England journal of medicine</journal-title></journal-title-group><issn pub-type="ppub">0028-4793</issn><issn pub-type="epub">1533-4406</issn></journal-meta><article-meta><article-id pub-id-type="pmid">23724846</article-id><article-id pub-id-type="pmc">4126516</article-id><article-id pub-id-type="doi">10.1056/NEJMoa1305133</article-id><article-id pub-id-type="manuscript">NIHMS517291</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Safety and Tumor Responses with Lambrolizumab (Anti–PD-1) in Melanoma</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Hamid</surname><given-names>Omid</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Robert</surname><given-names>Caroline</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Daud</surname><given-names>Adil</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Hodi</surname><given-names>F. Stephen</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Hwu</surname><given-names>Wen-Jen</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Kefford</surname><given-names>Richard</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Wolchok</surname><given-names>Jedd D.</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Hersey</surname><given-names>Peter</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Joseph</surname><given-names>Richard W.</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Weber</surname><given-names>Jeffrey S.</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Dronca</surname><given-names>Roxana</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Gangadhar</surname><given-names>Tara C.</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Patnaik</surname><given-names>Amita</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Zarour</surname><given-names>Hassane</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Joshua</surname><given-names>Anthony M.</given-names></name><degrees>M.B., B.S., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Gergich</surname><given-names>Kevin</given-names></name><degrees>M.A.</degrees></contrib><contrib contrib-type="author"><name><surname>Elassaiss-Schaap</surname><given-names>Jeroen</given-names></name><degrees>Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Algazi</surname><given-names>Alain</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Mateus</surname><given-names>Christine</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Boasberg</surname><given-names>Peter</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Tumeh</surname><given-names>Paul C.</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Chmielowski</surname><given-names>Bartosz</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Ebbinghaus</surname><given-names>Scot W.</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Li</surname><given-names>Xiaoyun Nicole</given-names></name><degrees>Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Kang</surname><given-names>S. Peter</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Ribas</surname><given-names>Antoni</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><aff id="A1">Angeles Clinic and Research Institute (O.H., P.B.) and the University of California, Los Angeles (P.C.T., B.C., A.R.) — both in Los Angeles; Institute Gustave Roussy, Villejuif, France (C.R., C.M.); University of California, San Francisco, San Francisco (A.D., A.A.); Dana–Farber Cancer Institute, Boston (F.S.H.); University of Texas M.D. Anderson Cancer Center, Houston (W.-J.H.); Westmead Hospital and Melanoma Institute Australia, University of Sydney, Sydney (R.K.), and Kolling Institute, Melanoma Institute of Australia and Newcastle Melanoma Unit, Newcastle, NSW (P.H.) — both in Australia; Memorial Sloan-Kettering Cancer Center, New York (J.D.W.); Mayo Clinic, Jacksonville (R.W.J.), and H. Lee Moffitt Cancer Center, Tampa (J.S.W.) — both in Florida; Mayo Clinic, Rochester, MN (R.D.); Abramson Cancer Center of the University of Pennsylvania, Philadelphia (T.C.G.); South Texas Accelerated Research Therapeutics, San Antonio (A.P.); University of Pittsburgh, Pittsburgh (H.Z.); Princess Margaret Cancer Centre, Toronto (A.M.J.); and Merck Sharp and Dohme, Whitehouse Station, NJ (K.G., J.E.-S., S.W.E., X.N.L., S.P.K.)</aff></contrib-group><author-notes><corresp id="FN1">Address reprint requests to Dr. Ribas at the Department of Medicine, Division of Hematology-Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, 11-934 Factor Bldg., 10833 Le Conte Ave., Los Angeles, CA 90095-1782, or at <email>aribas@mednet.ucla.edu</email></corresp><fn id="FN2" fn-type="equal"><p>Drs. Hamid, Robert, Daud, Kang, and Ribas contributed equally to this article.</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>17</day><month>6</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>02</day><month>6</month><year>2013</year></pub-date><pub-date pub-type="ppub"><day>11</day><month>7</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>08</day><month>8</month><year>2014</year></pub-date><volume>369</volume><issue>2</issue><fpage>134</fpage><lpage>144</lpage><pmc-comment>elocation-id from pubmed: 10.1056/NEJMoa1305133</pmc-comment>
<permissions><copyright-statement>Copyright © 2013 Massachusetts Medical Society. All rights reserved.</copyright-statement><copyright-year>2013</copyright-year></permissions><abstract><sec id="S1"><title>BACKGROUND</title><p id="P1">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.</p></sec><sec id="S2"><title>METHODS</title><p id="P2">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.</p></sec><sec id="S3"><title>RESULTS</title><p id="P3">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.</p></sec><sec id="S4"><title>CONCLUSIONS</title><p id="P4">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. (Funded by Merck Sharp and Dohme; ClinicalTrials.gov number, NCT01295827.)</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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