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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials</title><author><name sortKey="Flaherty, Keith T" sort="Flaherty, Keith T" uniqKey="Flaherty K" first="Keith T" last="Flaherty">Keith T. Flaherty</name></author><author><name sortKey="Hennig, Michael" sort="Hennig, Michael" uniqKey="Hennig M" first="Michael" last="Hennig">Michael Hennig</name></author><author><name sortKey="Lee, Sandra J" sort="Lee, Sandra J" uniqKey="Lee S" first="Sandra J" last="Lee">Sandra J. Lee</name></author><author><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name></author><author><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name></author><author><name sortKey="Eggermont, Alexander M M" sort="Eggermont, Alexander M M" uniqKey="Eggermont A" first="Alexander M M" last="Eggermont">Alexander M M. Eggermont</name></author><author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name></author><author><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M" last="Kirkwood">John M. Kirkwood</name></author><author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name></author><author><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name></author><author><name sortKey="Mackensen, Andreas" sort="Mackensen, Andreas" uniqKey="Mackensen A" first="Andreas" last="Mackensen">Andreas Mackensen</name></author><author><name sortKey="Mcarthur, Grant" sort="Mcarthur, Grant" uniqKey="Mcarthur G" first="Grant" last="Mcarthur">Grant Mcarthur</name></author><author><name sortKey="O Day, Steven" sort="O Day, Steven" uniqKey="O Day S" first="Steven" last="O'Day">Steven O'Day</name></author><author><name sortKey="Patel, Poulam M" sort="Patel, Poulam M" uniqKey="Patel P" first="Poulam M" last="Patel">Poulam M. Patel</name></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name></author><author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24485879</idno><idno type="pmc">4443445</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4443445</idno><idno type="RBID">PMC:4443445</idno><idno type="doi">10.1016/S1470-2045(14)70007-5</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">001D80</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001D80</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials</title><author><name sortKey="Flaherty, Keith T" sort="Flaherty, Keith T" uniqKey="Flaherty K" first="Keith T" last="Flaherty">Keith T. Flaherty</name></author><author><name sortKey="Hennig, Michael" sort="Hennig, Michael" uniqKey="Hennig M" first="Michael" last="Hennig">Michael Hennig</name></author><author><name sortKey="Lee, Sandra J" sort="Lee, Sandra J" uniqKey="Lee S" first="Sandra J" last="Lee">Sandra J. Lee</name></author><author><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name></author><author><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name></author><author><name sortKey="Eggermont, Alexander M M" sort="Eggermont, Alexander M M" uniqKey="Eggermont A" first="Alexander M M" last="Eggermont">Alexander M M. Eggermont</name></author><author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name></author><author><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M" last="Kirkwood">John M. Kirkwood</name></author><author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name></author><author><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name></author><author><name sortKey="Mackensen, Andreas" sort="Mackensen, Andreas" uniqKey="Mackensen A" first="Andreas" last="Mackensen">Andreas Mackensen</name></author><author><name sortKey="Mcarthur, Grant" sort="Mcarthur, Grant" uniqKey="Mcarthur G" first="Grant" last="Mcarthur">Grant Mcarthur</name></author><author><name sortKey="O Day, Steven" sort="O Day, Steven" uniqKey="O Day S" first="Steven" last="O'Day">Steven O'Day</name></author><author><name sortKey="Patel, Poulam M" sort="Patel, Poulam M" uniqKey="Patel P" first="Poulam M" last="Patel">Poulam M. Patel</name></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name></author><author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="ISSN">1470-2045</idno><idno type="eISSN">1474-5488</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><sec id="S1"><title>Background</title><p id="P1">Recent phase 3 trials have shown an overall survival benefit in metastatic melanoma. We aimed to assess whether progression-free survival (PFS) could be regarded as a reliable surrogate for overall survival through a meta-analysis of randomised trials.</p></sec><sec id="S2"><title>Methods</title><p id="P2">We systematically reviewed randomised trials comparing treatment regimens in metastatic melanoma that included dacarbazine as the control arm, and which reported both PFS and overall survival with a standard hazard ratio (HR). We correlated HRs for overall survival and PFS, weighted by sample size or by precision of the HR estimate, assuming fixed and random effects. We did sensitivity analyses according to presence of crossover, trial size, and dacarbazine dose.</p></sec><sec id="S3"><title>Findings</title><p id="P3">After screening 1649 reports and meeting abstracts published before Sept 8, 2013, we identified 12 eligible randomised trials that enrolled 4416 patients with metastatic melanoma. Irrespective of weighting strategy, we noted a strong correlation between the treatment effects for PFS and overall survival, which seemed independent of treatment type. Pearson correlation coefficients were 0.71 (95% CI 0.29–0.90) with a random-effects assumption, 0.85 (0.59–0.95) with a fixed-effects assumption, and 0.89 (0.68–0.97) with sample-size weighting. For nine trials without crossover, the correlation coefficient was 0.96 (0.81–0.99), which decreased to 0.93 (0.74–0.98) when two additional trials with less than 50% crossover were included. Inclusion of mature follow-up data after at least 50% crossover (in vemurafenib and dabrafenib phase 3 trials) weakened the PFS to overall survival correlation (0.55, 0.03–0.84). Inclusion of trials with no or little crossover with the random-effects assumption yielded a conservative statement of the PFS to overall survival correlation of 0.85 (0.51–0.96).</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">PFS can be regarded as a robust surrogate for overall survival in dacarbazine-controlled randomised trials of metastatic melanoma; we postulate that this association will hold as treatment standards evolve and are adopted as the control arm in future trials.</p></sec><sec id="S5"><title>Funding</title><p id="P5">None.</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">100957246</journal-id><journal-id journal-id-type="pubmed-jr-id">27004</journal-id><journal-id journal-id-type="nlm-ta">Lancet Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Lancet Oncol.</journal-id><journal-title-group><journal-title>The Lancet. Oncology</journal-title></journal-title-group><issn pub-type="ppub">1470-2045</issn><issn pub-type="epub">1474-5488</issn></journal-meta><article-meta><article-id pub-id-type="pmid">24485879</article-id><article-id pub-id-type="pmc">4443445</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(14)70007-5</article-id><article-id pub-id-type="manuscript">NIHMS685440</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Flaherty</surname><given-names>Keith T</given-names></name><degrees>MD</degrees><aff id="A1">Center for Melanoma, Massachusetts General Hospital Cancer Center, Boston, MA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Hennig</surname><given-names>Michael</given-names></name><degrees>PhD</degrees><aff id="A2">Biostatistics and Epidemiology, GlaxoSmithKline, Munich, Germany</aff></contrib><contrib contrib-type="author"><name><surname>Lee</surname><given-names>Sandra J</given-names></name><degrees>PhD</degrees><aff id="A3">Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Ascierto</surname><given-names>Paolo A</given-names></name><degrees>MD</degrees><aff id="A4">Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy—Istituto Nazionale Tumori Fondazione “G Pascale”, Napoli, Italy</aff></contrib><contrib contrib-type="author"><name><surname>Dummer</surname><given-names>Reinhard</given-names><suffix>Prof</suffix></name><degrees>MD</degrees><aff id="A5">Department of Dermatology, University Hospital Zurich, Zurich, Switzerland</aff></contrib><contrib contrib-type="author"><name><surname>Eggermont</surname><given-names>Alexander M M</given-names><suffix>Prof</suffix></name><degrees>PhD</degrees><aff id="A6">Gustave Roussy Cancer Campus, Paris-Sud University Grand Paris, Villejuif, France</aff></contrib><contrib contrib-type="author"><name><surname>Hauschild</surname><given-names>Axel</given-names></name><degrees>MD</degrees><aff id="A7">Department of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, University Hospital Kiel, Kiel, Germany</aff></contrib><contrib contrib-type="author"><name><surname>Kefford</surname><given-names>Richard</given-names><suffix>Prof</suffix></name><degrees>PhD</degrees><aff id="A8">Westmead Hospital and Melanoma Institute Australia, University of Sydney, NSW, Australia</aff></contrib><contrib contrib-type="author"><name><surname>Kirkwood</surname><given-names>John M</given-names><suffix>Prof</suffix></name><degrees>MD</degrees><aff id="A9">Skin Cancer Program University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Long</surname><given-names>Georgina V</given-names></name><degrees>PhD</degrees><aff id="A10">Melanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia</aff></contrib><contrib contrib-type="author"><name><surname>Lorigan</surname><given-names>Paul</given-names></name><degrees>MD</degrees><aff id="A11">Institute of Cancer Sciences, Faculty of Medical & Human Sciences, University of Manchester, Manchester, UK</aff></contrib><contrib contrib-type="author"><name><surname>Mackensen</surname><given-names>Andreas</given-names><suffix>Prof</suffix></name><degrees>MD</degrees><aff id="A12">Department of Internal Medicine 5—Hematology/Oncology, University of Erlangen, Erlangen, Germany</aff></contrib><contrib contrib-type="author"><name><surname>McArthur</surname><given-names>Grant</given-names></name><degrees>PhD</degrees><aff id="A13">Peter MacCallum Cancer Institute, St Andrews Place, East Melbourne, VIC, Australia</aff></contrib><contrib contrib-type="author"><name><surname>O'Day</surname><given-names>Steven</given-names></name><degrees>MD</degrees><aff id="A14">Beverly Hills Cancer Center, Beverly Hills, CA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Patel</surname><given-names>Poulam M</given-names></name><degrees>MD</degrees><aff id="A15">Academic Unit of Oncology, University of Nottingham, Nottingham, UK</aff></contrib><contrib contrib-type="author"><name><surname>Robert</surname><given-names>Caroline</given-names></name><degrees>PhD</degrees><aff id="A16">Dermatology and INSERM Unit 981 Gustave Roussy Cancer Campus and Paris-Sud University Grand Paris, Villejuif, France</aff></contrib><contrib contrib-type="author"><name><surname>Schadendorf</surname><given-names>Dirk</given-names><suffix>Prof</suffix></name><degrees>MD</degrees><aff id="A17">Department of Dermatology, University Hospital Essen, Essen, Germany</aff></contrib></contrib-group><author-notes><corresp id="FN1">Correspondence to: Prof Dirk Schadendorf, Department of Dermatology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany <email>dirk.schadendorf@uk-essen.de</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>30</day><month>4</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>31</day><month>1</month><year>2014</year></pub-date><pub-date pub-type="ppub"><month>3</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>26</day><month>5</month><year>2015</year></pub-date><volume>15</volume><issue>3</issue><fpage>297</fpage><lpage>304</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S1470-2045(14)70007-5</pmc-comment>
<abstract><title>Summary</title><sec id="S1"><title>Background</title><p id="P1">Recent phase 3 trials have shown an overall survival benefit in metastatic melanoma. We aimed to assess whether progression-free survival (PFS) could be regarded as a reliable surrogate for overall survival through a meta-analysis of randomised trials.</p></sec><sec id="S2"><title>Methods</title><p id="P2">We systematically reviewed randomised trials comparing treatment regimens in metastatic melanoma that included dacarbazine as the control arm, and which reported both PFS and overall survival with a standard hazard ratio (HR). We correlated HRs for overall survival and PFS, weighted by sample size or by precision of the HR estimate, assuming fixed and random effects. We did sensitivity analyses according to presence of crossover, trial size, and dacarbazine dose.</p></sec><sec id="S3"><title>Findings</title><p id="P3">After screening 1649 reports and meeting abstracts published before Sept 8, 2013, we identified 12 eligible randomised trials that enrolled 4416 patients with metastatic melanoma. Irrespective of weighting strategy, we noted a strong correlation between the treatment effects for PFS and overall survival, which seemed independent of treatment type. Pearson correlation coefficients were 0.71 (95% CI 0.29–0.90) with a random-effects assumption, 0.85 (0.59–0.95) with a fixed-effects assumption, and 0.89 (0.68–0.97) with sample-size weighting. For nine trials without crossover, the correlation coefficient was 0.96 (0.81–0.99), which decreased to 0.93 (0.74–0.98) when two additional trials with less than 50% crossover were included. Inclusion of mature follow-up data after at least 50% crossover (in vemurafenib and dabrafenib phase 3 trials) weakened the PFS to overall survival correlation (0.55, 0.03–0.84). Inclusion of trials with no or little crossover with the random-effects assumption yielded a conservative statement of the PFS to overall survival correlation of 0.85 (0.51–0.96).</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">PFS can be regarded as a robust surrogate for overall survival in dacarbazine-controlled randomised trials of metastatic melanoma; we postulate that this association will hold as treatment standards evolve and are adopted as the control arm in future trials.</p></sec><sec id="S5"><title>Funding</title><p id="P5">None.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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