Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials
Identifieur interne : 003489 ( Main/Exploration ); précédent : 003488; suivant : 003490Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials
Auteurs : Keith T. Flaherty ; Michael Hennig ; Sandra J. Lee ; Paolo A. Ascierto ; Reinhard Dummer ; Alexander M M. Eggermont ; Axel Hauschild ; Richard Kefford ; John M. Kirkwood ; Georgina V. Long ; Paul Lorigan ; Andreas Mackensen ; Grant Mcarthur ; Steven O'Day ; Poulam M. Patel ; Caroline Robert ; Dirk SchadendorfSource :
- The Lancet. Oncology [ 1470-2045 ] ; 2014.
Descripteurs français
- KwdFr :
- MESH :
- mortalité : Mélanome.
- secondaire : Mélanome.
- traitement médicamenteux : Mélanome.
- usage thérapeutique : Antinéoplasiques alcoylants, Dacarbazine.
- Essais contrôlés randomisés comme sujet, Humains, Marqueurs biologiques, Survie sans rechute.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Antineoplastic Agents, Alkylating, Dacarbazine.
- chemical : Biomarkers.
- drug therapy : Melanoma.
- mortality : Melanoma.
- secondary : Melanoma.
- Disease-Free Survival, Humans, Randomized Controlled Trials as Topic.
Abstract
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.
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.
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).
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.
None.
Url:
DOI: 10.1016/S1470-2045(14)70007-5
PubMed: 24485879
PubMed Central: 4443445
Affiliations:
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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><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Agents, Alkylating (therapeutic use)</term><term>Biomarkers</term><term>Dacarbazine (therapeutic use)</term><term>Disease-Free Survival</term><term>Humans</term><term>Melanoma (drug therapy)</term><term>Melanoma (mortality)</term><term>Melanoma (secondary)</term><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Antinéoplasiques alcoylants (usage thérapeutique)</term><term>Dacarbazine (usage thérapeutique)</term><term>Essais contrôlés randomisés comme sujet</term><term>Humains</term><term>Marqueurs biologiques</term><term>Mélanome (mortalité)</term><term>Mélanome (secondaire)</term><term>Mélanome (traitement médicamenteux)</term><term>Survie sans rechute</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents, Alkylating</term><term>Dacarbazine</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Biomarkers</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Mélanome</term></keywords><keywords scheme="MESH" qualifier="secondaire" xml:lang="fr"><term>Mélanome</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Melanoma</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Mélanome</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antinéoplasiques alcoylants</term><term>Dacarbazine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disease-Free Survival</term><term>Humans</term><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term><term>Humains</term><term>Marqueurs biologiques</term><term>Survie sans rechute</term></keywords></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><affiliations><list></list><tree><noCountry><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name><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><name sortKey="Flaherty, Keith T" sort="Flaherty, Keith T" uniqKey="Flaherty K" first="Keith T" last="Flaherty">Keith T. Flaherty</name><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name><name sortKey="Hennig, Michael" sort="Hennig, Michael" uniqKey="Hennig M" first="Michael" last="Hennig">Michael Hennig</name><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M" last="Kirkwood">John M. Kirkwood</name><name sortKey="Lee, Sandra J" sort="Lee, Sandra J" uniqKey="Lee S" first="Sandra J" last="Lee">Sandra J. Lee</name><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name><name sortKey="Mackensen, Andreas" sort="Mackensen, Andreas" uniqKey="Mackensen A" first="Andreas" last="Mackensen">Andreas Mackensen</name><name sortKey="Mcarthur, Grant" sort="Mcarthur, Grant" uniqKey="Mcarthur G" first="Grant" last="Mcarthur">Grant Mcarthur</name><name sortKey="O Day, Steven" sort="O Day, Steven" uniqKey="O Day S" first="Steven" last="O'Day">Steven O'Day</name><name sortKey="Patel, Poulam M" sort="Patel, Poulam M" uniqKey="Patel P" first="Poulam M" last="Patel">Poulam M. Patel</name><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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