Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies
Identifieur interne : 000A65 ( Main/Exploration ); précédent : 000A64; suivant : 000A66Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies
Auteurs : R. Thertulien [États-Unis] ; G. M. Manikhas [Russie] ; L. Y. Dirix [Belgique] ; J. B. Vermorken [Belgique] ; K. Park [Corée du Sud] ; M. M. Jain [Inde] ; J. J. Jiao [États-Unis] ; J. Natarajan [États-Unis] ; T. Parekh [États-Unis] ; P. Zannikos [États-Unis] ; A. P. Staddon [États-Unis]Source :
- Cancer Chemotherapy and Pharmacology [ 0344-5704 ] ; 2011.
Abstract
The primary objective of this study was to access the potential effects of trabectedin on the QT/QTc interval in patients with locally advanced or metastatic solid tumors.
Patients (
The upper limits of the 90% confidence interval for ΔΔQTcF and ΔΔQTcB at all time points were less than the prespecified noninferiority margin of 10 ms (≤6.65 ms). No patient had a QTc > 500 ms or a time-matched increase from baseline in QTc > 60 ms at any time point. Regression analyses indicated ΔΔQTc was poorly correlated with trabectedin concentration. No adverse events suggestive of proarrhythmic potential were reported.
Trabectedin did not prolong the QTc interval. Safety and pharmacokinetic profiles of trabectedin were similar to that observed in other ovarian and breast cancer studies.
Url:
DOI: 10.1007/s00280-011-1697-6
PubMed: 21739119
PubMed Central: 3265736
Affiliations:
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<series><title level="j">Cancer Chemotherapy and Pharmacology</title>
<idno type="ISSN">0344-5704</idno>
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<front><div type="abstract" xml:lang="en"><sec><title>Purpose</title>
<p>The primary objective of this study was to access the potential effects of trabectedin on the QT/QTc interval in patients with locally advanced or metastatic solid tumors.</p>
</sec>
<sec><title>Methods</title>
<p>Patients (<italic>n</italic>
= 75) who had received ≤3 previous lines of chemotherapy and had either relapsed or had progressive disease were enrolled. Patients were administered 3-h intravenous infusions of placebo (saline) on day 1 and trabectedin (1.3 mg/m<sup>2</sup>
) on day 2. Time-matched serial triplicate ECG recordings and pharmacokinetic blood samples were collected over 24 h on both days. Heart rate corrected mean QT intervals and changes from predose baseline in QTc (ΔQTc) were assessed. The difference in ΔQTc between trabectedin and placebo was calculated at each time point (ΔΔQTc).</p>
</sec>
<sec><title>Results</title>
<p>The upper limits of the 90% confidence interval for ΔΔQTcF and ΔΔQTcB at all time points were less than the prespecified noninferiority margin of 10 ms (≤6.65 ms). No patient had a QTc > 500 ms or a time-matched increase from baseline in QTc > 60 ms at any time point. Regression analyses indicated ΔΔQTc was poorly correlated with trabectedin concentration. No adverse events suggestive of proarrhythmic potential were reported.</p>
</sec>
<sec><title>Conclusion</title>
<p>Trabectedin did not prolong the QTc interval. Safety and pharmacokinetic profiles of trabectedin were similar to that observed in other ovarian and breast cancer studies.</p>
</sec>
</div>
</front>
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</TEI>
<affiliations><list><country><li>Belgique</li>
<li>Corée du Sud</li>
<li>Inde</li>
<li>Russie</li>
<li>États-Unis</li>
</country>
<region><li>Caroline du Nord</li>
<li>New Jersey</li>
<li>Pennsylvanie</li>
</region>
<settlement><li>Séoul</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Thertulien, R" sort="Thertulien, R" uniqKey="Thertulien R" first="R." last="Thertulien">R. Thertulien</name>
</region>
<name sortKey="Jiao, J J" sort="Jiao, J J" uniqKey="Jiao J" first="J. J." last="Jiao">J. J. Jiao</name>
<name sortKey="Natarajan, J" sort="Natarajan, J" uniqKey="Natarajan J" first="J." last="Natarajan">J. Natarajan</name>
<name sortKey="Parekh, T" sort="Parekh, T" uniqKey="Parekh T" first="T." last="Parekh">T. Parekh</name>
<name sortKey="Staddon, A P" sort="Staddon, A P" uniqKey="Staddon A" first="A. P." last="Staddon">A. P. Staddon</name>
<name sortKey="Zannikos, P" sort="Zannikos, P" uniqKey="Zannikos P" first="P." last="Zannikos">P. Zannikos</name>
</country>
<country name="Russie"><noRegion><name sortKey="Manikhas, G M" sort="Manikhas, G M" uniqKey="Manikhas G" first="G. M." last="Manikhas">G. M. Manikhas</name>
</noRegion>
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<country name="Corée du Sud"><noRegion><name sortKey="Park, K" sort="Park, K" uniqKey="Park K" first="K." last="Park">K. Park</name>
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<country name="Inde"><noRegion><name sortKey="Jain, M M" sort="Jain, M M" uniqKey="Jain M" first="M. M." last="Jain">M. M. Jain</name>
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</tree>
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</record>
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