Phase II, Open-Label, Randomized Trial of the MEK1/2 Inhibitor Selumetinib as Monotherapy versus Temozolomide in Patients with Advanced Melanoma
Identifieur interne : 000549 ( France/Analysis ); précédent : 000548; suivant : 000550Phase II, Open-Label, Randomized Trial of the MEK1/2 Inhibitor Selumetinib as Monotherapy versus Temozolomide in Patients with Advanced Melanoma
Auteurs : John M. Kirkwood [États-Unis] ; Lars Bastholt [Danemark] ; Caroline Robert [France] ; Jeff Sosman [États-Unis] ; James Larkin [Royaume-Uni] ; Peter Hersey [Australie] ; Mark Middleton [Royaume-Uni] ; Mireille Cantarini [Royaume-Uni] ; Victoria Zazulina [Royaume-Uni] ; Karin Kemsley [Royaume-Uni] ; Reinhard Dummer [Suisse]Source :
- Clinical cancer research [ 1078-0432 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Purpose: To compare the efficacy and tolerability of the mitogen-activated protein (MAP)/extracellular signal-regulated (ERK) kinase (MEK) 1/2 inhibitor selumetinib versus temozolomide in chemotherapy-naive patients with unresectable stage III/IV melanoma. Experimental Design: This phase II, open-label, multicenter, randomized, parallel-group study examined the effect of 100 mg oral selumetinib twice daily in 28-day cycles versus oral temozolomide (200 mg/m2/d for 5 days, then 23 days off-treatment). The primary endpoint was progression-free survival. Results: Two hundred patients were randomized. Progression-free survival did not differ significantly between selumetinib and temozolomide (median time to event 78 and 80 days, respectively; hazard ratio, 1.07; 80% confidence interval, 0.86-1.32). Objective response was observed in six (5.8%) patients receiving selumetinib and nine (9.4%) patients in the temozolomide group. Among patients with BRAF mutations, objective responses were similar between selumetinib and temozolomide groups (11.1% and 10.7%, respectively). However, five of the six selumetinib partial responders were BRAF mutated. Frequently reported adverse events with selumetinib were dermatitis acneiform (papular pustular rash; 59.6%), diarrhea (56.6%), nausea (50.5%), and peripheral edema (40.4%), whereas nausea (64.2%), constipation (47.4%), and vomiting (44.2%) were reported with temozolomide. Conclusions: No significant difference in progression-free survival was observed between patients with unresectable stage III/IV melanoma unselected for BRAF/NRAS mutations, who received therapy with selumetinib or temozolomide. Five of six patients with partial response to selumetinib had BRAF mutant tumors.
Affiliations:
- Australie, Danemark, France, Royaume-Uni, Suisse, États-Unis
- Angleterre, Grand Londres, Oxfordshire, Pennsylvanie, Tennessee
- Londres, Oxford, Pittsburgh
- Université de Pittsburgh
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Pascal:12-0187040Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Phase II, Open-Label, Randomized Trial of the MEK1/2 Inhibitor Selumetinib as Monotherapy versus Temozolomide in Patients with Advanced Melanoma</title>
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<author><name sortKey="Sosman, Jeff" sort="Sosman, Jeff" uniqKey="Sosman J" first="Jeff" last="Sosman">Jeff Sosman</name>
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<author><name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
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<author><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
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<s2>Newcastle, New South Wales</s2>
<s3>AUS</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Newcastle Melanoma Unit</wicri:noRegion>
</affiliation>
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<author><name sortKey="Middleton, Mark" sort="Middleton, Mark" uniqKey="Middleton M" first="Mark" last="Middleton">Mark Middleton</name>
<affiliation wicri:level="3"><inist:fA14 i1="08"><s1>NIHR Biomedical Research Centre, Churchill Hospital</s1>
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<author><name sortKey="Cantarini, Mireille" sort="Cantarini, Mireille" uniqKey="Cantarini M" first="Mireille" last="Cantarini">Mireille Cantarini</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
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<country>Royaume-Uni</country>
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<author><name sortKey="Zazulina, Victoria" sort="Zazulina, Victoria" uniqKey="Zazulina V" first="Victoria" last="Zazulina">Victoria Zazulina</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
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<wicri:noRegion>Macclesfield</wicri:noRegion>
</affiliation>
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<author><name sortKey="Kemsley, Karin" sort="Kemsley, Karin" uniqKey="Kemsley K" first="Karin" last="Kemsley">Karin Kemsley</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>AstraZeneca, Alderley Park</s1>
<s2>Macclesfield</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Macclesfield</wicri:noRegion>
</affiliation>
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<author><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Dermatology, Zurich University Hospital</s1>
<s2>Zurich</s2>
<s3>CHE</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Zurich</wicri:noRegion>
</affiliation>
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<series><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2012">2012</date>
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<seriesStmt><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Antineoplastic agent</term>
<term>Clinical trial</term>
<term>Comparative study</term>
<term>Human</term>
<term>Inhibitor</term>
<term>Malignant melanoma</term>
<term>Monotherapy</term>
<term>Patient</term>
<term>Phase II trial</term>
<term>Randomization</term>
<term>Selumetinib</term>
<term>Temozolomide</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase II</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Inhibiteur</term>
<term>Etude comparative</term>
<term>Témozolomide</term>
<term>Homme</term>
<term>Malade</term>
<term>Stade avancé</term>
<term>Mélanome malin</term>
<term>Anticancéreux</term>
<term>Sélumétinib</term>
<term>Monothérapie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
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<front><div type="abstract" xml:lang="en">Purpose: To compare the efficacy and tolerability of the mitogen-activated protein (MAP)/extracellular signal-regulated (ERK) kinase (MEK) 1/2 inhibitor selumetinib versus temozolomide in chemotherapy-naive patients with unresectable stage III/IV melanoma. Experimental Design: This phase II, open-label, multicenter, randomized, parallel-group study examined the effect of 100 mg oral selumetinib twice daily in 28-day cycles versus oral temozolomide (200 mg/m<sup>2</sup>
/d for 5 days, then 23 days off-treatment). The primary endpoint was progression-free survival. Results: Two hundred patients were randomized. Progression-free survival did not differ significantly between selumetinib and temozolomide (median time to event 78 and 80 days, respectively; hazard ratio, 1.07; 80% confidence interval, 0.86-1.32). Objective response was observed in six (5.8%) patients receiving selumetinib and nine (9.4%) patients in the temozolomide group. Among patients with BRAF mutations, objective responses were similar between selumetinib and temozolomide groups (11.1% and 10.7%, respectively). However, five of the six selumetinib partial responders were BRAF mutated. Frequently reported adverse events with selumetinib were dermatitis acneiform (papular pustular rash; 59.6%), diarrhea (56.6%), nausea (50.5%), and peripheral edema (40.4%), whereas nausea (64.2%), constipation (47.4%), and vomiting (44.2%) were reported with temozolomide. Conclusions: No significant difference in progression-free survival was observed between patients with unresectable stage III/IV melanoma unselected for BRAF/NRAS mutations, who received therapy with selumetinib or temozolomide. Five of six patients with partial response to selumetinib had BRAF mutant tumors.</div>
</front>
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<affiliations><list><country><li>Australie</li>
<li>Danemark</li>
<li>France</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Grand Londres</li>
<li>Oxfordshire</li>
<li>Pennsylvanie</li>
<li>Tennessee</li>
</region>
<settlement><li>Londres</li>
<li>Oxford</li>
<li>Pittsburgh</li>
</settlement>
<orgName><li>Université de Pittsburgh</li>
</orgName>
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<tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name>
</region>
<name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name>
<name sortKey="Sosman, Jeff" sort="Sosman, Jeff" uniqKey="Sosman J" first="Jeff" last="Sosman">Jeff Sosman</name>
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<country name="Danemark"><noRegion><name sortKey="Bastholt, Lars" sort="Bastholt, Lars" uniqKey="Bastholt L" first="Lars" last="Bastholt">Lars Bastholt</name>
</noRegion>
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<country name="France"><noRegion><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
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<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
</region>
<name sortKey="Cantarini, Mireille" sort="Cantarini, Mireille" uniqKey="Cantarini M" first="Mireille" last="Cantarini">Mireille Cantarini</name>
<name sortKey="Kemsley, Karin" sort="Kemsley, Karin" uniqKey="Kemsley K" first="Karin" last="Kemsley">Karin Kemsley</name>
<name sortKey="Middleton, Mark" sort="Middleton, Mark" uniqKey="Middleton M" first="Mark" last="Middleton">Mark Middleton</name>
<name sortKey="Zazulina, Victoria" sort="Zazulina, Victoria" uniqKey="Zazulina V" first="Victoria" last="Zazulina">Victoria Zazulina</name>
</country>
<country name="Australie"><noRegion><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Dummer, Reinhard" sort="Dummer, Reinhard" uniqKey="Dummer R" first="Reinhard" last="Dummer">Reinhard Dummer</name>
</noRegion>
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</affiliations>
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