AustralieFrV1, Main, Exploration, bibRecord, 00B087

Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma

Identifieur interne : 00B087 ( Main/Exploration ); précédent : 00B086; suivant : 00B088

Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma

Auteurs : Nicholas J. Vogelzang [États-Unis, Allemagne, France, Australie, Turquie] ; James J. Rusthoven ; James Symanowski ; Claude Denham ; E. Kaukel ; Pierre Ruffie ; Ulrich Gatzemeier ; Michael Boyer ; Salih Emri ; Christian Manegold ; Clet Niyikiza ; Paolo Paoletti

Source :

Journal of clinical oncology [ 0732-183X ] ; 2003.

RBID : Pascal:03-0505020

Descripteurs français

Pascal (Inist)
- Mésothéliome malin, Plèvre, Pémétrexed, Antimétabolite, Antifolate, Cisplatine, Agent alkylant, Inhibiteur enzyme, Thymidylate synthase, Anticancéreux, Association médicamenteuse, Voie intraveineuse, Chimiothérapie, Traitement, Essai clinique phase III, Pronostic, Homme, Platine II Complexe.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Alkylating agent, Antifolate, Antimetabolic, Antineoplastic agent, Chemotherapy, Cisplatin, Drug combination, Enzyme inhibitor, Human, Intravenous administration, Malignant mesothelioma, Pemetrexed, Phase III trial, Platinum II Complexes, Pleura, Prognosis, Thymidylate synthase, Treatment.

Abstract

Purpose: Patients with malignant pleural mesothelioma, a rapidly progressing malignancy with a median survival time of 6 to 9 months, have previously responded poorly to chemotherapy. We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone. Patients and Methods: Chemotherapy-naive patients who were not eligible for curative surgery were randomly assigned to receive pemetrexed 500 mg/m² and cisplatin 75 mg/m² on day 1, or cisplatin 75 mg/m² on day 1. Both regimens were given intravenously every 21 days. Results: A total of 456 patients were assigned: 226 received pemetrexed and cisplatin, 222 received cisplatin alone, and eight never received therapy. Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm (P = .020, two-sided log-rank test). The hazard ratio for death of patients in the pemetrexed/ cisplatin arm versus those in the control arm was 0.77. Median time to progression was significantly longer in the pemetrexed/cisplatin arm: 5.7 months versus 3.9 months (P = .001). Response rates were 41.3% in the pemetrexed/cisplatin arm versus 16.7% in the control arm (P <.0001). After 117 patients had enrolled, folic acid and vitamin B₁₂ were added to reduce toxicity, resulting in a significant reduction in toxicities in the pemetrexed/cisplatin arm. Conclusion: Treatment with pemetrexed plus cisplatin and vitamin supplementation resulted in superior survival time, time to progression, and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma. Addition of folic acid and vitamin B₁₂ significantly reduced toxicity without adversely affecting survival time.

Affiliations:

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma</title>
<author><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
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<placeName><settlement type="city">Hambourg</settlement>
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<s3>DEU</s3>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Grosshansdorf</wicri:noRegion>
<wicri:noRegion>Krankenhaus Grosshansdorf</wicri:noRegion>
<wicri:noRegion>Krankenhaus Grosshansdorf</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Thoraxklinik-Rohrbach</s1>
<s2>Heidelberg</s2>
<s3>DEU</s3>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Institut Gustave Roussy</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Villejuif</wicri:noRegion>
<wicri:noRegion>Institut Gustave Roussy</wicri:noRegion>
<wicri:noRegion>Institut Gustave Roussy</wicri:noRegion>
</affiliation>
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<country>Australie</country>
<wicri:noRegion>Royal Prince Alfred Hospital</wicri:noRegion>
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<author><name sortKey="Rusthoven, James J" sort="Rusthoven, James J" uniqKey="Rusthoven J" first="James J." last="Rusthoven">James J. Rusthoven</name>
</author>
<author><name sortKey="Symanowski, James" sort="Symanowski, James" uniqKey="Symanowski J" first="James" last="Symanowski">James Symanowski</name>
</author>
<author><name sortKey="Denham, Claude" sort="Denham, Claude" uniqKey="Denham C" first="Claude" last="Denham">Claude Denham</name>
</author>
<author><name sortKey="Kaukel, E" sort="Kaukel, E" uniqKey="Kaukel E" first="E." last="Kaukel">E. Kaukel</name>
</author>
<author><name sortKey="Ruffie, Pierre" sort="Ruffie, Pierre" uniqKey="Ruffie P" first="Pierre" last="Ruffie">Pierre Ruffie</name>
</author>
<author><name sortKey="Gatzemeier, Ulrich" sort="Gatzemeier, Ulrich" uniqKey="Gatzemeier U" first="Ulrich" last="Gatzemeier">Ulrich Gatzemeier</name>
</author>
<author><name sortKey="Boyer, Michael" sort="Boyer, Michael" uniqKey="Boyer M" first="Michael" last="Boyer">Michael Boyer</name>
</author>
<author><name sortKey="Emri, Salih" sort="Emri, Salih" uniqKey="Emri S" first="Salih" last="Emri">Salih Emri</name>
</author>
<author><name sortKey="Manegold, Christian" sort="Manegold, Christian" uniqKey="Manegold C" first="Christian" last="Manegold">Christian Manegold</name>
</author>
<author><name sortKey="Niyikiza, Clet" sort="Niyikiza, Clet" uniqKey="Niyikiza C" first="Clet" last="Niyikiza">Clet Niyikiza</name>
</author>
<author><name sortKey="Paoletti, Paolo" sort="Paoletti, Paolo" uniqKey="Paoletti P" first="Paolo" last="Paoletti">Paolo Paoletti</name>
</author>
</analytic>
<series><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint><date when="2003">2003</date>
</imprint>
</series>
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<seriesStmt><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Alkylating agent</term>
<term>Antifolate</term>
<term>Antimetabolic</term>
<term>Antineoplastic agent</term>
<term>Chemotherapy</term>
<term>Cisplatin</term>
<term>Drug combination</term>
<term>Enzyme inhibitor</term>
<term>Human</term>
<term>Intravenous administration</term>
<term>Malignant mesothelioma</term>
<term>Pemetrexed</term>
<term>Phase III trial</term>
<term>Platinum II Complexes</term>
<term>Pleura</term>
<term>Prognosis</term>
<term>Thymidylate synthase</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Mésothéliome malin</term>
<term>Plèvre</term>
<term>Pémétrexed</term>
<term>Antimétabolite</term>
<term>Antifolate</term>
<term>Cisplatine</term>
<term>Agent alkylant</term>
<term>Inhibiteur enzyme</term>
<term>Thymidylate synthase</term>
<term>Anticancéreux</term>
<term>Association médicamenteuse</term>
<term>Voie intraveineuse</term>
<term>Chimiothérapie</term>
<term>Traitement</term>
<term>Essai clinique phase III</term>
<term>Pronostic</term>
<term>Homme</term>
<term>Platine II Complexe</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose: Patients with malignant pleural mesothelioma, a rapidly progressing malignancy with a median survival time of 6 to 9 months, have previously responded poorly to chemotherapy. We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone. Patients and Methods: Chemotherapy-naive patients who were not eligible for curative surgery were randomly assigned to receive pemetrexed 500 mg/m<sup>2</sup>
 and cisplatin 75 mg/m<sup>2</sup>
 on day 1, or cisplatin 75 mg/m<sup>2</sup>
 on day 1. Both regimens were given intravenously every 21 days. Results: A total of 456 patients were assigned: 226 received pemetrexed and cisplatin, 222 received cisplatin alone, and eight never received therapy. Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm (P = .020, two-sided log-rank test). The hazard ratio for death of patients in the pemetrexed/ cisplatin arm versus those in the control arm was 0.77. Median time to progression was significantly longer in the pemetrexed/cisplatin arm: 5.7 months versus 3.9 months (P = .001). Response rates were 41.3% in the pemetrexed/cisplatin arm versus 16.7% in the control arm (P <.0001). After 117 patients had enrolled, folic acid and vitamin B<sub>12</sub>
 were added to reduce toxicity, resulting in a significant reduction in toxicities in the pemetrexed/cisplatin arm. Conclusion: Treatment with pemetrexed plus cisplatin and vitamin supplementation resulted in superior survival time, time to progression, and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma. Addition of folic acid and vitamin B<sub>12</sub>
 significantly reduced toxicity without adversely affecting survival time.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Turquie</li>
<li>États-Unis</li>
</country>
<region><li>Bade-Wurtemberg</li>
<li>District de Karlsruhe</li>
<li>Hambourg</li>
</region>
<settlement><li>Hambourg</li>
<li>Heidelberg</li>
</settlement>
</list>
<tree><noCountry><name sortKey="Boyer, Michael" sort="Boyer, Michael" uniqKey="Boyer M" first="Michael" last="Boyer">Michael Boyer</name>
<name sortKey="Denham, Claude" sort="Denham, Claude" uniqKey="Denham C" first="Claude" last="Denham">Claude Denham</name>
<name sortKey="Emri, Salih" sort="Emri, Salih" uniqKey="Emri S" first="Salih" last="Emri">Salih Emri</name>
<name sortKey="Gatzemeier, Ulrich" sort="Gatzemeier, Ulrich" uniqKey="Gatzemeier U" first="Ulrich" last="Gatzemeier">Ulrich Gatzemeier</name>
<name sortKey="Kaukel, E" sort="Kaukel, E" uniqKey="Kaukel E" first="E." last="Kaukel">E. Kaukel</name>
<name sortKey="Manegold, Christian" sort="Manegold, Christian" uniqKey="Manegold C" first="Christian" last="Manegold">Christian Manegold</name>
<name sortKey="Niyikiza, Clet" sort="Niyikiza, Clet" uniqKey="Niyikiza C" first="Clet" last="Niyikiza">Clet Niyikiza</name>
<name sortKey="Paoletti, Paolo" sort="Paoletti, Paolo" uniqKey="Paoletti P" first="Paolo" last="Paoletti">Paolo Paoletti</name>
<name sortKey="Ruffie, Pierre" sort="Ruffie, Pierre" uniqKey="Ruffie P" first="Pierre" last="Ruffie">Pierre Ruffie</name>
<name sortKey="Rusthoven, James J" sort="Rusthoven, James J" uniqKey="Rusthoven J" first="James J." last="Rusthoven">James J. Rusthoven</name>
<name sortKey="Symanowski, James" sort="Symanowski, James" uniqKey="Symanowski J" first="James" last="Symanowski">James Symanowski</name>
</noCountry>
<country name="États-Unis"><noRegion><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
</noRegion>
<name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
<name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
</country>
<country name="Allemagne"><region name="Hambourg"><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
</region>
<name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
<name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
</country>
<country name="France"><noRegion><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
</noRegion>
</country>
<country name="Turquie"><noRegion><name sortKey="Vogelzang, Nicholas J" sort="Vogelzang, Nicholas J" uniqKey="Vogelzang N" first="Nicholas J." last="Vogelzang">Nicholas J. Vogelzang</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma

Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma

Source :

Descripteurs français

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Abstract

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