Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer
Identifieur interne : 008A93 ( Main/Curation ); précédent : 008A92; suivant : 008A94Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer
Auteurs : M. J. Mckeage [Nouvelle-Zélande] ; J. Von Pawel [Allemagne] ; M. Reck [Allemagne] ; M. B. Jameson [Nouvelle-Zélande] ; M. A. Rosenthal [Australie] ; R. Sullivan [Nouvelle-Zélande] ; D. Gibbs [Nouvelle-Zélande] ; P. N. Mainwaring [Australie] ; M. Serke [Allemagne] ; J-J. Lafitte [France] ; C. Chouaid [France] ; L. Freitag [Allemagne] ; E. Quoix [France]Source :
- British journal of cancer [ 0007-0920 ] ; 2008.
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Abstract
ASA404 (5,6-dimethylxanthenone-4-acetic acid or DMXAA) is a small-molecule tumour-vascular disrupting agent (Tumour-VDA). This randomised phase II study evaluated ASA404 plus standard therapy of carboplatin and paclitaxel in patients with histologically confirmed stage Illb or IV non-small cell lung cancer (NSCLC) not previously treated with chemotherapy. Patients were randomised to receive <6 cycles of carboplatin area under the plasma concentration-time curve 6 mg ml-1 min and paclitaxel 175 mg m-2 (CP, n = 36) or standard therapy plus ASA404 1200 mg m-2 (ASA404-CP, n = 37). There was little change in the systemic exposure of either total or free carboplatin or paclitaxel on addition of ASA404. Safety profiles were similar and manageable in both groups, with most adverse effects attributed to standard therapy. Tumour response rate (3 1 vs 22%), median time to tumour progression (5.4 vs 4.4 months) and median survival (14.0 vs 8.8 months, hazard ratio 0.73, 95% Cl 0.39, 1.38) were improved in the ASA404 combination group compared with the standard therapy group. In conclusion, this study establishes the feasibility of combining ASA404 with carboplatin and paclitaxel in patients with previously untreated, advanced NSCLC, demonstrating a manageable safety profile and lack of adverse pharmacokinetic interactions. The results indicate that there may be a benefit associated with ASA404, but this needs to be evaluated in a larger trial.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer</title><author><name sortKey="Mckeage, M J" sort="Mckeage, M J" uniqKey="Mckeage M" first="M. J." last="Mckeage">M. J. Mckeage</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Auckland, 85 Park Road, Grafton, Private Bag 92019</s1><s2>Auckland 1142</s2><s3>NZL</s3><sZ>1 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Auckland 1142</wicri:noRegion></affiliation></author><author><name sortKey="Von Pawel, J" sort="Von Pawel, J" uniqKey="Von Pawel J" first="J." last="Von Pawel">J. 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Mainwaring</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Mater Health Services</s1><s2>Brisbane 4101, Queensland</s2><s3>AUS</s3><sZ>8 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Mater Health Services</wicri:noRegion></affiliation></author><author><name sortKey="Serke, M" sort="Serke, M" uniqKey="Serke M" first="M." last="Serke">M. Serke</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn, Walterhöferstrasse II</s1><s2>14165 Berlin</s2><s3>DEU</s3><sZ>9 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Lafitte, J J" sort="Lafitte, J J" uniqKey="Lafitte J" first="J-J." last="Lafitte">J-J. Lafitte</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Hôpital Calmette Service de Pneumologie, Boulevard du professeur jules Leclercq</s1><s2>59037 Lille</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>59037 Lille</wicri:noRegion><wicri:noRegion>Boulevard du professeur jules Leclercq</wicri:noRegion><wicri:noRegion>59037 Lille</wicri:noRegion></affiliation></author><author><name sortKey="Chouaid, C" sort="Chouaid, C" uniqKey="Chouaid C" first="C." last="Chouaid">C. 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J." last="Mckeage">M. J. Mckeage</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Auckland, 85 Park Road, Grafton, Private Bag 92019</s1><s2>Auckland 1142</s2><s3>NZL</s3><sZ>1 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Auckland 1142</wicri:noRegion></affiliation></author><author><name sortKey="Von Pawel, J" sort="Von Pawel, J" uniqKey="Von Pawel J" first="J." last="Von Pawel">J. Von Pawel</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Asklepios Fachkliniken, Robert-Koch-Allee 2</s1><s2>82131 Gauting</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>82131 Gauting</wicri:noRegion><wicri:noRegion>Robert-Koch-Allee 2</wicri:noRegion><wicri:noRegion>82131 Gauting</wicri:noRegion></affiliation></author><author><name sortKey="Reck, M" sort="Reck, M" uniqKey="Reck M" first="M." last="Reck">M. Reck</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Krankenhaus Grosshansdorf, Woehrendamm 80</s1><s2>22927 Grosshansdorf</s2><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>22927 Grosshansdorf</wicri:noRegion><wicri:noRegion>Woehrendamm 80</wicri:noRegion><wicri:noRegion>22927 Grosshansdorf</wicri:noRegion></affiliation></author><author><name sortKey="Jameson, M B" sort="Jameson, M B" uniqKey="Jameson M" first="M. B." last="Jameson">M. B. Jameson</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Waikato Hospital, Private Bag 3200</s1><s2>Hamilton</s2><s3>NZL</s3><sZ>4 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Hamilton</wicri:noRegion></affiliation></author><author><name sortKey="Rosenthal, M A" sort="Rosenthal, M A" uniqKey="Rosenthal M" first="M. A." last="Rosenthal">M. A. Rosenthal</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Royal Melbourne Hospital</s1><s2>Melbourne 3050, Victoria</s2><s3>AUS</s3><sZ>5 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Royal Melbourne Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Sullivan, R" sort="Sullivan, R" uniqKey="Sullivan R" first="R." last="Sullivan">R. Sullivan</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Auckland City Hospital, 2 Pork Rood</s1><s2>Grafton, Auckland 1023</s2><s3>NZL</s3><sZ>6 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Grafton, Auckland 1023</wicri:noRegion></affiliation></author><author><name sortKey="Gibbs, D" sort="Gibbs, D" uniqKey="Gibbs D" first="D." last="Gibbs">D. Gibbs</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Christchurch Hospital, Private Bag 4710</s1><s2>Christchurch</s2><s3>NZL</s3><sZ>7 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Christchurch</wicri:noRegion></affiliation></author><author><name sortKey="Mainwaring, P N" sort="Mainwaring, P N" uniqKey="Mainwaring P" first="P. N." last="Mainwaring">P. N. Mainwaring</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Mater Health Services</s1><s2>Brisbane 4101, Queensland</s2><s3>AUS</s3><sZ>8 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Mater Health Services</wicri:noRegion></affiliation></author><author><name sortKey="Serke, M" sort="Serke, M" uniqKey="Serke M" first="M." last="Serke">M. Serke</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn, Walterhöferstrasse II</s1><s2>14165 Berlin</s2><s3>DEU</s3><sZ>9 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Lafitte, J J" sort="Lafitte, J J" uniqKey="Lafitte J" first="J-J." last="Lafitte">J-J. Lafitte</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Hôpital Calmette Service de Pneumologie, Boulevard du professeur jules Leclercq</s1><s2>59037 Lille</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>59037 Lille</wicri:noRegion><wicri:noRegion>Boulevard du professeur jules Leclercq</wicri:noRegion><wicri:noRegion>59037 Lille</wicri:noRegion></affiliation></author><author><name sortKey="Chouaid, C" sort="Chouaid, C" uniqKey="Chouaid C" first="C." last="Chouaid">C. Chouaid</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Hôpital Saint Antoine, 184, rue du Faubourg, Saint Antoine</s1><s2>75571 Paris</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>75571 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Freitag, L" sort="Freitag, L" uniqKey="Freitag L" first="L." last="Freitag">L. Freitag</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Lungenklinik Hemer, Theo-Funccius-Strasse I</s1><s2>58675 Hemer</s2><s3>DEU</s3><sZ>12 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>58675 Hemer</wicri:noRegion><wicri:noRegion>Theo-Funccius-Strasse I</wicri:noRegion><wicri:noRegion>58675 Hemer</wicri:noRegion></affiliation></author><author><name sortKey="Quoix, E" sort="Quoix, E" uniqKey="Quoix E" first="E." last="Quoix">E. Quoix</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Service de Pneumologie, Hopitaux Universitaires</s1><s2>67091 Strasbourg</s2><s3>FRA</s3><sZ>13 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>67091 Strasbourg</wicri:noRegion><placeName><settlement type="city">Strasbourg</settlement><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Alsace (région administrative)</region></placeName></affiliation></author></analytic><series><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. J. cancer</title><idno type="ISSN">0007-0920</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. J. cancer</title><idno type="ISSN">0007-0920</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antineoplastic agent</term><term>Antivascular agent</term><term>Cancerology</term><term>Carboplatin</term><term>Drug combination</term><term>Lung cancer</term><term>Paclitaxel</term><term>Phase II trial</term><term>Randomization</term><term>Treatment</term><term>non-small cell lung carcinoma</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase II</term><term>Randomisation</term><term>Traitement</term><term>Carboplatine</term><term>Association médicamenteuse</term><term>Stade avancé</term><term>Paclitaxel</term><term>Cancer du poumon</term><term>Anticancéreux</term><term>Carcinome non petite cellule bronchopulmonaire</term><term>Antivasculaire</term><term>Cancérologie</term><term>Xanthène-4-acétique acide(5,6-diméthyl-9-oxo)</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">ASA404 (5,6-dimethylxanthenone-4-acetic acid or DMXAA) is a small-molecule tumour-vascular disrupting agent (Tumour-VDA). This randomised phase II study evaluated ASA404 plus standard therapy of carboplatin and paclitaxel in patients with histologically confirmed stage Illb or IV non-small cell lung cancer (NSCLC) not previously treated with chemotherapy. Patients were randomised to receive <6 cycles of carboplatin area under the plasma concentration-time curve 6 mg ml<sup>-1</sup> min and paclitaxel 175 mg m<sup>-2</sup> (CP, n = 36) or standard therapy plus ASA404 1200 mg m<sup>-2</sup> (ASA404-CP, n = 37). There was little change in the systemic exposure of either total or free carboplatin or paclitaxel on addition of ASA404. Safety profiles were similar and manageable in both groups, with most adverse effects attributed to standard therapy. Tumour response rate (3 1 vs 22%), median time to tumour progression (5.4 vs 4.4 months) and median survival (14.0 vs 8.8 months, hazard ratio 0.73, 95% Cl 0.39, 1.38) were improved in the ASA404 combination group compared with the standard therapy group. In conclusion, this study establishes the feasibility of combining ASA404 with carboplatin and paclitaxel in patients with previously untreated, advanced NSCLC, demonstrating a manageable safety profile and lack of adverse pharmacokinetic interactions. The results indicate that there may be a benefit associated with ASA404, but this needs to be evaluated in a larger trial.</div></front></TEI><double idat="0007-0920:2008:Mckeage M:randomised:phase:ii"><INIST><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer</title><author><name sortKey="Mckeage, M J" sort="Mckeage, M J" uniqKey="Mckeage M" first="M. J." last="Mckeage">M. J. Mckeage</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Auckland, 85 Park Road, Grafton, Private Bag 92019</s1><s2>Auckland 1142</s2><s3>NZL</s3><sZ>1 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Auckland 1142</wicri:noRegion></affiliation></author><author><name sortKey="Von Pawel, J" sort="Von Pawel, J" uniqKey="Von Pawel J" first="J." last="Von Pawel">J. Von Pawel</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Asklepios Fachkliniken, Robert-Koch-Allee 2</s1><s2>82131 Gauting</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>82131 Gauting</wicri:noRegion><wicri:noRegion>Robert-Koch-Allee 2</wicri:noRegion><wicri:noRegion>82131 Gauting</wicri:noRegion></affiliation></author><author><name sortKey="Reck, M" sort="Reck, M" uniqKey="Reck M" first="M." last="Reck">M. Reck</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Krankenhaus Grosshansdorf, Woehrendamm 80</s1><s2>22927 Grosshansdorf</s2><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>22927 Grosshansdorf</wicri:noRegion><wicri:noRegion>Woehrendamm 80</wicri:noRegion><wicri:noRegion>22927 Grosshansdorf</wicri:noRegion></affiliation></author><author><name sortKey="Jameson, M B" sort="Jameson, M B" uniqKey="Jameson M" first="M. B." last="Jameson">M. B. Jameson</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Waikato Hospital, Private Bag 3200</s1><s2>Hamilton</s2><s3>NZL</s3><sZ>4 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Hamilton</wicri:noRegion></affiliation></author><author><name sortKey="Rosenthal, M A" sort="Rosenthal, M A" uniqKey="Rosenthal M" first="M. A." last="Rosenthal">M. A. Rosenthal</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Royal Melbourne Hospital</s1><s2>Melbourne 3050, Victoria</s2><s3>AUS</s3><sZ>5 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Royal Melbourne Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Sullivan, R" sort="Sullivan, R" uniqKey="Sullivan R" first="R." last="Sullivan">R. Sullivan</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Auckland City Hospital, 2 Pork Rood</s1><s2>Grafton, Auckland 1023</s2><s3>NZL</s3><sZ>6 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Grafton, Auckland 1023</wicri:noRegion></affiliation></author><author><name sortKey="Gibbs, D" sort="Gibbs, D" uniqKey="Gibbs D" first="D." last="Gibbs">D. Gibbs</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Christchurch Hospital, Private Bag 4710</s1><s2>Christchurch</s2><s3>NZL</s3><sZ>7 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Christchurch</wicri:noRegion></affiliation></author><author><name sortKey="Mainwaring, P N" sort="Mainwaring, P N" uniqKey="Mainwaring P" first="P. N." last="Mainwaring">P. N. Mainwaring</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Mater Health Services</s1><s2>Brisbane 4101, Queensland</s2><s3>AUS</s3><sZ>8 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Mater Health Services</wicri:noRegion></affiliation></author><author><name sortKey="Serke, M" sort="Serke, M" uniqKey="Serke M" first="M." last="Serke">M. Serke</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn, Walterhöferstrasse II</s1><s2>14165 Berlin</s2><s3>DEU</s3><sZ>9 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Lafitte, J J" sort="Lafitte, J J" uniqKey="Lafitte J" first="J-J." last="Lafitte">J-J. Lafitte</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Hôpital Calmette Service de Pneumologie, Boulevard du professeur jules Leclercq</s1><s2>59037 Lille</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>59037 Lille</wicri:noRegion><wicri:noRegion>Boulevard du professeur jules Leclercq</wicri:noRegion><wicri:noRegion>59037 Lille</wicri:noRegion></affiliation></author><author><name sortKey="Chouaid, C" sort="Chouaid, C" uniqKey="Chouaid C" first="C." last="Chouaid">C. Chouaid</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Hôpital Saint Antoine, 184, rue du Faubourg, Saint Antoine</s1><s2>75571 Paris</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>75571 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Freitag, L" sort="Freitag, L" uniqKey="Freitag L" first="L." last="Freitag">L. Freitag</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Lungenklinik Hemer, Theo-Funccius-Strasse I</s1><s2>58675 Hemer</s2><s3>DEU</s3><sZ>12 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>58675 Hemer</wicri:noRegion><wicri:noRegion>Theo-Funccius-Strasse I</wicri:noRegion><wicri:noRegion>58675 Hemer</wicri:noRegion></affiliation></author><author><name sortKey="Quoix, E" sort="Quoix, E" uniqKey="Quoix E" first="E." last="Quoix">E. Quoix</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Service de Pneumologie, Hopitaux Universitaires</s1><s2>67091 Strasbourg</s2><s3>FRA</s3><sZ>13 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>67091 Strasbourg</wicri:noRegion><placeName><settlement type="city">Strasbourg</settlement><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Alsace (région administrative)</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">09-0065855</idno><date when="2008">2008</date><idno type="stanalyst">PASCAL 09-0065855 INIST</idno><idno type="RBID">Pascal:09-0065855</idno><idno type="wicri:Area/PascalFrancis/Corpus">003045</idno><idno type="wicri:Area/PascalFrancis/Curation">002F72</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">002F64</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">002F64</idno><idno type="wicri:doubleKey">0007-0920:2008:Mckeage M:randomised:phase:ii</idno><idno type="wicri:Area/Main/Merge">009378</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer</title><author><name sortKey="Mckeage, M J" sort="Mckeage, M J" uniqKey="Mckeage M" first="M. J." last="Mckeage">M. J. Mckeage</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University of Auckland, 85 Park Road, Grafton, Private Bag 92019</s1><s2>Auckland 1142</s2><s3>NZL</s3><sZ>1 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Auckland 1142</wicri:noRegion></affiliation></author><author><name sortKey="Von Pawel, J" sort="Von Pawel, J" uniqKey="Von Pawel J" first="J." last="Von Pawel">J. Von Pawel</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Asklepios Fachkliniken, Robert-Koch-Allee 2</s1><s2>82131 Gauting</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>82131 Gauting</wicri:noRegion><wicri:noRegion>Robert-Koch-Allee 2</wicri:noRegion><wicri:noRegion>82131 Gauting</wicri:noRegion></affiliation></author><author><name sortKey="Reck, M" sort="Reck, M" uniqKey="Reck M" first="M." last="Reck">M. Reck</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Krankenhaus Grosshansdorf, Woehrendamm 80</s1><s2>22927 Grosshansdorf</s2><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>22927 Grosshansdorf</wicri:noRegion><wicri:noRegion>Woehrendamm 80</wicri:noRegion><wicri:noRegion>22927 Grosshansdorf</wicri:noRegion></affiliation></author><author><name sortKey="Jameson, M B" sort="Jameson, M B" uniqKey="Jameson M" first="M. B." last="Jameson">M. B. Jameson</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Waikato Hospital, Private Bag 3200</s1><s2>Hamilton</s2><s3>NZL</s3><sZ>4 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Hamilton</wicri:noRegion></affiliation></author><author><name sortKey="Rosenthal, M A" sort="Rosenthal, M A" uniqKey="Rosenthal M" first="M. A." last="Rosenthal">M. A. Rosenthal</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Royal Melbourne Hospital</s1><s2>Melbourne 3050, Victoria</s2><s3>AUS</s3><sZ>5 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Royal Melbourne Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Sullivan, R" sort="Sullivan, R" uniqKey="Sullivan R" first="R." last="Sullivan">R. Sullivan</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Auckland City Hospital, 2 Pork Rood</s1><s2>Grafton, Auckland 1023</s2><s3>NZL</s3><sZ>6 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Grafton, Auckland 1023</wicri:noRegion></affiliation></author><author><name sortKey="Gibbs, D" sort="Gibbs, D" uniqKey="Gibbs D" first="D." last="Gibbs">D. Gibbs</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Christchurch Hospital, Private Bag 4710</s1><s2>Christchurch</s2><s3>NZL</s3><sZ>7 aut.</sZ></inist:fA14><country>Nouvelle-Zélande</country><wicri:noRegion>Christchurch</wicri:noRegion></affiliation></author><author><name sortKey="Mainwaring, P N" sort="Mainwaring, P N" uniqKey="Mainwaring P" first="P. N." last="Mainwaring">P. N. Mainwaring</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Mater Health Services</s1><s2>Brisbane 4101, Queensland</s2><s3>AUS</s3><sZ>8 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Mater Health Services</wicri:noRegion></affiliation></author><author><name sortKey="Serke, M" sort="Serke, M" uniqKey="Serke M" first="M." last="Serke">M. Serke</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn, Walterhöferstrasse II</s1><s2>14165 Berlin</s2><s3>DEU</s3><sZ>9 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Lafitte, J J" sort="Lafitte, J J" uniqKey="Lafitte J" first="J-J." last="Lafitte">J-J. Lafitte</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Hôpital Calmette Service de Pneumologie, Boulevard du professeur jules Leclercq</s1><s2>59037 Lille</s2><s3>FRA</s3><sZ>10 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>59037 Lille</wicri:noRegion><wicri:noRegion>Boulevard du professeur jules Leclercq</wicri:noRegion><wicri:noRegion>59037 Lille</wicri:noRegion></affiliation></author><author><name sortKey="Chouaid, C" sort="Chouaid, C" uniqKey="Chouaid C" first="C." last="Chouaid">C. Chouaid</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Hôpital Saint Antoine, 184, rue du Faubourg, Saint Antoine</s1><s2>75571 Paris</s2><s3>FRA</s3><sZ>11 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>75571 Paris</wicri:noRegion><placeName><settlement type="city">Paris</settlement><region type="région" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Freitag, L" sort="Freitag, L" uniqKey="Freitag L" first="L." last="Freitag">L. Freitag</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Lungenklinik Hemer, Theo-Funccius-Strasse I</s1><s2>58675 Hemer</s2><s3>DEU</s3><sZ>12 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>58675 Hemer</wicri:noRegion><wicri:noRegion>Theo-Funccius-Strasse I</wicri:noRegion><wicri:noRegion>58675 Hemer</wicri:noRegion></affiliation></author><author><name sortKey="Quoix, E" sort="Quoix, E" uniqKey="Quoix E" first="E." last="Quoix">E. Quoix</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Service de Pneumologie, Hopitaux Universitaires</s1><s2>67091 Strasbourg</s2><s3>FRA</s3><sZ>13 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>67091 Strasbourg</wicri:noRegion><placeName><settlement type="city">Strasbourg</settlement><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Alsace (région administrative)</region></placeName></affiliation></author></analytic><series><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. J. cancer</title><idno type="ISSN">0007-0920</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. J. cancer</title><idno type="ISSN">0007-0920</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antineoplastic agent</term><term>Antivascular agent</term><term>Cancerology</term><term>Carboplatin</term><term>Drug combination</term><term>Lung cancer</term><term>Paclitaxel</term><term>Phase II trial</term><term>Randomization</term><term>Treatment</term><term>non-small cell lung carcinoma</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase II</term><term>Randomisation</term><term>Traitement</term><term>Carboplatine</term><term>Association médicamenteuse</term><term>Stade avancé</term><term>Paclitaxel</term><term>Cancer du poumon</term><term>Anticancéreux</term><term>Carcinome non petite cellule bronchopulmonaire</term><term>Antivasculaire</term><term>Cancérologie</term><term>Xanthène-4-acétique acide(5,6-diméthyl-9-oxo)</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">ASA404 (5,6-dimethylxanthenone-4-acetic acid or DMXAA) is a small-molecule tumour-vascular disrupting agent (Tumour-VDA). This randomised phase II study evaluated ASA404 plus standard therapy of carboplatin and paclitaxel in patients with histologically confirmed stage Illb or IV non-small cell lung cancer (NSCLC) not previously treated with chemotherapy. Patients were randomised to receive <6 cycles of carboplatin area under the plasma concentration-time curve 6 mg ml<sup>-1</sup> min and paclitaxel 175 mg m<sup>-2</sup> (CP, n = 36) or standard therapy plus ASA404 1200 mg m<sup>-2</sup> (ASA404-CP, n = 37). There was little change in the systemic exposure of either total or free carboplatin or paclitaxel on addition of ASA404. Safety profiles were similar and manageable in both groups, with most adverse effects attributed to standard therapy. Tumour response rate (3 1 vs 22%), median time to tumour progression (5.4 vs 4.4 months) and median survival (14.0 vs 8.8 months, hazard ratio 0.73, 95% Cl 0.39, 1.38) were improved in the ASA404 combination group compared with the standard therapy group. In conclusion, this study establishes the feasibility of combining ASA404 with carboplatin and paclitaxel in patients with previously untreated, advanced NSCLC, demonstrating a manageable safety profile and lack of adverse pharmacokinetic interactions. The results indicate that there may be a benefit associated with ASA404, but this needs to be evaluated in a larger trial.</div></front></TEI></INIST><PMC><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer</title><author><name sortKey="Mckeage, M J" sort="Mckeage, M J" uniqKey="Mckeage M" first="M J" last="Mckeage">M J Mckeage</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>University of Auckland</institution> 85 Park Road, Grafton, Private Bag 92019, Auckland 1142,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Von Pawel, J" sort="Von Pawel, J" uniqKey="Von Pawel J" first="J" last="Von Pawel">J. Von Pawel</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Asklepios Fachkliniken, Robert-Koch-Allee 2</institution> D-82131 Gauting,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Reck, M" sort="Reck, M" uniqKey="Reck M" first="M" last="Reck">M. Reck</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Krankenhaus Grosshansdorf, Woehrendamm 80</institution> D-22927 Grosshansdorf,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Jameson, M B" sort="Jameson, M B" uniqKey="Jameson M" first="M B" last="Jameson">M B Jameson</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Waikato Hospital, Private Bag 3200</institution> Hamilton,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rosenthal, M A" sort="Rosenthal, M A" uniqKey="Rosenthal M" first="M A" last="Rosenthal">M A Rosenthal</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Royal Melbourne Hospital</institution> Melbourne 3050, Victoria,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sullivan, R" sort="Sullivan, R" uniqKey="Sullivan R" first="R" last="Sullivan">R. Sullivan</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Auckland City Hospital</institution> 2 Park Road, Grafton, Auckland 1023,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gibbs, D" sort="Gibbs, D" uniqKey="Gibbs D" first="D" last="Gibbs">D. Gibbs</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Christchurch Hospital</institution> Private Bag 4710, Christchurch,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mainwaring, P N" sort="Mainwaring, P N" uniqKey="Mainwaring P" first="P N" last="Mainwaring">P N Mainwaring</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Mater Health Services</institution> Brisbane 4101, Queensland,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Serke, M" sort="Serke, M" uniqKey="Serke M" first="M" last="Serke">M. Serke</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn, Walterhöferstrasse 11</institution> D-14165 Berlin,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lafitte, J J" sort="Lafitte, J J" uniqKey="Lafitte J" first="J-J" last="Lafitte">J-J Lafitte</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Hôpital Calmette Service de Pneumologie, Boulevard du professeur Jules Leclercq</institution> 59037 Lille,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Chouaid, C" sort="Chouaid, C" uniqKey="Chouaid C" first="C" last="Chouaid">C. Chouaid</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Hôpital Saint Antoine, 184, rue du Faubourg, Saint Antoine</institution> 75571 Paris Cedex,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Freitag, L" sort="Freitag, L" uniqKey="Freitag L" first="L" last="Freitag">L. Freitag</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Lungenklinik Hemer, Theo-Funccius-Strasse 1</institution> D-58675 Hemer,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Quoix, E" sort="Quoix, E" uniqKey="Quoix E" first="E" last="Quoix">E. Quoix</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Service de Pneumologie, Hôpitaux Universitaires</institution> 67091 Strasbourg Cedex,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">19078952</idno><idno type="pmc">2607218</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2607218</idno><idno type="RBID">PMC:2607218</idno><idno type="doi">10.1038/sj.bjc.6604808</idno><date when="2008">2008</date><idno type="wicri:Area/Pmc/Corpus">000023</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000023</idno><idno type="wicri:Area/Pmc/Curation">000023</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000023</idno><idno type="wicri:Area/Pmc/Checkpoint">002932</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">002932</idno><idno type="wicri:Area/Ncbi/Merge">000497</idno><idno type="wicri:Area/Ncbi/Curation">000497</idno><idno type="wicri:Area/Ncbi/Checkpoint">000497</idno><idno type="wicri:doubleKey">0007-0920:2008:Mckeage M:randomised:phase:ii</idno><idno type="wicri:Area/Main/Merge">008D89</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer</title><author><name sortKey="Mckeage, M J" sort="Mckeage, M J" uniqKey="Mckeage M" first="M J" last="Mckeage">M J Mckeage</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>University of Auckland</institution> 85 Park Road, Grafton, Private Bag 92019, Auckland 1142,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Von Pawel, J" sort="Von Pawel, J" uniqKey="Von Pawel J" first="J" last="Von Pawel">J. Von Pawel</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Asklepios Fachkliniken, Robert-Koch-Allee 2</institution> D-82131 Gauting,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Reck, M" sort="Reck, M" uniqKey="Reck M" first="M" last="Reck">M. Reck</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Krankenhaus Grosshansdorf, Woehrendamm 80</institution> D-22927 Grosshansdorf,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Jameson, M B" sort="Jameson, M B" uniqKey="Jameson M" first="M B" last="Jameson">M B Jameson</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Waikato Hospital, Private Bag 3200</institution> Hamilton,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rosenthal, M A" sort="Rosenthal, M A" uniqKey="Rosenthal M" first="M A" last="Rosenthal">M A Rosenthal</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Royal Melbourne Hospital</institution> Melbourne 3050, Victoria,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sullivan, R" sort="Sullivan, R" uniqKey="Sullivan R" first="R" last="Sullivan">R. Sullivan</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Auckland City Hospital</institution> 2 Park Road, Grafton, Auckland 1023,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gibbs, D" sort="Gibbs, D" uniqKey="Gibbs D" first="D" last="Gibbs">D. Gibbs</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Christchurch Hospital</institution> Private Bag 4710, Christchurch,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mainwaring, P N" sort="Mainwaring, P N" uniqKey="Mainwaring P" first="P N" last="Mainwaring">P N Mainwaring</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Mater Health Services</institution> Brisbane 4101, Queensland,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Serke, M" sort="Serke, M" uniqKey="Serke M" first="M" last="Serke">M. Serke</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn, Walterhöferstrasse 11</institution> D-14165 Berlin,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lafitte, J J" sort="Lafitte, J J" uniqKey="Lafitte J" first="J-J" last="Lafitte">J-J Lafitte</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Hôpital Calmette Service de Pneumologie, Boulevard du professeur Jules Leclercq</institution> 59037 Lille,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Chouaid, C" sort="Chouaid, C" uniqKey="Chouaid C" first="C" last="Chouaid">C. Chouaid</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Hôpital Saint Antoine, 184, rue du Faubourg, Saint Antoine</institution> 75571 Paris Cedex,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Freitag, L" sort="Freitag, L" uniqKey="Freitag L" first="L" last="Freitag">L. Freitag</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Lungenklinik Hemer, Theo-Funccius-Strasse 1</institution> D-58675 Hemer,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Quoix, E" sort="Quoix, E" uniqKey="Quoix E" first="E" last="Quoix">E. Quoix</name><affiliation wicri:level="1"><nlm:aff id="aff13"><institution>Service de Pneumologie, Hôpitaux Universitaires</institution> 67091 Strasbourg Cedex,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">British Journal of Cancer</title><idno type="ISSN">0007-0920</idno><idno type="eISSN">1532-1827</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>ASA404 (5,6-dimethylxanthenone-4-acetic acid or DMXAA) is a small-molecule tumour-vascular disrupting agent (Tumour-VDA). This randomised phase II study evaluated ASA404 plus standard therapy of carboplatin and paclitaxel in patients with histologically confirmed stage IIIb or IV non-small cell lung cancer (NSCLC) not previously treated with chemotherapy. Patients were randomised to receive ⩽6 cycles of carboplatin area under the plasma concentration–time curve 6 mg ml<sup>−1</sup> min and paclitaxel 175 mg m<sup>−2</sup> (CP, <italic>n</italic>=36) or standard therapy plus ASA404 1200 mg m<sup>−2</sup> (ASA404-CP, <italic>n</italic>=37). There was little change in the systemic exposure of either total or free carboplatin or paclitaxel on addition of ASA404. Safety profiles were similar and manageable in both groups, with most adverse effects attributed to standard therapy. Tumour response rate (31 <italic>vs</italic> 22%), median time to tumour progression (5.4 <italic>vs</italic> 4.4 months) and median survival (14.0 <italic>vs</italic> 8.8 months, hazard ratio 0.73, 95% CI 0.39, 1.38) were improved in the ASA404 combination group compared with the standard therapy group. In conclusion, this study establishes the feasibility of combining ASA404 with carboplatin and paclitaxel in patients with previously untreated, advanced NSCLC, demonstrating a manageable safety profile and lack of adverse pharmacokinetic interactions. The results indicate that there may be a benefit associated with ASA404, but this needs to be evaluated in a larger trial.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI></PMC></double></record>Pour manipuler ce document sous Unix (Dilib)
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