Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer
Identifieur interne : 000023 ( Pmc/Curation ); précédent : 000022; suivant : 000024Randomised 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.
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 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−1 min and paclitaxel 175 mg m−2 (CP,
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DOI: 10.1038/sj.bjc.6604808
PubMed: 19078952
PubMed Central: 2607218
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<record><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></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 article-type="other"><pmc-dir>properties open_access</pmc-dir>
<pmc-comment> Original-type: cy</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Br J Cancer</journal-id><journal-title>British Journal of Cancer</journal-title><issn pub-type="ppub">0007-0920</issn><issn pub-type="epub">1532-1827</issn><publisher><publisher-name>Nature Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19078952</article-id><article-id pub-id-type="pmc">2607218</article-id><article-id pub-id-type="pii">6604808</article-id><article-id pub-id-type="doi">10.1038/sj.bjc.6604808</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical Studies</subject></subj-group></article-categories><title-group><article-title>Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>McKeage</surname><given-names>M J</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="corresp" rid="caf1">*</xref></contrib><contrib contrib-type="author"><name><surname>Von Pawel</surname><given-names>J</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Reck</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Jameson</surname><given-names>M B</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Rosenthal</surname><given-names>M A</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Sullivan</surname><given-names>R</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Gibbs</surname><given-names>D</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Mainwaring</surname><given-names>P N</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Serke</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Lafitte</surname><given-names>J-J</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Chouaid</surname><given-names>C</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Freitag</surname><given-names>L</given-names></name><xref ref-type="aff" rid="aff12">12</xref></contrib><contrib contrib-type="author"><name><surname>Quoix</surname><given-names>E</given-names></name><xref ref-type="aff" rid="aff13">13</xref></contrib></contrib-group><aff id="aff1"><label>1</label><institution>University of Auckland</institution> 85 Park Road, Grafton, Private Bag 92019, Auckland 1142,<country>New Zealand</country></aff><aff id="aff2"><label>2</label><institution>Asklepios Fachkliniken, Robert-Koch-Allee 2</institution> D-82131 Gauting,<country>Germany</country></aff><aff id="aff3"><label>3</label><institution>Krankenhaus Grosshansdorf, Woehrendamm 80</institution> D-22927 Grosshansdorf,<country>Germany</country></aff><aff id="aff4"><label>4</label><institution>Waikato Hospital, Private Bag 3200</institution> Hamilton,<country>New Zealand</country></aff><aff id="aff5"><label>5</label><institution>Royal Melbourne Hospital</institution> Melbourne 3050, Victoria,<country>Australia</country></aff><aff id="aff6"><label>6</label><institution>Auckland City Hospital</institution> 2 Park Road, Grafton, Auckland 1023,<country>New Zealand</country></aff><aff id="aff7"><label>7</label><institution>Christchurch Hospital</institution> Private Bag 4710, Christchurch,<country>New Zealand</country></aff><aff id="aff8"><label>8</label><institution>Mater Health Services</institution> Brisbane 4101, Queensland,<country>Australia</country></aff><aff id="aff9"><label>9</label><institution>Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn, Walterhöferstrasse 11</institution> D-14165 Berlin,<country>Germany</country></aff><aff id="aff10"><label>10</label><institution>Hôpital Calmette Service de Pneumologie, Boulevard du professeur Jules Leclercq</institution> 59037 Lille,<country>France</country></aff><aff id="aff11"><label>11</label><institution>Hôpital Saint Antoine, 184, rue du Faubourg, Saint Antoine</institution> 75571 Paris Cedex,<country>France</country></aff><aff id="aff12"><label>12</label><institution>Lungenklinik Hemer, Theo-Funccius-Strasse 1</institution> D-58675 Hemer,<country>Germany</country></aff><aff id="aff13"><label>13</label><institution>Service de Pneumologie, Hôpitaux Universitaires</institution> 67091 Strasbourg Cedex,<country>France</country></aff><author-notes><corresp id="caf1"><label>*</label>Author for correspondence: <email xlink:href="mailto:m.mckeage@auckland.ac.nz">m.mckeage@auckland.ac.nz</email></corresp></author-notes><pub-date pub-type="epub"><day>09</day><month>12</month><year>2008</year></pub-date><pub-date pub-type="ppub"><day>09</day><month>12</month><year>2008</year></pub-date><volume>99</volume><issue>12</issue><fpage>2006</fpage><lpage>2012</lpage><history><date date-type="received"><day>14</day><month>07</month><year>2008</year></date><date date-type="rev-recd"><day>05</day><month>11</month><year>2008</year></date><date date-type="accepted"><day>08</day><month>11</month><year>2008</year></date></history><copyright-statement>Copyright 2008, Cancer Research UK</copyright-statement><copyright-year>2008</copyright-year><permissions><copyright-holder>Cancer Research UK</copyright-holder></permissions><abstract><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></abstract><kwd-group><kwd>ASA404</kwd><kwd>AS1404</kwd><kwd>DMXAA</kwd><kwd>VDA</kwd><kwd>tumour-VDA</kwd><kwd>non-small cell lung cancer</kwd></kwd-group></article-meta></front><floats-wrap><fig id="fig1"><label>Figure 1</label><caption><p>Kaplan–Meier estimate of the time to tumour progression; eligible population (ASA404-CP <italic>n</italic>=34, CP <italic>n</italic>=36).</p></caption><graphic mime-subtype="eps" xlink:href="6604808f1"></graphic></fig><fig id="fig2"><label>Figure 2</label><caption><p>Kaplan–Meier estimate of the probability of survival; eligible population (ASA404-CP <italic>n</italic>=34, CP <italic>n</italic>=36).</p></caption><graphic mime-subtype="eps" xlink:href="6604808f2"></graphic></fig><table-wrap id="tbl1" position="float"><label>Table 1</label><caption><p content-type="table-title">Baseline characteristics of randomised patients (safety population)</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="char" char="("></col><col align="char" char="("></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" char="(" charoff="50"><bold>ASA404-CP (<italic>n</italic>=37)</bold></th><th align="center" valign="top" char="(" charoff="50"><bold>CP (<italic>n</italic>=36)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">Men, <italic>n</italic> (%)</td><td align="char" valign="top" char="(" charoff="50">23 (62.2)</td><td align="char" valign="top" char="(" charoff="50">24 (66.7)</td></tr><tr><td align="left" valign="top" charoff="50">Women, <italic>n</italic> (%)</td><td align="char" valign="top" char="(" charoff="50">14 (37.8)</td><td align="char" valign="top" char="(" charoff="50">12 (33.3)</td></tr><tr><td align="left" valign="top" charoff="50">Age (years), mean±s.d.</td><td align="char" valign="top" char="(" charoff="50">59.4±8.91</td><td align="char" valign="top" char="(" charoff="50">61.0±10.76</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Histological subtype,</italic> n (%)</td></tr><tr><td align="left" valign="top" charoff="50"> Squamous cell carcinoma/undifferentiated</td><td align="char" valign="top" char="(" charoff="50">11 (29.7)</td><td align="char" valign="top" char="(" charoff="50">11 (30.6)</td></tr><tr><td align="left" valign="top" charoff="50"> Adenocarcinoma</td><td align="char" valign="top" char="(" charoff="50">25 (67.6)</td><td align="char" valign="top" char="(" charoff="50">22 (61.1)</td></tr><tr><td align="left" valign="top" charoff="50"> Large cell carcinoma</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td></tr><tr><td align="left" valign="top" charoff="50"> Other</td><td align="char" valign="top" char="(" charoff="50">1 (2.7)</td><td align="char" valign="top" char="(" charoff="50">1 (2.8)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Stage,</italic> n (%)</td></tr><tr><td align="left" valign="top" charoff="50"> IIIb</td><td align="char" valign="top" char="(" charoff="50">11 (29.7)</td><td align="char" valign="top" char="(" charoff="50">13 (36.1)</td></tr><tr><td align="left" valign="top" charoff="50"> IV</td><td align="char" valign="top" char="(" charoff="50">26 (70.3)</td><td align="char" valign="top" char="(" charoff="50">23 (63.9)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Karnofsky performance status,</italic> n (%)</td></tr><tr><td align="left" valign="top" charoff="50"> 70</td><td align="char" valign="top" char="(" charoff="50">1 (2.7)</td><td align="char" valign="top" char="(" charoff="50">3 (8.3)</td></tr><tr><td align="left" valign="top" charoff="50"> 80</td><td align="char" valign="top" char="(" charoff="50">9 (24.3)</td><td align="char" valign="top" char="(" charoff="50">9 (25.0)</td></tr><tr><td align="left" valign="top" charoff="50"> 90</td><td align="char" valign="top" char="(" charoff="50">17 (45.9)</td><td align="char" valign="top" char="(" charoff="50">14 (38.9)</td></tr><tr><td align="left" valign="top" charoff="50"> 100</td><td align="char" valign="top" char="(" charoff="50">10 (27.0)</td><td align="char" valign="top" char="(" charoff="50">10 (27.8)</td></tr></tbody></table><table-wrap-foot><fn id="t1-fn1"><label></label><p>ASA404-CP=ASA404 combined with carboplatin and paclitaxel; CP=carboplatin and paclitaxel; s.d.=standard deviation.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl2" position="float"><label>Table 2</label><caption><p content-type="table-title">Ratios (co-administration/alone<sup>a</sup>) of mean PK parameters for CP cycle 2/cycle 1 and for ASA404 cycle 2/cycle 7 (<italic>n</italic>=6)</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col><col align="char" char="."></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" char="." charoff="50"><bold>Total carboplatin<sup>b</sup></bold></th><th align="center" valign="top" char="." charoff="50"><bold>Free carboplatin<sup>b</sup></bold></th><th align="center" valign="top" char="." charoff="50"><bold>Paclitaxel<sup>c</sup></bold></th><th align="center" valign="top" char="." charoff="50"><bold>Paclitaxel metabolite<sup>c</sup></bold></th><th align="center" valign="top" char="." charoff="50"><bold>Total ASA404<sup>d</sup></bold></th><th align="center" valign="top" char="." charoff="50"><bold>Free ASA404<sup>d</sup></bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">AUC<sub>(0−t)</sub></td><td align="char" valign="top" char="." charoff="50">1.19</td><td align="char" valign="top" char="." charoff="50">1.38</td><td align="char" valign="top" char="." charoff="50">1.10</td><td align="char" valign="top" char="." charoff="50">0.96</td><td align="char" valign="top" char="." charoff="50">1.05</td><td align="char" valign="top" char="." charoff="50">7.95</td></tr><tr><td align="left" valign="top" charoff="50">95% CI</td><td align="char" valign="top" char="." charoff="50">0.97, 1.41</td><td align="char" valign="top" char="." charoff="50">0.98, 1.77</td><td align="char" valign="top" char="." charoff="50">0.93, 1.27</td><td align="char" valign="top" char="." charoff="50">0.62, 1.29</td><td align="char" valign="top" char="." charoff="50">0.46, 1.64</td><td align="char" valign="top" char="." charoff="50">2.05, 13.84</td></tr><tr><td align="left" valign="top" charoff="50"><italic>C</italic><sub>max</sub></td><td align="char" valign="top" char="." charoff="50">1.26</td><td align="char" valign="top" char="." charoff="50">1.36</td><td align="char" valign="top" char="." charoff="50">0.88</td><td align="char" valign="top" char="." charoff="50">1.04</td><td align="char" valign="top" char="." charoff="50">1.01</td><td align="char" valign="top" char="." charoff="50">5.72</td></tr><tr><td align="left" valign="top" charoff="50">95% CI</td><td align="char" valign="top" char="." charoff="50">0.76, 1.76</td><td align="char" valign="top" char="." charoff="50">0.37, 2.35</td><td align="char" valign="top" char="." charoff="50">0.69, 1.07</td><td align="char" valign="top" char="." charoff="50">0.69, 1.40</td><td align="char" valign="top" char="." charoff="50">0.50, 1.52</td><td align="char" valign="top" char="." charoff="50">2.01, 9.43</td></tr></tbody></table><table-wrap-foot><fn id="t2-fn1"><label>a</label><p>In cycle 1 CP was given alone, in cycle 2 CP was co-administered with ASA404 and in cycle 7 ASA404 was given alone.</p></fn><fn id="t2-fn2"><label>b</label><p><italic>t</italic>=20.25 h for carboplatin.</p></fn><fn id="t2-fn3"><label>c</label><p><italic>t</italic>=45 h for paclitaxel.</p></fn><fn id="t2-fn4"><label>d</label><p><italic>t</italic>=43.75 h for ASA404.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl3" position="float"><label>Table 3</label><caption><p content-type="table-title">Summary of treatment-emergent adverse events (safety population)</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="char" char="("></col><col align="char" char="("></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>No. of patients (%)</bold><hr></hr></th></tr><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" char="(" charoff="50"><bold>ASA404-CP (<italic>n</italic>=37)</bold></th><th align="center" valign="top" char="(" charoff="50"><bold>CP (<italic>n</italic>=36)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50"><italic>⩾1 adverse event</italic></td><td align="char" valign="top" char="(" charoff="50">34 (91.9)</td><td align="char" valign="top" char="(" charoff="50">36 (100.0)</td></tr><tr><td align="left" valign="top" charoff="50"> Related to ASA404</td><td align="char" valign="top" char="(" charoff="50">27 (73.0)</td><td align="char" valign="top" char="(" charoff="50">—</td></tr><tr><td align="left" valign="top" charoff="50"> Related to standard therapy</td><td align="char" valign="top" char="(" charoff="50">28 (75.7)</td><td align="char" valign="top" char="(" charoff="50">31 (86.1)</td></tr><tr><td align="left" valign="top" charoff="50"> Grade 1<sup>a</sup>/mild<sup>b</sup></td><td align="char" valign="top" char="(" charoff="50">3 (8.1)</td><td align="char" valign="top" char="(" charoff="50">4 (11.1)</td></tr><tr><td align="left" valign="top" charoff="50"> Grade 2<sup>a</sup>/moderate<sup>b</sup></td><td align="char" valign="top" char="(" charoff="50">6 (16.2)</td><td align="char" valign="top" char="(" charoff="50">8 (22.2)</td></tr><tr><td align="left" valign="top" charoff="50"> Grade 3<sup>a</sup>/severe<sup>b</sup></td><td align="char" valign="top" char="(" charoff="50">17 (45.9)</td><td align="char" valign="top" char="(" charoff="50">22 (61.1)</td></tr><tr><td align="left" valign="top" charoff="50"> Grade 4<sup>a,</sup><sup>b</sup></td><td align="char" valign="top" char="(" charoff="50">5 (13.5)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50"> Grade 5<sup>a,</sup><sup>b</sup></td><td align="char" valign="top" char="(" charoff="50">3 (8.1)</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50"><italic>⩾1 serious adverse event</italic></td><td align="char" valign="top" char="(" charoff="50">16 (43.2)</td><td align="char" valign="top" char="(" charoff="50">17 (47.2)</td></tr><tr><td align="left" valign="top" charoff="50"> Related to ASA404</td><td align="char" valign="top" char="(" charoff="50">1 (2.7)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50"> Related to standard therapy</td><td align="char" valign="top" char="(" charoff="50">5 (13.5)</td><td align="char" valign="top" char="(" charoff="50">6 (16.7)</td></tr><tr><td align="left" valign="top" charoff="50"> Adverse event leading to death</td><td align="char" valign="top" char="(" charoff="50">2 (5.4)</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td></tr><tr><td align="left" valign="top" charoff="50"> Adverse event leading to withdrawal</td><td align="char" valign="top" char="(" charoff="50">5 (13.5)</td><td align="char" valign="top" char="(" charoff="50">9 (25.0)</td></tr></tbody></table><table-wrap-foot><fn id="t3-fn1"><label></label><p>ASA404-CP=ASA404 combined with carboplatin and paclitaxel; CP=carboplatin and paclitaxel.</p></fn><fn id="t3-fn2"><label>a</label><p>National Cancer Institute Common Terminology Criteria for Adverse Events grading.</p></fn><fn id="t3-fn3"><label>b</label><p>Worst severity grade.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl4" position="float"><label>Table 4</label><caption><p content-type="table-title">Most common grade 3 and 4 toxicities (safety population)</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="char" char="("></col><col align="char" char="("></col><col align="char" char="("></col><col align="char" char="("></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th colspan="4" align="center" valign="top" char="(" charoff="50"><bold>No. of patients (%)</bold><hr></hr></th></tr><tr><th align="left" valign="top" charoff="50"> </th><th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>ASA404-CP (<italic>n</italic>=37)</bold><hr></hr></th><th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>CP (<italic>n</italic>=36)</bold><hr></hr></th></tr><tr><th align="left" valign="top" charoff="50"><bold>Toxicity</bold></th><th align="center" valign="top" char="(" charoff="50"><bold>Grade 3</bold></th><th align="center" valign="top" char="(" charoff="50"><bold>Grade 4</bold></th><th align="center" valign="top" char="(" charoff="50"><bold>Grade 3</bold></th><th align="center" valign="top" char="(" charoff="50"><bold>Grade 4</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">Neutropenia</td><td align="char" valign="top" char="(" charoff="50">8 (21.6)</td><td align="char" valign="top" char="(" charoff="50">15 (40.5)</td><td align="char" valign="top" char="(" charoff="50">10 (27.8)</td><td align="char" valign="top" char="(" charoff="50">4 (11.1)</td></tr><tr><td align="left" valign="top" charoff="50">Leukopenia</td><td align="char" valign="top" char="(" charoff="50">5 (13.5)</td><td align="char" valign="top" char="(" charoff="50">5 (13.5)</td><td align="char" valign="top" char="(" charoff="50">9 (25.0)</td><td align="char" valign="top" char="(" charoff="50">1 (2.8)</td></tr><tr><td align="left" valign="top" charoff="50">Alopecia</td><td align="char" valign="top" char="(" charoff="50">7 (18.9)</td><td align="char" valign="top" char="(" charoff="50">1 (2.7)</td><td align="char" valign="top" char="(" charoff="50">10 (27.8)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Hyperglycaemia</td><td align="char" valign="top" char="(" charoff="50">5 (13.5)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">9 (25.0)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Neuropathy</td><td align="char" valign="top" char="(" charoff="50">2 (5.4)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">7 (19.4)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Anaemia</td><td align="char" valign="top" char="(" charoff="50">3 (8.1)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">5 (13.9)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Thrombocytopenia</td><td align="char" valign="top" char="(" charoff="50">2 (5.4)</td><td align="char" valign="top" char="(" charoff="50">2 (5.4)</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Gastrointestinal disorders</td><td align="char" valign="top" char="(" charoff="50">3 (8.1)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td><td align="char" valign="top" char="(" charoff="50">1 (2.8)</td></tr><tr><td align="left" valign="top" charoff="50">Infection</td><td align="char" valign="top" char="(" charoff="50">4 (10.8)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">1 (2.8)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Arthralgia, back or extremity pain</td><td align="char" valign="top" char="(" charoff="50">2 (5.4)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">3 (8.3)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Cardiac disorders</td><td align="char" valign="top" char="(" charoff="50">3 (8.1)</td><td align="char" valign="top" char="(" charoff="50">1 (2.7)</td><td align="char" valign="top" char="(" charoff="50">1 (2.8)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Hypokalaemia</td><td align="char" valign="top" char="(" charoff="50">3 (8.1)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Respiratory, thoracic and mediastinal</td><td align="char" valign="top" char="(" charoff="50">3 (8.1)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Infusion site burning/pain</td><td align="char" valign="top" char="(" charoff="50">2 (5.4)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Dehydration</td><td align="char" valign="top" char="(" charoff="50">1 (2.7)</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">1 (2.8)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Anaphylactic shock or hypersensitivity</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Neoplasms benign, malignant and unspecified</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Flushing or hypotension</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">2 (5.6)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Febrile neutropenia</td><td align="char" valign="top" char="(" charoff="50">0</td><td align="char" valign="top" char="(" charoff="50">1 (2.7)</td><td align="char" valign="top" char="(" charoff="50">1 (2.8)</td><td align="char" valign="top" char="(" charoff="50">0</td></tr></tbody></table><table-wrap-foot><fn id="t4-fn1"><label></label><p>ASA404-CP=ASA404 combined with carboplatin and paclitaxel; CP=carboplatin and paclitaxel.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl5" position="float"><label>Table 5</label><caption><p content-type="table-title">Tumour response rate (eligible population)</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="char" char="("></col><col align="char" char="("></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>No. of patients (%)</bold><hr></hr></th></tr><tr><th align="left" valign="top" charoff="50"> </th><th align="center" valign="top" char="(" charoff="50"><bold>ASA404-CP (<italic>n</italic>=34)</bold></th><th align="center" valign="top" char="(" charoff="50"><bold>CP (<italic>n</italic>=36)</bold></th></tr></thead><tbody valign="top"><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Investigator assessment</italic></td></tr><tr><td align="left" valign="top" charoff="50"> Number of patients available for assessment</td><td align="char" valign="top" char="(" charoff="50">32 (100.0)</td><td align="char" valign="top" char="(" charoff="50">31 (100.0)</td></tr><tr><td align="left" valign="top" charoff="50"> Partial response (confirmed)</td><td align="char" valign="top" char="(" charoff="50">11 (34.4)</td><td align="char" valign="top" char="(" charoff="50">9 (29.0)</td></tr><tr><td align="left" valign="top" charoff="50"> Partial response (unconfirmed)</td><td align="char" valign="top" char="(" charoff="50">2 (6.3)</td><td align="char" valign="top" char="(" charoff="50">3 (9.7)</td></tr><tr><td align="left" valign="top" charoff="50"> Stable disease</td><td align="char" valign="top" char="(" charoff="50">14 (43.8)</td><td align="char" valign="top" char="(" charoff="50">10 (32.3)</td></tr><tr><td align="left" valign="top" charoff="50"> Progressive disease</td><td align="char" valign="top" char="(" charoff="50">5 (15.6)</td><td align="char" valign="top" char="(" charoff="50">9 (29.0)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td><td align="char" valign="top" char="(" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Independent assessment</italic></td></tr><tr><td align="left" valign="top" charoff="50"> Number of patients available for assessment<sup>a</sup></td><td align="char" valign="top" char="(" charoff="50">32 (100.0)</td><td align="char" valign="top" char="(" charoff="50">27 (100.0)</td></tr><tr><td align="left" valign="top" charoff="50"> Partial response</td><td align="char" valign="top" char="(" charoff="50">10 (31.3)</td><td align="char" valign="top" char="(" charoff="50">6 (22.2)</td></tr><tr><td align="left" valign="top" charoff="50"> Stable disease</td><td align="char" valign="top" char="(" charoff="50">21 (65.6)</td><td align="char" valign="top" char="(" charoff="50">19 (70.4)</td></tr><tr><td align="left" valign="top" charoff="50"> Progressive disease</td><td align="char" valign="top" char="(" charoff="50">1 (3.1)</td><td align="char" valign="top" char="(" charoff="50">2 (7.4)</td></tr></tbody></table><table-wrap-foot><fn id="t5-fn1"><label></label><p>ASA404-CP=ASA404 combined with carboplatin and paclitaxel; CP=carboplatin and paclitaxel.</p></fn><fn id="t5-fn2"><label>a</label><p>Tumour response could not be evaluated in 11 eligible patients by independent assessment due to: patient death before second tumour assessment (<italic>n</italic>=3); patient withdrawal before second tumour assessment (<italic>n</italic>=3); disease progression after cycle 1 and no subsequent scans available (<italic>n</italic>=2); no target lesion present (<italic>n</italic>=2); or no baseline scan available (<italic>n</italic>=1).</p></fn></table-wrap-foot></table-wrap></floats-wrap></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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