Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer

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dc.contributor.author McKeage, Mark en
dc.contributor.author von Pawel, J en
dc.contributor.author Reck, M en
dc.contributor.author Jameson, Michael en
dc.contributor.author Rosenthal, MA en
dc.contributor.author Sullivan, R en
dc.contributor.author Gibbs, D en
dc.contributor.author Mainwaring, PN en
dc.contributor.author Serke, M en
dc.contributor.author Lafitte, JJ en
dc.contributor.author Chouaid, C en
dc.contributor.author Freitag, L en
dc.contributor.author Quoix, E en
dc.date.accessioned 2012-03-06T19:17:28Z en
dc.date.issued 2008 en
dc.identifier.citation BRIT J CANCER 99(12):2006-2012 09 Dec 2008 en
dc.identifier.issn 0007-0920 en
dc.identifier.uri http://hdl.handle.net/2292/13077 en
dc.description.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 less than or equal to6 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 (31 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% 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. en
dc.publisher Cancer Research UK en
dc.relation.ispartofseries British Journal of Cancer en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. Details obtained from http://www.sherpa.ac.uk/romeo/issn/0007-0920/ en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.title Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer en
dc.type Journal Article en
dc.identifier.doi 10.1038/sj.bjc.6604808 en
pubs.issue 12 en
pubs.begin-page 2006 en
pubs.volume 99 en
dc.rights.holder Copyright: Cancer Research UK en
dc.identifier.pmid 19078952 en
pubs.end-page 2012 en
dc.rights.accessrights http://purl.org/eprint/accessRights/RestrictedAccess en
pubs.subtype Article en
pubs.elements-id 83596 en
pubs.org-id Medical and Health Sciences en
pubs.org-id Medical Sciences en
pubs.org-id Pharmacology en
pubs.org-id School of Medicine en
pubs.org-id Waikato Clinical school en
pubs.org-id Science en
pubs.org-id Science Research en
pubs.org-id Maurice Wilkins Centre (2010-2014) en
pubs.record-created-at-source-date 2010-09-01 en
pubs.dimensions-id 19078952 en

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