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

被引：0
作者：
M J McKeage
J Von Pawel
M Reck
M B Jameson
M A Rosenthal
R Sullivan
D Gibbs
P N Mainwaring
M Serke
J-J Lafitte
C Chouaid
L Freitag
E Quoix
机构：
[1] University of Auckland,
[2] Asklepios Fachkliniken,undefined
[3] Robert-Koch-Allee 2,undefined
[4] Krankenhaus Grosshansdorf,undefined
[5] Woehrendamm 80,undefined
[6] Waikato Hospital,undefined
[7] Private Bag 3200,undefined
[8] Royal Melbourne Hospital,undefined
[9] Auckland City Hospital,undefined
[10] Christchurch Hospital,undefined
[11] Mater Health Services,undefined
[12] Helios Klinikum Emil von Behring,undefined
[13] Lungenklinik Heckeshorn,undefined
[14] Walterhöferstrasse 11,undefined
[15] Hôpital Calmette Service de Pneumologie,undefined
[16] Boulevard du professeur Jules Leclercq,undefined
[17] Hôpital Saint Antoine,undefined
[18] 184,undefined
[19] rue du Faubourg,undefined
[20] Saint Antoine,undefined
[21] Lungenklinik Hemer,undefined
[22] Theo-Funccius-Strasse 1,undefined
[23] Service de Pneumologie,undefined
[24] Hôpitaux Universitaires,undefined
来源：
British Journal of Cancer | 2008年 / 99卷
关键词：
ASA404; AS1404; DMXAA; VDA; tumour-VDA; non-small cell lung cancer;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
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, 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.
引用
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页码：2006 / 2012
页数：6
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