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Multicenter phase II trial of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer

Cited 221 time in Web of Science Cited 238 time in Scopus
Authors
Kim, Dong-Wan; Kim, S. -Y.; Kim, H. -K.; Kim, S. -W.; Shin, S. W.; Kim, J. S.; Park, K.; Lee, M. Y.; Heo, Dae Seog
Issue Date
2007-12
Publisher
Oxford University Press
Citation
Annals of Oncology, Vol.18 No.12, pp.2009-2014
Keywords
chemotherapyGenexol-PMnon-small-cell lung cancerphase II
Abstract
Background: Genexol-PM is a novel Cremophor EL (CrEL)-free polymeric micelle formulation of paclitaxel (Taxol). This multicenter phase II study was designed to evaluate the efficacy and safety of the combination of Genexol-PM and cisplatin for the treatment of advanced non-small-cell lung cancer (NSCLC). Patients and methods: Patients with advanced NSCLC received Genexol-PM 230 mg/m(2) and cisplatin 60 mg/m(2) on day 1 of a 3-week cycle as first-line therapy. Intrapatient dose escalation of Genexol-PM to 300 mg/m(2) was carried out from the second cycle if the prespecified toxic effects were not observed after the first cycle. Results: Sixty-nine patients were enrolled in this study. Overall response rate was 37.7%. The median time to progression was 5.8 months and the median survival period was 21.7 months. The major non-hematologic toxic effects included grade 3 peripheral sensory neuropathy (13.0%) and grade 3/4 arthralgia (7.3%). Four patients (5.8%) experienced grade 3/4 hypersensitivity reactions. The major hematological toxic effects were grade 3/4 neutropenia (29.0% and 17.4%, respectively). Conclusion: Genexol-PM plus cisplatin combination chemotherapy showed significant antitumor activity. The use of CrEL-free, polymeric micelle formulation of paclitaxel allowed administration of higher doses of paclitaxel compared with the CrEL-based formulation without significant increased toxicity.
ISSN
0923-7534
Language
English
URI
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17785767

http://hdl.handle.net/10371/27818
DOI
https://doi.org/10.1093/annonc/mdm374
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Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
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