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Annals of Oncology Advance Access originally published online on September 4, 2007
Annals of Oncology 2007 18(12):2009-2014; doi:10.1093/annonc/mdm374
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© 2007 European Society for Medical Oncology

lung cancer

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

D. -W. Kim1,2, S. -Y. Kim3, H. -K. Kim4, S. -W. Kim5, S. W. Shin6, J. S. Kim7, K. Park8, M. Y. Lee9 and D. S. Heo1,2,*

1 Department of Internal Medicine, Seoul National University Hospital, Seoul
2 Cancer Research Institute, Seoul National University College of Medicine, Seoul
3 Department of Internal Medicine, Kyung Hee University Hospital, Seoul
4 Department of Internal Medicine, St Vincent's Hospital, Suwon
5 Department of Internal Medicine, Asan Medical Center, Seoul
6 Department of Internal Medicine, Korea University Anam Hospital, Seoul
7 Department of Internal Medicine, Korea University Guro Hospital, Seoul
8 Department of Medicine, Samsung Medical Center, Seoul
9 Samyang Corporation, Seoul, Korea

* Correspondence to: Prof. D. S. Heo, Department of Internal Medicine, Seoul National University Hospital, 28 Yongon-Dong, Chongro-Gu, Seoul 110-744, Korea. Tel: +82-2-2072-2857; Fax: +82-2-747-2199; E-mail: heo1013{at}plaza.snu.ac.kr

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/m2 and cisplatin 60 mg/m2 on day 1 of a 3-week cycle as first-line therapy. Intrapatient dose escalation of Genexol-PM to 300 mg/m2 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.

Key words: chemotherapy, Genexol-PM, non-small-cell lung cancer, phase II

Received for publication January 12, 2007. Revision received June 22, 2007. Accepted for publication July 2, 2007.


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