S-Space College of Medicine/School of Medicine (의과대학/대학원) Internal Medicine (내과학전공) Journal Papers (저널논문_내과학전공)
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
- Kim, D-W; Kim, S-Y; Kim, H-K; Kim, S-W; Shin, S W; Kim, J S; Park, K; Lee, M Y; Heo, D S
- Issue Date
- Oxford University Press
- Ann Oncol. 2007 Dec;18(12):2009-14. Epub 2007 Sep 4.
- Adult; Aged; Antineoplastic Combined Chemotherapy Protocols/administration &; dosage/*therapeutic use; Carcinoma, Non-Small-Cell Lung/*drug therapy; Cisplatin/administration & dosage; Female; Humans; Lung Neoplasms/*drug therapy; Male; Micelles; Middle Aged; Paclitaxel/administration & dosage; Polymers; Treatment Outcome
- 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.
- 1569-8041 (Electronic)
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