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. Kim, S. Y. Kim, H. K. Kim, S. W. Kim, Sang Won Shin, J. S. Kim, K. Park, M. Y. Lee, D. S. Heo

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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/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.

Original languageEnglish
Pages (from-to)2009-2014
Number of pages6
JournalAnnals of Oncology
Volume18
Issue number12
DOIs
Publication statusPublished - 2007 Dec 1

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Keywords

  • Chemotherapy
  • Genexol-PM
  • Non-small-cell lung cancer
  • Phase II

ASJC Scopus subject areas

  • Hematology
  • Oncology

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