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

Research output: Contribution to journalArticle

228 Citations (Scopus)

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

Fingerprint

Micelles
Paclitaxel
Non-Small Cell Lung Carcinoma
Poisons
Cisplatin
Arthralgia
Peripheral Nervous System Diseases
Combination Drug Therapy
Neutropenia
Hypersensitivity
Safety
Survival
cremophor
TP protocol
Therapeutics
cremophor EL

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

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, Sang Won; Kim, J. S.; Park, K.; Lee, M. Y.; Heo, D. S.

In: Annals of Oncology, Vol. 18, No. 12, 01.12.2007, p. 2009-2014.

Research output: Contribution to journalArticle

Kim, D. W. ; Kim, S. Y. ; Kim, H. K. ; Kim, S. W. ; Shin, Sang Won ; Kim, J. S. ; Park, K. ; Lee, M. Y. ; Heo, D. S. / 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. In: Annals of Oncology. 2007 ; Vol. 18, No. 12. pp. 2009-2014.
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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.",
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T1 - 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

AU - Kim, D. W.

AU - Kim, S. Y.

AU - Kim, H. K.

AU - Kim, S. W.

AU - Shin, Sang Won

AU - Kim, J. S.

AU - Park, K.

AU - Lee, M. Y.

AU - Heo, D. S.

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N2 - 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.

AB - 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.

KW - Chemotherapy

KW - Genexol-PM

KW - Non-small-cell lung cancer

KW - Phase II

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