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.

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.

• Authors: D-W Kim, S-Y Kim, H-K Kim, S-W Kim, S W Shin, J S Kim, K Park, M Y Lee, D S Heo
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 18 Issue 12 Pg. 2009-14 (Dec 2007) ISSN: 1569-8041 [Electronic] England
• PMID: 17785767 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Micelles
• Polymers
• Paclitaxel
• Cisplatin

Topics

• 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