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

被引:267
作者
Kim, D. -W. [1 ,2 ]
Kim, S. -Y. [3 ]
Kim, H. -K. [4 ]
Kim, S. -W. [5 ]
Shin, S. W. [6 ]
Kim, J. S. [7 ]
Park, K. [8 ]
Lee, M. Y. [9 ]
Heo, D. S. [1 ,2 ]
机构
[1] Seoul Natl Univ Hosp, Dept Internal Med, Seoul 110744, South Korea
[2] Seoul Natl Univ, Coll Med, Canc Res Inst, Seoul, South Korea
[3] Kyung Hee Univ Hosp, Dept Internal Med, Seoul, South Korea
[4] St Vincents Hosp, Dept Internal Med, Suwon, South Korea
[5] Asan Med Ctr, Dept Internal Med, Seoul, South Korea
[6] Korea Univ, Anam Hosp, Dept Internal Med, Seoul 136701, South Korea
[7] Korea Univ, Guro Hosp, Dept Internal Med, Seoul 136701, South Korea
[8] Samsung Med Ctr, Dept Med, Seoul, South Korea
[9] Samyang Corp, Seoul, South Korea
关键词
chemotherapy; Genexol-PM; non-small-cell lung cancer; phase II;
D O I
10.1093/annonc/mdm374
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:2009 / 2014
页数:6
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