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Paclitaxel-Loaded Polymeric Micelle (230 mg/m2) and Cisplatin (60 mg/m2) vs. Paclitaxel (175 mg/m2) and Cisplatin (60 mg/m2) in Advanced Non–Small-Cell Lung Cancer: A Multicenter Randomized Phase IIB Trial

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Author(s)
전영준
Alternative Author(s)
Jeon, Young June
Publication Year
2013
Abstract
Paclitaxel-loaded polymeric micelle is a novel Cremophor EL–free formulation of paclitaxel that showed
antitumor activity against non–small-cell lung cancer. We performed a phase IIB trial to evaluate that the
response rate of paclitaxel-loaded polymeric micelle plus cisplatin is not inferior to those of a paclitaxel plus
cisplatin regimen in patients with advanced non–small-cell lung cancer and who are chemonaive. The efficacy
of paclitaxel-loaded polymeric micelle plus cisplatin was noninferior to that of paclitaxel plus cisplatin, and the
overall incidence of adverse events was similar for both groups.
Introduction: The development of paclitaxel-loaded polymeric micelle (PPM) has circumvented many of the infusion-related
difficulties associated with standard solvent-based paclitaxel.PPMplus cisplatin combination chemotherapy showed significant
antitumor activity in phase I and II studies. This prospective randomized controlled phase IIB study assessed the noninferiority
of the efficacy and tolerability of high-dose PPM plus cisplatin to a standard dose of paclitaxel plus cisplatin. Patients and
Methods: Patients with stage IIIB/IV or recurrent non–small-cell lung cancer (NSCLC) who were chemonaive were eligible for
participation. The patients were randomly assigned to receive PPM 230 mg/m2 plus cisplatin 60 mg/m2 or paclitaxel 175 mg/m2
plus cisplatin 60 mg/m2 once every 3-week cycle. The primary endpoint was to compare the response rate (RR) between the
groups with coprimary analyses to assess noninferiority. Secondary endpoints included progression-free survival, overall
survival, and safety. Results: A total of 276 patients were randomized to PPM plus cisplatin (n 140) or paclitaxel
plus cisplatin (n 136). RR was 43.6% in the PPM plus cisplatin group and 41.9% in the paclitaxel plus cisplatin
group. Noninferiority of PPM plus cisplatin compared with paclitaxel plus cisplatin was confirmed for RR. There
were no differences in progression-free survival and overall survival between the groups. Although there was a
higher rate of grade 3 neutropenia in the PPM plus cisplatin group, the overall rate of adverse events was
comparable between the 2 groups. Conclusion: PPM in combination with cisplatin was well tolerated, and its response
rate was noninferior to that of paclitaxel plus cisplatin in patients with advanced NSCLC and who were chemonaive.
Department
Dept. of Internal Medicine (내과학)
Publisher
School of Medicine
Citation
Clinical Lung Cancer, Vol.14(3) : 275-282, 2013
Type
Article
ISSN
1525-7304
DOI
10.1016/j.cllc.2012.11.005
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/35495
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