Lee, Sung Yong; Park, Hee Sun; Lee, Kye Young; Kim, Hee Joung; Jeon, Young June; Jang, Tae Won; Lee, Kwan Ho; Kim, Young Chul; Kim, Kyu Sik; Oh, In Jae; Kim, Sun Young
Clinical lung cancer
2013May ; 14 ( 3 ) :275-82.
PMID : 23290819
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Lee, Sung Yong -
Park, Hee Sun -
Lee, Kye Young -
Kim, Hee Joung -
Jeon, Young June -
Jang, Tae Won -
Lee, Kwan Ho -
Kim, Young Chul -
Kim, Kyu Sik -
Oh, In Jae -
Kim, Sun Young -
ABSTRACT
INTRODUCTION: The development of paclitaxel-loaded polymeric micelle (PPM) has circumvented many of the infusion-related difficulties associated with standard solvent-based paclitaxel. PPM plus 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/m(2) plus cisplatin 60 mg/m(2) or paclitaxel 175 mg/m(2) plus cisplatin 60 mg/m(2) 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. CI - Copyright ??2013 Elsevier Inc. All rights reserved.
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MESH
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse, Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality, Cisplatin/administration & dosage/adverse effects, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Lung Neoplasms/*drug therapy/mortality, Male, Micelles, Middle Aged, Paclitaxel/administration & dosage/adverse effects, Proportional Hazards Models
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