Please use this identifier to cite or link to this item: http://cmuir.cmu.ac.th/jspui/handle/6653943832/56807
Title: Efficacy according to blind independent central review: Post-hoc analyses from the phase III, randomized, multicenter, IPASS study of first-line gefitinib versus carboplatin/paclitaxel in Asian patients with EGFR mutation-positive advanced NSCLC
Authors: Yi Long Wu
Nagahiro Saijo
Sumitra Thongprasert
J. C.H. Yang
Baohui Han
Benjamin Margono
Busayamas Chewaskulyong
Patrapim Sunpaweravong
Yuichiro Ohe
Yukito Ichinose
Jin Ji Yang
Tony S.K. Mok
Helen Young
Vincent Haddad
Yuri Rukazenkov
Masahiro Fukuoka
Keywords: Biochemistry, Genetics and Molecular Biology
Medicine
Issue Date: 1-Feb-2017
Abstract: © 2016 The Authors Objective The Phase III, randomized, open-label IPASS study (NCT00322452) of first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) gefitinib versus carboplatin/paclitaxel for Asian patients with advanced non-small-cell lung cancer (NSCLC) showed that investigator-assessed progression-free survival (PFS) and objective response rate (ORR) were significantly prolonged in patients with EGFR mutation-positive NSCLC who received gefitinib versus patients with EGFR mutation-negative NSCLC. We report post-hoc analyses of IPASS data by blind independent central review (BICR), performed at the request of the US FDA, in a subset of patients with EGFR mutation-positive NSCLC. Patients and methods Eligible patients (aged ≥18 years; histologically/cytologically confirmed Stage IIB/IV adenocarcinoma NSCLC; non- or former light-smokers; treatment-naïve) were randomly assigned 1:1 to gefitinib (250 mg/day) or carboplatin (dose calculated to produce an area under the curve of 5 or 6 mg/mL/minute)/paclitaxel (200 mg/m2). Primary endpoint: PFS. BICR analyses included PFS, ORR, and duration of response (DoR). Results Scans from 186 IPASS patients (gefitinib n = 88, carboplatin/paclitaxel n = 98) with EGFR mutation-positive NSCLC were available for BICR. Consistent with investigator-assessed results, in patients with EGFR mutation-positive NSCLC: PFS (hazard ratio 0.54; 95% confidence interval [CI] 0.38, 0.79; p = 0.0012) and ORR (odds ratio 3.00; 95% CI 1.63, 5.54; p = 0.0004) were significantly longer with gefitinib versus carboplatin/paclitaxel. The median DoR by BICR was 9.6 months with gefitinib and 5.5 months with carboplatin/paclitaxel. Conclusion BICR analysis of IPASS data support the original, investigator-assessed results. EGFR mutation-positive status remains a significant predictor of response to first-line TKI therapy.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85009789298&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/56807
ISSN: 18728332
01695002
Appears in Collections:CMUL: Journal Articles

Files in This Item:
There are no files associated with this item.


Items in CMUIR are protected by copyright, with all rights reserved, unless otherwise indicated.