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

© 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 inv...

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Main 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
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Published: 2018
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/46442
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spelling th-cmuir.6653943832-464422018-04-25T07:28:30Z 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 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 Agricultural and Biological Sciences © 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/m 2 ). 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. 2018-04-25T06:54:58Z 2018-04-25T06:54:58Z 2017-02-01 Journal 18728332 01695002 2-s2.0-85009789298 10.1016/j.lungcan.2016.11.022 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85009789298&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/46442
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Agricultural and Biological Sciences
spellingShingle Agricultural and Biological Sciences
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
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
description © 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/m 2 ). 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.
format Journal
author 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
author_facet 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
author_sort Yi Long Wu
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
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85009789298&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/46442
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