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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

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ชื่อเรื่อง : 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
นักวิจัย : Wu Y. , Saijo N. , Thongprasert S. , Yang J. , Han B. , Margono B. , Chewaskulyong B. , Sunpaweravong P. , Ohe Y. , Ichinose Y. , Yang J. , Mok T. , Young H. , Haddad V. , Rukazenkov Y. , Fukuoka M.
คำค้น : -
หน่วยงาน : มหาวิทยาลัยเชียงใหม่
ผู้ร่วมงาน : -
ปีพิมพ์ : 2560
อ้างอิง : 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/6653943832/40817
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ความเชี่ยวชาญ : -
ความสัมพันธ์ : -
ขอบเขตของเนื้อหา : -
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© 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.

บรรณานุกรม :
Wu Y. , Saijo N. , Thongprasert S. , Yang J. , Han B. , Margono B. , Chewaskulyong B. , Sunpaweravong P. , Ohe Y. , Ichinose Y. , Yang J. , Mok T. , Young H. , Haddad V. , Rukazenkov Y. , Fukuoka M. . (2560). 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.
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Wu Y. , Saijo N. , Thongprasert S. , Yang J. , Han B. , Margono B. , Chewaskulyong B. , Sunpaweravong P. , Ohe Y. , Ichinose Y. , Yang J. , Mok T. , Young H. , Haddad V. , Rukazenkov Y. , Fukuoka M. . 2560. "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".
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Wu Y. , Saijo N. , Thongprasert S. , Yang J. , Han B. , Margono B. , Chewaskulyong B. , Sunpaweravong P. , Ohe Y. , Ichinose Y. , Yang J. , Mok T. , Young H. , Haddad V. , Rukazenkov Y. , Fukuoka M. . "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."
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ , 2560. Print.
Wu Y. , Saijo N. , Thongprasert S. , Yang J. , Han B. , Margono B. , Chewaskulyong B. , Sunpaweravong P. , Ohe Y. , Ichinose Y. , Yang J. , Mok T. , Young H. , Haddad V. , Rukazenkov Y. , Fukuoka M. . 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. เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ ; 2560.