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Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non - small-cell lung cancer in Asia (IPASS)

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ชื่อเรื่อง : Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non - small-cell lung cancer in Asia (IPASS)
นักวิจัย : Fukuoka M. , Wu Y. , Thongprasert S. , Sunpaweravong P. , Leong S. , Sriuranpong V. , Chao T. , Nakagawa K. , Chu D. , Saijo N.
คำค้น : -
หน่วยงาน : มหาวิทยาลัยเชียงใหม่
ผู้ร่วมงาน : -
ปีพิมพ์ : 2554
อ้างอิง : 0732183X , 2-s2.0-79960702788 , 10.1200/JCO.2010.33.4235 , https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=79960702788&origin=inward , http://cmuir.cmu.ac.th/jspui/handle/6653943832/43028
ที่มา : -
ความเชี่ยวชาญ : -
ความสัมพันธ์ : -
ขอบเขตของเนื้อหา : -
บทคัดย่อ/คำอธิบาย :

Purpose: The results of the Iressa Pan-Asia Study (IPASS), which compared gefitinib and carboplatin/paclitaxel in previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma were published previously. This report presents overall survival (OS) and efficacy according to epidermal growth factor receptor (EGFR) biomarker status. Patients and Methods: In all, 1,217 patients were randomly assigned. Biomarkers analyzed were EGFR mutation (amplification mutation refractory system; 437 patients evaluable), EGFR gene copy number (fluorescent in situ hybridization; 406 patients evaluable), and EGFR protein expression (immunohistochemistry; 365 patients evaluable). OS analysis was performed at 78% maturity. A Cox proportional hazards model was used to assess biomarker status by randomly assigned treatment interactions for progression-free survival (PFS) and OS. Results: OS (954 deaths) was similar for gefitinib and carboplatin/paclitaxel with no significant difference between treatments overall (hazard ratio [HR], 0.90; 95% CI, 0.79 to 1.02; P = .109) or in EGFR mutation - positive (HR, 1.00; 95% CI, 0.76 to 1.33; P = .990) or EGFR mutation - negative (HR, 1.18; 95% CI, 0.86 to 1.63; P = .309; treatment by EGFR mutation interaction P = .480) subgroups. A high proportion (64.3%) of EGFR mutation - positive patients randomly assigned to carboplatin/paclitaxel received subsequent EGFR tyrosine kinase inhibitors. PFS was significantly longer with gefitinib for patients whose tumors had both high EGFR gene copy number and EGFR mutation (HR, 0.48; 95% CI, 0.34 to 0.67) but significantly shorter when high EGFR gene copy number was not accompanied by EGFR mutation (HR, 3.85; 95% CI, 2.09 to 7.09). Conclusion: EGFR mutations are the strongest predictive biomarker for PFS and tumor response to first-line gefitinib versus carboplatin/paclitaxel. The predictive value of EGFR gene copy number was driven by coexisting EGFR mutation (post hoc analysis). Treatment-related differences observed for PFS in the EGFR mutation - positive subgroup were not apparent for OS. OS results were likely confounded by the high proportion of patients crossing over to the alternative treatment. © 2011 by American Society of Clinical Oncology.

บรรณานุกรม :
Fukuoka M. , Wu Y. , Thongprasert S. , Sunpaweravong P. , Leong S. , Sriuranpong V. , Chao T. , Nakagawa K. , Chu D. , Saijo N. . (2554). Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non - small-cell lung cancer in Asia (IPASS).
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Fukuoka M. , Wu Y. , Thongprasert S. , Sunpaweravong P. , Leong S. , Sriuranpong V. , Chao T. , Nakagawa K. , Chu D. , Saijo N. . 2554. "Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non - small-cell lung cancer in Asia (IPASS)".
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ .
Fukuoka M. , Wu Y. , Thongprasert S. , Sunpaweravong P. , Leong S. , Sriuranpong V. , Chao T. , Nakagawa K. , Chu D. , Saijo N. . "Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non - small-cell lung cancer in Asia (IPASS)."
    เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ , 2554. Print.
Fukuoka M. , Wu Y. , Thongprasert S. , Sunpaweravong P. , Leong S. , Sriuranpong V. , Chao T. , Nakagawa K. , Chu D. , Saijo N. . Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non - small-cell lung cancer in Asia (IPASS). เชียงใหม่ : มหาวิทยาลัยเชียงใหม่ ; 2554.