https://scholars.lib.ntu.edu.tw/handle/123456789/494988
標題: | Gefitinib maintenance therapy versus gefitinib monotherapy in east asian never-smoker patients with locally advanced or metastatic nonsquamous non-small cell lung cancer: Final overall survival results from a randomized phase 3 study | 作者: | CHIH-HSIN YANG Srimuninnimit V Ahn M.-J CHIA-CHI LIN Kim S.-W Tsai C.-M Mok T Orlando M Puri T Wang X Park K. |
公開日期: | 2016 | 出版社: | Lippincott Williams and Wilkins | 卷: | 11 | 期: | 3 | 起(迄)頁: | 370-379 | 來源出版物: | Journal of Thoracic Oncology | 摘要: | Introduction: The primary analysis of this open-label, randomized, multicenter phase 3 study revealed no significant difference in progression-free survival between pemetrexed plus cisplatin followed by maintenance gefitinib (PC/G) and gefitinib monotherapy (G) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) and unknown epidermal growth factor receptor gene (EGFR) mutation status; however, the hazard ratio favored PC/G. This report describes the final overall survival (OS) results. Methods: Chemonaive, East Asian light ex-smokers/neversmokers with advanced nonsquamous NSCLC and unknown EGFR mutation status were randomized (1:1) to PC/G (n = 118) or G (n = 118). EGFR mutation status was retrospectively determined for 76 patients, 52 (68.4%) of whom had EGFR-mutated tumors (exon 19 deletions in 26 and L858R point mutation in 24). OS was analyzed by the Kaplan-Meier method. The study was registered at ClinicalTrials.gov (NCT01017874). Results: Median OS was similar in the PC/G (26.9 months) and G (27.9 months) groups (hazard ratio = 0.94, 95% confidence interval: 0.68-1.31, p = 0.717). Median OS was longer with PC/G than with G in patients with EGFR wildtype tumors (28.4 versus 8.9 months) and longer with G than with PC/G in patients with EGFR-mutated tumors (45.7 versus 32.4 months), especially those with exon 19 deletions. Second-line postdiscontinuation therapy was common and included chemotherapy (PC/G, 41 of 118 [34.7%]; G, 73 of 118 [61.9%]) and rechallenge with an EGFR tyrosine kinase inhibitor (PC/G, 27 of 118 [22.9%]; G, 9 of 118 [7.6%]). Conclusions: The progression-free survival and OS results from this study further demonstrate the importance of determining EGFR mutation status to select the most appropriate first-line treatment for patients with advanced NSCLC. ? 2015 International Association for the Study of Lung Cancer. Published by Elsevier Inc. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84962549634&doi=10.1016%2fj.jtho.2015.11.008&partnerID=40&md5=f3ddf2a35c8e94a97d30a656bee7cd8a https://scholars.lib.ntu.edu.tw/handle/123456789/494988 |
ISSN: | 1556-0864 | DOI: | 10.1016/j.jtho.2015.11.008 | SDG/關鍵字: | afatinib; cisplatin; epidermal growth factor receptor kinase inhibitor; erlotinib; gefitinib; pemetrexed; antineoplastic agent; cisplatin; gefitinib; pemetrexed; quinazoline derivative; adult; advanced cancer; aged; cancer patient; comparative study; Conference Paper; controlled study; decreased appetite; diarrhea; drug safety; drug tolerability; drug withdrawal; East Asian; EGFR gene; exon; female; gene deletion; human; Kaplan Meier method; maintenance therapy; major clinical study; male; monotherapy; multicenter study (topic); multiple cycle treatment; nausea; non small cell lung cancer; overall survival; phase 3 clinical trial (topic); point mutation; priority journal; progression free survival; pruritus; randomized controlled trial (topic); rash; receptor gene; retrospective study; smoking; vomiting; wild type; Asian continental ancestry group; Carcinoma, Non-Small-Cell Lung; clinical trial; genetics; Lung Neoplasms; middle aged; multicenter study; pathology; phase 3 clinical trial; randomized controlled trial; Antineoplastic Combined Chemotherapy Protocols; Asian Continental Ancestry Group; Carcinoma, Non-Small-Cell Lung; Cisplatin; Female; Humans; Lung Neoplasms; Male; Middle Aged; Pemetrexed; Quinazolines |
顯示於: | 腫瘤醫學研究所 |
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