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First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study 期刊论文 WOS高被引论文

编号：

8e70d4d6-9633-46d9-bf2d-8965dac4fd38
作者：

Wu, Y. L.(吴一龙)#*^[1,2]Zhou, C.^[3];Liam, C. K.^[4];Wu, G.^[5];Liu, X.^[6];Zhong, Z.^[7];Lu, S.^[8];Cheng, Y.^[9];Han, B.^[8];Chen, L.^[10];Huang, C.^[11];Qin, S.^[12];Zhu, Y.(朱允中)^[13]Pan, H.^[14];Liang, H.^[15];Li, E.^[16];Jiang, G.^[17];How, S. H.^[18];Fernando, M. C. L.^[19];Zhang, Y.^[20];Xia, F.^[20];Zuo, Y.^[20];
语种：

英文
期刊：

ANNALS OF ONCOLOGY ISSN：0923-7534 2015 年 26 卷 9 期 (1883 - 1889) ; SEP
收录：
学科：

肿瘤学科肺癌学科
关键词：

NSCLC erlotinib first-line EGFR mutation-positive Asian
摘要：

The phase III, randomized, open-label ENSURE study (NCT01342965) evaluated first-line erlotinib versus gemcitabine/cisplatin (GP) in patients from China, Malaysia and the Philippines with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).
Patients a parts per thousand yen18 years old with histologically/cytologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC and Eastern Cooperative Oncology Group performance status 0-2 were randomized 1:1 to receive erlotinib (oral; 150 mg once daily until progression/unacceptable toxicity) or GP [G 1250 mg/m(2) i.v. days 1 and 8 (3-weekly cycle); P 75 mg/m(2) i.v. day 1, (3-weekly cycle) for up to four cycles]. Primary end point: investigator-assessed progression-free survival (PFS). Other end points include objective response rate (ORR), overall survival (OS), and safety.
A total of 217 patients were randomized: 110 to erlotinib and 107 to GP. Investigator-assessed median PFS was 11.0 months versus 5.5 months, erlotinib versus GP, respectively [hazard ratio (HR), 0.34, 95% confidence interval (CI) 0.22-0.51; log-rank P < 0.0001]. Independent Review Committee-assessed median PFS was consistent (HR, 0.42). Median OS was 26.3 versus 25.5 months, erlotinib versus GP, respectively (HR, 0.91, 95% CI 0.63-1.31; log-rank P = .607). ORR was 62.7% for erlotinib and 33.6% for GP. Treatment-related serious adverse events (AEs) occurred in 2.7% versus 10.6% of erlotinib and GP patients, respectively. The most common grade a parts per thousand yen3 AEs were rash (6.4%) with erlotinib, and neutropenia (25.0%), leukopenia (14.4%), and anemia (12.5%) with GP.
These analyses demonstrate that first-line erlotinib provides a statistically significant improvement in PFS versus GP in Asian patients withEGFR mutation-positive NSCLC (NCT01342965).
推荐引用方式
GB/T 7714：

Wu Y. -L.,Zhou C.,Liam C. -K., et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study [J].ANNALS OF ONCOLOGY,2015,26(9):1883-1889.
APA：

Wu Y. -L.,Zhou C.,Liam C. -K.,Wu G.,&Zuo Y..(2015).First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study .ANNALS OF ONCOLOGY,26(9):1883-1889.
MLA：

Wu Y. -L., et al. "First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study" .ANNALS OF ONCOLOGY 26,9(2015):1883-1889.
入库时间：

11/11/2019 4:51:08 PM
更新时间：

11/11/2019 4:51:08 PM
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