Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non–Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study

Author:

Zhong Wen-Zhao1,Chen Ke-Neng2,Chen Chun3,Gu Chun-Dong4,Wang Jun5,Yang Xue-Ning1,Mao Wei-Min6,Wang Qun7,Qiao Gui-Bin18,Cheng Ying9,Xu Lin10,Wang Chang-Li11,Chen Ming-Wei12,Kang Xiaozheng2,Yan Wanpu2,Yan Hong-Hong1,Liao Ri-Qiang1,Yang Jin-Ji1,Zhang Xu-Chao1,Zhou Qing1,Wu Yi-Long1

Affiliation:

1. Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People’s Republic of China

2. Peking University Cancer Hospital and Institute, Beijing, People’s Republic of China

3. Fujian Medical University Union Hospital, Fuzhou, People’s Republic of China

4. First Affiliated Hospital of Dalian Medical University, Dalian, People’s Republic of China

5. Peking University People’s Hospital, Beijing, People’s Republic of China

6. Zhejiang Cancer Hospital, Hangzhou, People’s Republic of China

7. Zhongshan Hospital, Shanghai, People’s Republic of China

8. Guangzhou Liuhuaqiao Hospital, Guangzhou, People’s Republic of China

9. Jilin Provincial Tumor Hospital, Changchun, People’s Republic of China

10. Jiangsu Cancer Institute and Hospital, Nanjing, People’s Republic of China

11. Tianjin Medical University Cancer Institute and Hospital, Tianjin, People’s Republic of China

12. First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China

Abstract

PURPOSE To assess the benefits of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as neoadjuvant/adjuvant therapies in locally advanced EGFR mutation-positive non–small-cell lung cancer. PATIENTS AND METHODS This was a multicenter (17 centers in China), open-label, phase II, randomized controlled trial of erlotinib versus gemcitabine plus cisplatin (GC chemotherapy) as neoadjuvant/adjuvant therapy in patients with stage IIIA-N2 non–small-cell lung cancer with EGFR mutations in exon 19 or 21 (EMERGING). Patients received erlotinib 150 mg/d (neoadjuvant therapy, 42 days; adjuvant therapy, up to 12 months) or gemcitabine 1,250 mg/m2 plus cisplatin 75 mg/m2 (neoadjuvant therapy, two cycles; adjuvant therapy, up to two cycles). Assessments were performed at 6 weeks and every 3 months postsurgery. The primary end point was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; secondary end points were pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability. RESULTS Of 386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment). The ORR for neoadjuvant erlotinib versus GC chemotherapy was 54.1% versus 34.3% (odds ratio, 2.26; 95% CI, 0.87 to 5.84; P = .092). No pathologic complete response was identified in either arm. Three (9.7%) of 31 patients and zero of 23 patients in the erlotinib and GC chemotherapy arms, respectively, had a major pathologic response. Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67; P < .001). Observed adverse events reflected those most commonly seen with the two treatments. CONCLUSION The primary end point of ORR with 42 days of neoadjuvant erlotinib was not met, but the secondary end point PFS was significantly improved.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3