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J Hematol Oncol. 2015 May 17;8:54. doi: 10.1186/s13045-015-0151-3.

Phase II study of biomarker-guided neoadjuvant treatment strategy for IIIA-N2 non-small cell lung cancer based on epidermal growth factor receptor mutation status.

Author information

1
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. 13609777314@163.com.
2
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. yangxncn@qq.com.
3
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. yanhonghong385@126.com.
4
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. zhxuchao3000@hotmail.com.
5
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. 13725338633@139.com.
6
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. wczh2002@163.com.
7
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. gzfekl@hotmail.com.
8
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. bulaier6480@163.com.
9
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. dsong@aliyun.com.
10
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. gzzhouqing@126.com.
11
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. yangjinji2003@163.com.
12
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. thoraciconcology88@163.com.
13
Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, People's Republic of China. syylwu@live.cn.

Abstract

BACKGROUND:

Neoadjuvant erlotinib and customized adjuvant therapy are appealing but controversial. The purpose of this study was to evaluate the role of biomarker-guided neoadjuvant treatment strategy in patients with IIIA-N2 non-small cell lung cancer (NSCLC) stratified by epidermal growth factor receptor (EGFR) mutation status.

FINDINGS:

Patients with resectable histologically documented stage IIIA-N2 NSCLC were assigned to a neoadjuvant erlotinib arm or a gemcitabine/carboplatin (GC) arm based on EGFR mutation status. The primary endpoint was response rate (RR). Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Twenty-four patients with IIIA-N2 NSCLC were enrolled in the trial from January 2008 until May 2011. The overall response rate was 41.7% and the PFS and OS were 7.9 and 23.2 months, respectively, in overall population. The RR was 58.3% (7/12) for the erlotinib arm with mutant EGFR and 25.0% (3/12) for the GC arm with wild type EGFR (P = 0.18). Median PFS was 6.9 months versus 9.0 months, respectively (P = 0.071). Median OS was 14.5 months for the erlotinib arm and 28.1 months for the GC arm (P = 0.201). No unexpected toxicities were observed.

CONCLUSIONS:

The primary endpoint was met and biomarker-guided neoadjuvant treatment strategy in patients with IIIA-N2 NSCLC is feasible. Erlotinib alone in neoadjuvant setting of EGFR mutant population showed an improved response but without survival benefits.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00600587 https://www.clinicaltrials.gov/ct2/show/NCT00600587?term=NCT00600587&rank=1.

PMID:
25981169
PMCID:
PMC4455050
DOI:
10.1186/s13045-015-0151-3
[Indexed for MEDLINE]
Free PMC Article

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