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

Journal of Hematology & Oncology

Yi-Long Wu¹  Haiyan Tu¹  Jinji Yang¹  Qing Zhou¹  Song Dong¹  Qiang Nie¹  Riqiang Liao¹  Zhihong Chen¹  Jian Su¹  Xuchao Zhang¹  Honghong Yan¹  Xuening Yang¹  Wenzhao Zhong¹ 

[1] Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou 510080, Guangdong, People’s Republic of China

关键词: Neoadjuvant therapy;    Lung cancer;    EGFR mutation;    Biomarker guided;    IIIA-N2;   

Others  :  1217411
DOI  :  10.1186/s13045-015-0151-3

 received in 2015-03-02, accepted in 2015-05-07,  发布年份 2015

【 摘 要 】

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 webcite

【 授权许可】

   
2015 Zhong et al.

【 图 表 】

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