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.

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.

• Authors: Wenzhao Zhong, Xuening Yang, Honghong Yan, Xuchao Zhang, Jian Su, Zhihong Chen, Riqiang Liao, Qiang Nie, Song Dong, Qing Zhou, Jinji Yang, Haiyan Tu, Yi-Long Wu
• Journal: Journal of hematology & oncology (J Hematol Oncol) Vol. 8 Pg. 54 (May 17 2015) ISSN: 1756-8722 [Electronic] England
• PMID: 25981169 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• EGFR protein, human
• ErbB Receptors

Topics

• Carcinoma, Non-Small-Cell Lung (genetics)
• ErbB Receptors (metabolism)
• Female
• Humans
• Lung Neoplasms (genetics)
• Male
• Middle Aged
• Mutation
• Neoadjuvant Therapy
• Neoplasm Staging
• Prognosis