Journal
JOURNAL OF HEMATOLOGY & ONCOLOGY
Volume 8, Issue -, Pages -Publisher
BIOMED CENTRAL LTD
DOI: 10.1186/s13045-015-0151-3
Keywords
IIIA-N2; Biomarker guided; EGFR mutation; Lung cancer; Neoadjuvant therapy
Categories
Funding
- National Natural Science Foundation of China [81001031, 81372285]
- Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine [2012A061400006]
- Special Fund for Research in the Public Interest from National Health and Family Planning Commission of PRC [201402031]
- Guangzhou Science and Technology Bureau [2011Y2-00014]
- Natural Science Foundation of Guangdong [S2013010016354]
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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.
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