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The EGFR tyrosine kinase inhibitors as second-line therapy for EGFR wild-type non-small-cell lung cancer: a real-world study in People’s Republic of China
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Abstract
Introduction
Clinical evidence comparing chemotherapy and tyrosine kinase inhibitors (TKIs) as
second-line therapy for epidermal growth factor receptor (EGFR) wild-type non-small-cell
lung cancer (NSCLC) are conflicting.
Methods
We retrospectively reviewed stage IV EGFR wild-type NSCLC patients who relapsed on
first-line chemotherapy at the Shanghai Chest Hospital to compare the efficacy of
TKIs and chemotherapy as second-line therapy among different clinical subgroups.
Results
The progression-free survival (PFS) and overall survival for patients receiving chemotherapy
as second-line therapy for NSCLC were longer than patients who received TKIs. The
hazard ratios (HRs) were 0.40 (
P<0.001) and 0.50 (
P<0.001), respectively. Subgroup analyses showed that second-line TKI therapy resulted
in inferior PFS among smokers (HR =0.24,
P<0.001), males (HR =0.33,
P<0.001), females (HR =0.54,
P=0.004), and patients with adenocarcinoma (HR =0.48,
P<0.001) and nonadenocarcinoma histology (HR =0.20,
P<0.001). Among never-smokers, the PFS in cohorts receiving second-line chemotherapy
or TKIs was not significantly different (HR =0.70,
P=0.08).
Conclusion
These results suggest that EGFR TKI therapy was inferior compared to chemotherapy
in EGFR wild-type NSCLC patients who relapsed from first-line chemotherapy; however,
among never-smokers, these two treatment strategies were comparable.
Our aim was to determine whether abundance of epidermal growth factor receptor (EGFR) mutations in tumors predicts benefit from treatment with EGFR-tyrosine kinase inhibitors (TKIs) for advanced non-small-cell lung cancer (NSCLC). We detected EGFR mutations in 100 lung cancer samples using direct DNA sequencing and amplification refractory mutation system (ARMS). Mutation-positive tumors by both methods carried high abundance of EGFR mutations. Tumors that were mutation positive by ARMS but mutation negative by direct DNA sequencing harbored low abundance of EGFR mutations. Mutation-negative tumors by both methods carried wild-type EGFR. All patients received gefitinib treatment. The correlation between EGFR mutation abundance and clinical benefit from gefitinib treatment was analyzed. Of 100 samples, 51 and 18 harbored high and low abundances of EGFR mutations, respectively; 31 carried wild-type EGFR. Median progression-free survival (PFS) was 11.3 (95% CI, 7.4 to 15.2) and 6.9 months (95% CI, 5.5 to 8.4) in patients with high and low abundances of EGFR mutations, respectively (P = .014). Median PFS of patients with low abundance of EGFR mutations was significantly longer than that of those with wild-type tumors (2.1 months; 95% CI, 1.0 to 3.2; P = .010). Objective response rates (ORRs) were 62.7%, 44.4%, and 16.1%, and overall survival (OS) rates were 15.9 (95% CI, 13.4 to 18.3), 10.9 (95% CI, 2.7 to 19.1), and 8.7 months (95% CI, 4.6 to 12.7) for patients with high abundance of EGFR mutations, low abundance of EGFR mutations, and wild-type EGFR, respectively. The difference between patients with high and low abundances of EGFR mutations was not significant regarding ORR and OS. The relative EGFR mutation abundance could predict benefit from EGFR-TKI treatment for advanced NSCLC.
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