Egfr Mutation And Survival Outcomes In Patients With Completely Resected Lung Adenocarcinoma A Multiple Centers, Non-Interventional Study (Ican Trial)

Y. Wu, X. Chu, J. Wang, Z. Liu, Y. Shen, H. Ma,X. Fu,J. Hu, N. Zhou,Y. Liu, X. Zhou, J. Wang, K. Yang,J. Li,L. Xu,S. Wang,Q. Wang,L. Liu, S. Xu, X. Zhang

ANNALS OF ONCOLOGY(2014)

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摘要
ABSTRACT Aim: ICAN study (NCT01106781) was designed to investigate EGFR gene mutation status, clinical outcomes and recurrent risk factors in early stage Chinese NSCLC patients with adenocarcinoma (ADC) histology after complete resection. Methods: Patients were ≥18 years old, with histological diagnosis of NSCLC ADC, and received surgical complete resection. Tumor sample EGFR mutation status was determined according to clinical routine practice. All eligible patients were followed up for 3 years to collect the clinical information and the survival outcomes. Results: Of 568 patients from 26 sites, 313 (55.1%) patients were EGFR mutation positive. The most common mutations were exon19 deletion and exon 21 L858R mutation found in 139 (24.5%) and 128 (22.5%) patients respectively. 4(0.7%) patients were exon19 deletion + exon 21 L858R mutations and 42 (7.4%) patients were with rare mutations. Frequency of EGFR mutation was not correlated to postoperative pathological stage (P = 0.1047). The 3-year DFS was 58.8%. Subgroup analysis found that 65.6% 3y DFS in EGFR mutant patients and 56.8% in wild type patients (P = 0.0347); 63.8% in exon 19 deletion, 67.2% in exon21 L858R mutation, 100% in exon19 deletion + exon 21 L858R mutations and 63.4% in rare mutations (p = 0.5810). There were 50.7% of the patients who received adjuvant therapy, among which 45.4% received chemotherapy, 4.6% received radiotherapy and 1.8% received TKI therapy, respectively. Among EGFR mutant patients, adjuvant therapy correlated significantly to 3-year DFS (P = 0.0024), but was not significant when adjusted for postoperative pathological stage. Female showed a higher 3-year DFS rate than male patients (67.90% vs 55.70%, P = 0.0041). There was statistically significant difference of 3-year DFS among patients with different postoperative pathologic stage (P Conclusions: The overall EGFR mutation positive rate in operable Chinese ADC was 55.1%. 3-year DFS rate was 58.8%. EGFR mutant patients have a favorable 3-year DFS compared with EGFR wild type. Postoperative pathologic stage had a statistically significant association with 3-year DFS, while age, smoking pack-years didn't show statistically significant associations with 3-year DFS. Disclosure: Y. Wu: Recieved speaker fees from AstraZeneca, Roche, Eli Lilly, Sanofi, Pfizer. All other authors have declared no conflicts of interest.
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