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Background  Epidermal growth factor receptor ( EGFR ) mutations occur in about 50% of Asian patients with non‐small cell lung cancer ( NSCLC ). Patients with advanced  NSCLC  and  EGFR  mutations derive clinical benefit from treatment with  EGFR ‐tyrosine kinase inhibitors ( TKIs ). This study assessed the efficacy and safety of adjuvant icotinib without chemotherapy in  EGFR ‐mutated  NSCLC  patients undergoing resection of stage  IB – IIIA .    Methods  Our retrospective study enrolled 20 patients treated with icotinib as adjuvant therapy. Survival factors were evaluated by univariate and Cox regression analysis.    Results  The median follow‐up time was 30 months (range 24–41). At the data cut‐off, five patients (25%) had recurrence or metastasis and one patient had died of the disease. The two‐year disease‐free survival ( DFS ) rate was 85%. No recurrence occurred in the high‐risk stage  IB  subgroup during the follow‐up period. In univariate analysis, the micropapillary pattern had a statistically significant effect on  DFS  (  P   = 0.040). Multivariate logistic regression analysis showed that there was no independent predictor. Drug related adverse events ( AEs ) occurred in nine patients (45.0%). The most common  AE s were skin‐related events and diarrhea, but were relatively mild. No grade 3  AE s or occurrences of intolerable toxicity were observed.    Conclusions  Icotinib as adjuvant therapy is effective in patients harboring  EGFR  mutations after complete resection, with an acceptable  AE  profile. Further trials with larger sample sizes might confirm the efficiency of adjuvant  TKI  in selected patients.

Retrospective study of adjuvant icotinib in postoperative lung cancer patients harboring epidermal growth factor receptor mutations