Research in context
Evidence before this study
We searched PubMed and ClinicalTrials.gov with the terms “resected NSCLC” and “EGFR”, to identify trials of adjuvant treatments for patients with early-stage non-small-cell lung cancer (NSCLC) and EGFR mutations. We restricted our search to reports published in English between Jan 1, 2002, and Dec 31, 2016. We retrieved reports for two randomised trials—one of gefitinib (BR19) and one of erlotinib (RADIANT)—in which an EGFR tyrosine kinase inhibitor was compared with placebo as adjuvant treatment for resected NSCLC. Results from these trials reported no benefit of EGFR tyrosine kinase inhibitors in the adjuvant setting, although most patients enrolled in both studies had EGFR wild-type tumours. However, results from retrospective analyses and the prospective phase 2 SELECT study suggest that patients with EGFR-mutant stage IB–IIIA resected NSCLC might benefit from adjuvant EGFR tyrosine kinase inhibitor treatment.
Added value of this study
To our knowledge, our study is the first head-to-head, prospective, phase 3 trial to show that adjuvant gefitinib leads to significantly longer disease-free survival compared with that for vinorelbine plus cisplatin in patients with resected stage II–IIIA (N1–N2) NSCLC whose tumours harbour EGFR mutations. Safety, tolerability, and health-related quality of life also favoured gefitinib, and no cases of interstitial lung disease were reported.
Implications of all the available evidence
Adjuvant gefitinib could be considered as a treatment option for patients with stage II–IIIA (N1–N2) EGFR-mutant NSCLC. However, mature overall survival data are needed, and the optimum duration of treatment with tyrosine kinase inhibitors beyond 24 months is uncertain.