Gefitinib adjuvant therapy for patients with completely resected stage II-IIIA EGFR-mutant non-small cell lung cancer (NSCLC) significantly prolonged disease-free survival (DFS) compared with vinorelbine plus cisplatin, a study published in Lancet Oncology has shown.

A previous study cast doubt on the efficacy of adjuvant therapy with tyrosine kinase inhibitors in the treatment of NSCLC, but a long-term analysis revealed that there may be potential benefit for patients with EGFR-mutated disease. 

For this randomized, phase 3 study, researchers assigned 222 patients with exon 19 deletion or exon Leu585Arg NSCLC who underwent complete resection to receive oral gefitinib daily for 2 years vs intravenous vinorelbine plus IV cisplatin for 4 cycles.

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After a median follow-up of nearly 37 months, patients in the gefitinib arm had a significantly prolonged DFS of 28.7 months (95% CI, 24.9-32.5) compared with 18.0 months (95% CI, 13.6-22.3) among patients in the vinorelbine plus cisplatin arm (hazard ratio [HR], 0.60; 95% CI, 0.42-0.87; P =.0054).

In the safety population, which included all study patients treated with at least 1 dose of treatment, the most frequently reported grade 3 or worse adverse event (AE) for the gefitinib arm was elevated ALT/AST. Patients in the vinorelbine plus cisplatin arm reported grade 3 or greater AEs of neutropenia, leukopenia, and vomiting. Seven percent and 23% of patients in the gefitinib arm compared with the vinorelbine arm reported experiencing serious AEs.

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The authors noted that data for duration of benefit and overall survival is still pending, but concluded that “[b]ased on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients.”


Zhong WZ, Wang Q, Nai WM, et al. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II_IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study [Published online November 21,2017]. Lancet Oncol. doi: 10.1016/S1470-2045(17)30729-5