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.
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.
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