Treatment of patients aged 75 years and older with advanced, EGFR mutation-positive non-small cell lung cancer with afatinib was found to be associated with high response rates and improved survival, although dose adjustments were common, according to the results of a phase 2 trial published in BMC Cancer.

Subgroup analyses of the LUX-Lung trials demonstrated that afatinib was tolerable and effective among patients with advanced EGFR-mutated NSCLC, regardless of age. The aim of this study was to evaluate the efficacy and safety of afatinib specifically among patients aged 75 years and older.

The open-label, multicenter, single-arm phase 2 North East Japan Study Group trial NEJ027 included 38 patients with previously untreated, EGFR-mutated, advanced NSCLC who underwent treatment with afatinib at a dose of 40 mg. The primary endpoint was objective response rate (ORR) and secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.

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At baseline, the median age was 77 years; 40.5% of patients were men, and 67.6% of patients were never smokers. The majority of patients had stage IV disease and 83.8% had comorbidities. Brain metastases were present among 35.1% of patients. EGFR mutations included an exon 19 deletion among 59.5% of patients and an L858R mutation among 40.5% of patients.

Among the 37 evaluable patients, the ORR was 75.7%, which included 2 complete responses. During a median follow-up of 838 days, the median PFS was 14.2 months. The median OS was 35.2 months, which translated to a 2-year OS of 78.3%.

Dose reductions were common, with 78.9% of patients requiring a dose reduction due to treatment-related adverse events (TRAEs). Treatment discontinuation due to TRAEs occurred among 21.1% of patients. Diarrhea, paronychia, and rash/acne were the most commonly reported grade 3 to 4 TRAEs. There were no treatment-related deaths reported.

The authors concluded that, “these findings support the use of first-line afatinib at a starting dose of 40 mg in elderly EGFR mutation–positive patients with NSCLC.”


Minegishi Y, Yamaguchi O, Sugawara S, et al. A phase II study of first-line afatinib for patients aged ≥75 years with EGFR mutation-positive advanced non-small cell lung cancer: North East Japan Study Group trial NEJ027. BMC Cancer. 2021;21:208. doi:10.1186/s12885-021-07861-1