A real‐world study of dacomitinib in later‐line settings for advanced non‐small cell lung cancer patients harboring EGFR mutations

OBJECTIVE: Dacomitinib has been approved for the first‐line treatment of non‐small cell lung cancer (NSCLC) carrying classical epidermal growth factor receptor (EGFR) mutations; however, real‐world data on its later‐line application are lacking. MATERIALS AND METHODS: Patients’ data were retrospectively collected from the Chinese National Cancer Center and the PLA hospital between August 2019 and August 2021. Kaplan‐Meier method and Log‐rank test were utilized to assess progression‐free survival (PFS) and overall survival (OS). Univariate and multivariate Cox regression analysis was conducted to determine prognostic indicators. RESULTS: In total, 56 NSCLC patients harboring EGFR mutations treated with later‐line single dacomitinib or combinatory dacomitinib were enrolled. A total of 53 patients (94.6%) had treatment‐related adverse events; eight patients (14.3%) had grade 3 or 4 events. Among 49 evaluable patients, 26.5% (13 patients) had a confirmed partial response and 73.5% (36 patients) had disease control; the median duration of follow‐up was 9.6 months (95% confidence interval [CI], 8.4–10.8 months), the median progression‐free survival was 5.4 months (95% CI, 3.5–7.3 months), and the half‐year, 1‐year, and 2‐year OS rate were 79.2%, 70.6%, and 64.1%, respectively. Univariate analysis suggested that smoking, line of dacomitinib, and interval between last EGFR‐tyrosine kinase inhibitor (TKI) and dacomitinib were associated with PFS and OS; chemotherapy between last EGFR‐TKI and dacomitinib, and EGFR‐TKI generation followed by dacomitinib were respectively associated with PFS and OS; multivariate analysis indicated chemotherapy between last EGFR‐TKI and dacomitinib negatively affect PFS, and smoking and third‐generation EGFR‐TKI followed by dacomitinib negatively affect OS. CONCLUSIONS: This real‐world study has shown that dacomitinib is active and well‐tolerated in NSCLC patients harboring different EGFR mutations in later‐line settings, even for those with brain metastases. Patients who benefited more from the first TKI were more likely to benefit from dacomitinib, and earlier application of dacomitinib after front‐line TKI resistance may be considered.