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Afatinib in EGFR TKI-naïve patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer: Interim analysis of a phase 3b study

Lung Cancer Dec 21, 2020

de Marinis F, Laktionov KK, Poltoratskiy A, et al. - The suitability of afatinib as a treatment choice for epidermal growth factor receptor mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC) has been reported in randomized controlled trials but patients treated in routine clinical practice are often excluded from such studies, so researchers present interim findings from a phase 3b, open-label, multicenter, single-arm, exploratory trial that tested afatinib in a real-world setting. Until disease progression, or voluntary withdrawal, afatinib 40 mg, once-daily was orally administered to patients with EGFRm + tyrosine kinase inhibitor -naïve NSCLC. Safety was the primary objective. Findings showed good tolerability of afatinib, with no new safety signals, as well as encouraging effectiveness when used in routine clinical practice to treat patients with EGFRm + NSCLC. Experts noted that treatment-related adverse events were generally manageable with tolerability-guided dose decreases. Overall, results from randomized controlled trials of afatinib in EGFRm + NSCLC are independently supported by these observations.

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