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  • Title: Afatinib as First-Line Treatment in Asian Patients with EGFR Mutation-Positive NSCLC: A Narrative Review of Real-World Evidence.
    Author: Lu S, Shih JY, Jang TW, Liam CK, Yu Y.
    Journal: Adv Ther; 2021 May; 38(5):2038-2053. PubMed ID: 33730350.
    Abstract:
    Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) are a standard of care in the first-line treatment of patients with EGFR mutation-positive metastatic non-small-cell lung cancer (NSCLC). EGFR mutations are relatively common in Asian patients with NSCLC, and there is an increasing number of studies supporting the effectiveness of the second-generation TKI afatinib in routine clinical practice in Asia. This article reviews these real-world studies investigating afatinib as first-line treatment for EGFR mutation-positive NSCLC in Asian patients. Evidence from real-world studies with afatinib in this patient population supports findings from randomized controlled trials (RCTs) showing that afatinib is associated with more favorable outcomes compared with the first-generation EGFR TKIs. The effectiveness of afatinib has also been shown in real-world studies in Asian patients with poor prognostic factors, who are often under-represented or excluded from RCTs, such as those with uncommon EGFR mutations, brain metastases, or poor performance status, and elderly patients. The tolerability profile of afatinib in the real-world setting reflects that seen in RCTs, with no new safety signals reported in real-world studies in Asian patients with EGFR mutation-positive NSCLC. Dose-modification strategies also seem to be effective in the real world, with results of the RealGido study, which included 44% Asian patients, confirming findings from prospective clinical trials showing that tolerability-guided afatinib dose modifications can reduce the incidence of adverse events without adversely affecting clinical outcomes. While further research, including clinical trial data, is needed, real-world data have also demonstrated the feasibility of sequential afatinib followed by the third-generation TKI osimertinib in T790M-positive EGFR mutation-positive patients, which showed longer overall survival. Together, these real-world results demonstrate the real-world clinical effectiveness of afatinib as first-line treatment for patients with EGFR mutation-positive NSCLC. Some patients with non-small-cell lung cancer (NSCLC) have a mutation in the EGFR gene, whose normal function is to regulate cell division. The proportion of NSCLC patients with these EGFR mutations is particularly high in Asian populations. Treatment of patients with EGFR mutation-positive NSCLC has changed markedly in recent years following the development of drugs called EGFR tyrosine kinase inhibitors (TKIs). Several EGFR TKIs have been developed, and clinical trial data have shown that the second-generation TKI afatinib and the third-generation TKI osimertinib are more effective than the first-generation TKIs erlotinib and gefitinib. However, these clinical trials, known as randomized controlled trials (RCTs), are highly selective, and many patients, such as elderly patients or those in poor health and/or with underlying diseases, are excluded. Consequently, less is known about how well TKIs work in these patients. Therefore, other less-selective studies, known as observational or ‘real-world’ studies, are used to provide information on the safety and effectiveness of EGFR TKIs across all patient groups seen in the clinic, not just those included in RCTs. In this article, we review the real-world evidence for the TKI afatinib as a treatment for Asian patients with EGFR mutation-positive NSCLC. Evidence from these real-world studies confirms that afatinib is more effective than erlotinib and gefitinib in real-world patients in Asia. Importantly, the efficacy and safety of afatinib is seen in groups of Asian patients often excluded from clinical trials including the elderly, those with brain metastases, and frail patients or those with other underlying diseases. Importantly, the safety profile of afatinib was similar to that seen in RCTs, and no additional side effects were identified in real-world patients. Also, importantly, real-world studies show that side effects can be effectively controlled by reducing the dose of afatinib. Real-world studies have also been used to demonstrate the feasibility and effectiveness of the sequential use of EGFR TKIs, particularly in Asian patients.
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