Effect of Dose Adjustments on the Safety and Efficacy of Afatinib in Chinese Patients with EGFR-Mutated Non-Small Cell Lung Cancer Who Participated in the LUX-Lung Clinical Trial Program.
作者： Hai-Yan Tu , Yi-Long Wu
DOI: 10.2147/OTT.S273866
关键词: Medicine 、 Clinical trial 、 Post-hoc analysis 、 Internal medicine 、 Gefitinib 、 Lung cancer 、 Oncology 、 Adverse effect 、 Clinical endpoint 、 Afatinib 、 Tolerability
摘要: Background Post hoc analysis of the LUX-Lung 3 and 6 (LL3/6) Phase III trials showed that tolerability-guided dose-adjustments afatinib reduced treatment-related adverse events (TRAEs) without affecting progression-free survival (PFS) in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). The current post evaluated outcomes dose adjustments enrolled LL3/6/7 Chinese centers. Patients Methods had advanced EGFR NSCLC. LL3 LL7 recruited globally (including China) LL6 Asian from China, Thailand, South Korea. In LL6, were randomized to 40 mg/day or cisplatin-based chemotherapy. IIb trial, gefitinib. Tolerability-guided permitted for TRAEs, PFS was primary endpoint. This pooled data centers analyzed frequency severity TRAEs before after reductions during first months. overall (OS) compared who a reduction months those did not. Results Overall, 299 centers; 68 (23%) <40 Prior reduction, 55/68 (81%) experienced grade ≥3 TRAE versus 13/68 (19%) reduction. Grade much more common than Median 11.0 both groups, median OS not differ significantly: 23.1 26.9 reduction. Conclusion adjustment is an effective strategy reduce efficacy patients.
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