An Observational Study to Assess the Molecular Epidemiology and Direct Medical Costs of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer Treated with Afatinib in Real-World Clinical Settings in Greece.
Giannis Mountzios, Sofia Lampaki, Georgia-Angeliki Koliou, Athanassios Vozikis, Ioannis Kontogiorgos, Panagiotis Papantoniou, Margarita-Ioanna Koufaki, Eleni Res, Anastasios Boutis, Athina Christopoulou, Nicoleta Pastelli, Anastasios Grivas, Gerasimos Aravantinos, Efthalia Lalla, Georgios Oikonomopoulos, Anna Koumarianou, Dionisios Spyratos, Dimitrios Bafaloukos, Georgios Rigakos, Pavlos Papakotoulas, George Fountzilas, Helena Linardou
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引用次数: 1
Abstract
Purpose: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the preferred first-line option for patients with advanced, EGFR-mutant non-small cell lung cancer (NSCLC). Afatinib, a second-generation irreversible EGFR-TKI, has been extensively used in Greece in this setting; however, real-world data regarding molecular epidemiology and financial implications of afatinib use are lacking.
Materials and methods: This was an observational, non-interventional, multicenter, retrospective cohort study, based on real-world data collected from the medical charts/records of patients treated with afatinib between 15/03/2015 and 25/06/2020 and were recorded on a web-based data capture system. Cox models were used to assess the prognostic significance of clinicopathological parameters with respect to clinical outcomes of interest. Cost analysis was conducted from a public third-payer perspective, and only direct medical costs reimbursed by the payer were considered.
Results: A total of 59 patients were treated with afatinib for their EGFR mutation-positive advanced NSCLC; the median age was 61 years (range: 37-91). Performance status was zero in 61%, and brain metastases were present in 13.6%. Forty-four patients (74.6%) had a deletion in exon 19 only, while nine (15.3%) had a mutation in exon 21, 8 of them in L858R and one in L861Q. At a median follow-up of 41.8 months (95% CI 35.9-51.4), the median PFS was 14.3 months (95% CI 12.2-16.4), and the median OS was 29 months (95% CI 25.6-33.4). Corresponding values for patients with deletion 19 only were 14.3 months (95% CI 11.5-18.5) and 28.1 months (95% CI 21.1-32.6), respectively. The mean expenditure for the treatment of each patient equals €25,333.68; with €21,865.06 being attributed to drug acquisition costs, €3325.35 to monitoring costs and €143.27 to adverse event treatment-related costs.
Conclusion: Long-term data in the real-world setting in Greece confirm activity, tolerability and cost-effectiveness of afatinib as first-line treatment of patients with advanced EGFR-mutant NSCLC.
目的:表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKIs)是晚期EGFR突变的非小细胞肺癌(NSCLC)患者的首选一线治疗方案。Afatinib是第二代不可逆EGFR-TKI,已在希腊广泛使用。然而,关于使用阿法替尼的分子流行病学和财务影响的实际数据缺乏。材料和方法:这是一项观察性、非介入性、多中心、回顾性队列研究,基于从2015年3月15日至2020年6月25日接受阿法替尼治疗的患者的医疗图表/记录中收集的真实数据,并记录在基于网络的数据采集系统上。Cox模型用于评估临床病理参数对临床结果的预后意义。成本分析是从公共第三方付款人的角度进行的,只考虑付款人报销的直接医疗费用。结果:共有59例EGFR突变阳性的晚期NSCLC患者接受了阿法替尼治疗;中位年龄为61岁(范围:37-91岁)。61%的患者表现为零,13.6%的患者出现脑转移。44例(74.6%)患者仅在外显子19缺失,9例(15.3%)外显子21突变,其中8例在L858R, 1例在L861Q。中位随访41.8个月(95% CI 35.9-51.4),中位PFS为14.3个月(95% CI 12.2-16.4),中位OS为29个月(95% CI 25.6-33.4)。仅缺失19的患者相应值分别为14.3个月(95% CI 11.5-18.5)和28.1个月(95% CI 21.1-32.6)。每位患者的平均治疗费用为25,333.68欧元;其中药品采购成本为21865.06欧元,监测成本为3325.35欧元,不良事件治疗相关成本为143.27欧元。结论:希腊现实世界的长期数据证实了阿法替尼作为晚期egfr突变NSCLC患者一线治疗的活性、耐受性和成本效益。临床试验注册:Clinicaltrials.gov NCT04640870。