Hornberger John, Hirsch Fred R, Li Qianyi, Page Ray D
Department of Internal Medicine, Stanford University School of Medicine, 291 Campus Dr., Stanford, CA 94305, USA; Cedar Associates LLC, 3715 Haven Avenue, Suite 100, Menlo Park, CA 94025, USA.
Departments of Medicine and Pathology, Colorado University of Colorado Cancer Center, 1665 Aurora Ct, Aurora, CO 80045, USA.
Lung Cancer. 2015 May;88(2):223-30. doi: 10.1016/j.lungcan.2015.03.006. Epub 2015 Mar 12.
Lung cancer accounts for a significant number of new cancer cases and deaths, with the majority of patients presenting with non-small cell lung cancer (NSCLC). Although epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors are recommended as an alternative to chemotherapy for certain patients, challenges exist for clinical utilization. The objective of this analysis was to assess the outcome and economic implications of a clinically validated serum-based proteomic test to guide treatment decisions in patients with advanced NSCLC, who are EGFR-negative or status unknown, and have progressed following at least one chemotherapy regimen.
This analysis was conducted from a US payer perspective. Clinical outcomes were evaluated over the lifetime of a patient, based on data from randomized trials and clinical studies. The clinical endpoints included treatment utilization, adverse events, survival, and a composite measure of length and quality of life, referred to as the quality-adjusted life year (QALY). Costs for testing, treatment, surveillance, and management of adverse events were analyzed based on publicly available costs of the related procedures. The economic endpoints were cumulative lifetime direct medical costs and cost per QALY gained.
In the base case, treatment recommendation for 27.3% of the patient population changed from erlotinib to chemotherapy after using the proteomic test. Overall survival increased by 0.091 year and QALYs increased by 0.050 year. The total lifetime direct medical cost per patient decreased by $135 with test-guided treatment. The findings were robust over a wide range of variation in the input parameters.
The serum-based proteomic test informed treatment selection for patients with advanced NSCLC who failed previous chemotherapy regimen(s), improving QALYs and saving costs.
肺癌占新增癌症病例和死亡人数的很大比例，大多数患者为非小细胞肺癌（NSCLC）。尽管表皮生长因子受体（EGFR）酪氨酸激酶抑制剂被推荐作为某些患者化疗的替代方案，但临床应用仍存在挑战。本分析的目的是评估一种经过临床验证的基于血清的蛋白质组学检测对晚期NSCLC患者治疗决策的影响及经济意义，这些患者EGFR为阴性或状态未知，且在至少一种化疗方案后病情进展。
本分析从美国医保支付方的角度进行。基于随机试验和临床研究的数据，对患者的终身临床结局进行评估。临床终点包括治疗利用情况、不良事件、生存率以及长度和生活质量的综合指标，即质量调整生命年（QALY）。根据相关程序的公开成本，分析检测、治疗、监测和不良事件管理的成本。经济终点为累积终身直接医疗成本和每获得一个QALY的成本。
在基础病例中，使用蛋白质组学检测后，27.3%的患者群体的治疗推荐从厄洛替尼改为化疗。总生存期增加了0.091年，QALY增加了0.050年。检测指导治疗使每位患者的终身直接医疗总成本降低了135美元。在输入参数的广泛变化范围内，研究结果具有稳健性。
基于血清的蛋白质组学检测为先前化疗方案失败的晚期NSCLC患者的治疗选择提供了依据，改善了QALY并节省了成本。
