背景:预测性生物标志物检测在非小细胞肺癌(NSCLC)患者的治疗决策中具有关键作用,并且是(国际)国家指南的要求。这项研究的目的是在2019年在荷兰建立遵循指南的生物标志物检测率,并检查人口统计,临床,和环境因素与指南依从性测试。
方法:本研究涉及荷兰癌症注册中心的临床数据与荷兰全国病理学数据库的病理学报告的整合。从这些报告中提取的数据包括样本类型,诊断,和预测性生物标志物的分子检测状态。研究人群包括2019年在荷兰诊断为转移性非鳞状NSCLC的所有患者。
结果:在接受调查的3877例转移性非鳞状细胞肺癌患者队列中,非融合预测性生物标志物的总体分子检测率(EGFR,KRAS,BRAF,ERBB2,MET)范围为73.9%至89.0%,而融合驱动剂的分子测试(ALK,ROS1,RET,NTRK)的范围为12.6%至63.9%。EGFR的指导依附性检测,KRAS,85.2%的患者进行了ALK,地区率从76.0%到90.8%。与遵循指南的生物标志物测试相关的人口统计学和临床因素包括年龄较低(OR=1.05/1年下降;p<0.001),女性(OR=1.36;p=0.002),诊断为腺癌(OR=2.48;p<0.001),组织学肿瘤材料的可用性(OR=2.46;p<0.001),和转移性疾病的临床分期(p=0.002)。与遵循指南的生物标志物检测相关的其他因素包括学术中心的诊断(OR=1.87;p=0.002)和患者居住地区(p<0.001)。
结论:需要优化荷兰NSCLC患者的预测性生物标志物检测的护理链,以便为这些患者提供充分的护理。
BACKGROUND: Predictive biomarker testing has a key role in the treatment decision-making for patients with non-small cell lung cancer (NSCLC) and is mandated by (inter)national guidelines. The aim of this study was to establish guideline-adherent biomarker testing rates in the Netherlands in 2019 and to examine associations of demographical, clinical, and environmental factors with guideline-adherent testing.
METHODS: This study involved the integration of clinical data of the Netherlands Cancer Registry with pathology reports of the Dutch Nationwide Pathology Databank. Data extracted from these reports included sample type, diagnosis, and molecular testing status of predictive biomarkers. The study population comprised all patients diagnosed with metastatic non-squamous NSCLC in the Netherlands in 2019.
RESULTS: In the cohort of 3877 patients with metastatic non-squamous NSCLC under investigation, overall molecular testing rates for non-fusion predictive biomarkers (EGFR, KRAS, BRAF, ERBB2, MET) ranged from 73.9 to 89.0 %, while molecular testing for fusion-drivers (ALK, ROS1, RET, NTRK) ranged from 12.6 % to 63.9 %. Guideline-adherent testing of EGFR, KRAS, and ALK was performed in 85.2 % of patients, with regional rates spanning from 76.0 % to 90.8 %. Demographical and clinical factors associated with guideline-adherent biomarker testing included lower age (OR = 1.05 per one year decrease; p < 0.001), female sex (OR = 1.36; p = 0.002), diagnosis of adenocarcinoma (OR = 2.48; p < 0.001), availability of histological tumor material (OR = 2.46; p < 0.001), and clinical stage of metastatic disease (p = 0.002). Other factors associated with guideline-adherent biomarker testing included diagnosis at academic center (OR = 1.87; p = 0.002) and patient\'s region of residence (p < 0∙001).
CONCLUSIONS: Optimization of the chain-of-care of predictive biomarker testing in patients with NSCLC in the Netherlands is needed to provide adequate care for these patients.