Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, Tennessee.
Thoracic Oncology Research Group, Baptist Cancer Center, Memphis, Tennessee.
J Thorac Oncol. 2021 May;16(5):774-783. doi: 10.1016/j.jtho.2021.01.1618. Epub 2021 Feb 12.
The adverse prognostic impact of poor pathologic nodal staging has stimulated efforts to heighten awareness of the problem through guidelines, without guidance on processes to overcome it. We compared heightened awareness (HA) of nodal staging quality versus a lymph node collection kit.
We categorized curative-intent lung cancer resections from 2009 to 2020 in a population-based, nonrandomized stepped-wedge implementation study of both interventions, into preintervention baseline, HA, and kit subcohorts. We used differences in proportion and hazard ratios across the subcohorts to estimate the effect of the interventions on poor quality (nonexamination of nodes [pNX] or nonexamination of mediastinal lymph nodes) and attainment of quality recommendations of the National Comprehensive Cancer Network, the Commission on Cancer, and the proposed complete resection definition of the International Association for the Study of Lung Cancer across the three cohorts.
Of 3734 resections, 39% were preintervention, 40% kit, and 21% HA cases. Cohort proportions were the following: pNX, 11% (baseline) versus 0% (kit) versus 9% (HA); nonexamination of mediastinal lymph nodes, 27% versus 1% versus 22%; Commission on Cancer benchmark attainment, 14% versus 77% versus 30%; International Association for the Study of Lung Cancer-defined complete resection, 11% versus 58% versus 24%; National Comprehensive Cancer Network attainment, 23% versus 79% versus 35% (p < 0.001 for all, except pNX rate baseline versus HA). Survival rate was significantly higher for both interventions compared with baseline (p < 0.0001).
Resections with HA or the kit significantly improved surgical quality and outcomes, but the kit was more effective. We propose to conduct a prospective, institutional cluster-randomized clinical trial comparing both interventions.
较差的病理淋巴结分期的不良预后影响促使人们通过指南来提高对这一问题的认识,但并未提供克服该问题的流程指导。我们比较了提高对淋巴结分期质量的认识(HA)与使用淋巴结采集套件的效果。
我们将 2009 年至 2020 年间在人群中进行的非随机阶梯式实施研究中的根治性肺癌切除术,分为干预前的基线、HA 和试剂盒亚组。我们使用亚组之间比例和风险比的差异来估计这两种干预措施对不良质量(未检查淋巴结 [pNX] 或未检查纵隔淋巴结)和达到国家综合癌症网络、癌症委员会以及国际肺癌研究协会提出的完全切除定义的质量建议的影响。
在 3734 例切除术中,39%为干预前,40%为试剂盒,21%为 HA 病例。队列比例如下:pNX,11%(基线)与 0%(试剂盒)与 9%(HA);未检查纵隔淋巴结,27%与 1%与 22%;癌症委员会基准达标,14%与 77%与 30%;国际肺癌研究协会定义的完全切除,11%与 58%与 24%;国家综合癌症网络达标,23%与 79%与 35%(除 pNX 率基线与 HA 外,所有均 p<0.001)。与基线相比,HA 或试剂盒的两种干预措施均显著提高了手术质量和结果(p<0.0001)。我们建议进行一项前瞻性的机构集群随机临床试验,比较这两种干预措施。