Kheir Fayez, Uribe Juan P, Cedeno Juan, Munera Gustavo, Patel Harsh, Abdelghani Ramsy, Matta Atul, Benzaquen Sadia, Villalobos Regina, Majid Adnan
Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
J Thorac Dis. 2023 Jul 31;15(7):3557-3567. doi: 10.21037/jtd-23-42. Epub 2023 Jun 13.
An integrated classifier that utilizes plasma proteomic biomarker along with five clinical and imaging factors was previously shown to be potentially useful in lung nodule evaluation. This study evaluated the impact of the integrated proteomic classifier on management decisions in patients with a pretest probability of cancer (pCA) ≤50% in "real-world" clinical setting.
Retrospective study examining patients with lung nodules who were evaluated using the integrated classifier as compared to standard clinical care during the same period, with at least 1-year follow-up.
A total of 995 patients were evaluated for lung nodules over 1 year following the implementation of the integrated classifier with 17.3% prevalence of lung cancer. 231 patients met the study eligibility criteria; 102 (44.2%) were tested with the integrated classifier, while 129 (55.8%) did not. The median number of chest imaging studies was 2 [interquartile range (IQR), 1-2] in the integrated classifier arm and 2 [IQR, 1-3] in the non-integrated classifier arm (P=0.09). The median outpatient clinic visit was 2.00 (IQR, 1.00-3.00) in the integrated classifier arm and 2.00 (IQR, 2.00-3.00) in the non-integrated classifier (P=0.004). Fewer invasive procedures were pursued in the integrated classifier arm as compared to non-integrated classifier respectively (26.5% 79.1%, P<0.001). All patients in the integrated classifier arm with post-pCA (likely benign n=39) had designated benign diagnosis at 1-year follow-up.
In patients with lung nodules with a pCA ≤50%, use of the integrated classifier was associated with fewer invasive procedures and clinic visits without misclassifying patients with likely benign lung nodules results at 1-year follow-up.
先前的研究表明，一种结合血浆蛋白质组学生物标志物以及五个临床和影像因素的综合分类器在肺结节评估中可能具有潜在应用价值。本研究评估了在“真实世界”临床环境中，该综合蛋白质组分类器对癌症预测试概率（pCA）≤50%的患者管理决策的影响。
一项回顾性研究，对使用综合分类器评估的肺结节患者与同期接受标准临床护理的患者进行比较，并进行至少1年的随访。
在实施综合分类器后的1年里，共有995例患者接受了肺结节评估，肺癌患病率为17.3%。231例患者符合研究纳入标准；102例（44.2%）接受了综合分类器检测，而129例（55.8%）未接受。综合分类器组胸部影像学检查的中位数为2次[四分位间距（IQR），1 - 2]，非综合分类器组为2次[IQR，1 - 3]（P = 0.09）。综合分类器组门诊就诊的中位数为2.00（IQR，1.00 - 3.00），非综合分类器组为2.00（IQR，2.00 - 3.00）（P = 0.004）。与非综合分类器组相比，综合分类器组进行的侵入性检查更少（分别为26.5% 对79.1%，P < 0.001）。综合分类器组所有pCA后（可能为良性，n = 39）的患者在1年随访时均被诊断为良性。
在pCA≤50%的肺结节患者中，使用综合分类器与侵入性检查和门诊就诊次数减少相关，且在1年随访时未对可能为良性的肺结节患者进行错误分类。
