Kathryn J. Long MD , Gerard A. Silvestri MD , Michael N. Kammer PhD , Sarah Gibbs MD , Wei Wu MD, PhD , Monica Johal MPH , Sudhakar Pipavath MD , Trevor Pitcher PhD , James Jett MD , Viswam S. Nair MD
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Accurately identifying malignant nodules can pose a diagnostic challenge; therefore, a high-specificity biomarker could help clinicians identify malignant nodules and ideally lead to the earlier diagnosis of lung cancer.</div></div><div><h3>Research Question</h3><div>What are the performance characteristics of a blood-based biomarker for identifying malignancy in patients with a CT-detected PN?</div></div><div><h3>Study Design and Methods</h3><div>Banked plasma samples from 2 independent prospective observational cohorts of patients presenting with benign or malignant PNs 8 to 30 mm in size were tested using a 7-autoantibody panel. Sensitivity, specificity, and positive predictive value of the autoantibody test (AAT) to identify cancer were calculated for the individual and combined cohorts.</div></div><div><h3>Results</h3><div>Overall, 447 patients (263 and 184 from each cohort) were included in the analysis with a prevalence of malignancy of 55%. The performance of the AAT between the 2 cohorts was similar. The AAT demonstrated a specificity of 90% (95% CI, 85%-93%), a positive predictive value of 66% (95% CI, 52%-77%), sensitivity of 16% (95% CI, 12%-22%), and false-positive rate of 10% in the combined cohort. Using a pretest probability of cancer cutoff of 20% improved the positive predictive value to 76% (95% CI, 61%-88%) and resulted in a 52% decrease in the number of false-positive test results. In the subset of patients who had 18F-fluorodeoxyglucose PET imaging performed for clinical purposes (n = 222), specificity of the AAT was higher (93% vs 58%, <em>P</em> < .001), but the sensitivity was lower than 18F-fluorodeoxyglucose PET scan (17% vs 75%, <em>P</em> < .001).</div></div><div><h3>Interpretation</h3><div>This study validates the specificity of a blood-based autoantibody biomarker for identifying malignancy in patients with indeterminate PNs. 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引用次数: 0
摘要
背景肺结节（PNs）经常被胸部CT扫描发现，在临床实践中越来越多地使用。准确识别恶性结节可能对诊断构成挑战；因此，一种高特异性的生物标志物可以帮助临床医生识别恶性结节，并理想地导致肺癌的早期诊断。研究问题：基于血液的生物标志物在ct检测到的PN患者中识别恶性肿瘤的性能特征是什么？研究设计和方法来自2个独立的前瞻性观察队列的血浆样本，这些患者的良性或恶性PNs大小为8至30 mm，使用7-自身抗体检测。计算个体和联合队列中自身抗体测试（AAT）识别癌症的敏感性、特异性和阳性预测值。结果共纳入447例患者（每组263例和184例），恶性肿瘤患病率为55%。两组间AAT的表现相似。在联合队列中，AAT的特异性为90% (95% CI, 85%-93%)，阳性预测值为66% (95% CI, 52%-77%)，敏感性为16% (95% CI, 12%-22%)，假阳性率为10%。使用20%的癌症截止前检测概率将阳性预测值提高到76% (95% CI, 61%-88%)，并导致假阳性检测结果数量减少52%。在为临床目的进行18f -氟脱氧葡萄糖PET成像的患者亚组（n = 222）中，AAT的特异性更高(93% vs 58%, P <；.001)，但敏感性低于18f -氟脱氧葡萄糖PET扫描(17% vs 75%, P <；措施)。本研究验证了一种基于血液的自身抗体生物标志物在不确定PNs患者中识别恶性肿瘤的特异性。这种常规的生物标志物可能有助于加快恶性结节的检查。临床试验注册网站clinicaltrials .gov；否。: NCT01752114;URL: www.clinicaltrials.gov
Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules
Background
Pulmonary nodules (PNs) are frequently detected by chest CT scan, which is increasingly used in clinical practice. Accurately identifying malignant nodules can pose a diagnostic challenge; therefore, a high-specificity biomarker could help clinicians identify malignant nodules and ideally lead to the earlier diagnosis of lung cancer.
Research Question
What are the performance characteristics of a blood-based biomarker for identifying malignancy in patients with a CT-detected PN?
Study Design and Methods
Banked plasma samples from 2 independent prospective observational cohorts of patients presenting with benign or malignant PNs 8 to 30 mm in size were tested using a 7-autoantibody panel. Sensitivity, specificity, and positive predictive value of the autoantibody test (AAT) to identify cancer were calculated for the individual and combined cohorts.
Results
Overall, 447 patients (263 and 184 from each cohort) were included in the analysis with a prevalence of malignancy of 55%. The performance of the AAT between the 2 cohorts was similar. The AAT demonstrated a specificity of 90% (95% CI, 85%-93%), a positive predictive value of 66% (95% CI, 52%-77%), sensitivity of 16% (95% CI, 12%-22%), and false-positive rate of 10% in the combined cohort. Using a pretest probability of cancer cutoff of 20% improved the positive predictive value to 76% (95% CI, 61%-88%) and resulted in a 52% decrease in the number of false-positive test results. In the subset of patients who had 18F-fluorodeoxyglucose PET imaging performed for clinical purposes (n = 222), specificity of the AAT was higher (93% vs 58%, P < .001), but the sensitivity was lower than 18F-fluorodeoxyglucose PET scan (17% vs 75%, P < .001).
Interpretation
This study validates the specificity of a blood-based autoantibody biomarker for identifying malignancy in patients with indeterminate PNs. This rule-in biomarker may help to expedite workup of malignant nodules.
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