Abstract
BackgroundIncidental and screening-identified lung nodules are common, and a bronchoscopic evaluation is frequently nondiagnostic. The Percepta Genomic Sequencing Classifier (GSC) is a genomic classifier developed in current and former smokers which can be used for further risk stratification in these patients. Percepta GSC has the capability of up-classifying patients with a pre-bronchoscopy risk that is high (> 60%) to “very high risk” with a positive predictive value of 91.5%. This prospective, randomized decision impact survey was designed to test the hypothesis that an up-classification of risk of malignancy from high to very high will increase the rate of referral for surgical or ablative therapy without additional intervening procedures while increasing physician confidence.MethodsData were collected from 37 cases from the Percepta GSC validation cohort in which the pre-bronchoscopy risk of malignancy was high (> 60%), the bronchoscopy was nondiagnostic, and the patient was up-classified to very high risk by Percepta GSC. The cases were randomly presented to U.S pulmonologists in three formats: a pre-post cohort where each case is presented initially without and then with a GSG result, and two independent cohorts where each case is presented either with or without with a GSC result. Physicians were surveyed with respect to subsequent management steps and confidence in that decision.ResultsOne hundred and one survey takers provided a total of 1341 evaluations of the 37 patient cases across the three different cohorts. The rate of recommendation for surgical resection was significantly higher in the independent cohort with a GSC result compared to the independent cohort without a GSC result (45% vs. 17%, p < 0.001) In the pre-post cross-over cohort, the rate increased from 17 to 56% (p < 0.001) following the review of the GSC result. A GSC up-classification from high to very high risk of malignancy increased Pulmonologists’ confidence in decision-making following a nondiagnostic bronchoscopy.ConclusionsUse of the Percepta GSC classifier will allow more patients with early lung cancer to proceed more rapidly to potentially curative therapy while decreasing unnecessary intervening diagnostic procedures following a nondiagnostic bronchoscopy.
Highlights
Incidental and screening-identified lung nodules are common, and a bronchoscopic evaluation is frequently nondiagnostic
Considerable effort has gone into the development of technologies that seek to improve the diagnostic yield of bronchoscopy for suspicious lung lesions, but nondiagnostic procedures remain common [4]
The demographics of Percepta Genomic Sequencing Classifier (GSC) Users compared to non- users is shown in Additional file 1: Table 2
Summary
Incidental and screening-identified lung nodules are common, and a bronchoscopic evaluation is frequently nondiagnostic. Percepta GSC has the capability of up-classifying patients with a pre-bronchoscopy risk that is high (> 60%) to “very high risk” with a positive predictive value of 91.5%. This prospective, randomized decision impact survey was designed to test the hypothesis that an up-classification of risk of malignancy from high to very high will increase the rate of referral for surgical or ablative therapy without additional intervening procedures while increasing physician confidence. Larger lesions (> 30 mm) in at risk individuals have been shown to be highly predictive of cancer [6] These patients should be considered for surgical resection if data suggest that they are likely to have early stage disease. Considerable effort has gone into the development of technologies that seek to improve the diagnostic yield of bronchoscopy for suspicious lung lesions, but nondiagnostic procedures remain common [4]
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