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IMPACT OF A BLOOD-BASED RISK CLASSIFIER ON MANAGEMENT OF BENIGN PULMONARY NODULES IN A REAL-WORLD OBSERVATIONAL STUDY

      TOPIC: Procedures
      TYPE: Late Breaking
      PURPOSE: Established risk calculators and physician judgment are the primary tools for estimating patient probability of cancer (pCA) for incidental pulmonary nodules (IPN) as defined by guidelines. However, these tools are applied inconsistently, especially in low to moderate risk (pCA 5-65%) nodules, which can lead to delayed diagnosis of malignancies and overtreatment of benign nodules. A blood-based proteomic integrated classifier (IC, the Nodify XL2® test, Biodesix, Inc.) has been clinically validated as a tool to complement cancer risk assessment in nodules with pCA<=50% (PANOPTIC study, NCT01752114). A real-world multi-center observational study, ORACLE (NCT03766958), was designed to evaluate the IC’s impact on nodule management. Here we report preliminary results for IC impact on invasive procedure (IP, defined as transthoracic needle biopsy, bronchoscopy or surgery) utilization among ORACLE patients whose nodules were classified as benign.
      METHODS: Patients enrolled in ORACLE meeting the inclusion criteria (N=472) were evaluated with the IC test. Study inclusion criteria include Mayo calculator-based pCA<=50%, >=40 years of age, nodule 8-30 mm in diameter, and no history of lung cancer and/or active cancer within 5 years. Test results were reported to physicians and post-test treatment plans were recorded. Additionally, a cohort of historical controls (HC) also meeting the inclusion criteria (N=324) were enrolled by sequential chart review by each site. Use of IPs and CT surveillance in patients with benign nodules (as determined by radiological follow up and/or benign specific histopathology) enrolled in the study were compared to the HC cohort to estimate IC impact on physician decisions to use invasive procedures.
      RESULTS: In this preliminary analysis, we compared patients meeting the inclusion criteria that had IC results plus sufficient procedural data (N=219, 186/219 benign) to the HC cohort (N=249, 143/249 benign) to determine if the use of the IC reduced IPs on benign nodules. Patients with a benign lung nodule who were evaluated by IC were 80% less likely to receive an IP than those in the HC cohort (odds ratio 0.192 [95% CI: 0.086-0.393], absolute risk difference of 17.7% [95% CI: 10.4%, 25.8%]). Thus, for every 5.65 patients tested, the IC can help prevent one unnecessary IP on a benign nodule.
      CONCLUSIONS: These data suggest that supplementing physician judgment and standard of care risk assessment with a blood-based IC may reduce the number of invasive procedures performed on benign nodules compared to current real world practices. Further analyses in this patient population to evaluate the overall test performance are ongoing.
      CLINICAL IMPLICATIONS: The IC test impacts physician decisions and is associated with reduced unnecessary invasive procedure use in a real-world clinical population.
      DISCLOSURES: No relevant relationships by Alejandro Aragaki, source=Web Response
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