SESSION TITLE: Advances in the Diagnosis of Lung Cancer SESSION TYPE: Original Investigations PRESENTED ON: 10/09/2018 02:30 PM - 03:30 PM PURPOSE: Bronchoscopy is frequently used for evaluation of pulmonary lesions, but its sensitivity for detecting lung cancer can be limited. A bronchial genomic classifier (Percepta) has been validated as a complement to lung cancer diagnostic bronchoscopy to improve its sensitivity and negative predictive value. When bronchoscopy is inconclusive, Percepta can identify patients who can be considered for CT surveillance instead of undergoing another invasive diagnostic procedure. We report here on the clinical utility of Percepta among patients enrolled in the Percepta Registry at up to 12 months post bronchoscopy. METHODS: Patients were prospectively enrolled at 40 medical centers when Percepta was ordered due to an inconclusive bronchoscopy. The classifier sample was obtained by brushing the right mainstem bronchus during bronchoscopy, regardless of nodule size or location. Pre- and post-classifier clinical management recommendations were recorded and follow-up clinical, procedure, and imaging data were collected. RESULTS: 399 patients had an inconclusive bronchoscopy and were within indication (no prior cancer and current or former smoker). The majority of lesions were <30mm (77%), peripherally located (72%), solid (73%), and upper lobe (55%). Advanced bronchoscopic technologies were used in 68% of cases and PET was used prior to bronchoscopy in 37% of patients. This interim analysis focuses on the 289 patients (72%) with intermediate (245) or low (44) pre-test risk of malignancy. 32% of intermediate pre-test risk patients were down classified by Percepta to low risk, and 52% of low pre-test risk patients were down classified by Percepta to very low risk. These results are consistent with the results from the AEGIS 1 and 2 studies (Silvestri et al, NEJM 2015): 38% and 54% down classification, p = 0.85 and p =0.30 respectively. Among patients where risk of malignancy was down-classified by Percepta, physicians significantly reduced invasive procedure recommendations from 41% to 18% in the intermediate pre-test risk and 9% to 0% in the low pre-test risk group. This results in an overall procedure reduction of 34% to 14% (relative reduction of 59%, p=0.0005). 83% of those who were down-classified remained procedure free at 12 months follow up. CONCLUSIONS: We observed a significant reduction in additional invasive procedures compared to the pre-test management plan for patients who were down classified by Percepta after an inconclusive bronchoscopy. This reduction in procedures has been durable over 12 months. Additional data will help further determine the ultimate clinical utility of the test. CLINICAL IMPLICATIONS: A bronchial genomic classifier can reduce the number of unnecessary invasive procedures that are performed following an inconclusive bronchoscopy for suspect lung cancer. DISCLOSURES: No relevant relationships by Sadia Benzaquen, source=Web Response No relevant relationships by Michael Bernstein, source=Web Response Consultant relationship with Medtronic ILS Please note: $5001 - $20000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Biodesix Please note: $5001 - $20000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with Merit Endotek Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant relationship with BodyVision Please note: $1001 - $5000 Added 02/25/2018 by Krish Bhadra, source=Web Response, value=Consulting fee Consultant Consultant relationship with Auris Surgical Robotics Please note: $1001 - $5000 Added 03/03/2018 by Krish Bhadra, source=Web Response, value=Consulting fee No relevant relationships by Travis Dotson, source=Web Response No relevant relationships by Mark Esterle, source=Web Response researcher relationship with veracyte Please note: $1-$1000 Added 03/03/2018 by Joshiah Gordon, source=Web Response, value=Grant/Research Support Employee relationship with Veracyte, Inc. Please note: $20001 - $100000 Added 03/05/2018 by Bailey Griscom, source=Web Response, value=Salary Speaker/Speaker's Bureau relationship with Boston Scientific Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Shire Please note: $5001 - $20000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Honoraria Consultant relationship with Auris Please note: $1001 - $5000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Unrestricted Education Grant relationship with Boston Scientific Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Unrestricted Education Grant Consultant relationship with BronchiSense Please note: $20001 - $100000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with LX Medical Please note: $5001 - $20000 Added 03/01/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Biodesix Please note: $5001 - $20000 Added 03/02/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Body Vision Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Medtronic Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Auris Please note: >$100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Preora Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Speaker/Speaker's Bureau relationship with Grifols Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Honoraria Consultant relationship with Heritage Biologics Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Gala Therapeutics Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Consultant relationship with Matrix Analytics Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with OncoCyte Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Owner/Founder relationship with Medical Opinion Systems Please note: $20001 - $100000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Ownership interest Consultant relationship with Neurotronic Please note: $1001 - $5000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Veracyte Please note: $5001 - $20000 Added 03/03/2018 by D Hogarth, source=Web Response, value=Honoraria Employee relationship with Veracyte Inc Please note: >$100000 Added 03/04/2018 by Jing Huang, source=Web Response, value=Salary Employee relationship with Veracyte Please note: >$100000 Added 03/09/2018 by Marla Johnson, source=Web Response, value=Salary Removed 03/09/2018 by Marla Johnson, source=Web Response Employee relationship with Veracyte Please note: $20001 - $100000 Added 03/09/2018 by Marla Johnson, source=Web Response, value=Salary Employee relationship with Veracyte Please note: >$100000 Added 03/27/2018 by Giulia Kennedy, source=Admin input, value=Salary Consultant relationship with Veracyte Please note: $5001 - $20000 Added 03/09/2018 by Hans Lee, source=Web Response, value=Consulting fee Consultant relationship with Veran Medical Please note: $20001 - $100000 Added 03/09/2018 by Hans Lee, source=Web Response, value=Grant/Research Support Employee relationship with Veracyte Please note: >$100000 Added 03/03/2018 by Lori Lofaro, source=Web Response, value=Salary Advisory Committee Member relationship with Exact Sciences Please note: $1001 - $5000 Added 03/05/2018 by Peter Mazzone, source=Web Response, value=Consulting fee Research support relationship with Veracyte Please note: $5001 - $20000 Added 03/05/2018 by Peter Mazzone, source=Web Response, value=Grant/Research Support Research support relationship with Oncocyte Please note: $5001 - $20000 Added 03/05/2018 by Peter Mazzone, source=Web Response, value=Grant/Research Support Consultant relationship with Veracyte Please note: $20001 - $100000 Added 04/30/2018 by Avrum Spira, source=Admin input, value=Salary Consultant relationship with Janssen Pharmaceuticals Please note: $20001 - $100000 Added 04/30/2018 by Avrum Spira, source=Admin input, value=Consulting fee No relevant relationships by Patrick Whitten, source=Web Response

SESSION TITLE: Advances in Lung Cancer SESSION TYPE: Original Investigation Slide PRESENTED ON: Wednesday, November 1, 2017 at 08:45 AM - 10:00 AM PURPOSE: The Bronchial Genomic Classifier (BGC) improves the sensitivity and negative predictive value (NPV) of bronchoscopy for lung cancer detection. The BGC identifies patients who, with a pre-test intermediate (10-60%) risk of malignancy, and an inconclusive diagnostic bronchoscopy result, are at low risk of malignancy (<10%) and may be considered for radiographic monitoring instead of an additional invasive procedure. We report a planned interim utility analysis from a prospective, multi-center registry study of the BGC, designed to observe patient selection, classifier performance, clinical utility and safety across varied clinical settings. METHODS: The BGC Registry enrolls patients at 43 medical centers who have had an inconclusive diagnostic bronchoscopy for suspected lung cancer, and for whom the BGC was ordered. The BGC sample is obtained by brushing the normal appearing mucosa of the central airway during bronchoscopy. The BGC is measured in those samples after cytology on biospecimens collected at bronchoscopy are confirmed inconclusive. Pre- and post- BGC clinical management recommendations are recorded and follow-up clinical and imaging data are collected at regular time points up to 36 months. RESULTS: 665 eligible patients underwent a diagnostic bronchoscopy for evaluation of lung cancer. A diagnosis was made in 259 (39%) patients at index bronchoscopy: 182 (27%) with lung cancer and 77 (12%) with a benign condition. The BGC was not ordered in 39 (6%) patients and 13 (2%) were not consented, leaving 354 patients meeting enrollment criteria. Of these, 315 patients are evaluable with exclusions of 17 (2%) patients with a BGC 'no-result', and 22 patients with insufficient data. Demographics showed 60% ≥ 65 y/o; 50% female, with a median 40 pack-year smoking history. This interim analysis focuses on 209 (66%) patients with an intermediate pre-test risk of malignancy where CT scans showed 76% of index lesions were ≤ 30 mm, 69% were peripherally located, 60% were solid and 50% were in the upper lobe. Advanced bronchoscopic technologies were used in 68% of cases. The BGC test results reclassified 74 (35%) pre-test intermediate risk patients to post-test low risk. At 10-months median follow-up, the reclassified low risk group showed a 17% absolute (40% to 23%), or 40% relative reduction in the use of invasive procedures compared to their pre-test diagnostic management plan. Patients who remained intermediate post-test risk showed no increase in invasive procedures. Five (2%) reclassified low risk patients have, at a median of 10-months follow-up, been diagnosed with lung cancer, well within the NPV of the test (91%). Four of five patients have undergone successful resection without evidence of a stage shift. CONCLUSIONS: This interim analysis from this prospective registry confirms the performance of the BGC reported in the AEGIS I and II studies.The emerging safety of reclassified low risk patients is encouraging. Additional follow-up is required to evaluate the full impact of clinical utility. CLINICAL IMPLICATIONS: The BGC improves the sensitivity of diagnostic bronchoscopy for patients undergoing evaluation for lung cancer and can reduce the number of unnecessary invasive procedures that are performed following an inconclusive procedure. DISCLOSURE: Douglas Hogarth: Grant monies (from industry related sources): Industry funded research, Consultant fee, speaker bureau, advisory committee, etc.: Advisor Board Joshiah Gordon: Other: Paid for time it takes to enroll patients Kate Smith: Employee: I receive a salary and hold stock options from Veracyte. Pauline Bianchi: Employee: Employed by Veracyte Marc Lenburg: Consultant fee, speaker bureau, advisory committee, etc.: Veracyte, Grant monies (from sources other than industry): NIH Avrum Spira: Consultant fee, speaker bureau, advisory committee, etc.: Advisor The following authors have nothing to disclose: Hans Lee, Patrick Whitten, Krish Bhadra, Travis Dotson, Sadia Benzaquen, Michael Pritchett, Ajay Bedekar, Mark Esterle No Product/Research Disclosure Information

INTRODUCTION:Critically ill patients placed on enteral nutrition (EN) are usually underfed. A volume-based feeding (VBF) protocol designed to adjust the infusion rate to make up for interruptions in delivery should provide a greater volume of EN than the more common fixed hourly rate-based feeding (RBF) method.METHODS:This single-center, randomized (3:1; VBF/RBF) prospective study evaluated critically ill patients on mechanical ventilation expected to receive EN for ≥ 3 days. Once goal rate was achieved, the randomized feeding strategy was implemented. In the VBF group, physicians used a total goal volume of feeds to determine an hourly rate. For the RBF group, physicians determined a constant hourly rate of infusion to meet goal feeds.RESULTS:Sixty-three patients were enrolled in the study with a mean age of 52.6 years (60% male). Six patients were excluded after randomization because of early extubation. The VBF group (n = 37) received 92.9% of goal caloric requirements with a mean caloric deficit of -776.0 kcal compared with the RBF group (n = 20), which received 80.9% of goal calories (P = .01) and a caloric deficit of -1933.8 kcal (P = .01). Uninterrupted EN was delivered for 51.7% of all EN days in VFB patients compared with 54.5% in RBF patients. On days when feeding was interrupted, VFB patients overall received a mean 77.6% of goal calories (while RBF patients received 61.5% of goal calories, P = .001). No vomiting, regurgitation, or feeding intolerance occurred due to VBF.CONCLUSIONS:A VBF strategy is safe and improves delivery to better meet caloric requirements than the standard more commonly used rate-based strategy.

PURPOSE: Patients in the intensive care unit frequently receive less than their caloric requirement and a better method of feeding may prevent this chronic problem.