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E. Bendaly



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    P1.05 - Poster Session with Presenters Present (ID 457)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Early Stage NSCLC
    • Presentations: 1
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      P1.05-070 - Diagnostic Yield and Efficacy of EBUS TBNA in Molecular Testing for NSCLC Mutations (ID 4401)

      14:30 - 14:30  |  Author(s): E. Bendaly

      • Abstract

      Background:
      Non-small cell lung cancer (NSCLC) can be further defined at the molecular level by recurrent driver mutations including ALK, BRAF, EGFR, HER2, KRAS, MEK1, MET, NRAS, PIK3CA, RET, and ROS1. Genetic testing has become a routine part of diagnosis and staging for patients with NSCLC. The presence of mutations can influence response to targeted therapy; tailoring therapy accordingly has become standard practice.

      Methods:
      Sixty-nine patients referred to Indiana University Hospital with suspected or confirmed lung adenocarcinoma underwent EBUS-TBNA of lung masses or lymph nodes using a 21-gauge Olympus[TM] needle without suction. Samples were first reviewed by a pathologist, and if suspicious for NSCLC, were sent for different types of molecular testing based on the clinical scenario. At least 6 extra passes were placed in cell block. For Paradigm testing, 10 passes were sent. EGFR and KRAS testing were performed using the FDA approved Thera screen RGQ PCR Kit. Testing for ALK rearrangement was done using fluorescent in situ hybridization. In some cases, testing for these mutations in addition to ROS1, BRAF, and HER2 was done using the Paradigm Cancer Diagnostics test.

      Results:
      Sixty-nine samples from patients with NSCLC obtained by EBUS-TBNA were sent for molecular testing for EGFR. All samples were sufficient for analysis (Yield=100%). EGFR mutations were found in 3 patients (4.3%) vs. 66 wild-type (95.7%). 60 samples were sent for molecular testing for KRAS (yield = 100%), of which 10 had mutations (16.7%) vs. 50 wild-type (83.3%). 51 samples were sent for ROS1 testing (0 mutant, 48 wild-type); tissue samples were inadequate for testing in 3 patients (yield=94.1%). 64 samples were sent for ALK testing (3 (4.7%) mutant, 55 (85.9%) wild-type; yield = 90.6%). Ten samples were sent for BRAF testing and two samples were sent for HER2 testing, all of which were negative for mutations (yield = 100%). No complications were associated with EBUS TBNA.

      Conclusion:
      EBUS TBNA with a 21-gauge needle is a safe and efficient method for molecular mutational analysis in patients with NSCLC. It can be used effectively for diagnosis, staging and guiding treatment decisions for NCSLC. Adequate samples for mutational analysis can be obtained and placed in cell block without suction. Improving the yield of this technique and comparing the yield with and without suction is important as we start testing for a greater number of mutations.

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    P3.02a - Poster Session with Presenters Present (ID 470)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P3.02a-007 - Monitoring for and Characteristics of Crizotinib Progression: A Chart Review of ALK+ Non-Small Cell Lung Cancer Patients (ID 4443)

      14:30 - 14:30  |  Author(s): E. Bendaly

      • Abstract
      • Slides

      Background:
      Crizotinib is recommended as first-line therapy for non-small cell lung cancer (NSCLC) patients with ALK rearrangements. Following the approval of second-generation ALK inhibitors for patients who progress on or are intolerant to crizotinib, this study describes how physicians monitor for progression, diagnose progression, and alter treatments following progression on crizotinib therapy.

      Methods:
      A panel of US oncologists was surveyed regarding their monitoring practices and criteria for diagnosing progression on crizotinib. From March to June 2016, the oncologists provided data retrospectively from the medical charts of their adult patients diagnosed with locally-advanced or metastatic ALK+ NSCLC who progressed on crizotinib following the US approval of the first second-generation ALK inhibitor, ceritinib, in April 2014. Time to clinician-defined progression and treatment changes following progression were assessed using the medical chart data.

      Results:
      28 oncologists responded to the survey. Data was abstracted on 74 ALK+ NSCLC patients who progressed on crizotinib. 49% of the patients were male; 50% were never smokers. 81% of patients received crizotinib in first line; the median age at initiation was 61 years. Most physicians (71%) reported monitoring for radiographic progression every 3-4 months. In terms of course of action when new lesions are detected, physician response varied: most physicians (75%) prefer to add local therapy and resume crizotinib following a symptomatic isolated lesion, while, following multiple symptomatic lesions, 96% and 64% of physicians prefer to switch to a new therapy depending upon whether the lesions were systemic or isolated to the brain, respectively. Among the study sample, progression on crizotinib, as defined by physicians, was detected after a median of 10.4 months. 86% of patients discontinued crizotinib within 30 days of diagnosis of the physician-defined progression. Among all patients who discontinued, 77% switched to ceritinib, 14% to chemotherapy, and 1% to alectinib; the remaining 7% did not receive additional systemic antineoplastic therapy.

      Conclusion:
      The findings from this physician survey and retrospective chart review of ALK+ NSCLC crizotinib-treated patients suggest that physician response to the development of new lesions varies depending upon the location and extent of the lesions. Once physicians considered their patients to have progressed, most immediately switched their patients to ceritinib, a second-generation ALK inhibitor.

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      P3.02a-023 - Treatment Patterns and Early Outcomes of ALK+ Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study (ID 4641)

      14:30 - 14:30  |  Author(s): E. Bendaly

      • Abstract
      • Slides

      Background:
      Ceritinib is the first second-generation ALK inhibitor approved in the US to treat ALK+ non-small cell lung cancer (NSCLC) patients who progressed on or were intolerant to crizotinib. This study provides the first real-world description of the characteristics, treatment patterns, and early outcomes of ALK+ NSCLC patients who received ceritinib in clinical practice.

      Methods:
      From March to June 2016, 23 US oncologists provided data retrospectively from the medical charts of their adult patients diagnosed with locally-advanced or metastatic ALK+ NSCLC who received ceritinib following crizotinib therapy. Clinical characteristics, treatment patterns, and early outcomes on ceritinib were assessed. Best response on ceritinib was evaluated using RECIST criteria.

      Results:
      Participating oncologists reviewed charts of 58 ALK+ NSCLC patients treated with ceritinib. 41% of the patients were male, 52% were never smokers, and median age at ceritinib initiation was 63 years. Patients started ceritinib following a median of 10.6 months on crizotinib; 21% of patients had prior chemotherapy experience. At ceritinib initiation, many patients had multiple distant metastases, most commonly in the liver (60%), bone (53%), and brain (38%). While 71% initiated ceritinib at 750mg once daily, 19% received 600mg once daily, and 10% received 450mg once daily. 17% of patients were instructed to take ceritinib with food; 50% were instructed to fast. Median follow-up after ceritinib initiation was 3.8 months. Although follow-up was short, most patients achieved either a complete (8%) or partial (61%) response on ceritinib, regardless of metastatic site present at initiation (Table). Among the 21 patients who discontinued ceritinib, 6 received alectinib, 2 chemotherapy, 2 immunotherapy, and 11 received no further antineoplastic therapy.

      Conclusion:
      These early findings of ceritinib use in clinical practice suggest that ceritinib is effective at treating crizotinib-experienced ALK+ NSCLC patients, regardless of the location of metastatic sites. Future studies with longer follow-up are warranted. Figure 1



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