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K. Schulze



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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P1.01-007 - ALK Testing Trends and Patterns Among Community Practices in the United States (ID 8654)

      09:30 - 16:00  |  Author(s): K. Schulze

      • Abstract

      Background:
      The CAP/IASLC/AMP molecular testing guidelines recommend ALK testing on patients with lung adenocarcinoma, regardless of clinical characteristics. FISH is the recommended assay to detect ALK rearrangement, however other assays, such as NGS and IHC, are available. There have been limited published data to assess adherence to ALK testing guidelines using large real-world data sources. The objective of this study was to assess real-world ALK testing patterns among community practices in the United States.

      Method:
      The Flatiron database provides real-world clinical data collected from EHRs used by US cancer care providers. The Flatiron network comprises ~15% of US cancer patients and is geographically and demographically diverse. Patients with ≥2 visits within the Flatiron Network after Jan 1, 2011, >=18 years of age, and an stage IIIB/IV NSCLC diagnosis from 2011 through 2017 Q1 were included in this analysis. Logistic regression was used to identify patient characteristics associated with receiving ALK testing.

      Result:
      Of 29,903 patients identified from community-based clinics (mean age: 71.6, 52.2% male), ALK testing rates have steadily increased over time from 32.2% in 2011 to 61.0% in 2016 for all NSCLC patients, and 41.0% in 2011 to 74.0% in non-squamous patients. Patients that are younger, no history of smoking, women and living in the West region were more likely to be tested for ALK. Patients with Medicaid insurance, recurrent disease and squamous histology were less likely to be tested. The most common first assay to test for ALK was FISH (70%) followed by NGS (8%), PCR (4%) and IHC (1%). The median time from specimen receipt by lab to test result ranged from 6 days (FISH) to 11 days (NGS). Patients who had NGS testing were more likely to initiate chemotherapy prior to test result (34% of patients tested with NGS) than FISH (20%). 1235 patients had at least one FISH and another ALK test, with the percent agreement between FISH and other assays (NGS, PCR, IHC) ranging from 92% to 97%.

      Conclusion:
      Several patient characteristics predicted ALK testing indicating that some subgroups of patients may be under tested, according to guidelines. Consistent with guidelines, FISH was the most common assay and turnaround times from lab receipt to test result was under 2 weeks. There was a high agreement between FISH and NGS, indicating the potentially clinical utility of NGS, however NGS had also the longest turn around time and the highest proportion of patients initiating treatment prior to test results.

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      P1.01-008 - Real-World Patient Characteristics, Testing and Treatment Patterns of ALK+ NSCLC (ID 8681)

      09:30 - 16:00  |  Author(s): K. Schulze

      • Abstract

      Background:
      Based on clinical trials, ALK+ patients have been described as typically younger and never/former smokers, however patients enrolled in clinical trials may be different than those in the real-world. While the ALK positivity rate has been described as about 4% among all NSCLC patients, limited information is available on the positivity rates in patient subgroups. The objective of this study is to describe the real-world ALK positivity rates, patient characteristics and treatment patterns in ALK+ NSCLC patients.

      Method:
      The Flatiron database provides real-world clinical data collected from EHRs used by US cancer care providers. The Flatiron network comprises ~15% of US cancer patients and is geographically and demographically diverse. Patients with ≥2 visits within the Flatiron Network after Jan 1, 2011, ≥18 years of age, ≥1 ALK+ test result and an stage IIIB/IV NSCLC diagnosis from 2011 through 2017 Q1 were included in this analysis. Logistic regression was used to examine the association of ALK positivity and initiation of ALK inhibitor therapy based on patient characteristics. Survival model adjusting for censoring was used to estimate the time to ALK inhibitor order.

      Result:
      599 out of 15,551 ALK tested patients were identified to have an ALK positive test result, for a positivity rate of 3.9%. The ALK positivity rate varied by age (<65: 6.3% vs. ≥65: 2.9%), smoking status (no history of smoking: 11.6% vs. history of smoking: 2.3%), and histology (non-squamous: 4.0% vs. squamous: 1.8%). Factors associated with ALK positivity included younger age, academic practice, male, non-squamous histology, and no history of smoking. 78% of patients with ALK+ disease had evidence of an order for an ALK inhibitor after NSCLC diagnosis. The median time from test result to ALK inhibitor order was 24 days, with 42% of patients without an order for an ALK inhibitor within 90 days. Among patients with an order for an ALK inhibitor, 23% received chemotherapy prior to their ALK test result and 20% received chemotherapy after their test result but before the first order of ALK inhibitor. Patients diagnosed after 2014 and patients who received chemotherapy prior to the ALK test result were more likely to have an order for an ALK inhibitor.

      Conclusion:
      The ALK positivity rate and patient characteristics in this real-world NSCLC population are consistent with clinical trials, with some subgroups having higher positivity rates. ALK inhibitors were the most frequently ordered treatment, however many patients had a delayed time to ordering the ALK inhibitor.

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    P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
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      P3.04-003 - Phase II Trial of Atezolizumab Before and After Definitive Chemoradiation for Patients with Unresectable Stage III NSCLC (ID 9662)

      09:30 - 16:00  |  Author(s): K. Schulze

      • Abstract
      • Slides

      Background:
      More than 40,000 US patients per year present with stage III NSCLC. These patients are of particular interest in that most are not resectable and while they can be treated with curative intent with excellent initial responses, only approximately 25% will be cured by conventional chemoradiotherapy. This, together with the generally better health of this cohort compared to patients with metastatic NSCLC, makes these patients ideal candidates for studies of immunotherapy to increase cure rates. The combination of checkpoint inhibition to counter tumor related immunosuppression along with standard chemoradiotherapy that depletes T-regulatory cells should create immunologic “space” to facilitate clonal expansion of effector T-cells in an environment that fosters improved tumor immunogenicity by blocking PD-L1. Responses to immunotherapy seem to be higher in patients for whom significant cytoreduction can be achieved, such as with radiation of all known disease. Further, both chemotherapy and radiation may expose otherwise hidden antigens that can present additional targets to the reconstituting immune system.

      Method:
      This phase II single arm Alliance Foundation study (NCT03102242) will evaluate safety and efficacy of atezolizumab before and after definitive chemoradiotherapy. 63 patients with stage III NSCLC, PS 0-1, no active autoimmune disease, adequate cardiopulmonary function and no underlying organ dysfunction will be enrolled at 15 Alliance sites in the US. Treatment consists of 4 cycles of neoadjuvant atezolizumab 1200 mg IV q 21 days before chemoradiotherapy with restaging after cycles 2 and 4. Nonprogressing patients undergo weekly carboplatin and paclitaxel concurrent with 60 Gy thoracic radiotherapy followed by 2 cycles of carboplatin and paclitaxel consolidation followed by completion of one year of atezolizumab. The primary endpoint of this pilot study is disease control (CR+PR+SD) after neoadjuvant atezolizumab. Secondary endpoints include ORR, PFS and OS, safety and QoL assessed by the EORTC QLQ-30. Translational endpoints seek to define the role of PD-L1 biomarker testing in selecting the population most likely to respond to neoadjuvant and adjuvant immunotherapy together with standard chemoradiotherapy and to study the association of biomarkers, including immunologic signatures, with response and survival. Tumor tissue will be assessed at study entry and, where possible, at progression. Plasma and immune cells will be assessed at baseline, post neoadjuvant atezolizumab, post chemoradiotherapy, during adjuvant atezolizumab and at study completion or progression. Analyses may include multipanel immunohistochemistry, gene expression profiling, whole exome and T cell receptor sequencing, cytokine/chemokine analysis, flow cytometry immunophenotyping, and T cell function.

      Result:
      Section not applicable

      Conclusion:
      Section not applicable

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