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K. Kulig



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    MINI 03 - PD1 Axis Inhibition and EGFR (ID 101)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI03.07 - Clinical Attributes of Lung Cancer in US Community Oncology Practice: Implications for Immunotherapy (ID 733)

      16:45 - 18:15  |  Author(s): K. Kulig

      • Abstract
      • Presentation
      • Slides

      Background:
      The majority of lung cancer in the US is treated in the community. A prospective cohort study of stage IV non-small cell lung cancer (NSCLC) and extensive disease small cell lung cancer (ED SCLC) is being conducted in 70 US community oncology practices (Figure) to assess current standards of care (SOC) and outcomes in anticipation of immunotherapy as a new treatment modality. This study establishes a historical comparator cohort in a “pre-immunotherapy era” of lung cancer treatment. Figure 1



      Methods:
      Patients with stage IV NSCLC and ED SCLC, at any point in their care, with documented dates of diagnosis and prior treatment, are eligible for inclusion. Patients are followed prospectively for 36 months or until death, with data abstraction from medical records into electronic case report forms. Patient-reported outcomes are prospectively collected, as are archival tumor tissue and serial blood samples from consenting patients for molecular profiling studies.

      Results:
      This early analysis focused on patient clinical attributes and tumor sample characteristics of relevance to non-clinical trial patient populations and to biomarker testing (Table). Of 1,183 cases enrolled to date, at enrollment 17.6% were ECOG performance status (PS) 2 or 3, 18.8% of patients had brain metastases, 22.2% were on systemic steroids, 6.7% had history of a specific autoimmune condition, and 49.5% had had tissue samples from core needle or surgical specimens.118table.jpg Figure 1



      Conclusion:
      Many immunotherapy clinical trials exclude patients with brain metastases, certain steroid use, poor PS, and autoimmune disease, yet a substantial proportion of community-based lung cancer patients present with these attributes. Approximately half of advanced stage patients have tissue specimens amenable to current SOC biomarker testing. Efforts to develop additional biomarker tests for lung cancer patients need to consider the reality of limited tissue sample availability in the community setting.

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    MINI 04 - Clinical Care of Lung Cancer (ID 102)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI04.01 - Years of Life Lost and Lifetime Earnings Lost in Metastatic Lung Cancer: Potential Societal Benefits of Improved Survival by Age and Histology (ID 774)

      16:45 - 18:15  |  Author(s): K. Kulig

      • Abstract
      • Presentation
      • Slides

      Background:
      “Years of life lost” (YLL) and “lifetime earnings lost” (LEL) are used to describe the population burden of cancer. Lung cancer (LC) is one of the most common cancers in the US. While it affects older patients, the younger subgroups of LC are large. Approximately 57% of LC cases are metastatic at diagnosis, with a 5-year survival rate of approximately 5%. Nivolumab, a recently-approved fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, demonstrated a mortality risk reduction of 41% compared to docetaxel in patients previously treated with platinum-based therapy for metastatic squamous, non-small cell LC (NSCLC) (hazard ratio [HR]: 0.59; 95% CI: 0.44, 0.79). This analysis quantifies YLL and LEL prior to the introduction of LC immunotherapy in order to benchmark potential population-level effects of improved long-term survival.

      Methods:
      A simulation model was developed using real-world US patients with LC diagnosed 1/1/2000–12/31/2011 in the Surveillance, Epidemiology, and End Results Program, with follow-up through 12/31/2012. Age-, sex-, and race-specific life expectancy were estimated using flexible parametric survival models. Comparable life expectancy was projected for the general US population using US vital statistics data. Life expectancy was combined with US Bureau of Labor Statistics income data to derive lifetime earnings in 2014 US dollars. Earnings reflect 18 possible income sources, including salary, investments, social security, and other retirement income. Mean YLL and LEL were estimated as the differences between patients with LC and the general US population. Results were stratified by age (<65; ≥65) and histology subtype (small cell, non-squamous NSCLC; squamous NSCLC).

      Results:
      An estimated 1,223,031 patients in the US were diagnosed with metastatic LC from 2000–2011. Estimated patient counts, expected survival, and expected lifetime earnings within each age and histology subtype are provided (Table). For patients aged <65, YLL per patient due to LC varied from 22.8–23.7 years by histology subtype, while for patients aged ≥65, YLL varied from 9.9–11.3 years. LEL per patient ranged from $862,000–$887,000 for patients aged <65, and from $274,000–$313,000 for patients aged ≥65. Figure 1



      Conclusion:
      YLL and LEL values across LC histologies are substantial in both older and, perhaps even more noticeably, younger populations. Improvements in survival reported with promising new LC therapies have the potential to substantially decrease the societal burden caused by YLL and LEL.

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