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B.J. Addario



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    MS 18 - Advocacy Snapshots (ID 36)

    • Event: WCLC 2015
    • Type: Mini Symposium
    • Track: Advocacy
    • Presentations: 1
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      MS18.05 - Excellence in Treatment - Exporting Teaching Hospital Standards of Care to the Community Hospital Setting (ID 1930)

      14:15 - 15:45  |  Author(s): B.J. Addario

      • Abstract
      • Presentation

      Abstract:
      The Community Hospital Centers of Excellence (COE) seal and program is a paradigm shift in lung cancer care to greatly increase positive patient outcomes. This necessity is driven by the reality that the 5-year patient survival rate has remained unchanged and abysmally low at approximately 16% for 40+ years. 80% of lung cancer patients in the US receive treatment by a general oncologist at community hospitals, most often without disease-specific cancer doctors. Unfortunately, generalists lack access to the most up-to-date knowledge to specifically treat lung cancer, the world’s number one cancer killer that takes more lives annually than the other top five cancer killers combined. Because of the tremendous volume and pace of scientific discovery, it is impossible for community general oncologists to stay abreast of emerging treatment options, the complexities of each disease state (lung, breast, colon, etc) and practice-changing clinical information. Due to this gap generalists cannot fully inform patients about all treatment options that exist, are expected and used every day by specialists at academic institutions where the enhanced standard of care includes molecular testing, tumor board review, clinical trials, personalized/targeted treatment, multi-disciplinary care, etc. Health literacy of physicians and patients impacts survival. The lung cancer knowledge gap especially affects patients who have limited education, are low income, ethnic minorities, recent immigrants and non-native English speakers. Knowledge and access are the currency of success and the pathway for all patients/physicians to get the right information leading to the right treatment at the right time. Information is also key for patients and their families to act as their own advocates. EVERY PATIENT NEEDS TO KNOW EVERY OPTION. ALCF acknowledges this problem and provides an innovative, first-of-its-kind solution – Community Hospital Centers of Excellence (COE) – to give all patients 360[0] care. Our solution provides community hospitals access to the same standard of care used at academic institutions to ensure that every physician and patient has access to and is educated about the newest, most effective diagnostic and therapeutic techniques, clinical resources, partners and people. Increasing lung cancer patient survival to the same high level as other cancers (breast/89.2%; prostate/98.9%) depends upon addressing disparities at the root – community hospitals – and to providing access to multi-institutional, collaborative, comprehensive care based on existing best practices. Equalizing access benefits all populations – insured, uninsured, underserved, geographically disadvantaged – fighting this disease. Physicians/hospitals in the COE national network commit to being fully informed partners with their patients in understanding, sharing and discussing treatment options. ALCF lung-specific community centers of excellence will be tracked by metrics to improve outcomes and reinforce ALCF’s belief that enhanced standard of care can extend survivability, improve quality of life, and some cases, save lives. ALCF, along with GE Healthcare and El Camino Hospital in California, has already shown success in its pilot program launched in 2012. Simultaneously, underlying research projects will be conducted to achieve milestones and increase discovery of treatment regimens for individualized therapy and survival acceleration through ALCF’s sister organization, the Addario Lung Cancer Medical Institute (ALCMI). At Centers of Excellence an on-site Patient Navigator oversees each patient’s care from the initial diagnosis. Care includes molecular testing for all patients to determine the unique genetic profile of the individual’s lung cancer. This knowledge will determine the best first-line treatment to achieve a positive outcome and will ensure that the right patient gets the right treatment at the right time. Community Hospital Centers of Excellence (COE) – Primary objectives are: ● Provide lung cancer patient program participants with multi-disciplinary, multi-institutional, collaborative, extensive, and comprehensive access to best care available. This “big picture” approach includes a Patient Navigator overseeing each patient’s care to include prospective tumor board review, molecular testing, targeted radiation therapy, and access to clinical trials, from a fully integrated team (oncologist, pulmonologist, radiologist, pathologist, immuno-oncologist, etc). ● Establish and implement improved standard of care (SOC) at community hospitals nationwide by giving patients and physicians access to the SOC used at academic institutions. This standard will be measured through patient data tracking, follow-up and patient surveys, and benchmarked against national data and statistics. In addition, ALCF will actively support the adoption and scaling of its lung cancer “standard of care” model to apply across the cancer spectrum and to other diseases and disciplines, as applicable. ● Improve progression free and overall survival rate and quality of life for patients. ● Implement best practices with expected outcomes being a new patient-centric paradigm for lung cancer patient treatment with best practices managed and documented by ALCF and findings shared with ALCF key partners and prospective Community Hospital COE sites. Because outcomes/data are essential to determine program success, tracking and measurement of all COE patients will include: Method of Diagnosis Early Detection vs. Incidental Findings Diagnosis Date Lung Cancer Type Lung Cancer Stage at Diagnosis Molecular Testing - % of Patients Received Tumor Board Review 30 Day Survival Number of ER Visits 1 and 5 Year Survival (Progression Free and Overall) Clinical Trial Referral Quality of Life (i.e. Pulmonary Function, Neuropathy, Fatigue, Appetite etc) Patient Satisfaction Survey Line of Treatment Where Applicable: Dollars Lost/Impact on Community due to Early vs. Late Stage Diagnosis Business Impact on Hospital During our pilot program's first year (El Camino Hospital, Mtn View, CA) metrics have already shown a dramatically improved standard of care (diagnosis to treatment time improved from a national average of 40+ days to 14.5 days; 100% of patients have had molecular testing; 61% have had tumor board review vs. 15% pre-program; 26% diagnosed at stage 2b or below). In adopting this collaborative, integrated standard of care, each hospital must have capacity to enroll at least 200 patients yearly. At minimum, ALCF excpects 10,000 patients will be served by 2015 end thriough 20 COEs. By equalizing physician/patient access to education and a standard of care, all populations affected by lung cancer--insured, uninsured, underserved, geographically disadvantaged--will benefit. COE will clearly be able to track outcomes and will define success through lives extended and in some cases, saved. By redesigning lung cancer patient health care delivery, COE provides an unprecedented coordination of care using technology and access to existing expertise/knowledge.

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    ORAL 22 - Moving Beyond a Smoking Related-Cancer to the Young, Never-smokers and Inherited Disease (ID 117)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      ORAL22.05 - The Genomics of Young Lung Cancer Study (ID 503)

      10:45 - 12:15  |  Author(s): B.J. Addario

      • Abstract
      • Presentation
      • Slides

      Background:
      Primary lung cancer is increasingly understood as a heterogeneous disease made up of genomically defined subtypes requiring distinct treatment strategies. We hypothesize young age at diagnosis (< 40 years) is a clinical characteristic associated with an increased chance for a targetable genomic alteration. Our ALCMI study prospectively characterizes the somatic and germline genomics of young lung cancer (GYLC). Our goals are to identify a genomically enriched subtype of lung cancer, facilitate delivery of targeted therapy and lay groundwork for further studies of heritable and environmental lung cancer risk factors.

      Methods:
      Accrual opened July 2014. Patients are eligible if they were diagnosed with bronchogenic lung cancer less than age 40. A study website allows for virtual consenting so patients can participate remotely from anywhere in the world; and use social media to share our trial. We have an integrated data and bio repository that allows for seamless communication and completion of study activities like remote consenting and routing of blood and tumor specimens. We have defined 7 genomic alterations of interest based on the Lung Cancer Mutational Consortium (LCMC) (EGFR, KRAS, HER2, BRAF, ALK, ROS1, RET). We aim to demonstrate that the prevalence of targetable genomic alterations will be greater in our population compared to the LCMC and have powered our study to show an increase from 35% to 50%; and an improvement in use of targeted therapy from 22% to 40%. On study subjects without a known genotype will undergo comprehensive genomic profiling with the FoundationOne test to ensure that all of these genes have been tested. Subjects with advanced adenocarcinoma who are wild type for all 7 genes will receive additional genomic profiling using the FoundationOne Heme test; with the goal of identifying novel oncogenic drivers. Additional investigational genomics will include blood for germline analysis and plasma genomics. All on study genomic analysis is at no cost to the participant.

      Results:
      Preliminary results of the first 33 subjects show: Average age at diagnosis: 33 years; Range 22-39; Histology: adenocarcinoma n=29, squamous cell n=4; Stage at diagnosis: stage 4 n=26 (79%) stages 1-3 n=7 (21%). Of those with stage 4 adenocarcinoma (n=24); 18:24 (75%) have either an ALK re arrangement n=10 (42%), an EGFR activating mutation n=5 (21%) or a ROS1 fusion n=3 (13%).

      Conclusion:
      The trial is currently accruing (NCT02273336) https://www.openmednet.org/site/alcmi-goyl. We have accrued patients from the USA, Europe and Australia. Thus far in our prospective series those diagnosed with primary NSCLC < age 40 tend to have stage 4 adenocarcinoma. Preliminary results exceed our statistical expectation with 75% of our metastatic adenocarcinoma patients having an actionable mutation. We plan on presenting data for the first time at WCLC-2015 on the first 50 subjects. (Study, supported by grants from BJALCF, Beth Longwell Foundation, Peter Barker Foundation, Genentech, Schmidt Legacy Foundation, and Upstage Lung Cancer)

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