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    MA19 - Looking at PROs in Greater Detail - What Patients Actually Want and Expect (ID 147)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 12
    • Now Available
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      MA19.01 - Empirical Identification of Distress Clusters in Lung Cancer Patients (Now Available) (ID 2085)

      11:30 - 13:00  |  Presenting Author(s): Mary Ellen Hand  |  Author(s): Teresa Lillis, Mary M. Pasquinelli, Zane Deliu, Christine Weldon, Julia Trosman, Lawrence Eric Feldman, Michael Huber

      • Abstract
      • Presentation
      • Slides

      Background

      Screening for distress from the time of diagnosis is emerging as standard cancer care. Although there is heterogeneity in patients’ experience of distress, identification of subgroups of patients with unique distress profiles may inform interventions for distressed patients. Accordingly, we aimed to identify unique subgroups of patients based on their distress screening responses from a large sample of newly diagnosed lung cancer patients across two urban academic medical centers in Chicago, IL.

      Method

      Lung cancer patients (N=596) were screened for distress at their diagnostic visit between (2/22/16 – 8/14/18) with the Coleman Foundation “Patient Screening Questions for Supportive Care” tool; a 34-item screener that identifies patient needs across psychological, physical, family/caregiver, and treatment and care concerns. A Two-Step cluster analysis was conducted to identify natural clusters of patients based on similar responses to distress screening items.

      Result

      Cluster analysis results revealed a two-cluster outcome: “High Distress” (N=332) and “Low Distress” (N=264). The items that best distinguished High Distress patients from Low Distress patients were concerns about cancer stage/diagnosis, concerns about prognosis/long-term outcome, concerns about treatment options, and having higher average number of total concerns. Cancer stage at screening was not predictive of cluster membership. Demographic characteristics, descriptive statistics, and group difference tests for survey items by cluster and for the total sample are presented in Table 1.

      Conclusion

      More than half of lung cancer patients were grouped as experiencing high distress on screening. While cancer stage was not predictive of high distress grouping, concerns about stage, treatment, and prognosis were most predictive of high distress cluster membership. An intervention to improve communication between providers and patients about these concerns may reduce distress.

      Table 1

      High Distress (N=332/55.7%)

      Low Distress (N=264/ 44.3%)

      Total Sample (N=596)

      Significance

      Tests

      Demographics

      Age

      M=65.75 (SD=9.95)

      M=66.25 (SD=9.71)

      M=65.97 (SD=9.84)

      F=.39 (p>.05)

      Female

      N=171 (51.5%)

      N=144 (54.5%)

      N=315 (52.9%)

      χ2=.55 (p>.05)

      Race/Ethnicity

      χ2=30.83 (p<.01)

      White

      N=124 (37.3%)

      N=154 (58.3%)

      N=278 (46.6%)

      p<.01

      African American

      N=161 (48.5%)

      N=72 (27.3%)

      N=233 (39.1%)

      p<.01

      Other

      N=47 (14.2%)

      N=38 (14.4%)

      N=85 (14.3%)

      p>.05

      Stage IV

      N=160 (48.2%)

      N=118 (44.7%)

      N=278 (46.6%)

      χ2=.72 (p>.05)

      Physical & Psychological Health

      Psychological Distress (PhQ-4)

      M=3.55 (SD=3.63)

      M=1.56 (SD=2.14)

      M=2.67 (SD=3.29)

      F=58.86 (p<.01)

      Pain

      M=5.13 (SD=4.76)

      M=4.76 (SD=3.45)

      M=4.99 (SD=3.66)

      F=1.04 (p>.05)

      Fatigue

      M=8.56 (SD=5.31)

      M=7.63 (SD=4.74)

      M=8.15 (SD=5.01)

      F=4.34 (p<.05)

      Physical Activity

      M=12.63 (SD=7.74)

      M=16.70 (SD=8.52)

      M=14.42 (SD=8.33)

      F=35.55 (p<.01)

      Concerns

      Practical Concerns

      Childcare

      N=8 (2.5%)

      N=2 (.8%)

      N=10 (1.7%)

      χ2=2.43 (p>.05)

      Food & Housing

      N=58 (17.8%)

      N=13 (5.0%)

      N=71 (12.2%)

      χ2=22.06 (p<.01)

      Transportation

      N=72 (22.0%)

      N=14 (5.4%)

      N=86 (14.7%)

      χ2=31.29 (p<.01)

      Work/School

      N=19 (5.9%)

      N=8 (3.1%)

      N=27 (4.7%)

      χ2=2.49 (p>.05)

      Paying for Medication

      N=79 (24.1%)

      N=35 (13.6%)

      N=114 (19.5%)

      χ2=10.19 (p<.01)

      Family/Caregiver Concerns

      Children

      N=46 (18.7%)

      N=18 (8.0%)

      N=64 (13.6%)

      χ2=11.58 (p<.01)

      Partner

      N=51 (20.9%)

      N=24 (10.6%)

      N=75 (15.9%)

      χ2=9.37 (p<.01)

      Caregiver

      N=23 (9.5%)

      N=8 (3.5%)

      N=31 (6.6%)

      χ2=6.91 (p<.01)

      Ability to have children

      N=8 (3.3%)

      N=2 (.9%)

      N=10 (2.1%)

      χ2=3.35 (p>.05)

      Family

      N=62 (25.6%)

      N=24 (10.5%)

      N=86 (N=18.3%)

      χ2=18.07 (p<.01)

      Treatment & Care Concerns

      Cancer Diagnosis & Stage

      N=303 (93.5%)

      N=8 (3.3%)

      N=311 (55.1%)

      χ2=453.34(p<.01)

      Prognosis & Long-term Outcome

      N=312 (95.7%)

      N=37 (15.4%)

      N=349 (61.6%)

      χ2=378.04 (p<.01)

      Treatment Options

      N=246 (75.7%)

      N=11 (4.6%)

      N=257 (45.4%)

      χ2=282.43 (p<.01)

      Communicating treatment wishes

      N=165 (52.1%)

      N=7 (2.9%)

      N=172 (30.8%)

      χ2=155.09 (p<.01)

      Physical Health Concerns

      Breathing

      N=160 (64.3%)

      N=78 (35.5%)

      N=238 (50.7%)

      χ2=38.77 (p<.01)

      Constipation

      N=86 (43.4%)

      N=41 (20.0%)

      N=127 (31.5%)

      χ2=25.63 (p<.01)

      Diarrhea

      N=47 (27.0%)

      N=17 (8.5%)

      N=64 (17.1%)

      χ2=22.68 (p<.01)

      Fevers

      N=22 (13.3%)

      N=4 (2.1%)

      N=26 (7.2%)

      χ2=16.72 (p<.01)

      Nausea/Vomiting

      N=66 (33.7%)

      N=16 (8.1%)

      N=82 (20.8%)

      χ2=39.15 (p<.01)

      Sleep

      N=137 (59.3%)

      N=58 (27.4%)

      N=195 (44.0%)

      χ2=45.79 (p<.01)

      Urination

      N=46 (26.1%)

      N=12 (6.0%)

      N=58 (15.5%)

      χ2=28.79 (p<.01)

      Chewing/Swallowing

      N=49 (27.1%)

      N=18 (9.1%)

      N=67 (17.7%)

      χ2=21.01 (p<.01)

      Mouth Sores

      N=24 (14.5%)

      N=13 (6.6%)

      N=37 (10.2%)

      χ2=6.18 (p<.05)

      Dry Mouth

      N=116 (53.2%)

      N=51 (24.5%)

      N=167 (39.2%)

      χ2=36.76 (p<.01)

      Swollen Arms or Legs

      N=76 (39.6%)

      N=21 (10.5%)

      N=97 (24.7%)

      χ2=44.49 (p<.01)

      Feeling full quickly or swollen abdomen

      N=57 (32.0%)

      N=18 (9.2%)

      N=75 (20.1%)

      χ2=30.35 (p<.01)

      Sexual Intimacy or Functioning

      N=54 (28.3%)

      N=17 (8.4%)

      N=71 (18.0%)

      χ2=23.37 (p<.01)

      Dry/Itchy or Blistered Skin

      N=94 (46.3%)

      N=43 (20.7%)

      N=137 (33.3%)

      χ2=30.37 (p<.01)

      Tingling in hands/feet

      N=84 (43.5%)

      N=33 (16.8%)

      N=117 (30.1%)

      χ2=32.93 (p<.01)

      Appearance

      N=31 (19.35)

      N=14 (7.2%)

      N=45 (12.7%)

      χ2=11.52 (p<.01)

      Use of Alcohol or Drugs

      N=3 (2.0%)

      N=1 (.5%)

      N=4 (1.2%)

      χ2=1.59 (p>.05)

      Total # of Concerns

      M=7.84 (SD=3.71)

      M=2.53 (SD=2.47)

      M=5.49(SD=4.16)

      F=400.82 (p<.01)

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      MA19.02 - Psychological Distress in Never, Ex, Current, and Passive Smokers Diagnosed with Lung Cancer - Analyses from the EnRICH Program (Now Available) (ID 461)

      11:30 - 13:00  |  Presenting Author(s): Bea Brown  |  Author(s): John Simes, Michael Boyer, Phillip Hogg, Anthony Joshua, Jane Young, Christopher Brown

      • Abstract
      • Presentation
      • Slides

      Background

      Lung cancer is associated with greater psychological distress than any other cancer. In Australia, the prevalence of anxiety and depression in those with lung cancer is nearly 30% higher than the average of other major cancers. More than 50% of patients experience distress, anxiety and/or depression, resulting in diminished quality of life (QoL), and a fourfold increase in likelihood of suicide than the general population.

      Lung cancer stigma, arising from presumption about tobacco exposure and associated smoking stigma, contributes to high levels of distress. A national survey found that more than a third (35%) of Australians believe those living with lung cancer “have only themselves to blame” and almost 40% indicated, before expressing concern, the first question they would ask someone diagnosed with lung cancer is whether they smoked. This stigma makes lung cancer patients reluctant to seek psychosocial support and reduces their sense of entitlement to care and empathy. However, approximately one fifth (21%) are life-long never-smokers.

      This study aimed to describe differences in levels of psychological distress in never-and ever-smokers enrolled in the Sydney Catalyst EnRICH Program, a prospective clinical cohort of patients with lung cancer in New South Wales, Australia.

      Method

      Measures: EnRICH incorporates patient-reported outcome measures (PROMs) that assess dimensions of anxiety, depression, emotional function, and psychological distress, namely, the: (i) EORTC QLQ-C30; and (ii) NCCN Distress Thermometer.

      Sample: All patients with newly diagnosed lung cancer presenting to study hospitals are eligible for the EnRICH cohort. Consenting patients who completed PROMs comprise the sample for the current analyses.

      Statistical Methods: Subscales of the QLQ-C30 reflecting overall QoL and emotional function, and scores on the NCCN Distress Thermometer, were compared between patient groups by smoking status. Groups were combined into never-smokers (never, passive) and ever-smokers (ex, current) for analyses. Mean differences and 95% confidence intervals were computed.

      Result

      Among 205 patients who completed PROMs (69% of consenting patients), there were 52 never-smokers, 5 passive-smokers, 161 ex-smokers and 52 current-smokers at the time of diagnosis. Emotional function was worse in never-smokers (ever=75.3, never=63.2, difference=12.1 points 95%CI 2.4-21.7). There were no differences in other subscales. Although numbers are small, passive-smokers had the lowest mean scores for emotional-, role-, and social-functioning (Figure 1). Distress thermometer scores were 1.2 points worse in never-smokers [95%CI (0.56-1.8)].

      everneverscales.png

      Conclusion

      Never-smokers had worse emotional function and higher distress than other lung cancer patients. If confirmed in larger studies, additional supportive care services may improve outcomes for these patients.

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      MA19.03 - Differences in Symptom Burden Between Responsive and Progressive Disease in Advanced Non-Small Cell Lung Cancer (aNSCLC) (Now Available) (ID 845)

      11:30 - 13:00  |  Presenting Author(s): George R Simon  |  Author(s): Loretta Ann Williams, Qiuling Shi, Belqis El Ferjani, Meita S Hirschmann, Darcy Ponce, Seyedeh S Dibaj, Sheenu Chandwani, Emily Roarty, Waree Rinsurongkawong, Jeff Lewis, Thomas Burke, Charles S Cleeland, Jack Lee, Jack Roth, Stephen Swisher, John Victor Heymach, Jianjun Zhang

      • Abstract
      • Presentation
      • Slides

      Background

      We have established a real-world Advanced Non-Small Cell Lung Holistic Registry (ANCHoR) to assess how immunotherapy impacts treatment choice, clinical outcomes, and patient-reported outcomes (PROs) of aNSCLC. Our aim in this analysis was to assess the ability of the MDASI-LC to differentiate between patients who are responding or who are progressing during treatment.

      Method

      Between May 2017 and December 2018, patients with aNSCLC at a single institution were enrolled in ANCHoR and completed the MDASI-LC prior to therapy (PTT) and at routine clinic visits. The MDASI-LC consists of 16 symptom severity and 6 interference items rated on 0-10 scales (0 = no symptom or interference, 10 = worst imaginable symptom or complete interference). MDASI-LC scores from PTT to first recorded response determination (FRD) were compared by response group using linear mixed modeling (LMM).

      Result

      One hundred one patients completed the MDASI-LC PTT and at FRD. Mean patient age was 63.8 years (standard deviation = 10.29) and 55% were males. Fifty percent of patients received chemotherapy (CTX), 22% immunotherapy (IM), 19% CTX+IM or angiogenesis inhibitor, and 9% targeted therapy. Median time from PTT to FRD was 105 days (lower quartile = 63, upper quartile = 224). Forty-six percent of patients had a complete or partial response (RECIST criteria CR, PR), 14% had stable disease (RECIST SD), and 41% progressed (RECIST PD). LMM showed progressing patients had significantly more fatigue (estimated effect [est] =1.39; p = 0.031), sleep disturbance (est=1.37; p = 0.046), and drowsiness (est=1.33; p = 0.037) and reported significantly more interference with work (est=1.67; p = 0.016) over time than responding patients.

      Conclusion

      The MDASI-LC differentiated the symptom burden of patients with responding disease from that of patients with progressive disease. Patients with progressive disease had more fatigue, disturbed sleep, drowsiness, and greater interference with work than those with responsive disease. Further research is needed to determine if the MDASI-LC can predict response to therapy in patients and may be useful in delineating treatment benefit.

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      MA19.04 - Discussant - MA19.01, MA19.02, MA19.03 (Now Available) (ID 3796)

      11:30 - 13:00  |  Presenting Author(s): Gilberto Castro

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA19.05 - Improving Lung Cancer Outcomes and Quality in the US Community Setting with the Creation of Lung Cancer Centers of Excellence Program (Now Available) (ID 1939)

      11:30 - 13:00  |  Presenting Author(s): Amy Moore  |  Author(s): Luis Raez, Ray Osarogiagbon, Leah Fine

      • Abstract
      • Presentation
      • Slides

      Background

      The Addario Lung Cancer Foundation community hospital Centers of Excellence (COE) Program encourages community cancer centers in the US to implement ‘best practices’ across the lung cancer care continuum, including provision of coordinated, multidisciplinary care. By comparing performance metrics within and outside the network of COEs, the program seeks to ensure that lung cancer patients (pts) receive the highest quality of care in their local area whilst also enabling COE hospitals to gain insights that facilitate the rapid implementation of quality improvement cycles.

      Method

      The Impact Study was launched to conduct a comprehensive comparative analysis of COE member and non-member institutions across numerous quantitative and qualitative metrics from within the lung cancer care continuum. The 2018 analysis included 17 COE sites and 19 non-COE community hospitals representing approximately 5,000 pts in each cohort. The COE Impact study captured pts’ demographic and clinical information as well as performance metrics from early stage screening through late stage diagnosis and all aspects of pts’ care.

      Result

      Variable

      COE

      Non-COE

      P value

      # Cancer centers/hospitals

      17

      19

      Answers collected by nurse navigator

      41%

      100%

      <0.001

      Average # of hospital beds

      565

      342

      0.104

      Average # of lung cancer pts/institution

      497

      470

      0.968

      Lung cancer screening program

      94%

      42%

      0.001

      Endoscopic Bronchoscopy Ultrasound (EBUS)

      23%

      16%

      0.323

      Screening of pts for clinical trials

      81%

      35%

      <0.001

      Race: Caucasians

      81%

      37%

      <0.001

      Pathologist in tumor boards

      100%

      67%

      0.012

      ER visits the first 4 months of therapy

      14%

      32%

      0.022

      Molecular testing of pts with metastatic disease

      81%

      48%

      0.001

      Next generation sequencing

      58%

      22%

      0.009

      Conclusion

      Improved structure and processes of care delivery at COE hospitals may translate into improved quality of care, outcomes, and patient experiences. The Lung Cancer COE program, now including 38 community cancer centers encompassing 12,000 lung cancer patients, plans to conduct this study annually with prospective, longitudinal data collection for future trend analyses as a means of facilitating continuous quality improvement in community-level lung cancer care.

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      MA19.06 - Successful Development of Realtime Automatically Updated Data Warehouse in Health Care (ROOT-S) (Now Available) (ID 584)

      11:30 - 13:00  |  Presenting Author(s): Hyun Ae Jung  |  Author(s): Sunyoung Hong, JuYoun Park, MI RA Park, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Myung-Ju Ahn, Keunchil Park

      • Abstract
      • Presentation
      • Slides

      Background

      Clinical information is often not recorded in an organized way, and converting it to a structured format can be a time-consuming task that may not successfully capture all facets of the information. Clinical Data Warehouse is a real time database that consolidates data from a variety of clinical sources to present a unified view. However, the clinical data extracted from the CDW have not only structured data (SD) but also natural language (NP) generated during clinical practice, and there is a limitation that it is difficult to apply to clinical trials because it is not structured and formatted to find key-point contents. This study aims at developing a systematic and comprehensive cohort through an automatic real-time update system called CDW.

      Method

      The aim of this study was to evaluate clinical data of non-small cell lung cancer, small cell lung cancer, head and neck cancer, thymic cancer, and mesothelioma. In this study, we developed a unique algorithm that is optimized for each disease category using comprehensive natural language processing (NLP) systems and structured information from unstructured free text and structured data capture (SDC). We developed an algorithm using clinical information of patients diagnosed and treated during the past 10 years and designated validation sets of patients diagnosed and treated in 2018 for validation that these algorithms work automatically.

      Result

      We collected clinical data of 23,735 NSCLC patients, 2,077 SCLC patients, 5,032 head and neck cancer patients, 3,948 esophageal cancer patients, 747 thymic cancer patients and 138 mesothelioma patients diagnosed at Samsung Medical Center. We could demonstrate using the validation set that the program accurately extracts the data needed for the cohort of each cancer. The program is updated automatically every 24 hours, the source of each data is indicated separately, and the data that need to be integrated is transformed and systematically organized. The biggest advantage is that the scattered information is systematically integrated and automatically buildup to match the patient's cohort, so you can capture most updated survival or test results or treatment outcomes almost in real time. Data on the development of this program will be presented.

      Conclusion

      This study is the first study that successfully developed and validated real-time updated cohort using CDW. This study suggests a blueprint for constructing a big data -based cohort for clinical research and is expected to be a landmark trial. The detailed analysis of each cancer through the development of the program will be presented.

      wclc.png

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      MA19.07 - Testing an Optimal Care Coordination Model (OCCM) for Lung Cancer in a Multi-Site Study (Now Available) (ID 2659)

      11:30 - 13:00  |  Presenting Author(s): Matthew P Smeltzer  |  Author(s): Thomas Asfeldt, Nicholas Faris, Amanda Kramar, Christine Amorosi, Vikki G Nolan, Meredith Ray, Monique Dawkins, Mary Catherine Nalan, Walter Stevens, Lorna Lucas, Randall A Oyer, Christopher S Lathan, Ray Osarogiagbon

      • Abstract
      • Presentation
      • Slides

      Background

      Medicaid-insured lung cancer patients have worse outcomes than others. To address barriers to optimal care in the US Medicaid population, the Association of Community Cancer Centers (ACCC) created and tested the OCCM.

      Method

      The OCCM included 13 assessment areas: Patient Access to Care, Prospective Multidisciplinary Case Planning, Financial/Transportation/Housing, Care Coordination, Electronic Health Records, Survivorship Care, Supportive Care, Tobacco Cessation, and Clinical Trials. Each area had 5 defined levels of quality care delivery. With support from the Bristol-Myers Squibb Foundation, we pilot tested the model in 7 US cancer centers. Sites selected 1-2 assessment areas to evaluate using OCCM, developing relevant data benchmarks. Sites enrolled patients on Medicaid and Non-Medicaid controls. The ACCC team worked with each site to develop quality improvement projects with bi-weekly conference calls and 2 on-site visits. Data were collected and analyzed at a centralized data coordinating center. Statistical analyses were performed with Kruskal Wallis and chi-squared tests.

      Result

      Seven sites spanning 3,081 miles evaluated 10 of the 13 OCCM areas. Total enrollment was 927 patients (257 Medicaid/ 670 Non-Medicaid). The Medicaid population had an average age of 62 years, ranging from 58-68 across sites. The clinical stage distribution was 40% stage I/II and 60% stage III/IV. Medicaid patients were 47% adenocarcinoma histology, 29% squamous cell, 14% small cell, and 10% other. Sites differed by patient age (p=0.0041), race (p<0.0001), and smoking status (p=0.028).

      Three sites evaluated models for prospective multidisciplinary case planning for Medicaid patients including: bi-weekly tumor board (BTB), virtual tumor board (VTB), and multidisciplinary team huddle (MTH). VTB and MTH allowed for presentation of higher percentages of eligible patients (BTB: 23%, VTB: 100%, MTH: 100%, p<0.0001). BTB and MTH discussed all cases prospectively, while VTB achieved 80%. Median days from diagnosis to presentation were 18 (BTB), 14 (VTB), and 9 (MTH, p=0.14).

      Two sites evaluated smoking cessation programs. One, using trained cessation counselors, had 62% (18/29) active smokers, of whom 56% (10/18) expressed readiness to quit. Another site, using the freedom from smoking initiative, had 50% (11/22) active smokers and 55% (6/11) readiness to quit. 83% of those who started the cessation program quit smoking.

      Patient access to care was evaluated with timeliness of care metrics at two sites: one found 13 days (median) from lesion discovery to diagnosis and 21 days from diagnosis to treatment in Medicaid patients, which did not differ from Non-Medicaid controls (p=0.96 and 0.38). 94% met the site goal of treatment initiation within 45 days. Another site found 16 days (median) from discovery to diagnosis and 27 days from diagnosis to treatment (did not differ from Non-Medicaid controls, p=0.68 and 0.83).

      Conclusion

      Sites successfully used the OCCM to identify areas to improve and developed meaningful data benchmarks. The OCCM is a valuable tool for cancer centers to identify specific areas to target to improve lung cancer care delivery.

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      MA19.08 - Discussant - MA19.05, MA19.06, MA19.07 (Now Available) (ID 3797)

      11:30 - 13:00  |  Presenting Author(s): Riyaz Shah

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      MA19.09 - Assessing Clinical Frailty in Advanced Lung Cancer Patients - An Opportunity to Improve Patient Outcomes? (Now Available) (ID 2363)

      11:30 - 13:00  |  Presenting Author(s): Fabio Gomes  |  Author(s): Katie Baker, Jennifer Woods, Jonathan Bruce, Marie Eaton, Phill Higham, Laura Cove-Smith, Alex Garbett, Anthea Cree, Cassandra Ng, Fiona Blackhall, Neil Bayman

      • Abstract
      • Presentation
      • Slides

      Background

      The median age of non-small cell lung cancer (NSCLC) diagnosis in England is 73 years. At that age, 40% of the general population has some degree of clinical frailty which may impact survival, quality of life, anti-cancer treatment tolerability and access to clinical trials. However, clinical frailty is often not addressed or managed at the time of anti-cancer treatments. This project was designed to integrate frailty assessments and build frailty pathways within an advanced cancer care setting in order to better support patients and improve outcomes.

      Method

      This quality improvement project that used Plan-Do-Study-Act (PDSA) methodology. Phase one of the project focused on establishing a multidisciplinary team to integrate a frailty screening tool, the Rockwood Clinical Frailty Scale (CFS), into standard clinical practice. The primary aim was to implement and screen ≥80% of all new lung cancer patients at a high-volume tertiary cancer centre. The secondary aim was to explore the correlation of CFS with age, performance status (PS), treatment selection and systemic anti-cancer treatment (SACT) tolerability. Specialised training was provided to the clinical team and the CFS was integrated from 26/11/2018 on an electronic form routinely completed by clinicians. A digital dashboard was set-up to monitor real-time data and the frail group was defined as CFS score >3. Data cut-off for this analysis was 29-03-2019.

      Result

      335 lung cancer patients were screened using CSF by a team of 20 clinicians with a compliance rate of 89%. There was a strong correlation between PS and CFS (r= 0.77, p<0.01). The distribution of both CFS and PS correlated with ageing (r= 0.2 and r= 0.17, respectively; p<0.01). Patients ≥70 years were more likely to be frail (56% vs 40%; OR 1.4, 95%CI 1.2-1.7; p<0.01). Frailty reduced the likelihood of receiving any anti-cancer treatment by 20%. Amongst those who started SACT, patients classed as frail were less likely to go beyond the first cycle of treatment (64% vs 91%; OR 0.7, 95%CI 0.5-0.9; p<0.01).

      Conclusion

      CFS screening is feasible within a busy clinical practice when incorporated as a digital tool. CFS helps to identify patients who may potentially benefit from specialised frailty assessment and management. This could ultimately be used to better inform on treatment selection, and support requirements during treatment, to improve outcomes for patients in the future.

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      MA19.10 - Estimation of Quality-Adjusted Life Expectancy for Stage and Systemic Treatment in Non-Small Cell Lung Cancer in Rajavithi Hospital, Thailand (Now Available) (ID 585)

      11:30 - 13:00  |  Presenting Author(s): Sunatee Sa-nguansai  |  Author(s): Oranuch Kamnerdtong, Kunlatida Maneenil

      • Abstract
      • Presentation
      • Slides

      Background

      Owing to the high mortality and rapidly growing costs related to lung cancer, it is worth examining the health benefits of treatment in this cancer. This study attempts to quantify the real-life practice quality-adjusted life expectancy (QALE) of non-small cell lung cancer (NSCLC) patients with different stages and systemic treatments.

      Method

      This cross-sectional study was conducted by reviewing and collected quality of life (QoL) data from 256 eligible all stages NSCLC patients treated at Rajavithi hospital from May 1st to October 31st, 2018. The iSQoL statistical package was used to evaluate QALE compared with the reference Thai population in different stage of disease. For advanced stage, QALE was compared among treatment groups (chemotherapy and Epidermal growth factor receptor tyrosine kinase inhibitors; EGFR TKIs)

      Result

      The QALE for patients with early and advanced stage NSCLC were 4.49 ± 0.43 and 1.03 ± 0.08 QALY, with the corresponding loss-of-QALE were 14.02 ± 0.44 and 20.13 ± 0.09 QALY, respectively. The difference of QALE between early and advanced stage was 3.46 QALY (p<0.001).

      Based on systemic treatment in advanced stage, The QALE for patients who received chemotherapy and TKIs were 1.05 ± 0.08 and 2.19 ±0.28 QALY, with the corresponding loss-of-QALE were 20.48 ± 0.09 and 19.12 ± 0.29 QALY, respectively. The difference of QALE between treatment with chemotherapy and TKIs was 1.17 QALY (Figure, p=0.001).

      ca-lung_qale-results.dpi_300.jpg

      Conclusion

      The utility gained from treatment with TKIs in advanced NSCLC is substantial. Early stage had better QALE than advanced stage NSCLC patients.Future study will assess the cost-effectiveness of targeted therapy in Thailand.

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      MA19.11 - Population Based Analysis of End of Life Treatment Patterns in Thoracic Malignancies (Now Available) (ID 1154)

      11:30 - 13:00  |  Presenting Author(s): Graham Pitson  |  Author(s): Leigh Matheson, Peter Eastman, Margaret Rogers

      • Abstract
      • Presentation
      • Slides

      Background

      Active cancer treatment within the last month of life is unlikely to meaningfully benefit patients and ASCO guidelines recommend chemotherapy treatment rates be kept as low as possible. Patients with thoracic malignancies often have rapidly progressive disease and significant symptom burden and there is little population based data on patterns of care near end of life.

      Method

      The Evaluation of Cancer Outcomes Registry records clinical information on all newly diagnosed cancer patients within a region of Victoria, Australia. Core diagnostic, demographic, treatment and outcome details were extracted for all patients diagnosed from 2009-2015 with death data through to end of 2016. Patients with thoracic malignancies were further analysed for treatment patterns at end of life. Details of palliative radiotherapy (pRT) and active systemic treatment (AST – intravenous chemotherapy, targeted therapy and/or immunotherapy) were recorded for all patients. Details on oral chemotherapy and stereotactic radiotherapy were not recorded.

      Result

      The total cohort during the study period comprised 12760 patients. Of these, 1328 patients were recorded with a thoracic malignancy (TM) (non small cell lung cancer 82%, small cell lung cancer 10%, mesothelioma 7%) and 1118 of these died. At total of 39% (518) and 41% (538) of the 1328 TM patients received AST and pRT respectively at some point. Of these patients 15% (77/518) received AST and 23% (121/538) pRT within 30 days of death, compared with 7.0% (242/3436) (p<0.01) and 19% (178/965) (p=0.06) respectively for the total cohort excluding TM patients. Patients receiving AST within 30 days of death had a similar median age (66.7 vs. 67.8 years, p=NS) but shorter median survival from diagnosis (146 v. 281 days, p<0.01) than patients receiving final AST within 1-6 months. The frequency of some change in AST agents within the prior month was highest in the last month of life. The most common AST agents used in the final month of life were pemetrexed, etoposide and gemcitabine and most patients were treated with single agents. More pRT treatments were started in the last 30 days of life than in any other month near end of life. Patients receiving pRT in the last month of life also had a shorter median survival from diagnosis (113 v. 215 days, p<0.01) and the sites most commonly treated with pRT in the last month of life were chest/lung, spine and whole brain.

      Conclusion

      Patients with thoracic malignancies have higher rates of AST treatment within the last 30 days of life than other patients with cancer in the same geographic region. Those treated within 30 days of death also have shorter median overall survival and higher frequencies of changing AST agents or starting pRT, possibly suggesting aggressive, symptomatic and poorly responding disease.

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      MA19.12 - Discussant - MA19.09, MA19.10, MA19.11 (Now Available) (ID 3798)

      11:30 - 13:00  |  Presenting Author(s): Flavia Amaral Duarte

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    EP1.12 - Small Cell Lung Cancer/NET (ID 202)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.12-15 - Oncologic Treatments and Outcomes for Small-Cell Lung Cancer Patients with Brain Metastases (Now Available) (ID 1877)

      08:00 - 18:00  |  Presenting Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Brain metastases (BM) are common in patients with small-cell lung cancer (SCLC), and are associated with short survival. Few data are available on this specific population of patients with SCLC and BM, as they are usually excluded from prospective randomized clinical trials.

      Method

      We present data on all patients diagnosed with BM from SCLC from the Cancer Register of the Hospital Universitari Dr. Josep Trueta during 2013–2017. Age, gender, and treatment in patients were recorded. Data cut-off for survival analysis was 28th March 2019.

      Result

      We identified 50 patients with SCLC and BM. Median age: 66 y (range: 4882 y); male: 39 (78%). Synchronous BM were observed at the diagnosis of primary lung cancer in 33 (66%) patients. Impact of treatments on median overall survival (mOS) is summarized in Table 1. Only 1 patient received brain surgery (with an OS of 6.5 months). One-third of patients (34%) received best supportive treatment as unique treatment. The 1-year OS was 18% in our study.

      Table 1
      Treatment %

      mOS

      (without treatment)

      mOS

      (with treatment)
      p-value
      Brain radiotherapy 52 % 1.4 m 9.1 m < 0.000001
      Chemotherapy 50 % 1.5 m 6.9 m =0.003
      Brain radiotherapy and chemotherapy 34 % 1.6 m 10.7 m =0.000331

      Conclusion

      Our real-world data reinforce the need for better therapies to improve the prognosis of patients with SCLC and BM.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-111 - ATEZO-BRAIN, A Single-Arm Phase II Study of Atezolizumab Combined with Chemotherapy in Stage IV NSCLC Patients with Untreated Brain Metastases (ID 733)

      09:45 - 18:00  |  Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Brain metastases (BM) are a frequent complication in non-small cell lung cancer (NSCLC), have significant impact on quality of life and are associated with poor prognosis. Systemic therapies might be an alternative approach to whole brain radiotherapy (WBRT) to avoid cognitive-related adverse events. Immune checkpoint inhibitors (ICI) showed intracranial activity in advanced NSCLC patients with BM. However clinical data about efficacy and safety of immune checkpoint inhibitors in combination with chemotherapy in patients with untreated BM are limited and further research in this setting is needed. We hypothesize that addition of ICI to conventional platinum-based chemotherapy may increase intracranial tumor response and provide clinically relevant benefit in terms of PFS, OS and quality of life to the patients with asymptomatic and non-previously treated BM.

      Method

      This is an ongoing multicenter, open-label, single-arm phase 2 study (EUDRACT: 2017-005154-11) to evaluate the efficacy and safety of atezolizumab 1200 mg combined with 4-6 cycles of carboplatin AUC 5 and pemetrexed 500mg/m2 every 3 weeks followed by maintenance with atezolizumab 1200 mg plus pemetrexed 500mg/m2 every 3 weeks in stage IV non-squamous NSCLC patients with untreated synchronous BM. Patients should have multiple and measurable BM, adequate performance status and organic function, do not harbor EGFR or ALK genomic alterations, be treatment naïve and do not have any contraindication to receive immunotherapy. Exclusion criteria consist of active neurological symptoms, dexamethasone dose ≥ 4 mg QD, prior treatment with brain radiotherapy, presence of leptomeningeal carcinomatosis, spinal or hemorrhagic metastases in the central nervous system. Primary endpoints are progression-free survival (PFS) at 12 weeks according to RANO-BM and RECIST v1.1 criteria and safety based on CTCAE v4. Both primary endpoints will be assessed in 40 patients in 15 sites using a Bayesian approach. Patients will undergo tumor assessments by body CT scan and brain MRI at baseline every 6 weeks for the first 12 weeks and thereafter tumor assessments will be performed every 9 weeks until disease progression or loss of clinical benefit. Secondary endpoints: intracranial and systemic objective response rate and duration of response. Exploratory endpoints: to assess neurocognitive function and quality of life; to determine time to neurological deterioration and time to need of salvage brain radiotherapy. Enrollment started on August 2018 and currently 12 patients have been included in the study.

      Result

      Clinical trial in progress

      Conclusion

      Clinical trial in progress

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      P1.01-54 - Somatic Genome Alterations in Lung Cancer Patients Diagnosed with Li Fraumeni Syndrome (Now Available) (ID 1014)

      09:45 - 18:00  |  Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Li-Fraumeni syndrome (LFS) is a rare hereditary condition that consists of TP53 mutations inherited in autosomal dominant manner that confer high risk of developing cancer, including lung adenocarcinoma (LUAD). EGFR-mutated LUAD were reported in the context of LFS but there is no systematic description of somatic mutations and characteristics of lung cancer (LC) patients with LFS.

      Method

      We present a retrospective analysis of clinical and molecular characteristics of patients with LFS diagnosed with LC at the Catalan Institute of Oncology from 1999 to 2019. We collected demographical and clinicopathological features, germline and somatic mutational alterations, treatment and progression-free survival (PFS) and overall survival (OS).

      Result

      A total of 7 patients with LC and LFS were identified in the Genetic Counseling Unit database. They were carriers of germline mutations in TP53. Five of them were classified as pathogenic: c.638G>A; p.(Arg213Gln), c.725G>A; p.(Cys242Tyr), c.742C>T; p.(Arg248Trp), c.844C>T; p.(Arg282Trp) and c.1010G>A; p.(Arg337His) and two of them as likely pathogenic: c.374C>T; p.(Thr125Met) and c.473G>A; p.(Arg158His). Six out of 7 patients were female and 5 out of 7 never smoker. Median age at diagnosis was 38 year-old (range: 29-74). Five patients had stage IV at diagnosis and the most common histologic subtype was LUAD (5). Six patients had first grade family history of cancer with a median of 2 family members (range: 1-4) and 2 patients had prior history of cancer. Tumor somatic profile in LC was obtained in 6 patients, consisting on a ROS-1 rearrangement in one patient and EGFR mutations in 5 patients (exon 19 deletion in 3 patients and missense mutations in 2 patients, p.(Gly719Ala) at exon 18 and p.(Leu858Arg) at exon 21) and in 1 patient was unknown. All patients with mutant EGFR received EGFR tyrosine kinase inhibitors (TKI) with a median PFS of 29 months (95% CI 0-67). Four had partial response and one a complete response to TKI treatment. At disease progression, one patient had small cell transformation and another acquired EGFR T790M mutation. Median lines of treatment were 4 (range 1-6). Two patients are alive at data cut off. Median OS is 47 months (95% CI 32-62).

      Conclusion

      Patients diagnosed with LC and LFS are enriched with actionable genomic alterations and have an earlier onset of the disease. Clinical outcome of patients with EGFR mutations and LFS did not differ from EGFR mutated LC patients who do not carry TP53 germline mutations.

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    P1.09 - Pathology (ID 173)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Pathology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.09-32 - Concurrent Genomic Alterations in ALK-Rearranged Non-Small Cell Lung Cancer Patients (ID 2463)

      09:45 - 18:00  |  Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Recent progress in genomic analysis using next-generation sequencing (NGS) has enabled the comprehensive detection of targetable alterations in non-small cell lung cancer (NSCLC) patients. As the detection of ALK gene fusions is being established by NGS, identification of concurrent alterations will lead to better characterization of the molecular landscape of ALK-rearranged patients.

      Method

      Thirty-one NSCLC samples with known ALK status (18 positive and 13 negative) tested in our Institution using FISH, IHC, and NGS (Oncomine Focus Assay, ThermoFisher Scientific) were further evaluated by an expanded NGS gene panel (PGDx elio™ tissue complete assay (under developement), Personal Genome Diagnostics). This NGS panel comprises 500+ genes and screens for clinically relevant genomic alterations (single base substitutions/insertion and deletions, fusion genes and copy number variations), and provides TMB scores (expressed as mutations per megabase, exome equivalent). Statistical associations were assessed using Pearson’s χ2 and Mann-Whitney U test.

      Result

      ALK positive patients were 50% female with a median age of 59 years old and 54% of them never smokers. For the ALK negative cohort, young patients without any known driver alterations were selected: 69% male with a median age of 54 years old and 92% of them current smokers. Of the 18 ALK-positive cases identified, five were considered non-evaluable for expanded genomic analysis due to insufficient sequencing coverage (yield below minimum suggested DNA input). ALK fusions were detected by all techniques in the 13 ALK-positive cases available for analysis. EML4(13)-ALK(20) was the most prevalent gene fusion detected in seven out of 13 cases (54%). Remarkably, we detected a rare ALK gene fusion that has not been yet described: IRF2BP2(1)-ALK(20). The concurrent alterations identified by expanded genomic analysis are shown in an OncoPrint figure comparing both groups. The most frequent concomitant alteration was TP53 mutation: 62% in ALK-positive and 69% ALK-negative (p> 0.05). Regarding gene amplifications, we identified three ALK-positive cases with copy number alterations of which we highlight MYC in two of these cases. Interestingly, a high TMB was significantly associated with ALK-negative cases with a median of 19.9 mut/Mb compared to 7.0 mut/Mb in ALK-positive (p= 0.001).

      figure abstract wclc alk tmb.png

      Conclusion

      We have studied the presence of ALK fusion genes with a novel NGS panel that showed excellent correlation with standard techniques. ALK fusions can be interpreted as early strong drivers to carcinogenesis due to the low frequency of concurrent alterations. It remains to determine the clinical impact of these alterations in larger series.

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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-12 - A Phase I/II Trial of IO102 and Pembrolizumab With/Without Chemotherapy as First-line Treatment of Metastatic NSCLC (ID 706)

      10:15 - 18:15  |  Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Immunotherapy has significantly changed the treatment landscape of non-small cell lung cancer (NSCLC) with no driver mutations. However, despite the addition of anti-PD-1/PD-L1 therapies to the clinical armamentarium only a subset of patients derives durable benefit. IO102 is a novel, second generation, HLA-A unrestricted immune modulating T-win® vaccine targeting IDO. IO102 has a dual mode of action; remodulation of the tumour micro-environment through elimination of immune suppressive cells, and induction of CD8 T-cell mediated killing of IDO-expressing tumor cells. Our first-generation IDO vaccine (IO101) has shown promising antitumor activity and a favorable safety in heavily pretreated NSCLC patients (Iversen, CCR 2013).

      Method

      Phase I/II, international, multicenter, open-label, randomized trial with two parallel cohorts. Cohort A: IO102 (100µg s.c.) and pembrolizumab (200 mg) (PD-L1 ≥ 50%); Cohort B: IO102, pembrolizumab and carboplatin plus pemetrexed (PD-L1 < 50%). The maximum treatment duration is 35 cycles (app. 2 years). Key eligibility criteria include metastatic NSCLC or non-squamous NSCLC (cohort B) with no prior treatment for metastatic NSCLC and no driver mutations.

      Phase I is a non-randomized safety run-in with 6 patients per cohort investigating one dose level of the experimental arms. Only one DLT is allowed in each cohort. Phase II is following Sargent’s two-stage, three-outcome optimum design (Sargent, ClinTrial2001) with a 2:1 randomization in the cohorts. Cohort A: IO102 and pembrolizumab versus pembrolizumab alone; Cohort B: IO102, pembrolizumab and chemotherapy vs. pembrolizumab and chemotherapy. Provision of blood and tumour tissue is required for biomarker studies.

      The primary endpoint is safety and objective response rate (ORR) per RECIST 1.1 in Phases I and II, respectively. Secondary endpoints include ORR per iRECIST, duration of response, progression free survival, overall survival, and biomarkers including immunoscore in tissue, tumour mutational burden and immunomonitoring in blood.

      The study is enrolling in Europe. First patient was entered in September 2018 and recruitment is expected to continue throughout 2019: EudraCT Number 2018-000139-28 / IND Number: 018081.

      Result

      Section not applicable

      Conclusion

      Section not applicable

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      P2.01-49 - Targeting STAT3-Positive Reactive Astrocytes with Silibinin in the Therapeutic Landscape of Non-Small-Cell Lung Cancer with Brain Metastases (Now Available) (ID 1336)

      10:15 - 18:15  |  Presenting Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Silibinin is a bioactive flavonolignan extracted from milk thistle (Silybum marianum) and is a direct inhibitor of STAT3 – with high affinity to both the Src homology-2 domain and the DNA-binding domain of STAT3. Pre-clinical data indicate that blocking STAT3 signaling in reactive astrocytes, a major component of the brain metastasis microenvironment, can decrease the number and size of brain metastases (BM).

      Method

      We present data on all patients diagnosed with BM from non-small cell lung cancer (NSCLC) from the Cancer Register of the Hospital Universitari Dr. Josep Trueta during 2013–2017. Age, gender, histology, and treatment in patients were recorded. During this period, some patients received compassionate use of Legasil®, a commercially available silibinin-based nutraceutical, in addition to standard oncologic treatment. The data cut-off for survival analysis was 28th March 2019.

      Result

      We identified 221 patients with NSCLC and BM. Median age: 62 y (range: 3288 y); male: 161 (72.9%). Synchronous BM were observed at the diagnosis of primary lung cancer in 133 (60.2%) patients. Differences in median overall survival (mOS) were detected by histology subtype: adenocarcinoma (66.1%)=4.6 m, squamous (17.6%)=1.8 m, not otherwise specified (16.3%)=2.2 m, p=0.000003. Treatment effects on mOS are summarized in Table 1. In the subgroup of patients that received brain radiotherapy in addition to systemic therapy for BM, differences were maintained between patients that received Legasil® (n=15) or not (n=64):28.5 months vs 6.3 months (p=0.000052).

      Table 1
      Treatment %

      mOS

      (without)

      mOS

      (with treatment)
      p-value
      Brain radiotherapy 53.8% 1.9 m 5.1 m < 0.000001
      Systemic therapy 52% 1.6 m 6.9 m < 0.000001
      Brain surgery 5% 3.2 m 15.5 m =0.000127
      Silibinin supplementation 8.1% 3.5 m 22.8 m =0.000001

      Conclusion

      Our data indicate that silibinin supplementation could contribute to the control of BM in patients with NSCLC. Further evaluation of silibinin, or other STAT3 inhibitors, in clinical trials is warranted in this setting.

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    P2.03 - Biology (ID 162)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Biology
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.03-16 - Agreement Between Different Methodologies for Non-Invasive p.T790M and EGFR Sensitizing Mutation Testing (ID 1965)

      10:15 - 18:15  |  Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Tyrosine kinase inhibitors (TKIs) are the current standard of care for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). However, most patients progressed within 1 to 2 years. The EGFR p.T790M mutation is the most common resistance mechanism to first and second generation EGFR TKIs. The identification of p.T790M mutation is of considerable clinical relevance as osimertinib has demonstrated clinical efficacy in this setting. Guidelines recommend testing for the p.T790M mutation in blood at relapse to TKIs, and re-biopsy only in case of a negative result. Several blood based methodologies for detection of EGFR mutations have been developed in the recent years. However, the number of comparison studies between platforms is very limited.

      Method

      This is a multicenter, cross-sectional study (ClinicalTrials.gov Identifier: NCT03363139) performed by the Spanish Lung Cancer Group. Samples from 75 consecutive EGFR mutant NSCLC patients were collected at disease progression to first line TKI treatment. The presence of EGFR mutations in the cfDNA was evaluated in 39 samples by 7 methodologies, namely: Cobas® EGFR Mutation Test v2 (Roche Diagnostics), Therascreen EGFR Plasma RGQ PCR Kit (Qiagen), QuantStudio® 3D Digital PCR System (Thermofisher), a 5′-nuclease real-time PCR (TaqMan®) assay in presence of PNA, OncoBEAM EGFR (Sysmex Inostics), NGS with two different gene panels: Oncomine® (Thermofisher) and Lung Cancer Panel (Qiagen). The agreement between methodologies was assessed using the kappa coefficient (K) and its corresponding 95% confidence intervals (95% CI). For quantitative variables the concordance correlation coefficient (ccc) was used.

      Result

      Complete results are available for 39 patients. Overall, the agreement between all methodologies for the detection of p.T790M mutation as well as the original EGFR sensitizing mutation was good (K=0.669; 95CI: 0.504-0.835 and K=0.750 95CI: 0.599-0.899 respectively). Remarkably, the agreement between FDA-approved methodologies for p.T790M detection was almost perfect (K=0.926; 95CI: 0.712-1) and good for the EGFR sensitizing mutations (K=0.657; 95CI: 0.417-0.902). Similarly, the agreement between NGS-based methodologies for the detection of p.T790M and the EGFR activating mutations was very high (K=0.843; 95CI: 0.567-1 and K=0.872 95CI: 0.595-1 respectively). Moreover, concordance between both technologies for p.T790M and EGFR sensitizing mutation mutant allele frequency was excellent (ccc=0.956; 95CI: 0.906-1 and ccc=0.980 95CI: 0.950-1 respectively). The proportion of samples that were positive for p.T790M detection varied from 28% (PCR based technologies) to 37% depending on the methodology.

      Conclusion

      NGS and PCR-based methodologies show a good to excellent agreement for the detection of EGFR mutations, including the p.T790M. Our results support the use of liquid biopsies for non-invasive testing of clinically relevant mutations (Data from the whole cohort will be presented at the meeting).

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      P2.03-33 - ctDNA Levels Significantly Predicts Survival in NSCLC Patients with an EGFR Activating Mutation (ID 2016)

      10:15 - 18:15  |  Author(s): Joaquim Bosch-Barrera

      • Abstract

      Background

      Circulating tumor DNA (ctDNA) have been shown to be useful for non-invasive biomarker testing in non-small cell lung cancer (NSCLC). In addition, there is growing evidence supporting that ctDNA levels can be useful for tumor response to treatment monitoring. Nevertheless, data from large prospective clinical longitudinal studies still limited.

      Method

      300 plasma samples from 100 advanced NSCLC patients, with tumors harboring an EGFR activating mutation and treated with a first line tyrosine Kinase inhibitor were analyzed. Samples were collected before the start of treatment, at first follow up evaluation, at 7 month and at disease progression. ctDNA was analyzed by dPCR.

      Result

      Median follow up was 11.3 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, afatinib or gefitinib). Patients harboring a deletion in exon 19 or a mutation in exon 21 exhibited better survival than those with an insertion in exon 20 (P<0.001). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. ctDNA levels before the start of the treatment did not significantly predict survival, although a tendency was observed, with patients with high levels of ctDNA showing poorer outcome. On the contrary, patients in which the EGFR sensitizing mutation was undetectable at first follow up had a markedly better PFS and OS (HR=2.7; 95IC= 1.4-5.5 and HR= 5.5 95IC: 1.8-17 respectively). In the same way, patients in which the EGFR sensitizing mutation remained negative at 7months had a significantly increased PFS (HR: 2.8; 95IC: 1.2-6.6). None of the patients with undetectable levels at 7 months has deceased.

      Conclusion

      ctDNA levels is of prognostic significance in EGFR positive NSCLC patients with advance disease and can be useful to monitor treatment outcome

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    P2.05 - Interventional Diagnostic/Pulmonology (ID 168)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Interventional Diagnostics/Pulmonology
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.05-10 - Liquid Biopsy: Association Between the Burden of Disease in Patients with EGFR-Mutated NSCLC and the Frequency of Its Detection in Blood (ID 2384)

      10:15 - 18:15  |  Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      In the management of patient’s whit non small cell lung cancer (NSCLC) with EGFR mutations after progression to first and second generation tyrosine kinasa inhibitors (TKI), the mechanism of resistance is very important. Our objective is to analyse the appearance kinetics of the T790M by means of digital PCR techniques in liquid biopsy.

      Method

      We conducted a multicenter study with 100 patients with EGFR-mutated NSCLC, treated with first-line TKI therapy. We analyze the ctDNA by dPCR before the start of treatment, at first follow up evaluation, at 6 months and at disease progression.

      Result

      We included a total of 100 patients from July 2016 to December of 2017. Seven patients with Exon 20 insertion in EGFR were excluded (final sample 93). The median of follow-up was 12 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, gefitinib or afatinib). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. Of these cases, EGFR sensitizing mutation was detected in 75% of the patients with stage IVA and 85% in stage IVB respectively, p=0,075. The resistance mutation p.T790M was detected in 52% of the samples collected at disease progression. The probability to detect the resistance mutation p.T790M by liquid biopsy, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation (11% vs 62%) p 0,009. In cases with progression of the disease the percent of detection of p.T790M was 52% and 54% in patients with Exon 19 deletion and L858R mutation respectively. The OS in patients with progression of the disease and p.T790M negative was 85% at 12 months (95%CI: 60%-94%) and 75% with p.T790M positive (95%CI: 49%-88%), p=0,01.

      Conclusion

      The burden of disease in patients with NSCLC mutated with EGFR is related to the appearance of sensitivity and resistance mutations in liquid biopsy. The probability to detect the resistance mutation p.T790M in blood, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation.

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      P2.05-12 - Analysis of Biomarkers in Lung Cancer in Spain (ID 854)

      10:15 - 18:15  |  Author(s): Joaquim Bosch-Barrera

      • Abstract

      Background

      The analysis of biomarkers in lung cancer (LC) is currently one of the most important care needs, given the importance of their presence in the selection of specific treatments. Our objective was to know the implementation degree of these tests in a large cohort of patients in Spain using the Thoracic Tumor Registry (TTR) of the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group).

      Method

      The TTR is an observational cohort multicenter study of the LC in Spain. Information on patients (p) enrolled from August 2016 to December 2018. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating institute. The registry was approved by the Spanish Drug Agency as a non-post-authorization, non-interventional study.

      Result

      A total of 7,872 patients from 58 Spanish sites were enrolled. Analysis of molecular markers considering all the LC stages: A molecular test, the most frequent being the EGFR test, was performed in 4,456 patients (67.5%). The proportion of biomarker evaluation has varied over time, ranging from 57.9% prior to 2012 up to 73.7% in 2017.

      Molecular markers in patients with stage IV. Three thousand four hundred forty-six (3,446) patients (52.2%) had a stage IV on diagnosis. The molecular assessment of some biomarkers reached 81.4% of all the patients, there being differences between Regional Communities in regard to the molecular tests made.

      There was performed some biomarker test in 92% of the 2570 patients with stage IV and adenocarcinoma histology. The analysis of ALK was tested in 79% of the patients, this being in 40% only 2 years ago. ROS was studied in 20% of the cases and EGFR in 92%.

      Conclusion

      Although no national plan exists for molecular biomarker analysis in LC in Spain, the implementation of the biomarkers analysis in all the hospitals that contribute to the TTR is high, as close to the maximum as possible. The increase in the ALK analysis in the last period is relevant. As regional differences exist, it would be of interest to go in depth to study its cause

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    P2.10 - Prevention and Tobacco Control (ID 176)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Prevention and Tobacco Control
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.10-02 - Smoking Habit in Lung Cancer in Spain   (ID 732)

      10:15 - 18:15  |  Author(s): Joaquim Bosch-Barrera

      • Abstract
      • Slides

      Background

      Tobacco is the leading cause of lung cancer. The fight against the smoking habit is essential and should be continuous, to detect the national situation that makes it possible to design health care policies against this consumption. To do so, the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group) made this analysis within the context of the Thoracic Tumor Registry (TTR).

      Method

      The TTR is an observational cohort multicenter study in Spain. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating site. The registry was approved by the Spanish Drug Agency, as a non-post-authorization, non-interventional study.

      Result

      We collected data from 6,600 patients diagnosed of lung cancer from 58 different Spanish hospital sites.

      A total of 3,039 patients were former smokers (46%), 2,611 were active smokers (39%) and only 866 (12%) patients stated to be non-smokers; the status in 2% is unknown. If we make a comparison by gender regarding the presence of this habit, large differences (p-valor < 0.001) are observed, with a greater number of non-smokers in women (37 % vs. 4.5% in males), while the percentage of former smokers is much higher in the males (53.4% vs. 27.9% in women) and a minor difference in active smokers (42.1% vs. 34.4% in women).

      Significant differences were observed in the study on the distribution of the smoking habit by gender and year of diagnosis. An increase is also observed in the last two years regarding the percentage of patients who were active smoked, both for the total population as well as for each one of the two genders separately. The increase is greater among the women and, also, the number of women who are active smokers is greater in recent years.

      Mean age of onset of the smoking habit is 18.2 years. Significant differences are observed between both genders (p-valor < 0.001), with a mean age of initiation of 17.9 years in the men (95%CI 17.6-18.2 years) and 19.2 years in the women (95%CI 18.5-19.8 years). Significant differences between Regional Communities were also found in the mean age at onset of the habit, with much lower levels in the Valencian Community (16.6 years) or Navarra (16.9 years) regarding other communities, such as the Region of Murcia (22.9 years) or the Balearic Islands (21.6 years)

      Conclusion

      Lung cancer in Spain is associated to tobacco consumption in 85% of the cases diagnosed. Consumption has shown an increase in both genders in recent years and is especially rapid and worrisome in women. Anti-smoking campaigns should be reactivated and the causes of the regional differences analyzed in depth

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