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Ray Osarogiagbon



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    MA06 - Challenges in the Treatment of Early Stage NSCLC (ID 124)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Now Available
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      MA06.01 - Mediastinal Lymph Node Dissection (MLND) v Systematic Sampling (SS) v Neither (NN) in Population-Based Cohort (Now Available) (ID 2974)

      13:30 - 15:00  |  Author(s): Ray Osarogiagbon

      • Abstract
      • Presentation
      • Slides

      Background

      American College of Surgeons’ Oncology Group (ACOSOG) Z0030 revealed similar survival after MLND v SS for early-stage non-small cell lung cancer (NSCLC), but a recent meta-analysis of 1,980 patients in 5 randomized controlled trials from 1989-2007 suggested superior survival after MLND, raising doubts about Z0030 findings. We compared survival of patients with MLND v SS v NN in a population-based cohort.

      Method

      All resections for NSCLC in all institutions within 4 contiguous United States Hospital Referral Regions from 2009-2018 stratified by ACOSOG Z0030 nodal examination criteria into MLND (stations 2R,4R, 7, 8, 9 and 10R for right-side resections; 4L, 5, 6, 7, 8, 9, and 10L for left-sided), SS (minimum of 4R, 7, and 10R on the right and 5,6,7 and 10L on the left, but MLND definition not met), and NN (neither MLND nor SS ).

      Using appropriate statistical tests, we compared demographic and clinical characteristics, perioperative complication rates and survival, adjusting survival for extent of resection, histology, age, race, sex and insurance.

      Result

      2118 patients met Z0030 eligibility criteria (clinical T1/2,N0/non-hilar N1,M0): 15% had MLND, 15% SS, 69% NN. The distribution of age, race, insurance was similar, but 54% v 51% v 43% of MLND v SS v NN, were female (p=.0002). Use of preoperative PET-CT scans was similar (p=.5797), but invasive staging was used in 21% v 19% v 28% (p<.01), Although the distribution of clinical T,N and aggregate stage was similar (p>.05), 10% of the patients who met neither MLND nor SS criteria had no lymph nodes examined (pathologic NX). The median (interquartile range) number of mediastinal lymph nodes examined was 8(6-12), 5(4-8), 2 (0-5) (p<.001); hilar/intrapulmonary nodes 5(2-9), 6(3-10), 3(1-7) (p<.001). Postoperative complication rates were similar, including rates of cardiac arrhythmia, chylothorax and ICU re-admission. ICU length of stay (LOS) was 1(1-2) days in all groups, hospital LOS was 5(3-7), 5(3-8), 6(4-10) days. The 30-day mortality rate was 4% for all groups. Unadjusted hazard ratio (HR) was 0.80 (0.56-1.10, p=1.664) between MLND and SS; adjusted (a)HR 0.81 (0.58-1.138, p=0.2273). Survival of MLND and SS patients was significantly better than NN (Figure): aHR 0.62(0.48-0.81, p=0.0004) for MLND v NN; aHR 0.76 (0.60-0.98, p=0.0304) for SS v NN.

      figure acosog.png

      Conclusion

      ACOSOG systematic nodal dissection was achievable and safe in a ‘real-world,’ population-based cohort. SS was associated with similar survival to MLND in early-stage NSCLC, corroborating Z0030 findings. However, the majority of resections did not attain either criteria, with significantly worse survival.

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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: 2
    • Now Available
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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  |  Author(s): Ray Osarogiagbon

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

      11:30 - 13:00  |  Author(s): 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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    MS06 - An Interdisciplinary Approach to Optimal Nodal Staging (ID 69)

    • Event: WCLC 2019
    • Type: Mini Symposium
    • Track: Staging
    • Presentations: 1
    • Now Available
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      MS06.04 - Approaches to Overcoming the Nodal Staging Quality Gap (Now Available) (ID 3470)

      11:00 - 12:30  |  Presenting Author(s): Ray Osarogiagbon

      • Abstract
      • Presentation
      • Slides

      Abstract

      MS 06 04: Approaches to Overcoming the Nodal Staging Quality Gap: Extended Abstract.

      The importance of pathologic nodal staging. Surgical resection remains the most important curative-intent treatment modality for non-small cell lung cancer (NSCLC), with 75-85% of 5 year survivors having undergone resection. For such patients, the status of nodal involvement is the most important prognostic factor, which also has implications for subsequent management, since patients with any nodal involvement (pN1-3) benefit from adjuvant chemotherapy and those with mediastinal nodal involvement (pN2-3) may benefit from adjuvant radiation therapy. Nodal staging also influences risk-stratification for clinical trials eligibility.

      Defining nodal staging quality. There are no universally accepted criteria for defining nodal staging quality, but various professional organizations, including the American College of Surgeons Oncology Group (ACOSOG), the American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC), the American College of Surgeons Commission on Cancer (CoC), the European Society for Thoracic Surgery (ESTS), the International Association for the Study of Lung Cancer (IASLC) and the National Comprehensive Cancer Network (NCCN) have all proposed slightly different measures of the quality of pathologic staging, including nodal staging parameters.1

      The nodal staging quality gap. Despite the importance of pathologic nodal stage, the quality of application of nodal staging is highly variable. Three examples are: non-examination of lymph nodes in resection specimens (pNX) which exists in 12-18% of resections; non-examination of mediastinal lymph nodes, which is reported in up to 50% of resections; failure to achieve aggregate nodal staging quality requirements, such as the NCCN definition of quality, which is achieved in as few as 4% of surgical resections in population-based cohorts in the United States.2

      Survival implications. pNX resections have significantly inferior survival to pN0 resections, and are more similar to resections for pN1 NSCLC; pN0 and pN1 resections without examination of mediastinal nodes have 14% lower adjusted 5-year survival than those with at least one examined mediastinal lymph node; and achievement of all 4 elements of the NCCN definition of resection quality (anatomic resection, negative margins, examination of at least 1 hilar/intrapulmonary lymph node and at least 3 mediastinal nodal stations) is associated with 30% lower hazard of death within 5 years.3

      Causes of the gap, corrective interventions. The nodal staging quality gap can be localized to events during the surgical operation, the transfer of resection specimens and the pathology examination. Effective interventions must correct the problem at all its potential sites of origin. In the ‘chain of responsibility’ conceptual model, any breakdown in the surgical retrieval of lymph nodes, labeling of specimens, transfer of specimens, gross retrieval of lymph nodes from submitted material and pathologic examination of the retrieved material can break down the quality and accuracy of the final pathology report which is used for all subsequent oncologic care decision-making. Devices such as pre-labeled specimen collection kits are able to prevent breakdown at all links of this chain: they significantly increase the thoroughness of lymph node evaluation; rates of attainment of nodal staging quality measures; and survival. However, their impact on retrieval of intrapulmonary lymph nodes is limited.

      Specific interventions are also required to improve pathologic retrieval of intrapulmonary lymph nodes, given evidence that up to 90% of pulmonary resection specimens have lymph nodes discarded without examination, approximately 30% of which have metastasis, including in 12% of patients reported as having pN0. Patients with discarded intrapulmonary lymph node metastasis have worse survival than those without, irrespective of their pathologic nodal stage. Even in the mediastinal nodal dissection arm of the ACOSOG Z0030 trial, in which there was extensive evaluation of hilar and mediastinal lymph nodes, poor examination of intrapulmonary lymph nodes was common and had significant negative survival impact.4 Novel, anatomically sound gross dissection methods designed to focus on retrieval of lymph nodes in the peri-bronchial tree with particular emphasis on sites of bronchial bifurcation, significantly improve the yield of lymph nodes and decrease the incidence of discarded lymph nodes. Therefore, combining surgery with lymph node specimen collection kits and improved gross dissection methods is necessary to comprehensively overcome the nodal staging quality gap.

      What are the putative pathways for survival impact? Correct prognostication by more accurate risk-stratification, although beneficial in itself, would only impact on stage-stratified survival, without changing survival in aggregate populations. The finding of aggregate survival differences suggests benefit beyond mere stage re-categorization. One likely mechanism is improvement in identification of candidates for adjuvant therapy, which then provides an indirect means of risk-mitigation. However, given the larger reduction in hazard for death when surgical specimen collection kits are used, than would be expected from adjuvant therapy benefits alone, another plausible hypothesis is an inherent benefit of resecting oligo-metastatic lymph node disease. This hypothesis requires further testing. Interestingly, it fits the emerging understanding of suboptimal nodal staging as a type of incomplete resection (R-uncertain) and the IASLC’s proposal for creating a new category of ‘R-uncertain’ resections, the overwhelming majority of which are caused by poor nodal staging.5

      The emerging ability to conduct tests for minimal residual disease such as with cell-free DNA will provide a means of directly testing this hypothesis. If proven, it would open a pathway to future clinical trials of novel adjuvant treatments, such as checkpoint inhibitor therapy and other immunomodulatory treatments for these residually high-risk patients.

      References

      Smeltzer MP, et al. Association of Pathologic Nodal Staging Quality With Survival Among Patients With Non-Small Cell Lung Cancer After Resection With Curative Intent. JAMA Oncol. 2018 Jan 1;4(1):80-87.

      Allen JW, et al. Quality of surgical resection for nonsmall cell lung cancer in a US metropolitan area. Cancer. 2011 Jan 1; 117(1):134-42.

      Osarogiagbon RU, et al. Prognostic Value of National Comprehensive Cancer Network Lung Cancer Resection Quality Criteria. Ann Thorac Surg. 2017 May; 103(5):1557-1565.

      Osarogiagbon RU, et al. Survival Implications of Variation in the Thoroughness of Pathologic Lymph Node Examination in American College of Surgeons Oncology Group Z0030 (Alliance). Ann Thorac Surg. 2016 Aug;102(2):363-9.

      Rami-Porta, et al. Complete resection in lung cancer surgery: proposed definition. Lung Cancer. 2005 Jul;49(1):25-33.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-38 - Racial Disparities in Long-Term Survival After Surgical Resection in the US (Now Available) (ID 1968)

      09:45 - 18:00  |  Author(s): Ray Osarogiagbon

      • Abstract
      • Slides

      Background

      Racial disparities exist in US lung cancer care, including delayed access, lower use of invasive procedures such as curative-intent surgery, and worse surgical outcomes in African-Americans compared to Caucasians. We investigated if racial disparities persist in non-small cell lung cancer (NSCLC) patients who received curative-intent resection in a population-based cohort.

      Method

      We examined all patients from a prospective population-based cohort who underwent curative-intent resections for lung cancer from 12 hospitals across 7 healthcare systems from 2009-2018. We compared overall survival (OS) by race and adjusted for age, sex, smoking status, family history, tumor histology, and clinical stage. We used Chi-square tests, Kaplan-Meier plots, and Cox proportional hazards modeling, reporting unadjusted and adjusted hazard ratios (aHR) with 95% confidence intervals.

      Result

      Of the 3,418 patients, 78% were Caucasian, 22% were African-American; 42% had Medicare,15% Medicaid, 39% commercial insurance, and 3% were uninsured. Caucasians were older (mean age 67.8 vs. 64.1; p=<0.0001). African-Americans were more likely to be active smokers (p=0.0017), have adenocarcinoma histology (p=0.0167), and less likely to be clinical stage I (p=0.0453). Median follow-up time in censored patients was 3.4 years. Overall, we found no differences in OS by race (unadjusted HR: 0.97 [0.88-1.08]; aHR: 0.998 [0.87-1.15]). However, stratified by insurance, we found significant differences (p=0.0251). Among patients with Medicaid insurance, African-Americans had significantly better OS (aHR: 0.73 [0.55-0.97]) than Caucasians but among patients with commercial insurance, African-Americans had significantly worse OS (aHR: 1.26 [1.02-1.57]).

      youmedicaid31_resize.jpg

      youcommercial31_resize.jpg

      Conclusion

      When all patients receive curative-intent surgical resection, racial disparities in NSCLC survival may be reduced, but differences in the impact of race on survival by type of insurance suggest residual and complex disparities in both access and quality of care. Further exploration of the interaction between race, socio-economic factors, and the mechanisms of lung cancer outcome disparities is warranted.

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