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X. Yu



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    MINI 06 - Quality/Prognosis/Survival (ID 111)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Localized Disease - NSCLC
    • Presentations: 1
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      MINI06.04 - Impact of Attainment of the American College of Surgeons Commission on Cancer Quality Measure on Patient Survival After Lung Cancer Resection (ID 2177)

      17:00 - 17:05  |  Author(s): X. Yu

      • Abstract
      • Presentation
      • Slides

      Background:
      Institution-driven survival disparities persist among non-small cell lung cancer (NSCLC) patients who receive curative-intent surgical resection. Recently, the Commission on Cancer (CoC) established an institutional quality surveillance measure: the proportion of resected stage IA–IIB NSCLC with examination of ≥10 lymph nodes. We examined the potential impact of this measure on long-term patient survival.

      Methods:
      We analyzed all stage IA-IIB NSCLC resections in the Mid-South Quality of Surgical Resection cohort, a patient-level database of all lung cancer resections performed in 11 institutions in 5 Dartmouth Hospital Referral Regions in Eastern Arkansas, Northern Mississippi, and Western Tennessee from 2004-2013. We recorded pathologic staging details. Patients receiving pre-operative therapy were excluded. A trend analysis of quality and survival disparities was performed based on a Cox proportional hazard model, adjusted for age and pathologic stage.

      Results:
      Of 1,877 eligible patients, 77% were stage I and 23% stage II. The median number of lymph nodes retrieved during surgery was 6 (interquartile range [IQR]: 3-10). The CoC quality measure was achieved in 27.8% of cases. Conversely, 11% of resections had no lymph nodes examined (pNX). The proportion of cases meeting the CoC criteria increased from 18.8% in 2004 to 50% in 2013 (p<0.001). Large variations among institutions existed, ranging from 14% to 55% of institutional cases meeting the CoC measure. Compared to pNX resections, resections with at least one lymph node examined yielded some survival benefit (Hazard ratio (HR): 0.71, 95%CI: 0.54-0.93, p=0.014). Likewise, Patients with 10-12 lymph nodes examined had 43% overall survival benefit (HR: 0.57, 95%CI: 0.40-0.81, p=0.002), but survival did not significantly improve compared with 4-6 (the median) lymph nodes harvested (p=0.48). However, the survival benefit improved as more lymph nodes were examined, reaching an optimal point of a 72% benefit when 19-21 lymph nodes were harvested (HR: 0.28, 95%CI: 0.11-0.68, p=0.005). Compared with 4-6 lymph nodes, the survival benefit was 17% (p=0.06) (Figure 1). Furthermore, for those with any mediastinal lymph nodes sampled during the surgery, the survival benefit was 17% (HR: 0.82, 95%CI: 0.71-0.96, p=0.015). Figure 1



      Conclusion:
      Only 28% of NSCLC resections achieved the CoC measure, with large variations among institutions, but the overall rate of attainment has increased over time. Compared with no lymph nodes examined, meeting the CoC criteria provided a 43% overall survival benefit. However, more stringent measures, such as examining 20 lymph nodes (72%) or requiring mediastinal lymph node examination (17%), will have even greater survival impact.

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    ORAL 20 - Chemoradiotherapy (ID 124)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      ORAL20.07 - Survival Impact of Post-Operative Therapy Modalities after Incomplete and Complete Surgical Resection for Non-Small Cell Lung Cancer in the US (ID 1417)

      11:39 - 11:50  |  Author(s): X. Yu

      • Abstract
      • Presentation
      • Slides

      Background:
      Incomplete resection of potentially curable Non-Small Cell Lung Cancer (NSCLC) is a significantly negative clinical event for which adjuvant radiotherapy, chemotherapy, or combined chemo-radiotherapy is often used to reduce mortality risk. After complete (R0) resection, randomized controlled trials and the PORT meta-analysis show radiotherapy to be harmful to patients with stage I-II disease, and of marginal benefit in patients with N2-positive stage IIIA. After incomplete resection (R1/R2), current National Comprehensive Cancer Network (NCCN) guidelines recommend radiotherapy for stage IA/IB and chemo-radiotherapy for patients with stage IIA-IIIA. Adjuvant therapy recommendations after R1/R2 resection have never been verified.

      Methods:
      With the objective of validating NCCN post-operative therapy guidelines, we evaluated patients with surgically resected pathologic stage I-IIIA NSCLC in the National Cancer Data Base from 2004-2011. Recipients of pre-operative adjuvant therapy and those with no lymph nodes examined were excluded. Post-operative therapy modalities were classified as chemotherapy, radiotherapy, chemo-radiotherapy, or no treatment. Analyses were adjusted for patient demographic, clinical, and surgical characteristics, as well as institutional characteristics. Analyses were conducted by margin status and stage groups based on NCCN classifications (Table I). Unadjusted stage-specific 5-year overall survival (OS) estimates were calculated based on the Kaplan-Meier method and compared across post-treatment modalities with the log-rank test. Survival was modeled with Extended Cox Regression to adjust for all covariates and allow for non-proportional hazards.

      Results:
      Among 98,176 NSCLC patients who underwent curative-intent surgery during 2004-2011, 48% were male, 79% white, 34% privately insured, and 58% Medicare insured, with a median age of 68 years. The 5-year OS estimates by treatment modality are shown in Table I (NCCN recommendations highlighted). Margin negative patients with stage IA or IB/IIA who received post-operative radiotherapy had significantly lower OS compared to those with no treatment (both p-values<0.0001). We also observed lower OS with post-operative radiotherapy in margin positive patients with stage IA (p-value=0.0006) and IB/IIA (p-value=0.0302). Survival was significantly higher in persons with stages IB-IIIA who received post-operative chemotherapy compared to no treatment (all p-values<0.0001). Fully adjusted modeling analyses (not shown) yielded similar results.

      5 Year Survival (P-Value)
      NCCN Categorized Group Margin Positive Margin Negative
      Stage IA (T1ab,N0) No Treatment 60%(Ref) 71%(Ref)
      Chemo-Only 64%(0.86) 74%(0.33)
      Radiotherapy-Only 24%(0.0006) 47%(<0.0001)
      Chemo+Rad 44%(0.17) 43%(<0.0001)
      (N=458) (N=41279)
      Stage IB (T2a,N0) & Stage IIA (T2b,N0) No Treatment 48%(Ref) 57%(Ref)
      Chemo-Only 66%(0.0002) 69%(<0.0001)
      Radiotherapy-Only 30%(0.0302) 41%(<0.0001)
      Chemo+Rad 39%(0.28) 48%(<0.0001)
      (N=1016) (N=29111)
      Stage IIA (T1ab-T2a,N1) & Stage IIB (T3,N0;T2b,N1) No Treatment 27%(Ref) 39%(Ref)
      Chemo-Only 35%(<0.0001) 55%(<0.0001)
      Radiotherapy-Only 26%(0.84) 29%(<0.0001)
      Chemo+Rad 36%(<0.0001) 43%(0.0194)
      (N=1549) (N=15543)
      Stage IIIA (T1-3,N2;T3,N1) No Treatment 15%(Ref) 26%(Ref)
      Chemo-Only 25%(0.0013) 41%(<0.0001)
      Radiotherapy-Only 11%(0.76) 19%(0.0551)
      Chemo+Rad 26%(<0.0001) 39%(<0.0001)
      (N=1109) (N=8111)


      Conclusion:
      In patients with negative margins, results from the NCDB are consistent with randomized clinical trials and stage-specific NCCN post-operative adjuvant therapy recommendations. However, the NCCN recommendation of post-operative adjuvant radiotherapy for patients with early stage NSCLC with a positive resection margin is not supported by our results and should be further investigated in a randomized clinical trial.

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    ORAL 30 - Community Practice (ID 141)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Community Practice
    • Presentations: 1
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      ORAL30.01 - Evolution in the Surgical Care of Non-Small Cell Lung Cancer (NSCLC) Patients in the Mid-South Quality of Surgical Resection (MS-QSR) Cohort (ID 2980)

      16:45 - 16:56  |  Author(s): X. Yu

      • Abstract
      • Presentation
      • Slides

      Background:
      Surgical resection is the most important curative modality for NSCLC. However, gaps in the quality of surgery adversely affect patients’ survival. In the Mid-South region, at the center of the US lung cancer mortality belt, we began a project in 2009 to improve the quality of surgery and pathology examination across all hospitals. We report the evolution of surgical quality in this region from 2004-2013.

      Methods:
      The MS-QSR database includes patient-level details from all NSCLC resections in 11 institutions in 5 Dartmouth Hospital Referral Regions in Eastern Arkansas, North Mississippi, and Western Tennessee. Data span the care delivery process from initial radiographic detection, through diagnostic and staging tests, to surgical treatment and post-operative outcomes. We performed trend analysis and comparisons among institutions.

      Results:
      There were 2,410 curative-intent NSCLC resections. Patient demographics, rates of non-invasive staging tests and pre-operative adjuvant therapy did not change. 92% of patients had a pre-operative CT, 80% had a PET-CT scan. The use of invasive staging tests (endobronchial ultrasound, mediastinoscopy, etc.) increased from 11.3% in 2009 to 22.3% in 2013 (p<0.001). The pneumonectomy rate decreased from 12% in 2004 to 6.2% in 2013 (p=0.05). The margin positivity rate remained stable at 5.8%. Stage distributions remained unchanged, with 63% stage I, 18% stage II, and 19% stage III or above. The total number of lymph nodes retrieved during resection remained unchanged until 2010 (median 4-5 from 2004 to 2010), after which, it increased significantly (median 7 in 2011, 9.5 in 2012, and 10 in 2013) (p<0.001) (figure 1). The mediastinal lymph node (MLN) examination rate increased from 53% in 2004 to 82% in 2013 (p<0.001). However, the rate of non-examination of lymph nodes (pNX) remained stable at 10%. Although the proportion of patients with N1 disease remained stable (17.6%), the proportion with N2 disease increased during a pilot testing phase with a MLN specimen collection kit implementation (10.8% in 2010 and 2011, and 7-8% in all other years). Finally, the re-hospitalization rate was 13.3%; the 60-day mortality rate was 6.4%. Figure 1



      Conclusion:
      In this population-based cohort, pre-operative and intraoperative nodal staging practice improved significantly. However, other quality measures (margin positivity and pNX rates) need further improvement. This early analysis suggests that a regional quality improvement project can improve overall patient survival in this high lung cancer mortality zone of the US.

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    ORAL 34 - Quality/Survival/Prognosis in Localized Lung Cancer (ID 153)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Localized Disease - NSCLC
    • Presentations: 1
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      ORAL34.02 - Impact of Attainment of National Comprehensive Cancer Network (NCCN) Quality Parameters on Patient Survival after Resection of Lung Cancer (ID 2190)

      16:56 - 17:07  |  Author(s): X. Yu

      • Abstract
      • Presentation
      • Slides

      Background:
      The NCCN surgical resection guidelines for non-small cell lung cancer (NSCLC) recommend lobectomy or greater extent of resection, negative margins, and examination of lymph nodes from the hilum, and 3 or more mediastinal stations. We sought to determine the impact of these guidelines on patients’ long-term survival.

      Methods:
      We conducted a retrospective review of patient-level data from all curative-intent NSCLC resections at 11 institutions in 5 Dartmouth Hospital Referral Regions in Eastern Arkansas, North Mississippi, and Western Tennessee from 2004 to 2013. Following a descriptive analysis of the cohort, we used a Cox proportional hazard model to assess the overall survival impact of attaining the NCCN guidelines. All models were adjusted for patient age and pathologic stage.

      Results:
      Of the 2,410 eligible resections, 314 (13.1%) were sub-lobar, 86.9% were lobectomy or greater; 90.2% had negative margins, 5.8% had positive margins, 4% unknown margin status; 73.2% had hilar nodes sampled; but only 25.9% of surgeries had three or more mediastinal nodal stations sampled. Overall, although only 18% of surgeries met all four criteria, there was a significant increasing trend from 4% in 2004 and 12% in 2009, to 39% in 2013 (p<0.001). Patients whose surgery met all four criteria had a 23% survival benefit compared with those who did not (Hazard Ratio [HR]: 0.77, 95%CI: 0.64-0.94, p=0.009). Patients with negative margins had 15% survival benefit compared to those with positive margins (HR: 0.85, 95%CI: 0.66-1.08, p=0.18); those with lobectomy or greater resection had a 14% survival benefit over those with sub-lobar resection (HR: 0.86, 95%CI: 0.70-1.04, p=0.12); those with hilar node sampling had a 3% survival benefit (HR: 0.97, 95%CI: 0.83-1.13, p=0.68); and those with three or more mediastinal stations examined had a 17% survival benefit over those without (HR: 0.84, 95%CI: 0.71-0.98, p=0.03). Figure 1



      Conclusion:
      Although only 18% of NSCLC resections in this cohort from a high lung cancer mortality region of the US met all four NCCN good-quality surgical resection criteria, the rate of quality attainment has significantly increased during the past decade. Patients whose resections met NCCN quality criteria had a substantially survival benefit, which is particularly driven by the recommendation for sampling of ≥3 mediastinal nodal stations. Intraoperative mediastinal lymph node retrieval should be a focus of quality improvement for NSCLC resections.

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