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John C O'Donnell



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 4
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      44P - Temporal trends in treatment (Tx) and overall survival (OS) among patients (pts) with incident NSCLC in the UK: A real-oncology database analysis from the I-O Optimise initiative (ID 514)

      12:30 - 13:00  |  Author(s): John C O'Donnell

      • Abstract
      • Slides

      Background

      As part of I-O Optimise, a multinational research platform providing real-world insights into the management of lung cancers, temporal trends for initial Tx and OS are reported for pts diagnosed with NSCLC at Leeds Teaching Hospitals Trust (LTHT), hosting one of the largest integrated cancer centres in the UK.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      A retrospective cohort study using longitudinal data collected from electronic medical records at LTHT, including all adult pts diagnosed with NSCLC from Jan 2007 to Aug 2017 (follow-up to Mar 2018). Initial Tx was the 1st Tx received after diagnosis (categorised as surgery, radiotherapy or systemic anti-cancer therapy [SACT]). In this analysis, 2 diagnostic periods were compared: 2007–2012 and 2013–2017. Kaplan–Meier methods were used for OS.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Among 3739 pts with incident NSCLC, TNM stage distribution was: I, 19.2% (this increased noticeably from 14.0% in 2007–2012 to 24.8% in 2013–2017); II, 11.6%; IIIA, 12.5%; IIIB, 9.0%; and IV, 47.7%. Overall, 29.7% had non-squamous cell carcinoma (NSQ), 21.9% had squamous cell carcinoma (SQ), 11.7% had NSCLC NOS (this decreased noticeably from 18.8% in 2007 to 8.4% in 2016) and 2.4% had other histology; 34.3% of pts were diagnosed without pathology. Tx patterns for NSQ and SQ pts are shown by stage and year of diagnosis (Table). Between 2007–2012 and 2013–2017, median OS (in months) increased noticeably in stage I–IIIA NSQ (28.7 to 50.0) and SQ pts (17.4 to 32.1), but not in stage IIIB–IV NSQ (4.1 to 5.0) or SQ pts (5.3 to 4.8)

      Temporal changes in initial Tx (within 6 months of diagnosis) by pathology, TNM stage and year of diagnosis*
      Stage IStage IIStage IIIAStage IIIBStage IV
      2007-20122013-20172007-20122013-20172007-20122013-20172007-20122013-20172007-20122013-2017
      NSQn = 64n = 159n = 61n = 51n = 51n = 57n = 49n = 40n = 296n = 281
      Treatment (%)
      Surgery alone56.367.341.037.313.712.30.00.02.0M
      Surgery + SACT/RTMM21.321.69.817.50.00.0MM
      RT alone29.722.613.121.60.014.020.417.518.623.8
      SACT + RT0.00.09.8M21.633.324.530.016.217.1
      SACT aloneMMMM13.714.024.537.522.031.0
      Untreated (%)7.83.111.5M15.7M30.615.039.226.3
      SQn = 58n = 69n = 58n = 74n = 91n = 72n = 68n = 49n = 161n = 118
      Treatment (%)
      Surgery alone43.162.329.329.715.411.10.00.0MM
      Surgery + SACT/RTMM10.317.6MM0.00.0MM
      RT alone39.733.341.429.741.833.336.832.724.226.3
      SACT + RTM0.0M10.824.231.936.832.726.720.3
      SACT aloneM0.00.0MM11.111.814.316.821.2
      Untreated (%)MM13.810.813.28.314.718.429.227.1

      Data for patients with only clinical diagnosis and patients with initial treatment >6 months after diagnosis are not shown.

      M, masked as < 5 patients; RT, radiotherapy.

      .

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      OS improved in stage I–IIIA pts over time, most likely due to an increased proportion diagnosed at stage I and the evolution of initial Tx through the study period. In contrast, among stage IIIB–IV pts, SACT use remains relatively low and OS outcomes remain unchanged. Future analyses will help assess the impact of new therapies, including immunotherapy and 2nd-generation tyrosine kinase inhibitors, on Tx patterns and OS in the UK.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Editorial assistance was provided by Richard Daniel, PhD, of Parexel and funded by Bristol-Myers Squibb.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Bristol-Myers Squibb.

      213f68309caaa4ccc14d5f99789640ad Funding

      Bristol-Myers Squibb through an EU wide RWD initiative called IO-Optimize sponsored by BMS.

      682889d0a1d3b50267a69346a750433d Disclosure

      M. Snee: Grants, personal fees: IQVIA, during the conduct of the study. L. Lacoin: Consultant epidemiologist contracted by Bristol-Myers Squibb. W. Sopwith: Personal fees: IQVIA, during the conduct of the study and outside the submitted work. C. Chaib: Employee: Bristol-Myers Squibb; Bristol-Myers Squibb (BMS) is funding this work through an EU wide RWD initiative called IO-Optimize sponsored by BMS. J.R. Penrod: Employment, stock ownership: Bristol-Myers-Squibb. J.C. O’Donnell: Employee, shareholder: BMS. All other authors have declared no conflicts of interest.

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      45P - Treatment (Tx) patterns and overall survival (OS) in patients (pts) with stage IIIB&#x02013;IV NSCLC in Portugal: An IPO-PORTO database analysis from the I-O Optimise initiative (ID 210)

      12:30 - 13:00  |  Author(s): John C O'Donnell

      • Abstract
      • Slides

      Background

      Understanding Tx patterns and related outcomes in the rapidly changing NSCLC landscape informs clinical decision-making. As part of I-O Optimise, a multinational research platform providing real-world insights into the management of lung cancers, Tx patterns and OS are reported for pts with NSCLC prior to immunotherapy reimbursement in Portugal.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      IPO-Porto, Portugal’s largest oncology hospital, has a research database linked to the RORENO cancer registry, covering northern Portugal. This database has collected data on 1524 adult pts with NSCLC since 2012; the current analysis includes pts diagnosed at stage IIIB–IV from Jan 2015 (when systemic anticancer therapy [SACT] data became available) to Dec 2016 (follow-up to Jun 2017). Tx patterns are shown for the first 3 Tx lines. Kaplan–Meier methods were used for OS and time to next Tx or death (TTNT) from SACT initiation.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Of 595 pts diagnosed at stages I–IV in 2015–2016, 54 (9.1%) had stage IIIB and 338 (56.8%) had stage IV NSCLC (median age, 65 yrs [range: 27–90; 9.2% ≥80]; male, 77.3%; brain metastases, 16.3%; non-squamous [NSQ], 73.7%; squamous [SQ], 21.2%). Of the 372 NSQ/SQ pts, 284 (76.3%) had 1st-line SACT; 101 (27.2%) had 2nd-line, and 20 (5.4%) had 3rd-line (Table). Median OS from SACT initiation was 12.6 (NSQ) or 10.3 (SQ) months. Median OS was longer in stage IV pts without brain metastases (11.6 vs 7.6 months), and in treated NSQ pts with EGFR/ALK alterations vs wild type (14.4 vs 9.3 months). Most NSQ pts with EGFR/ALK alterations (73.0%) had a 1st-line tyrosine kinase inhibitor (TKI). Median TTNT was 11.0 months in NSQ pts on 1st-line TKI and 6.3 (NSQ) or 7.3 (SQ) months in pts on 1st-line platinum chemotherapy

      SACT regimen (%)Non-squamousSquamous
      1st-line Txn = 221n = 63
      Platinum-based chemotherapy72.987.3
      Non-platinum single agent4.512.7
      TKI (any)22.60.0
      Erlotinib12.70.0
      Crizotinib2.30.0
      Gefitinib7.70.0
      Anti-PD-1/anti-PD-L1 checkpoint inhibitors0.00.0
      2nd-line Txn = 82n = 19
      Platinum-based chemotherapy13.421.1
      Non-platinum single agent59.873.7
      TKI (any)24.40.0
      Erlotinib9.80.0
      Crizotinib11.00.0
      Other TKI3.60.0
      Anti-PD-1/anti-PD-L1 checkpoint inhibitors2.45.3
      3rd-line Txn = 17n = 3
      Platinum-based chemotherapy35.30.0
      Non-platinum single agent41.2100.0
      TKI (any)11.80.0
      Erlotinib5.90.0
      Crizotinib0.00.0
      Anti-PD-1/anti-PD-L1 checkpoint inhibitors11.80.0

      PD-1, programmed death-1; PD-L1, programmed death-ligand 1

      .

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Pts with advanced NSCLC have a high burden of disease, with most diagnosed at stage IV and a short OS from SACT initiation. Future analyses will assess the post-reimbursement impact of immunotherapies (and new TKIs) on Tx and OS in Portugal.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Professional medical writing assistance was provided by Richard Daniel, PhD, of Parexel and funded by Bristol-Myers Squibb.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Bristol-Myers-Squibb.

      213f68309caaa4ccc14d5f99789640ad Funding

      Bristol-Myers-Squibb through an EU wide RWD initiative called IO-Optimize sponsored by BMS.

      682889d0a1d3b50267a69346a750433d Disclosure

      M.A.S. Soares: Advisory boards, talks: Roche; Lilly, BMS, MSD; Boehringer Ingelheim, Pfizer, AstraZeneca, Novartis, outsider the submitted work. L. Antunes, P. Redondo, M.J. Bento: Grants: IQVIA, during the conduct of the study. M. Borges: Grants: IQVIA to IPO Porto, during the conduct of the study. R. Hermans, F. Grimson, R. Munro: Employee: IQVIA Real-World Insight Solutions (vendor paid by BMS). D. Patel: Personal fees: BMS, during the conduct of the study. C. Chaib: Employee: Bristol-Myers Squibb. L. Lacoin: Consultant epidemiologist contracted by Bristol-Myers-Squibb. All other authors have declared no conflicts of interest.

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      46P - Evolution of overall survival (OS) in patients (pts) with incident NSCLC in Denmark and Sweden: A SCAN-LEAF study analysis from the I-O Optimise initiative (ID 460)

      12:30 - 13:00  |  Author(s): John C O'Donnell

      • Abstract
      • Slides

      Background

      As part of I-O Optimise, a multinational research platform providing real-world insights into the management of lung cancers, the SCAN-LEAF study aims to describe the epidemiology, clinical care, and outcomes for pts with NSCLC in Scandinavia. Here, we report temporal OS trends among pts diagnosed with incident NSCLC from 2005 to 2015 in Denmark and Sweden.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      The SCAN-LEAF Danish and Swedish cohorts were established by linking respective national registries and include all adult pts diagnosed with incident NSCLC from Jan 2005 to Dec 2015 (follow-up to Dec 2016). The Kaplan–Meier method was used to estimate OS at 1, 3, and 5 yrs by histology (non-squamous cell [NSQ] or squamous cell [SQ]), TNM stage, and yr of diagnosis; changes in OS over time were assessed using the Cochrane–Armitage test.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      31,939 pts in Denmark and 30,067 pts in Sweden were diagnosed with NSCLC from 2005 to 2015. Most were diagnosed at stage IV (51.6% and 48.4%, respectively) and had NSQ histology (54.4% and 60.4%). Statistically significant trends (P < 0.05) for improved OS accompanied by an absolute OS rate increase of > 5% over the analysis period were seen for NSQ pts at 1 yr for all stages in both countries (Table); at 3 yrs for stages I–IIIB in Denmark (P ≤ 0.027), and stages I–II (P ≤ 0.0013) in Sweden; and at 5 yrs for stages I–II (P ≤ 0.026) in both countries. For SQ pts, this was seen only at 1 yr for stage IIIA in Denmark and stage I in Sweden (Table), and at 5 yrs for stage IIIA in Denmark (P = 0.02)

      1-yr survival probability*Year of Diagnosis
      P value for trend
      20052006200720082009201020112012201320142015
      DENMARK
      NSQ (n = 16,535)
      Stage I82%85%88%92%91%91%92%93%92%91%92%0.0001
      Stage II77%80%79%77%72%86%80%88%84%88%83%0.007
      Stage IIIA67%71%76%57%67%69%72%74%74%70%75%0.017
      Stage IIIB43%46%41%41%36%49%53%50%47%47%51%0.032
      Stage IV23%25%21%23%24%24%25%26%27%27%31%<0.0001
      SQ (n = 7987)
      Stage I80%79%82%79%85%85%87%85%83%86%83%0.114
      Stage II68%59%71%74%73%60%69%77%74%67%72%0.276
      Stage IIIA42%55%57%50%58%57%62%62%59%59%57%0.014
      Stage IIIB32%39%38%38%31%40%41%45%38%43%42%0.060
      Stage IV25%23%21%22%21%22%19%20%21%29%25%0.501
      SWEDEN
      NSQ (n = 16,847)
      Stage I87%91%87%92%90%92%93%94%93%94%95%<0.0001
      Stage II77%71%77%69%64%78%72%76%88%82%83%0.002
      Stage IIIA63%65%68%70%60%65%65%66%72%77%71%0.019
      Stage IIIB41%39%42%42%40%47%50%58%51%48%56%<0.0001
      Stage IV21%24%25%25%27%30%29%32%29%31%34%<0.0001
      SQ (n = 6574)
      Stage I77%88%82%74%81%83%85%85%86%87%89%0.024
      Stage II53%61%56%83%67%69%69%71%66%60%73%0.305
      Stage IIIA51%55%47%52%58%51%51%55%49%59%59%0.216
      Stage IIIB40%39%38%37%39%46%46%34%46%47%40%0.224
      Stage IV19%19%19%22%18%19%24%23%21%20%25%0.088

      Includes only patients with valid TNM staging classification at diagnosis. TNM, tumour, nodes, and metastasis.

      .

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Despite some improvements between 2005 and 2015, mainly in the short-term survival of pts with early-stage NSCLC, long-term OS rates for pts with late-stage disease did not change significantly and remained low. Even in pts with early-stage disease, OS outcomes were suboptimal, with a particular unmet need in the SQ population. Future analyses including data after 2015 will evaluate the potential impact on OS of increased use of new TKIs and immune checkpoint inhibitors.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Professional medical writing assistance was provided by Richard Daniel, PhD, of Parexel funded by Bristol-Myers Squibb.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Bristol-Myers Squibb.

      213f68309caaa4ccc14d5f99789640ad Funding

      Bristol-Myers Squibb.

      682889d0a1d3b50267a69346a750433d Disclosure

      S. Ekman: Grants: BMS, during the conduct of the study. P. Horvat: Employee: IQVIA. D. Patel: Personal fees: BMS, during the conduct of the study. M. Roselund, A. Mette-Kejs: Fees for service to institution (IQVIA) during the conduct of this study: BMS; Employee: IQVIA. A. Juarez-Garcia: Employee: BMS. L. Lacoin: Consultant epidemiologist contracted by Bristol-Myers-Squibb for the SCAN-LEAF Project. All other authors have declared no conflicts of interest.

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      47P - Treatment (Tx) patterns and overall survival (OS) in patients (pts) with NSCLC in Sweden: A SCAN-LEAF study analysis from the I-O Optimise initiative (ID 446)

      12:30 - 13:00  |  Author(s): John C O'Donnell

      • Abstract
      • Slides

      Background

      As part of I-O Optimise, a multinational research platform providing real-world insights into the management of lung cancers, the SCAN-LEAF study aims to describe the epidemiology, clinical care and outcomes for pts with NSCLC in Scandinavia. We report initial Tx and OS for pts with NSCLC prior to the availability of immunotherapies in Sweden.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      The analysis includes all adult pts diagnosed with NSCLC at Uppsala and Karolinska (Stockholm) University Hospitals from 2012 to 2015 (follow-up to Dec 2016). Electronic medical record data were extracted using Pygargus CXP software and linked with national registries. Bespoke rule-based algorithms were applied to describe Tx patterns; Kaplan–Meier methods were used to estimate OS.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      2779 pts were diagnosed with incident NSCLC (median age, 70 yrs [range: 22–96; 14.2% ≥80]; male, 48.5%; histology: non-squamous (NSQ), 70.9%, squamous (SQ), 17.7%, other, 11.4%; stage distribution: I, 19.3%; II, 7.7%; IIIA, 12.3%; IIIB, 7.2%; IV, 51.2%). Initial Tx (≤6 months from diagnosis) by stage and yr of diagnosis is shown in the table. Median OS (months) for NSQ and SQ pts: not reached and 52.8 in stage I, 43.2 and 23.6 in stage II, 26.7 and 20.4 in stage IIIA, 12.5 and 12.9 in stage IIIB, and 7.6 and 6.1 in stage IV, respectively. Among stage IIIB–IV pts, 60.7% (NSQ) and 53.5% (SQ) had ≥1 line of systemic anti-cancer therapy (SACT); median OS was 12.2 (NSQ) and 10.4 (SQ) months in pts on SACT, and 3.1 (NSQ) and 3.7 (SQ) months in pts not on SACT. Ongoing analyses will assess factors associated with SACT receipt in stage IIIB–IV pts

      Initial Tx following diagnosis (≤6 months) based on TNM stage and year of diagnosis*, %
      Stage I
      Stage II
      Stage IIIA
      Stage IIIB
      Stage IV
      2012–201420152012–201420152012–201420152012–201420152012–20142015
      NSQN = 263N = 100N = 97N = 32N = 136N = 61N = 67N = 29N = 736N = 267
      Surgery only52.950.027.815.68.83.30.00.00.30.0
      Surgery + SACT or RT6.57.025.843.810.316.40.00.00.40.8
      RT alone27.022.012.418.811.83.317.910.318.613.5
      Chemoradiation3.43.020.69.452.259.00.00.00.00.0
      SACT + RT in stage IIIB–IV0.00.00.00.00.00.038.837.920.516.9
      SACT alone2.73.06.26.38.19.823.931.037.646.8
      Not treated**7.615.07.26.38.88.219.420.722.622.1
      SQN = 65N = 19N = 35N = 18N = 60N = 31N = 44N = 23N = 123N = 38
      Surgery only44.636.825.716.73.33.20.00.00.80.0
      Surgery + SACT or RT7.75.314.316.810.16.50.04.30.00.0
      RT alone36.931.628.650.011.712.920.521.719.510.5
      Chemoradiation3.15.320.05.650.051.60.00.00.00.0
      SACT + RT in stage IIIB–IV0.00.00.00.00.00.038.747.813.021.1
      SACT alone3.110.55.711.111.76.527.38.734.144.7
      Not treated**4.610.55.70.013.319.413.617.432.523.7

      Data shown for 2244 pts receiving Tx within 6 months of diagnosis. Data for pts with initial Tx administered more than 6 months after diagnosis or who did not have a valid TNM stage are not shown.

      No record of surgery, RT, or SACT during follow-up.

      RT, radiotherapy; TNM, tumour, nodes, and metastasis.

      .

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Swedish pts with NSCLC had a high burden of disease, with most diagnosed at stage IV and a median OS of ∼1 yr in late-stage pts receiving SACT. There is also scope for improved prognosis in pts diagnosed at early stages, particularly in SQ pts. Future analyses will assess the potential impact of recent improvements in diagnostics and therapeutics on Tx patterns and OS in Swedish NSCLC pts.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Professional medical writing assistance was provided by Richard Daniel, PhD, of Parexel funded by Bristol-Myers Squibb.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Bristol-Myers Squibb.

      213f68309caaa4ccc14d5f99789640ad Funding

      Bristol-Myers Squibb.

      682889d0a1d3b50267a69346a750433d Disclosure

      S. Ekman: Grants: BMS, during the conduct of the study. P. Horvat, A. Mette Kejs: Employee: IQVIA. D. Patel: Personal fees: BMS, during the conduct of the study. M. Rosenlund: Employed: BMS, during the conduct of the study. A. Juarez-Garcia: Employed: BMS, outside the submitted work. L. Lacoin: Consultant epidemiologist contracted by Bristol-Myers-Squibb for the SCAN-LEAF Project. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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