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Barbara Melosky



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    EX04 - Mini Oral Abstract Session - MA08.06, MA18.02, MA19.02, MA20.11 (ID 1006)

    • Event: WCLC 2018
    • Type: Exhibit Showcase
    • Track: Advanced NSCLC
    • Presentations: 1
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      EX04.02 - The Impact of Treatment Evolution in NSCLC (iTEN) Model: Development and Validation (ID 13468)

      10:00 - 10:05  |  Author(s): Barbara Melosky

      • Abstract
      • Slides

      Background

      Background: The iTEN model was developed to estimate the survival impact of new treatments for advanced NSCLC (aNSCLC) patients. The structure and key assumptions of the iTEN model and outputs validated against published real-world survival data are presented.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Methods: The iTEN model is a discrete event simulation of aNSCLC patients’ treatment plans. Individual patient characteristics (histology, molecular subtypes (EGFR, ALK, ROS1, BRAF, PD-L1), and performance status) are generated by random sampling from Canadian prevalence estimates. All Health Canada approved agents for treatment of aNSCLC are included. Simulated patients start on first-line therapy and move to subsequent lines of therapy in modelled progression events. Up to six-lines of therapy can be included. Time-of-event for progression or death for each patient is calculated based on random probabilities and progression-free survival (PFS) and overall survival (OS) curves modelled from published clinical trials. For example, a simulated ALK+ patient might receive first-line crizotinib, followed by second-line ceritinib and BSC, based on PFS/OS data from PROFILE 1014 and ASCEND-5. Predicted OS is calculated as the cumulative time spent on active therapy and BSC. PFS/OS data were extrapolated using best practices. Treatment on previous therapies was assumed to have no impact on the efficacy of subsequent therapies. Model survival predictions were validated against published real-world estimates from the Ontario Cancer and Austrian (TYROL) registries, by reproducing the same treatment mix in the simulated patients as in the publications.

      4c3880bb027f159e801041b1021e88e8 Result

      Results: iTEN estimated two- to five-year survival rates were similar to those reported by the Ontario Cancer and TYROL registries.

      abstract1 image.png

      8eea62084ca7e541d918e823422bd82e Conclusion

      Conclusions: While further analyses are required, the iTEN model produces survival estimates comparable to published real-world data; therefore, the iTEN model may be a valid tool to estimate aNSCLC patient survival.

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    OA09 - Prevention and Cessation (ID 909)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Prevention and Tobacco Control
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 205 BD
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      OA09.07 - Association Between Outdoor Air Pollution And Lung Cancer in Female Never Smokers (Now Available) (ID 14485)

      16:20 - 16:30  |  Author(s): Barbara Melosky

      • Abstract
      • Presentation

      Background

      Long term exposure to ambient particulate matter (PM2.5) has been associated with an increased risk of developing lung cancer, and is estimated to be responsible for ~23% of global lung cancer deaths. No current lung cancer screening risk prediction model uses air pollution as an individual risk factor in its risk calculation. As smoking rates decrease globally, and air pollution increases, it is important to assess the effect of long term outdoor air pollution exposure on lung cancer risk especially in never smokers.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We enrolled 421 patients with newly diagnosed lung cancer presenting to BC Cancer and conducted a detailed residential history from birth to estimate their air pollution exposure since 1996 when accurate high-resolution concentration estimates of PM2.5 particulate matter derived from satellite observations and ground measurements became available. The average PM2.5 exposure was quantified by combining residential histories with exposure data.

      4c3880bb027f159e801041b1021e88e8 Result

      The demographics of the 262(62%) ever smokers, and 159(38%) never smokers with lung cancer are shown in Table 1. Median exposure of all cancer patients was 7.1 PM2.5 ug/m3 (IQR 6.8-7.3; Range 4.3-65.8). Of the ever smokers, 6.1% had a PM2.5 >10 ug/m3 whereas 15.1% of the never smokers had a PM2.5 >10 ug/m3. Among never smokers with lung cancer with high PM2.5 exposure >10 ug/m3, 74% were female and 83% were of Asian descent. Using a logistic regression model, we demonstrated a significant association between air pollution exposure and never smokers compared to ever smokers in women: Odds Ratioper_1_LN-transformed unit = 12.05 (p<0.001). This association was absent in males (interaction p=0.006).

      8eea62084ca7e541d918e823422bd82e Conclusion

      table1.jpgIn women with lung cancer, outdoor air pollution exposure was significantly higher in never smokers than in ever smokers. This association was not observed in men with lung cancer.

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      Information from this presentation has been removed upon request of the author.

      Information from this presentation has been removed upon request of the author.

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-28 - Impact of Afatinib Dosing on Safety and Efficacy Real-World in Patients with EGFR Mutation-Positive Advanced NSCLC (ID 13276)

      16:45 - 18:00  |  Author(s): Barbara Melosky

      • Abstract
      • Slides

      Background

      Tolerability-guided dose adjustment of afatinib reduced incidence and severity of adverse drug reactions (ADRs) without affecting efficacy in the LUX-Lung (LL) studies in patients with EGFR mutation-positive (EGFRm+) NSCLC. We evaluated the impact of modifying the recommended starting dose of afatinib (40mg) on efficacy and safety in a real-world setting.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This non-interventional, observational, multi-country/site study used medical records of TKI-naïve patients with EGFRm+ (Del19/L858R) NSCLC treated with first-line afatinib. Primary outcomes were % patients with ADRs by severity, time on treatment (TT), and time to progression (TTP), relative to LL3. Secondary outcomes were % of patients with/reasons for modified starting dose.

      4c3880bb027f159e801041b1021e88e8 Result

      228 patients from 13 countries were included. Baseline characteristics were generally similar to LL3, but with more Del19 patients (78% vs 49%) and fewer Asian patients (44% vs 72%); 12% had ECOG PS 2–3. 31% of patients received an afatinib starting dose of <40 mg; 20% of patients starting with <40 mg increased their dose during the study. 67% of 40 mg starters underwent dose reductions, with 86% of those occurring in the first 6 months. Dose reductions were more frequent in females, Eastern Asian patients, and those with lower body weight. The main reason for dose modification was ADRs. In <40 mg starters, overall ADR incidence was similar to that in ≥40 mg starters, with fewer G3 (17% vs 25%) and no G4 ADRs. There were no new safety signals, and fewer ≥G3 ADRs and serious adverse events (SAEs) than in LL3 (28% vs 49% and 5% vs 14%, respectively). >60% of patients received medications to treat diarrhea and manage skin AEs. Median TT and TTP were 18.7 months and 20.8 months, respectively, and were not impacted by reduced starting dose or dose modification (19.4/17.7/19.5 and 25.9/20.0/29.0 months for patients who started on ≤30 mg/reduced to <40 mg/remained on ≥40 mg, respectively). The efficacy of afatinib was demonstrated across all patient subgroups analysed (ECOG PS 0/1 vs 2/3, age <75 yrs vs 75 yrs, EGFR mutational status); TT and TTP were significantly longer in patients with ECOG PS0/1 versus PS2/3.

      8eea62084ca7e541d918e823422bd82e Conclusion

      As in pivotal trials, dose adjustments with afatinib in real-world practice reduced the frequency and intensity of ADRs without impacting efficacy. RealGido demonstrated long TT/TTP regardless of afatinib dose adjustment or reduced starting dose, and an acceptable safety profile. The results highlight the benefit of tailoring afatinib dose based on individual patient characteristics and ADRs to optimize outcomes.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 964)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.15-09 - The Impact of Treatment Evolution in NSCLC (iTEN) Model: Survival and Cost of Treating Patients with Advanced NSCLC in 2017 (ID 13477)

      16:45 - 18:00  |  Author(s): Barbara Melosky

      • Abstract
      • Slides

      Background

      Background: The life expectancy and healthcare costs of treating advanced NSCLC (aNSCLC) patients are expected to rise as new targeted and immuno-oncology (IO) therapies are approved for clinical practice. Here, we have used the iTEN model to estimate the cost of managing aNSCLC patients in Canada in 2017.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Methods: The iTEN model development and validation are presented in an accompanying abstract (“The iTEN model: Development and Validation”). A treatment algorithm for EGFRm, T790m, ALK re-arrangement and PD-L1+ aNSCLC patients in 2017 was generated through a modified Delphi process based on anonymous responses from Canadian clinical experts. The generated treatment algorithm was used to estimate the survival and life-time costs of managing patients. Health resource use and cost estimates included drug acquisition and administration, adverse events, laboratory and radiologic monitoring, physician visits and end of life costs (2018 costs). Cost estimates were based on published literature, Ontario formulary listings, Cancer Care Ontario recommendations and the Ontario Case Costing Initiative. The estimation of survival is described in the companion abstract.

      4c3880bb027f159e801041b1021e88e8 Result

      Results: Survey responses indicated that first-line therapy is consistent with current guideline recommended practice, but that care beyond the second-line is variable, particularly with respect to IO usage. Modelled life expectancy varied based on the molecular subtype of aNSCLC. Costs over the span of an average aNSCLC patient’s life-time were estimated to be $89,899 (range: $61,134-$194,158). In comparison, the life-time cost of treating a Canadian lung cancer patient in 2007 (ie, prior to the introduction of IOs and ALK TKIs), inflated to 2018 dollars, was an estimated $60,678 (de Oliveira et al., 2016).

      abstract2 image - corrected.png

      8eea62084ca7e541d918e823422bd82e Conclusion

      Conclusions: Results suggest that aNSCLC patient survival increases in conjunction with increased expenditure. The iTEN model may be used to assess the impacts of evolving treatment paradigms in aNSCLC.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    YI01 - Young Investigators Session (ID 988)

    • Event: WCLC 2018
    • Type: Young Investigator Session
    • Track:
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/23/2018, 08:00 - 11:30, Room 106
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      YI01.05 - Planning a Career in Lung Cancer - Education (Now Available) (ID 14674)

      08:40 - 08:50  |  Presenting Author(s): Barbara Melosky

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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