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T. Ellis-Caleo



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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02b-042 - Reduction in Peripheral Blood Cytokine Levels Observed in EGFR Mutant (EGFRm) Patients Treated with Erlotinib (ID 5403)

      14:30 - 15:45  |  Author(s): T. Ellis-Caleo

      • Abstract

      Background:
      A retrospective analysis of EGFRm non-small cell lung cancer (NSCLC) patients enrolled on ­­the KEYNOTE-001 trial at UCLA showed a significantly lower objective response rate for those treated with a tyrosine kinase inhibitor (TKI) prior to pembrolizumab than those who were TKI naïve (Garon et al, WCLC 2015). Since nivolumab treated squamous NSCLC patients that had high baseline cytokine levels had a median overall survival almost three times longer than those with low baseline levels (Lena et al, ELCC 2016), we used multiplex cytokine analysis to assess effects of an EGFR TKI on peripheral blood cytokine concentrations.

      Methods:
      Paired baseline and cycle 2 day 1 samples were evaluated in 60 stage IIIb or IV NSCLC patients [EGFRm=12, EGFR wild type (wt)=33, unknown EGFR=15] enrolled on a clinical trial of erlotinib +/- fulvestrant for 30 cytokines [Bio-Rad Bio-Plex Human Cytokine 27-plex and Bio-Plex Pro TGF 3-plex (M500KCAF0Y, 171W4001M)]. Cytokine concentration values were compared between EGFR groups with GEE models. In these models, cytokine values were log-transformed and terms for treatment, EFGR status, and their interaction were included. Age (continuous), sex (binary), smoking status (ever/never), and tumor stage (binary) were also included in the model. R software was used for analyses. A p-value <0.05 was considered statistically significant with no adjustment for multiple comparisons.

      Results:
      For the 12 EGFRm patients treated with erlotinib +/- fulvestrant, 83% (25/30) of the cytokines evaluated showed a quantitative decrease, 17% (5/30) showed a significant decrease, and none showed a significant increase. Similar patterns were not observed in the 33 EGFRwt patients, in whom only 23% (7/30) of the cytokines evaluated showed a decrease, significant in 7% (2/30) with 40% (12/30) showing a significant increase. No clear directional change based on inclusion of fulvestrant in the treatment regimen was seen.

      Conclusion:
      A decrease in peripheral blood cytokine concentrations was observed in EGFRm patients treated with erlotinib +/- fulvestrant but not EGFRwt patients. Although unknown whether these changes persist after erlotinib discontinuation, the decrease in EGFRm patient peripheral blood cytokine levels in response to TKI therapy could contribute to the lower efficacy of anti-PD-1 therapy observed in this population. Future studies will evaluate cytokine levels for EGFRm patients treated with 3[rd] generation TKIs, as well as patients enrolled on a single center investigator-initiated trial evaluating front-line pembrolizumab in EGFRm PD-L1+ patients.

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    P3.06 - Poster Session with Presenters Present (ID 492)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Trial Design/Statistics
    • Presentations: 1
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      P3.06-009 - Multiple Oral Presentations at Major International Conferences from a Single Clinical Trial Are Common (ID 6043)

      14:30 - 15:45  |  Author(s): T. Ellis-Caleo

      • Abstract

      Background:
      Traditionally, study results have been presented as abstracts at major scientific meetings at the conclusion of the analysis. Recently, presentations of studies in progress and updates to previously presented data have been allowed at major meetings. The frequency and implications of a single study being presented multiple times, particularly in high profile oral presentations, have not been fully evaluated.

      Methods:
      To identify studies presented multiple times, abstracts from an approximately one year period from international conferences for three major societies devoted largely or in part to lung cancer research were assessed (ASCO 2015, World Lung 2015, ESMO 2015 and ASCO 2016). Abstracts were selected in a two-step process. The first step was for subject matter based on keywords: NSCLC, SCLC or immunotherapy. Searches differed slightly based on individual website functionality, with ASCO searched by track, World Lung by session and ESMO by individual abstract. In a second step, abstracts for which clinical outcome data was presented from a trial with an identifiable NCT number were selected. Immunotherapy abstracts that did not include the treatment of NSCLC or SCLC were excluded in the second step.

      Results:
      851 abstracts were identified that were related to NSCLC, SCLC or immunotherapy. Of these, 357 referred to a clinical trial. 110 of 357 (30%) described clinical trials that were presented multiple times (mean 2.75, range 2-7), and in 44 (12%), this occurred at the same conference. 113 of 357 abstracts (31%) were oral presentations. 75 (66%) of the oral presentations presented data from clinical trials that were presented multiple times, including 35 (31%) which were presented as oral presentations at least twice. Of the 16 unique clinical trials leading to multiple oral presentations, a variety of issues led to the duplicate presentations, including different cohorts of the same trial, biomarker analysis, analysis by one study variable, or simply updated data. In total, only 6 of 16 of these studies presented additional patients in a subsequent oral presentation, two presenting unique cohorts, and the other four presenting updated data that included additional patients, in one case, fewer than ten patients.

      Conclusion:
      There is a pattern of multiple presentations of clinical trials, particularly in oral presentations, at major meetings. Although a second oral presentation on the same concept may sound confirmatory to a conference participant, in most cases, data presented in subsequent oral presentations related entirely to patients whose data was presented in the previous oral presentation.