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N. Pennell



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    MA 13 - New Insights of Diagnosis and Update of Treatment (ID 674)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Early Stage NSCLC
    • Presentations: 1
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      MA 13.03 - Quantitative Spatial Profiling of PD-1/PD-L1 Interaction Predicts Response to Adjuvant Chemotherapy Non–Small-Cell Lung Cancer (ID 8419)

      15:45 - 17:30  |  Author(s): N. Pennell

      • Abstract
      • Presentation
      • Slides

      Background:
      Adjuvant chemotherapy (ACT) for ES-NSCLC has a modest improvement in survival but it is often associated with serious adverse effects. Thus, identifying subgroups of ES-NSCLC patients who may benefit from ACT is of high clinical relevance. We evaluated the prognostic and predictive role of quantitative spatial profiling of PD-1/PD-L1 interaction in the tumor cells of ES-NSCLC patients.

      Method:
      451 whole tissue sections of formalin-fixed, paraffin embedded surgical resection specimens from ES-NSCLC patients with/without ACT were tested with a multiplexed fluorescence immunohistochemistry assay to detect PD-1, PD-L1, cytokeratin and DAPI labeling. Fluorescence Images were acquired on the Perkin Elmer Vectra platform and analyzed with AQUA® algorithms to determine the percent positivity of each biomarker as well as the co-localization of PD-1 and PD-L1 (the Interaction Score).

      Result:
      High PD-1/PD-L1 Interaction Scores correlated with improved progression-free and overall survival for ES-NSCLC patients receiving ACT after surgery (p = 0.01) whereas no difference in survival was observed for patients who received surgery alone (p = 0.9) (Figure 1). Interestingly, the levels of PD-1 or PD-L1 alone did not demonstrate any difference in survival for surgery + ACT or surgery alone patient populations. Figure 1



      Conclusion:
      PD-1/PD-L1 Interaction Score is predictive of benefit from ACT in patients with ES-NSCLC. Future studies will determine if this tool can be used to select patients that may be spared chemotherapy without compromising outcome.

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    P3.03 - Chemotherapy/Targeted Therapy (ID 719)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Chemotherapy/Targeted Therapy
    • Presentations: 1
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      P3.03-031b - Results of a Phase II Study of Stereotactic Radiosurgery Followed by Erlotinib for Patients with EGFR Mutation and Progression in 5 or Fewer Sites (ID 10207)

      09:30 - 16:00  |  Author(s): N. Pennell

      • Abstract

      Background:
      For patients with metastatic EGFR mutated NSCLC, 1[st] line treatment with EGFR TKIs such as erlotinib result in a median PFS of about 10 months. In patients with a limited number of progressing lesions, local ablation therapy (LAT) of progressive lesions followed by re-initiation of TKI has shown promise in retrospective studies but to date this strategy has not been testing in prospective fashion.

      Method:
      As part of an IRB approved open label prospective phase II trial, patients with EGFR mutated NSCLC and immediate progression on a TKI in < 5 locations were treated with stereotactic radiosurgery (SRS) to progressing lesions followed by re-initiation of erlotinib. Our primary endpoint was PFS, and we hypothesized that it would be at least 3 months.

      Result:
      25/40 planned patients were enrolled; data are available on 23 and will be updated prior to the conference to include 25. By local reporting, 14 had exon 19, 5 had exon 21, 1 had compound exon 18 and exon 20, 1 had compound exon 19 and EML4/ALK and 2 were unknown. 65% were female, all were non-Hispanic white, median age 62.5, PS0 65.2%/PS1 34.8%, median Charlson Comorbidity Index 6, and 71.4% were never smokers. Median number of lesions treated was 1 (range 1-3). There were no G3-4 AEs to SRS. Two subjects had grade 3 rash on erlotinib. Median PFS post treatment was 5.8 months (95% CI, 2.5 to 11.3) and median OS was 2.9 years (95% CI 1.1 to 2.9). Serum proteomics showed a Veristrat good signature for all but one subject; this result changed to good following LAT. No signatures turned to poor at progression.

      Conclusion:
      LAT resulted in a modest extension in the duration of targeted therapy, supporting retrospective data in this population. Accrual to this study has been challenging due to the availability of 3[rd] generation EGFR TKIs and because LAT is often done outside of a clinical trial.