Author of

• 20182

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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
  • Moderators:
  • Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 24591

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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 - 09:30  |  Author(s): A.M. Deal
    • 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.