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  P3.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 981)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall

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    P3.15-12 - Survival Impact of Patient Enrollment in Antineoplastic Drug Trials for Stage IV Non-Small Cell Lung Cancer (NSCLC) (ID 11673)

    12:00 - 13:30  |  Presenting Author(s): Bernardo H.L. Goulart
    • Abstract
    • Slides

    Background
    

    Patient enrollment in antineoplastic drug trials (ADT) is essential for the development of effective therapies in stage IV NSCLC. An open question is whether NSCLC patients derive a survival benefit by enrolling in ADTs. We hypothesized that patient enrollment in ADT is associated with longer overall survival (OS) because of access to novel therapies and closer follow up, compared with no ADT enrollment.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    We reviewed electronic medical records of 193 patients diagnosed with biopsy-proven, stage IV NSCLC between 01/01/2007 and 12/31/2014, who received treatments at the Seattle Cancer Care Alliance. Other inclusion criteria were age > 18 and receipt of ≥ 1 antineoplastic agent within 180 days from diagnosis. We abstracted patient clinical characteristics, tumor histology, EGFR and ALK mutation status, receipt of chemotherapy, targeted therapies, and immunotherapy up to 5 consecutive lines, participation in ADTs, and OS from diagnosis to death. We fitted multivariate Cox regression models to estimate the risk-adjusted effect of ADT participation on survival, compared with no trial participation.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Patients’ mean age was 63.4; 53.9% were female; 28.5% were never smokers; 75.1% had ECOG PS of 0-1; 95.3% had non-squamous histology; 27.5% had brain metastases; 20.7% and 4.1% had EGFR+ and ALK+ NSCLC. Fifty-three (27.5%) enrolled in ≥ 1 ADT, of whom 17 (32.0%) received trial drug(s) that later became FDA approved, and 44 (83.0%) and 13 (24.5%) enrolled in phases I/II or III trials. Adjusting for ECOG PS, smoking, EGFR mutation status, type of first line therapy, and number of treatment lines, participation in ≥ 1 ADT was associated with a hazard ratio for death of 0.62 (P = 0.02; Table 1).

    Trial Participation ( ≥ 1)	Median OS (months)	Adjusted Hazard Ratio (95% CI)	P-value
    No ( n=140)	12.4	reference
    Yes (n=53)	19.7	0.62 (0.42; 0.94)	0.020

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Participation in therapeutic trials is associated with longer OS in NSCLC. Besides supporting drug development, trial enrollment may improve patient outcomes. Efforts should focus on increasing patient enrollment in drug trials.

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