Author of

• 12648

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  P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12690

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    P3.11-042 - Molecular Inequality in the Treatment of Non-Small Cell Lung Cancer (NSCLC) and Implications for Clinical Trials (ID 2831)

    09:30 - 09:30  |  Author(s): P. Calvert
    • Abstract

    Background
    Activating mutations (MT) in the epidermal growth factor receptor (EGFR) gene are found in approximately 10-20% of patients with NSCLC. Guidelines recommend therapy with EGFR tyrosine kinase inhibitors (TKI’s) in these patients, and in patients with EGFR Wild type (WT) tumours beyond second line. Clinical trials have focussed on optimising the management of patients with an actionable target. The real-world management of patients with EGFR MT’s and clinical trial recruitment has yet to be explored. This retrospective study investigated treatment patterns in an Irish cohort of patients with non-squamous NSCLC, stratified by EGFR-MT status.

    Methods
    Patients with EGFR-MT positive tumours were identified from a National Multi-Institutional database. Patients with EGFR-WT tumours matched for age, stage and gender were identified. Treatment data including receipt of chemotherapy, EGFR TKI, and clinical trial participation were collected. Fisher’s exact and Mann-Whitney tests were used to compare variables. Cox model was used to examine the influence of treatment variables on overall survival (OS.) To ascertain the milieu of clinical trials applicable to this cohort, www.clinicaltrials.gov was searched for all phase III interventional studies in NSCLC between 1/1/2010 and 31/5/2013. Trial characteristics were summarized.

    Results
    We identified 416 patients with NSCLC. Forty (10%) patients had tumours with EGFR MT’s, of which data were available on 35 (87%) patients. Twelve (34%) patients had resected disease, and 23 (66%) had metastatic disease. Nineteen (82%) EGFR-MT positive patients with metastatic disease received first line systemic therapy, 12 (63%) receiving EGFR TKI (p=0.52.) Fifteen (65%) patients with EGFR-WT tumours received first line chemotherapy. The median number of lines of treatment was 1 (range: 0 – 4; 30% >1 line) for patients with EGFR-MT’s and 1 (range: 0 – 3; 13% >1 line) for EGFR-WT (p<0.01.) Receipt of second, third and fourth line therapy was 26%, 13% and 4.3% for EGFR-MT positive patients respectively, and 8.6%, 4.3% and 0% respectively in EGFR-WT (p<0.01.) Six (24%) patients with an EGFR MT and 0 (0%) with EGFR-WT participated in clinical trials (p<0.01.) Significant benefits were seen for 1) receipt of 1 line of treatment vs. 0 (HR=0.2, 95% CI=0.08 – 0.18, p=0.03) or 2) >1 line of treatment vs. 0 (HR=0.10, 95% CI= 0.01- 0.46, p< 0.01) Twenty-four phase III trials in advanced NSCLC were identified over the study period. The most commonly investigated agents were TKI's - 10 (42%) and monoclonal antibodies – 6 (25%). Ten (42%) trials required the presence of a driver mutation for eligibility, and 13 (54%) trials were in second line or beyond.

    Conclusion
    In Irish patients with NSCLC the incidence of EGFR MT’s is comparable to other European populations. Our real-world experience demonstrates that patients with EGFR MT’s tend to receive more lines of therapy and have a higher rate of clinical trials participation, reflecting the portfolio of currently available clinical trials. While trials should strive to optimise treatment for EGFR-MT positive NSCLC, the thoracic oncology community should consider that biological heterogeneity can lead to inequalities in clinical trial development and subsequent treatment.