Author of

• 11745

  +

  P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11751

    +

    P2.11-006 - Review of 10 Years of ASCO Abstracts for Non-Small Cell Lung Cancer (NSCLC) and the Impact of Molecular Biomarkers (MB) in Clinical Trial Selection Criteria (ID 901)

    09:30 - 09:30  |  Author(s): S.E. Yentz
    • Abstract

    Background
    Over the last decade, incorporation of new cytotoxic chemotherapeutics, introduction of maintenance therapy, and integration of targeted therapies have altered treatment paradigms for patients with metastatic NSCLC (mNSCLC). In a disease that was largely treated empirically, therapy is now tailored based upon histology and MB. We sought to analyze whether outcomes of clinical trials in mNSCLC reported over 10 years at the ASCO Annual Meeting reflected perceived gains in the treatment of patients with mNSCLC.

    Methods
    Data were collected from ASCO abstracts of Phase II–IV clinical trials for patients with mNSCLC from 2004–2013. Trials in Progress abstracts were excluded. Data collected included author names, histology and MB selection criteria, phase, primary endpoint, outcomes, and drugs used. We hypothesized that rates of positive clinical trial outcomes would increase over time and that trials using MB selection criteria would have higher rates of positive outcomes. Statistical comparisons were made using Fisher’s exact test with two-sided p-values. Trends were compared using Spearman’s rank correlation.

    Results
    711 of 2,540 identified mNSCLC category abstracts met selection criteria. Over 50% were published by the top 10% of 841 unique first/last authors. Annual abstracts fitting selection criteria declined from 107 to 41 from 2004–2013. Common primary endpoints were: not specified (31%), response rate (24%), progression-free survival (PFS, 22%), and overall survival (OS, 14%). Few phase II trials had primary endpoints of PFS or OS (20.4%, 6.0%). The proportion of trials with positive PFS outcomes increased from 3.7% to 26.8% despite decreases in total annual abstracts (correlation coefficient = –0.67, p=0.033) (see Figure). Positive OS outcomes increased from 0.9% to 4.9%. Trials with MB selection criteria (5.6%) or non-squamous (NS) histology (13% of trials without MB selection) increased from 0% to 22% and 18% annually, respectively, and were more likely to result in an improvement in PFS (20.0% vs. 9.2%, p=0.0482 and 23.0% vs. 7.3%, p=0.0001, respectively). These criteria had no significant association with OS or QOL outcomes. Figure 1

    Conclusion
    Despite fewer phase II–III clinical trials presented at ASCO annually, there was a significant increase in those with positive PFS outcomes. Increases in trials selective for MB or NS histology may account for the improved PFS results. These data suggest better trial design and efficient use of resources. These data may also reflect bias in selecting abstracts for presentation, which could result in missed learning opportunities for future trial design. Additionally, it is unclear whether PFS endpoints are as meaningful as OS.