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W.Z. Zhong



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    MS06 - Surgeons as Drivers of NSCLC Research (ID 23)

    • Event: WCLC 2013
    • Type: Mini Symposia
    • Track: Surgery
    • Presentations: 1
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      MS06.2 - Clinical Trial and Research Cooperation (ID 482)

      14:00 - 15:30  |  Author(s): W.Z. Zhong

      • Abstract
      • Presentation
      • Slides

      Abstract
      Clinical research in non-small-cell lung cancer is a rapidly evolving field. We conducted a survey of lung cancer surgical clinical trials listed on clinicaltrials.gov. 658 records were found, which were mainly consisted of trials studying the surgical procedure and (neo) adjuvant therapy. Phase III trials account for 15.5%. Only 34.9 %( 230 records) trials were completed, and 43 studies present results in clinicaltrials.gov. The median time to completion (MTC) of Ph III surgical procedure trials was 9.4 years. The MTC of Ph III neo-adjuvant and adjuvant trials had not been reached but are longer than 10 years. In comparison, the MTC of Ph III trials in first line setting were only 4.5 years. We summarized the characteristics of these trials with real-world case examples. Our analyses reveal that it is critically needed for regulatory authorities, clinical trial sponsors, collaborative research groups, and academic institutions to work together to build the infrastructure and research cooperation for clinical trials with surgical components. In 2007, a national collaborative clinical research group, Chinese Thoracic Oncology Group (CTONG), was established. CTONG is a network of researchers, physicians and healthcare professionals in public institutions across China. Currently, there are 22 member hospitals in the group. A CTONG-sponsored trial (CTONG1104) is discussed to illustrate our experience with surgical clinical trials. In summary, to expedite clinical research in early stage lung cancer, it is necessary for investigators to collaborate in cooperative clinical trials. As cancer treatment is multidisciplinary, while retaining a surgical focus, surgical trials require multidisciplinary collaboration.

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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-044 - Progression-free survival is a poor surrogate endpoint for overall survival in the first line EGFR-TKI treatment in advanced non-small-cell lung cancer with EGFR mutation (ID 2969)

      09:30 - 16:30  |  Author(s): W.Z. Zhong

      • Abstract

      Background
      （Although epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs), gefitinib and erlotinib have shown antitumor activity in patients with non-small cell lung cancer (NSCLC) , it is unclear if progrssion-free survival（PFS）could be a good surrogate endpoint for overall survival(OS) in the clinical trials of first-line EGFR-TKIs treatment in patients with advanced NSCLC, especially with activating EGFR mutation.）

      Methods
      A PubMed search identified 12 randomized trials comparing first-line EGFR-TKIs treatment with chemotherapy in patients with advanced NSCLC. A total of 1816 patients were enrolled and EGFR mutation status was known in 554 patients. Linear regression analysis was carried out to estimate the correlation of PFS, response rate (RR), and survival post-progression (SPP) with OS

      Results
      PFS, RR and PPS were all strongly associated with OS（r=0.942, 0.982 and 0.895, respectively, P< 0.01） for all trials. But in trials enolled patients with EGFR mutation, PFS and RR were poor correlate with OS (r =-0.121 and 0.131, respectively, P< 0.01), while PPS strongly associated with OS (r =0.849, P<0.01 ）PFS, RR and PPS were all strongly associated with OS（r=0.942, 0.982 and 0.895, respectively, P< 0.01） for all trials. But in trials enolled patients with EGFR mutation, PFS and RR were poor correlate with OS (r =-0.121 and 0.131, respectively, P< 0.01), while PPS strongly associated with OS (r =0.849, P<0.01 ）

      Conclusion
      Our findings indicate that PFS is a poor surrogate endpoint for OS in the first line EGFR-TKI treatment in advanced EGFR mutation NSCLC. Further studies are needed to search for appropriate surrogate endpoint for OS.