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N. Normanno



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    MINI 01 - Pathology (ID 93)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      MINI01.05 - Local Diagnostic Practices for Advanced Non-Small-Cell Lung Cancer in Europe and Japan: ASSESS Study (ID 2629)

      10:45 - 12:15  |  Author(s): N. Normanno

      • Abstract
      • Presentation
      • Slides

      Background:
      ASSESS (a large, multicentre, non-interventional, diagnostic study; NCT01785888) evaluated local diagnostic practices for patients with advanced non-small-cell lung cancer (aNSCLC) in Europe/Japan.

      Methods:
      Eligible patients: local/metastatic aNSCLC; chemotherapy-naïve, newly diagnosed/recurrent disease after resection; ineligible for curative treatment. We report diagnostic assessments and epidermal growth factor receptor (EGFR) mutation test turnaround times (secondary endpoints) associated with tissue/cytology samples from patients in Europe/Japan.

      Results:
      1311 patients enrolled (300 Japan). Immunohistochemistry (IHC) was used to confirm pathological diagnosis in 727/960 (76%) and 142/146 (97%) patients in Europe and Japan, respectively (where data were available); the following markers were assessed using IHC: TTF-1 (Europe 96% and Japan 79%); p65 (4% and 8%); and p40 (9% and 24%). EGFR mutation tests were not performed on samples from 110 patients and tested samples from 17 patients did not yield results. The most common reason for not testing was insufficient material provided (Europe 60% [47/78 responses]; Japan 56% [5/9 responses]). The percentages of neoplastic cells in samples (data available: Europe n=281; Japan n=20) were: <20% tumour cells: Europe 15% vs Japan 35%; 20–50% tumour cells: 23% vs 45%; >50% tumour cells: 61% vs 20%. Considering sampling methodologies, the most common sampling sites (data available: Europe n=996; Japan n=291) were the lung parenchyma (Europe 73%; Japan 79%) or lymph nodes (Europe 9%; Japan 9%); the most common sample collection method was bronchoscopy (Europe 39%; Japan 68%; Table 1). Median EGFR mutation test turnaround time was longer in Europe (11 days) versus Japan (8 days; Table 2). Mutation test success rates for Europe and Japan were 98.3% and 99.6%, respectively.

      Conclusion:
      Diagnostic assessments, sampling methodologies and EGFR mutation testing practices vary between and within Europe and Japan; further understanding of local practices will drive improvements and enable more patients to receive appropriate personalised treatment. Figure 1 Figure 2





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    P1.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 233)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      P1.04-044 - Local Diagnostic Practices for Advanced Non-Small-Cell Lung Cancer in Asia-Pacific and Russia: IGNITE Study (ID 2650)

      09:30 - 17:00  |  Author(s): N. Normanno

      • Abstract
      • Slides

      Background:
      IGNITE (a large, multicentre, interventional, non-comparative diagnostic study; NCT01788163) evaluated local diagnostic practices for patients with advanced non-small-cell lung cancer (aNSCLC) in Asia-Pacific/Russia.

      Methods:
      Eligible patients: local/metastatic aNSCLC; chemotherapy-naïve, newly diagnosed/recurrent disease after resection; ineligible for curative treatment. We report diagnostic assessments and epidermal growth factor receptor (EGFR) mutation test turnaround times (secondary endpoints) associated with tissue/cytology samples from patients in Asia-Pacific/Russia.

      Results:
      3382 patients enrolled (972 Russia). Immunohistochemistry (IHC) analysis was used to confirm diagnosis in 989/2093 (47%) and 165/949 (17%) patients in Asia-Pacific and Russia, respectively (where data were available). Where IHC was used, the markers assessed were: TTF-1 (Asia-Pacific 95% and Russia 90%); p65 (3% and 5%); and p40 (17% and 4%). EGFR mutation tests were not performed on samples from 262 patients and tested samples from 23 patients did not yield results. The most common reason for not testing was insufficient material provided to test (Asia-Pacific 93% [100/108 responses], Russia 67% [24/36]). The percentages of neoplastic cells in samples (data available: Asia-Pacific n=1042; Russia n=187) were: <20% tumour cells: Asia-Pacific 33% vs Russia 6%; 20–50% tumour cells: 28% vs 33%; and >50% tumour cells: 40% vs 61%. Considering sampling methodologies (data available: Asia-Pacific n=2410; Russia n=972), the most common sampling sites were the lungs (Asia-Pacific 68%; Russia 80%) or lymph nodes (Asia-Pacific 14%; Russia 10%); the most common sample collection method was bronchoscopy (Asia-Pacific 22%; Russia 45%; Table 1). Median EGFR mutation test turnaround time was within 2 weeks for all countries except Thailand (70 days; Table 2). Mutation test success rates were high for Asia-Pacific (99.5%) and Russia (98.7%).

      Conclusion:
      Diagnostic assessments, sampling methodologies and EGFR mutation testing practices vary between and within Asia-Pacific and Russia; further understanding of local practices will drive improvements and enable more patients to receive appropriate personalised treatment. Figure 1 Figure 2





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