Author of

• 10801

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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
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10812

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    P1.11-011 - Observational study of treatment of epidermal growth factor receptor activating mutation positive (EGFRm+) advanced or recurrent non-small-cell lung cancer (NSCLC), after radiological progression to the first-line therapy with EGFR tyrosine kinase inhibitors (EGFR-TKI). (ID 1077)

    09:30 - 09:30  |  Author(s): C. Tanai
    • Abstract

    Background
    Although NSCLC with activating EGFR mutation is generally sensitive to EGFR-TKI, such as gefitinib or erlotinib, it eventually gets acquired resistance. However, the clinical course after radiological (RECIST-based) “progressive disease (PD) judgment" is highly variable. Some patients are reported to do well with continuation of TKI beyond PD, with or without local therapy. But, prior reports are only on small-numbered and selected cases. The objective of this study is to investigate the clinical course and the actual pattern of care after radiological "progressive disease" to the first-line therapy with EGFR-TKI in such cases.

    Methods
    Thirty-four institutions in Japan participate in the survey of the patterns of care and outcomes of the patients with EGFRm+ advanced or recurrent NSCLC, who received first-line gefitinib or erlotinib during the period from 2009 to 2011. The primary endpoint is the time from RECIST-based radiological PD to clinical PD in patients who were continuously received EGFR-TKI beyond “RECIST PD”. Clinical PD was defined as one or more of the following events: 1) symptomatic progression, 2) worsening of performance status due to progression, 3) threat to major vital organ(s), 4) multi-organ unequivocal progression. Durations of TKI administration and reasons of discontinuation (RECEIST PD vs. clinical PD vs. toxicity), concomitant administration of chemotherapy and/or local therapy with TKI, occurrence of “flare” phenomenon after TKI stoppage, and overall survival were also recorded.

    Results
    At the time of the abstract submission, 24 institutions reported the number of patients. There were 1,177 patients (395 in 2009, 397 in 2010 and 385 in 2011) with EGFRm+ advanced or recurrent NSCLC. Among them, 602 (51.1%) received first-line EGFR-TKI. The median number of EGFRm+ patients per institution was 32 (range: 9 to 151). The rates of those who received first-line TKI varied substantially among institutions, ranging from 30% to 88%, and tended to increase over time (41.0% in 2009, 56.9% in 2010 and 55.6% in 2011). In 2009, there were no institutions which administered TKI to every EGFRm+ patient, whereas there were 1 and 3 such institutions in 2010 and 2011, respectively.

    Conclusion
    In this large observational study, we will collect data on approximately 1,600 patients with EGFRm+ NSCLC, some 800 of them received first-line EGFR-TKI. Since the median progression-free survival of those patients with TKI has generally been reported to be 1 year or less, we will be able to see the pattern of care and outcome after PD in the majority of the cases. Clinical significance of continuation of EGFR-TKI “beyond PD” in the real world will be clarified. This research was conducted by Comprehensive Support Project for Oncology Research (CSPOR) of Public Health Research Foundation. The research fund was provided to CSPOR with support from an Investigator Sponsored Study Programme of AstraZeneca. Trial registry with UMIN#000010538.