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Jack Mardekian



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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-30 - Treatment Sequencing in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) in Japan (ID 12786)

      12:00 - 13:30  |  Author(s): Jack Mardekian

      • Abstract
      • Slides

      Background

      Limited data are available on real-world treatment patterns and outcomes of ALK inhibitors used sequentially. Access to a large medical records database and availability of multiple ALK inhibitors in Japan, the first country to approve alectinib in 2014, presents a unique opportunity to evaluate real-world treatment sequencing and outcomes in ALK-positive NSCLC patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This descriptive, retrospective observational study used inpatient/outpatient medical and prescription records, claims and diagnoses from the Japan Medical Data Vision (MDV) Database. Included patients had confirmed diagnosis of lung cancer, an ALK test and first prescription order for an ALK inhibitor (prescription date = index date) on or before March 31, 2017. Descriptive analyses included demographics, baseline characteristics, treatment patterns including ALK inhibitor sequences, non-ALK inhibitor treatments received, and treatment duration.

      4c3880bb027f159e801041b1021e88e8 Result

      Overall, 378 patients (mean age 61 years; 53% female; 48% no history of smoking) met inclusion criteria. Baseline characteristics were similar among mutually exclusive groups of patients receiving 1, 2, or 3 ALK inhibitors. Similar proportions of patients received crizotinib (52%) and alectinib (48%) as index ALK inhibitor. Prior to the index date, 40% of patients received chemotherapy. ALK inhibitor sequences are shown (Table). In patients who had discontinued all ALK inhibitors, the next treatments were chemotherapy (46%) and immunotherapy (6%). The most common sequence was a crizotinib-led sequence of 2 ALK inhibitors; median duration of treatment was 53 months. Changes in treatment patterns over time and further duration of treatment data will be presented.

      Sequence

      Overall Population

      N = 378

      n (%)
      1 ALK inhibitor (n=261)
      Crizotinib 91 (24.07)
      Alectinib 170 (44.97)
      2 ALK inhibitors (n=98)
      Crizotinib -> Alectinib 89 (23.54)
      Crizotinib -> Ceritinib 1 (0.26)
      Alectinib -> Crizotinib 7 (1.85)
      Alectinib -> Ceritinib 1 (0.26)
      3 ALK inhibitors (n=19)
      Crizotinib -> Alectinib -> Ceritinib 16 (4.23)
      Alectinib -> Crizotinib -> Ceritinib 3 (0.79)
      8eea62084ca7e541d918e823422bd82e Conclusion

      Treatment patterns in ALK-positive NSCLC patients have evolved over time. The most common sequence for patients receiving > 1 ALK inhibitor was crizotinib-led. Median duration of treatment with crizotinib-led sequences is consistent with what has been reported previously. Additional research is warranted to evaluate non-crizotinib-led sequences as data mature.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.13 - Targeted Therapy (Not CME Accredited Session) (ID 979)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.13-03 - Real-World Anaplastic Lymphoma Kinase Testing Practices: Results from a Survey in the United States (ID 12603)

      12:00 - 13:30  |  Author(s): Jack Mardekian

      • Abstract

      Background

      Anaplastic lymphoma kinase (ALK) translocation is a clinically validated predictive biomarker in multiple cancer types including non-small cell lung cancer, and widespread adoption of diagnostic assays permits a review of test performance. This analysis presents ALK and epidermal growth factor receptor (EGFR) testing rates, expediency, and results from 4 large national laboratories.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Deidentified data from January 2013 to December 2015 were compiled from 40 states and Washington DC and included in the final analysis. ALK status was evaluated with the Vysis ALK Break Apart FISH Probe Kit; EGFR status was evaluated by therascreen EGFR RGQ PCR Kit, cobas EGFR Mutation Test, or Sanger sequencing. Results from the most recent conclusive test were used. Collection to order (time from date of biopsy to date of biomarker test order), order to results (time from date of biomarker test order to date of available results), and overall turnaround times (collection to order + order to results) were evaluated. Results were analyzed by laboratories and US regions (Northeast, Midwest, South, and West). Data were summarized with descriptive statistics.

      4c3880bb027f159e801041b1021e88e8 Result

      Results of 59,058 ALK and 50,992 EGFR tests were collected; 50,023 patients were tested for both ALK and EGFR, 9035 had results for ALK only, and 969 for EGFR only. Mean patient ages at ALK-positive (ALK+) and EGFR-positive (EGFR+) diagnoses were 62.5 and 69.0 years, respectively. Overall ALK+ and inconclusive rates were 2.8% and 6.5%, respectively, vs 10.4% and 6.2% for EGFR testing. ALK+ (2.3–5.1%) and inconclusive (1.1–17.4%) rates varied between test centers. In the western US, the ALK+ rate (3.3%) was comparably greater than in other regions (2.4–2.7%). The median turnaround time was 15 days, with a median of 10 days for collection to order and 4 days for order to results; some regional variation was seen in turnaround time (14–18 days). No correlation was seen between age and turnaround time.

      8eea62084ca7e541d918e823422bd82e Conclusion

      EGFR+ and ALK+ rates and age distributions were consistent with prior reports. An interesting geographic difference in ALK rates was seen that warrants further investigation. The average turnaround time was longer than current guidelines recommend, suggesting an opportunity to improve current testing practices.

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