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M. Abu-Amna



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    MA13 - Modern Technologies and Biological Factors in Radiotherapy (ID 395)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Radiotherapy
    • Presentations: 1
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      MA13.05 - Nivolumab in Non-Small Cell Lung Cancer (NSCLC): The Real-Life Data (ID 5582)

      16:00 - 17:30  |  Author(s): M. Abu-Amna

      • Abstract
      • Presentation
      • Slides

      Background:
      Nivolumab has been recently approved by the FDA as a 2[nd]-line treatment of NSCLC. The data regarding its efficacy in the real-life setting is lacking.

      Methods:
      260 consecutive patients with advanced NSCLC treated with nivolumab at five cancer centers in Israel between January 2015 and March 2016 were observed for OS and toxicity. OS was analyzed by the Cox proportional-hazards regression model.

      Results:
      Patient baseline characteristics: median age 67y (range 41-99); males 68%; smokers 76%; ECOG PS ≥2 46%; Non-sq/Sq/other 70%/23%/7%; KRASm/EGFRm/ALK+/other genetic aberration/none/NA 7%/5%/0%/4%/42%/42%; brain metastases 21%; liver metastases 21%; treatment (Tx) line: 1st/2nd/3rd+-line/NA 6%/64%/26%/4%. Median duration of follow-up was 4.3 mo (range 0.1-13.8); median Tx duration was 2.7 mo (range 0.1-15.5); median number of Tx cycles delivered was 6 (range 1-26). 130 (50%) patients died; median OS comprised 6.6 mo (95%CI 5.6-8.4). In univariate and multivariate analysis, the only variable which significantly correlated with OS was ECOG PS (table 1). Median OS of patients with ECOG PS 0/1 and ECOG PS ≥2 comprised 8.6 mo and 3.5 mo, respectively. Safety data is presented in table 2. Figure 1Figure 2





      Conclusion:
      Nivolumab has reasonable efficacy and good safety profile in the real-life setting. ECOG PS ≥2 is associated with poor prognosis.

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    P1.02 - Poster Session with Presenters Present (ID 454)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Biology/Pathology
    • Presentations: 1
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      P1.02-032 - Diagnosis and Treatment of EGFR Mutated NSCLC among Arabic Patients (ID 5306)

      14:30 - 15:45  |  Author(s): M. Abu-Amna

      • Abstract
      • Slides

      Background:
      About 15% of western patient population with advanced NSCLC harbor the epidermal growth factor receptor (EGFR) mutation compared to about 50% in the Asian population. These mutations are more frequently found in NSCLC with an adenocarcinoma histology, in women, East Asians and never smokers. EGFR tyrosine kinase inhibitors (TKIs) are the first-line treatment of choice for NSCLC patients harboring EGFR mutation. Nowadays there is only a scares information regarding EGFR epidemiology and response to EGFR TKI among other ethnicities, although there has been limited reports regarding increased rate of EGFR mutation among arabic patients.

      Methods:
      Single institution retrospective analysis of serial advanced NSCLC patients tested for EGFR mutation in 2011-2015. Information was obtained using the medical records.

      Results:
      Of 616 patients with advanced NSCLC tested for EGFR in our institutions in 2011-2015, there were a total of 134 Arabic patients, 38 of them harboring EGFR mutation (28%), as opposed to 64 (13%) among the non-arabic population. Twenty patients had exon 19 deletion, 9 patients had L858R and 1 patient had exon 21 mutation. The median age at diagnosis was 58 (39-80), 22 patients were males and 16 females, of them- 13 were never smokers, 5 are previous smokers, and 20 are active smokers. Thirty-six patients had adenocarcinoma histology while 2 patients had carcinosarcoma and squamous cell carcinoma. The median survival was longer than 9 months. Thirty patients were treated with EGFR TKI, 27 of them as 1[ST] line treatment, and 3 as 2[ND] line treatment. Of the 30 patients treated with EGFR TKI, 69% had partial response, 16% had stable disease.

      Conclusion:
      Among Arabic patients with NSCLC, the frequency of EGFR mutation is higher than in western population, and is more frequent among males and smokers. The response to EGFR TKI matches the reported literature.

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    P3.07 - Poster Session with Presenters Present (ID 493)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Regional Aspects/Health Policy/Public Health
    • Presentations: 1
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      P3.07-004 - Nivolumab for Non-Small Cell Lung Cancer (NSCLC): An Economic Model for Risk Sharing Based on Real-Life Data (ID 5452)

      14:30 - 15:45  |  Author(s): M. Abu-Amna

      • Abstract
      • Slides

      Background:
      Increasing costs of novel immunotherapy requires risk sharing between manufacturers and payers. Aside from the cost per dose of the compound, the total treatment cost (TTC) is affected by the duration of treatment (DOT). DOT in real life may differ significantly from that observed in the randomized clinical trials. The objective of this study was to develop a risk sharing strategy based on real world data for the use of nivolumab in NSCLC.

      Methods:
      We analyzed DOT for 260 consecutive patients with advanced NSCLC treated with nivolumab at five Israeli cancer centers between January 2015 and March 2016. We developed a model to incorporate the number of cycles delivered and to calculate the TTC for each patient. We calculated the “mid-point” (MP) to estimate the number of cycles for all patients to comprise half of the TTC for the population.

      Results:
      Median age 67y (range 41-99); males 68%; ECOG PS ≥2 46%; Non-squamous (Non-sq)/Squamous(Sq)/other histology 70%/23%/7%; treatment line: 1[st]/2[nd]/3[rd]+-line/NA 6%/64%/26%/4%. All patients received nivolumab as standard of care or within the compassionate use program. Median duration of follow-up was 4.3 mo (range 0.1-13.8); 27% of patients continued the treatment at the time of data cut-off. Median DOT was 2.7 mo (range 0.1-15.5). Median number of treatment cycles delivered calculated from a total of 206 patients was 6 (range 1-26 and 1-23 for Sq and Non-sq NSCLC, respectively). TTC distribution according to the treatment cycle and MP for Non-sq and Sq NCSLC are presented in Figure 1 (A and B), respectively. Figure 1



      Conclusion:
      Based on current list prices in Israel, the estimated mid-point for total treatment cost is the 5[th] cycle for Non-Sq NSCLC and the 4[th] cycle for Sq NSCLC. Our data may represent a basis for risk sharing discussion between the payers and the manufacturers.

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