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M. Zukin



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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02c-047 - Local Experience in an Expanded Access Program of Nivolumab in Advanced Non-Small Cell Lung Cancer in Brazil (ID 4782)

      14:30 - 14:30  |  Author(s): M. Zukin

      • Abstract

      Background:
      Nivolumab is a new standard-of-care in platinum-refractory Non-small cell lung cancer (NSCLC), with significant survival increment in comparison to docetaxel shown in two phase 3 trials. Herein, we report the local experience in an expanded access program in Brazil.

      Methods:
      Patients with recurrent or metastatic NSCLC, treated with at least one prior chemotherapy regimen, were potentially eligible. Overall, three hundred twenty-one patients were screened in the country, and 287 were enrolled. Around 10% of these (N=29) were treated in a single cancer institution in Rio de Janeiro. The aim was to describe the early outcome in these 29 patients.

      Results:
      Median age was 64 years (range 37-83), most patients were male (62%), white (66%), smoker or former smoker (21% and 55%, respectively). Most cases (59%) were classified as non-squamous, and only 3 had a documented EGFR mutation. Sixty-two percent had received 2 or more prior chemotherapy lines. After a median follow-up of 4.9 months (95% CI, 4.2-5.5), 1 partial response (3%) was documented, and 13 patients (45%) presented with disease stabilization by RECIST 1.1. Median PFS and OS were not reached, and 6-month OS was 52%. Seventeen patients (59%) had at least 1 adverse event, the most common being asthenia (9 patients). Only 1 (3%) grade 3 event was documented.

      Conclusion:
      Nivolumab was well tolerated and led to disease control in 48% of patients in this early analysis, after a short follow-up. Survival data will be updated for presentation.

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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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      P3.07-020 - Implementation of an International Value-Based Standard Set of Outcomes for Lung Cancer Patients in a Brazilian Center (ID 5826)

      14:30 - 14:30  |  Author(s): M. Zukin

      • Abstract

      Background:
      Measurement of value is increasingly important in cancer care, specially in lower-income countries. Grupo COI is a Brazilian private cancer care institution, member of the ICHOM (International Consortium for Health Outcomes Measurement) working group for lung cancer standard set definition. We report here feasibility and results for the first year of implementation.

      Methods:
      Lung cancer (LC) patients inclusion started on June/2015. Data were prospectively obtained from medical charts and patients interviews. All patients signed an informed consent (IC) and were only included if they would receive entire treatment at our center. ICHOM standard set outcomes included survival, complications during or within six months of treatment, baseline demographic, clinical, and tumor information and patient-reported quality of life evaluation (EORTC QLQ-C30 and QLQ-LC13) .

      Results:
      A total of 392 LC patients were admitted at COI, but only 120 patients (30.6%) met inclusion criteria. Main reasons for exclusion were partial cycle of care at COI (64.9%) and any treatment started before IC signature (11.3%). Median follow up was 7.9 months and baseline clinical data are presented in Table 1. Patient reported outcomes (PROs) were obtained from paper and phone calls. PROs assessment deviations were reported in 49 patients (38.5%) and reasons for them were application date error (63.2%) and patient or family refusal (36.7%). Cost data are being registered for future analysis. Table 1. Baseline Clinical and Demographic Characteristics

      Median age - years (variation) 68 (36 – 91)
      Gender
      Male 57 (47%)
      Female 63 (52%)
      Educational Level
      Primary 21 (17%)
      Secondary 36 (30%)
      Tertiary 63 (52%)
      Performance status
      0-1 101 (84%)
      2 6 (5%)
      3-4 0
      Non specified 13 (10%)
      Histology
      Adenocarcinoma 66 (55%)
      Squamous-cell carcinoma 29 (24%)
      Small cell carcinoma 12 (10%)
      Others 13 (10%)
      Stage
      I-II 21 (17%)
      III 29 (24%)
      IV 70 (58%)


      Conclusion:
      Applying an international value-based outcome standard set at a Brazilian institution is feasible. Based on these first data, improvements on PROs assessment methodology are being considered, like self-report electronic forms. Some inclusion criteria should also be revised to avoid this large number of patients exclusion, in order to reproduce a real-world scenario.