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C. Martins



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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): C. Martins

      • 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.