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O. Donnay



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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      187P - Nivolumab-related immune-related adverse events in advanced NSCLC predict therapeutic objective response (ID 461)

      12:30 - 13:00  |  Author(s): O. Donnay

      • Abstract
      • Slides

      Background:
      It has been described that the efficacy of Nivolumab, an anti-PD-1 inmune checkpoint inhibitor antibody, in melanoma is associated with the development of immune-related adverse events (irAEs). This relationship is not defined in other malignant diseases. Our study explores whether Nivolumab-induced irAEs in Non-Small-Cell Lung Cancer (NSCLC) are associated with treatment efficacy.

      Methods:
      We carried out a review of the medical records of 40 cases of NSCLC treated with Nivolumab between January 2015 and May 2017 at the Hospital Universitario de La Princesa of Madrid. The efficacy of Nivolumab was evaluated using objective response (OR) criteria of iRECIST, progression-free survival (PFS) and overall survival (OS). Odds Ratio tests were performed to determine the association between irAEs and OR and log-rank and cox proportional hazards models for PFS and OS.

      Results:
      25% of the patients treated with Nivolumab developed irAEs (10/40). The most frequent toxicity was hypothyroidism, with 6 cases, five of them in grade 1, and one grade 3. Other toxicities were hepatitis, colitis, nephritis and hyperthiroidism immune-related (one patient each, all grade 1–2). Nivolumab response was as follows: 1 patient had complete response and 13 patients had partial response (objective response -OR-, 14/40: 35%); 17 patients had stable disease, and 9 patients had progressive disease at the first evaluation. Six of the 10 patients developing irAEs had an OR, compared to 8/30 patients without IRAEs (60% vs. 26%, OR 4.1, IC95% 0.83–20.3, p = 0.056). Patients who developed irAEs had similar PFS (6 vs 5.5 months, HR 1.59, CI 95% 0.7–3.7, p = 0.2) and OS (28 vs 21 months, HR 1.8, CI 95% 0.8–4.5, p = 0.1).

      Conclusions:
      We have found an association between the development of Nivolumab related irAEs and the OR using iRECIST criteria, in patients with NSCLC, but not PFS or OS. Patients who develop irAEs presents four times more probability to have an OR to Nivolumab.

      Clinical trial identification:


      Legal entity responsible for the study:
      Instituto de investigación sanitaria Princesa

      Funding:
      Has not received any funding

      Disclosure:
      All authors have declared no conflicts of interest.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

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      190P - Are neutrophil-to-lymphocyte ratio (NLR) and neutrophil count percentage (NCP) predictors of nivolumab outcome and toxicity in NSCLC? (ID 463)

      12:30 - 13:00  |  Author(s): O. Donnay

      • Abstract
      • Slides

      Background:
      There is limited data of the effect of inflammatory markers on Nivolumab efficacy. We assessed the association between NLR and NCP in NSCLC and the efficacy of Nivolumab. In order to establish whether the effect was either predictive or prognostic, we studied NLR and NCP in two independent cohorts, one treated with Nivolumab and one treated with chemotherapy. Finally, we also analyzed the relationship of NLR and NCP with immune-related adverse events (irAEs).

      Methods:
      Data from 40 NSCLC patients treated with Nivolumab between January 2015 and May 2017 were retrospectively collected. Population was dichotomized according to NLR of 5 and NCP of 80%. The association between NLR or NCP and progression free survival (PFS) and overall survival (OS) was analyzed by univariate and multivariate models. A cohort of 54 chemotherapy-treated NSCLC patients was also analyzed. The association between development of irAEs and NLR or NCP was estudiad by chi square test and Odds Ratio.

      Results:
      Multivariate analysis demonstrated that patients treated with Nivolumab and baseline NLR < 5 have a favourable PFS (6 vs 2 months, HR 8.3, p < 0.001) and OS (26 vs 10.5 months, HR 4.40, p < 0.000001) than cases with NLR ≥ 5. Patients treated with nivolumab and NCP < 80% have also a favourable PFS (6 vs 1.5 months, HR 0.10, p < 0.001) and OS (21.5 vs 9.5 months, HR 0.21, p < 0.05) than cases with NCP ≥ 80%. Patients who received chemotherapy and NLR < 5 have significative better PFS and OS too (15.5 vs 6.5 months, HR 5.9, p < 0.00001) and OS (24 vs 17 months, HR 6.7, p < 0.0001), but this was not observed with NCP < 80%, since no significant diferences showed in the multivariate analysis (PFS 4 vs 2.5 months, p = 0.8; OS 14 vs 9.5 months, p = 0.54). In our analysis, NLR and NCP were not associated with the development of irAEs.

      Conclusions:
      Neutrophil count percentage is a predictive biomarker of Nivolumab clinical course in NSCLC. NCP < 80% was associated with improved PFS and OS. In contrast, neutrophil-to-lymphocyte ratio had a prognostic but not a predictive value. Our results may relevant in the future when patients with NSCLC initiate nivolumab therapy.

      Clinical trial identification:


      Legal entity responsible for the study:
      Instituto de investigación sanitaria Princesa

      Funding:
      Has not received any funding

      Disclosure:
      All authors have declared no conflicts of interest.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.