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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-057 - Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC) (ID 8742)

      09:30 - 16:00  |  Author(s): B. Obispo

      • Abstract
      • Slides

      Background:
      Nivolumab, a monoclonal antibody against the Programmed Death 1 (PD-1) pathway, has been shown to improve outcome and safety compared to Docetaxel in second-line NSCLC. We evaluated the actual use of Nivolumab in routine clinical practice at a single center in patients with NSCLC.

      Method:
      Data from patients with a diagnosis of advanced NSCLC who were treated with Nivolumab at standard dose (3mg/kg every 14 days), between January 2016 and March 2017 in our Hospital, were retrospectively collected. We performed a descriptive analysis of multiple demographic, clinical and analytical variables, as well as seeking differences between progression-free survival (PFS) according to squamous (SqCC) and non-squamous (Non-SqCC) histology, ECOG Performance Status (PS) and prior lines received by log-rank, Kaplan-Meier methods and Cox proportional models.

      Result:
      Forty patients were treated. Median age was 67; 67.5% were male; 80% were smokers. Histologies: Non-SqCC 42.5%, SqCC 52.5%, 5% NOS. ECOG PS: 50% ECOG 2, 45% ECOG 1, 5% ECOG 0. Twenty patients were treated as second-line (50%), and 20 had received ≥ 2 prior systemic therapies (50%). Median PFS was 3 months. Response rate: 35% (2.5% of patients had complete response); 42.5% of patients had stable disease and 22.5% progression disease. Adverse events were mostly grade 1 and 2, as expected, just one patient discontinued treatment due to grade 4 inmuno-mediated colitis. Patients with SqCC achieved a longer median PFS than Non-SqCC patients (4.9 vs 2.8 months, HR 2.14, 95% CI 1.1-4.6, p <0.05). Median PFS in patients who received 1 prior line was 2 months vs 3.5 months in patients who received ≥2 prior lines (log-rank, p=0.5). PFS in ECOG PS 0-1 patients was 3 months vs 2 months in ECOG PS 2 (log-rank, p=0.2).

      Conclusion:
      Nivolumab in NSCLC routine clinical practice is a safe and active alternative to chemotherapy. Nivolumab achieve a good outcome in both histologies, SqCC and Non-SqCC, but we detected a longer PFS in SqCC. Adverse events were as expected, grade 1 and 2.

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    P2.02 - Biology/Pathology (ID 616)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Biology/Pathology
    • Presentations: 1
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      P2.02-027 - Are Inflammatory Markers Predictive of Nivolumab Efficacy in Advanced Non-Small-Cell Lung Cancer (NSCLC)? (ID 8042)

      09:30 - 16:00  |  Author(s): B. Obispo

      • Abstract
      • Slides

      Background:
      Elevated neutrophile-to-lymphocyte ratio (NLR) is a systemic inflammatory marker that has been associated with poor prognosis in NSCLC (Bar-Ad, 2016). There is, however, limited data of the effect of inflammatory markers on Nivolumab efficacy. We assessed whether there is an association between NLR and efficacy of Nivolumab in NSCLC. We also evaluated the value of neutrophil count percentage (NCP). Finally, to establish if the effect was predictive of Nivolumab or prognostic of a therapeutic effect, we studied also NLR and NCP in a cohort of chemotherapy-treated NSCLC.

      Method:
      Data from NSCLC patients treated with Nivolumab (N=40) in routine clinical practice in our Hospital between January 2015 and May 2017 were retrospectively collected. Population was dichotomized according to whether they had NLR≥5 or <5. Cut-off for NCP was established at 80% using the minimum p-value method. The association between NLR or NCP and progression free survival (PFS) and overall survival (OS) was analyzed by log-rank, Kaplan-Meier method and Cox proportional models. A cohort of chemotherapy-treated NSCLC patients (N=54) were also analyzed.

      Result:
      In Nivolumab cohort, median age was 67. Thirteen patients (32.5%) were NLR≥5 and five (12.5%) were NCP≥80%. In chemotherapy cohort, median age was 69. Thirty-one patients (57%) were NLR≥5 and ten (18.5%) were NCP≥80%. In Nivolumab cohort, PFS and OS were longer with NLR<5 (log-rank p<0.0001). This effect was also observed with NCP<80% (log-rank p<0.0001 -PFS-, p=0.01 -OS-). In chemotherapy-treated patients, a similar effect was observed. Complete data of median PFS and OS, and Cox proportional models is shown in table 1.

      Treatment Inflammatory marker Median PFS (months) Cox proportional models median PFS Median OS (months) Cox proportional models median OS
      Nivolumab NLR<5 ≥5 6 2 HR 6.7 CI 95% 2.9-15.3 p<0.000001 25 10.5 HR 4.4 CI 95% 1.9-9.2 p<0.0000001
      Nivolumab NCP<80% ≥80% 6 1.5 HR 0.09 CI 95% 0.02-0.34 p<0.0000001 21 9.5 HR 0.2 CI 95% 0.09-0.84 p=0.02
      Chemotherapy NLR<5 ≥5 15.5 6.5 HR 6.7 CI 95% 3.0-15.1 p<0.0000001 24 17 HR 8.9 CI 95% 3.6-21.9 p<0.0000001
      Chemotherapy NCP<80% ≥80% 4 2.5 HR 0.45 CI 95% 0.2-0.9 p=0.03 14 9.5 HR 0.35 CI 95% 0.16-0.75 p=0.007


      Conclusion:
      Systemic inflammation biomarker NLR, and to a lesser extent NCP are prognostic, but not predictive, factors of Nivolumab efficacy in NSCLC. NLR<5 and NCP<80% are associated with improved PFS and OS in NSCLC regardless of treatment evaluated.

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