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C. Noberasco
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P2.01 - Poster Session with Presenters Present (ID 461)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.01-044 - Baseline Peripheral Blood Cell Subsets Associated with Survival Outcomes in Advanced NSCLC Treated with Nivolumab in Second-Line Setting (ID 4103)
14:30 - 14:30 | Author(s): C. Noberasco
- Abstract
Background:
Nivolumab is the first checkpoint inhibitor approved for the treatment of Squamous (Sq) and non-Squamous (non-Sq) metastatic NSCLC in second-line setting, showing a survival benefit in randomized phase III trials. The aim of this study is to investigate the potential role of baseline peripheral blood cells in relation to clinical outcomes following nivolumab treatment.
Methods:
From November 2015 to to June 2016, we evaluated 45 patients with Sq (n = 10) and non-Sq (n = 35) NSCLC, previously treated with first-line platinum-based chemotherapy, that received nivolumab 3 mg/kg IV on day 1 of each 2 week treatment cycle. Clinical characteristics (T-Stage, lymph nodes involvement, M-Stage) were assessed. Total numbers of leukocytes, myeloid-derived suppressor cells (MDSCs), including both monocytic (Mo-MDSC) and granulocytic (Gr-MDSC) type, regulatory T cells (T-regs), and serum lactate dehydrogenase (LDH) were assessed. Endpoints were correlation with objective response (OR), progression-free survival (PFS, categorized as ≤ 3 or > 3 months) and overall survival (OS). Tumor response was assessed using RECIST criteria, version 1.1, at week 9 and every 6 weeks thereafter until disease progression. Statistical methods were based on univariate analyses (Wilcoxon rank test).
Results:
The median PFS of the overall study population was 3 months. Data about Gr-MDSCs (identified by flow cytometry as Lin-CD15+CD14-CD11b+HLA-DR[low/-]), Mo-MDSCs (Lin-CD14-CD11b+HLA-DR[low/-]) and absolute eosinophil counts (AEC) were available in 37/45 patients (82%) of treated patients. Baseline absolute numbers of Gr-MDSCs, Mo-MDSCs and AEC were greater in patients with good prognosis (PFS > 3 months) and better outcomes. In particular among patients with shorter PFS, the median numbers of Gr-MDSCs, Mo-MDSCs and AEC were significantly lower than those detected in patients with longer PFS (4 vs 13 cell/µl, p=0.01; 4 vs 21 cell/µl, p=0.06; 55 vs 155 cell/µl; p=0.02, respectively). No correlation was observed between T-regs, LDH, absolute neutrophil, monocyte, lymphocyte counts and clinical outcomes.
Conclusion:
A baseline blood signature characterized by low levels of Gr-MDSCs, Mo-MDSCs and AEC is associated with poor outcome (median PFS ≤ of 3 months) in 67.6% of patients treated with nivolumab. In contrast, patients (32.4%) with high levels of these three biomarkers showed a median PFS significant longer than 3 months. Overall survival analysis is ongoing.
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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
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-094 - Italian Nivolumab Advanced Squamous NSCLC Expanded Access Program: Efficacy and Safety in Patients with Brain Metastases (ID 5144)
14:30 - 14:30 | Author(s): C. Noberasco
- Abstract
Background:
The prognosis of NSCLC patients (pts) with brain metastases is still quite poor. These pts usually do not meet the inclusion criteria to be enrolled in clinical trials. Nivolumab Italian Expanded Access Program (EAP) allowed this subpopulation of pts to be included, providing the opportunity to evaluate safety and efficacy of nivolumab treatment in pts with brain metastases.
Methods:
upon physician written request, nivolumab was provided to pts who met the following inclusion criteria: aged ≥18 years, who had received a diagnosis of squamous NSCLC, and who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV squamous NSCLC. Nivolumab is administered intravenously at the dose of 3 mg/kg every 2 weeks for a maximum duration of 24 months. We describe efficacy and safety of nivolumab in pts who received at least one dose. Adverse events were monitored using Common Terminology Criteria for Adverse Events.
Results:
from our cohort of 372 patients diagnosed with squamous NSCLC, we report the results of 38 (10.2%) pts with treated and asymptomatic brain metastases. In these pts, with median follow-up of 4.5 months and median number of doses of 6 (range, 1–18), disease control rate was 47.3%, including 1 complete response, 6 partial responses and 11 stable diseases. Treatment beyond RECIST defined progression was allowed, under protocol defined circumstances, in 4 pts. Median progression-free survival was 5.5 months, and overall survival was 6.5 months (data lock of April 2016). Out of the 38 pts included, only 1 discontinued treatment due to AE (2.6%), whereas 21 pts (55.3%) discontinued treatment for non-toxicity related reasons.
Conclusion:
although preliminary, these results demonstrate efficacy of nivolumab in squamous NSCLC pts with brain metastases. Safety of nivolumab in these pts is consistent with previously reported data from clinical trials. These results suggest nivolumab could be beneficial in this subpopulation of pts with unfavourable prognosis.
