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D. Rocco
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-046 - Can We Better Manage Advanced NSCLC in the Elderly with the New Therapeutic Agents? Preliminary Analysis of a Real-Life Multicenter Study (ID 5814)
14:30 - 14:30 | Author(s): D. Rocco
- Abstract
Background:
Systemic treatment of NSCLC has profoundly changed over the past years with novel therapeutic strategies recently implemented in clinical practice. Benefit of these novel agents in elderly patients (pts) is uncertain, given the paucity of prospective data in this population. Moreover, elderly pts are often undertreated, due to comorbidities and toxicity concerns. Therefore, we aimed to evaluate the access, safety and outcome with novel therapeutic agents in pts ≥ 70 years (yrs).
Methods:
We planned an observational study to retrospectively evaluate consecutive elderly patients (≥ 70 yrs) with metastatic NSCLC treated at 9 Italian Centers between January 2014 and December 2015. Data collected include clinical and pathological characteristics, treatment types, safety and outcome report.
Results:
220 patients with stage IV NSCLC were included in this preliminary analysis (53% IVa, 47% IVb). Median age was 74,5 (range 70-85) and 69% were male. 15% of pts aged 80 years or older. ECOG PS was 0, 1, 2 in 37%, 51% and 12% of pts, respectively. According to comprehensive geriatric assessment, 59% of pts were fit, 28% vulnerable and 13% frail. Histology was 23% squamous cell carcinoma, 72% non-squamous cell carcinoma and 5% NOS. EGFR mutation was diagnosed in 24% of cases; 1,4% and 1% of pts had ALK and ROS-1 translocations, respectively. 90% of pts received a systemic therapy: 48% a platinum doublet chemotherapy (CHT), 27% a mono-CHT, 25% an EGFR tyrosine kinase inhibitor (TKI). Only 1% of pts were treated with antiangiogenic drugs. Immunotherapy (IT) was administered in 16% of all treated pts. 7% of pts received only BSC. Second- and third-line treatment were given to 44% and 8% of pts, respectively. 51% of pts who received second line treatment and 60% of pts treated with a third line therapy had a novel therapeutic agent (II line TKI 20%, IT 31%; III line TKI 33%, IT 27%). 31% of pts were included in clinical trials. A dose reduction was reported in 41% of therapies and the discontinuation rate was 9%. Survival data are not mature at this time.
Conclusion:
Our data, albeit preliminary, suggest an evolution in the management of NSCLC in the elderly. The interesting activity and the good safety profile encourage the use of novel agents also in this setting of NSCLC. Adequate selection of elderly pts and personalized approach are still matters of debate. Use of adapted schedule and dose reduction could warrant a good compromise between safety and efficacy.
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P2.01 - Poster Session with Presenters Present (ID 461)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Biology/Pathology
- Presentations: 2
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.01-008 - SiRe Next Generation Sequencing Panel: Effective Diagnostic Tool for Circulating Free DNA Analysis (ID 5624)
14:30 - 14:30 | Author(s): D. Rocco
- Abstract
Background:
Tissue availability is a crucial point in NSCLC. The introduction of Liquid Biopsies allows to determine circulant biomarkers, specifically using free DNA. To simultaneously analyze multiple patients sample at high sensitivity, Next Generation Sequencing (NGS) can be narrowed to target a limited number of actionable genes. Here we prospectically applied a lab-developed narrowed gene panel (SiRe) to produce a DNA library covering 568 actionable mutations in six gene (EGFR, KRAS, NRAS, BRAF, cKIT and PDGFRα).
Methods:
This daily clinical practice study was performed on cfDNA obtained from Non Small Cell Lung Cancer blood samples (serum and plasma) prospectically collected either prior to treatment administration in patients without tissue availability (n = 46) or after a progressive disease (n = 19) from a first line gefitinib (n = 14) or afatinib (n = 5) therapy.
Results:
SiRe detected an activating EGFR mutation in 4/46 (8.9%) cases and in T790M in 9/19 (47.4%) at the time of tumor progression. Using tissue data as gold standard, the SiRe panel showed a sensibility of 90.5% and specificity of 100%.
Conclusion:
The SiRe panel is an effective tool enabling the implementation of NGS for cfDNA mutational profiling in molecular pathology practice.
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P2.01-093 - Exo-ALK Proof of Concept: Exosomal Analysis of ALK Alterations in Advanced NSCLC Patients (ID 5471)
14:30 - 14:30 | Author(s): D. Rocco
- Abstract
Background:
A subset of NSCLCs (approx. 5%), present alterations in ALK gene. This produces abnormal ALK proteins that induce cells to grow and spread. Different generation of ALK inhibitors are available for targeted therapy and their indication depends on the detection of ALK alterations in the tissue. Thus, it is mandatory to develop new techniques that allow us to demonstrate ALK alterations in peripheral blood. The purpose of this study is to analyze the feasibility to determine ALK alterations in exosomes (Exo-ALK) in NSCLC patients and determine the sensitivity and specificity of the technique.
Methods:
This study is performed in blind in a cohort 19 NSCLC with and without known alterations of ALK in tumoral tissue. ALK-positive tissue samples were identified by FISH or IHQ and patients were included independently of stage and time of disease. Exosomal RNA is isolated by exoRNeasy Serum/Plasma (Qiagen) and retrotranscripted by ProtoScript II First Strand cDNA Synthesis kit. The ALK gene present in the exosomes was determined by NGS and bioinformatic analysis by OncoDNA. Samples and data from patients included in the study were provided by the Biobank of the University of Navarra and were processed following standard operating procedures approved by the Ethical and Scientific Committees, were provided also by UZA Biobank and by the University of Naples Federico II.
Results:
The analyzed samples have been 16 ALK-EML4 tissue positive patients and 3 ALK-EML4 tissue negative, defined in this case by FISH. After analysis, we have been able to detect 9 positive ALK-EML4 patients, 8 negative samples and 2 samples where the RNA was degraded. Looking at the clinical data, the 9 positive samples detected in the exosomal RNA were positive also for ALK-EML4 translocation in the tissue, and comparing the 8 negative samples, 3 were tissue negative and 5 tissue positive. These data show a specificity of 64% and a specificity of 100%. No correlation has been found comparing naïve patients with treated patients.
Conclusion:
Exosomes are raising as one of the most promising tools to understand the tumor due to their stability in the blood and their similarity to the cells of origin. Our preliminary results show a high specificity and sensitivity for a proof of concept analysis. Further studies with a bigger number of patients and a crossvalidation analysis are required, but as we represent in this abstract, exosomes can represent an important tool for the clinical management of this specific NSCLC population.
