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S. Carnio



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    P2.06 - Poster Session 2 - Prognostic and Predictive Biomarkers (ID 165)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P2.06-013 - Genetic profiling of lung cancer in young adults patients: early data assessment using Next-Generation Sequencing. (ID 1189)

      09:30 - 09:30  |  Author(s): S. Carnio

      • Abstract

      Background
      In 3% of cases, lung cancer is diagnosed in patients younger than 45 years. The epidemiology, biology and clinical history of young lung cancer patients is generally different from the adult counterpart: the higher percentage of mutations has the potential to influence both tolerability and response to treatment with consequent impact on quality of life and survival. The biomolecular characterization of the disease in this subgroup will allow the design of clinical studies dedicated to young patients, that will lead to the identification of specific items that are not deducible from trials opened to the general adult population. In this study, Next-Generation Sequencing (NGS) technology has been applied to archival tissue samples to enhance tumor-specific genomic profile knowledge in this selected cohort of young patients (pts).

      Methods
      A retrospective analysis has been performed at the Thoracic Unit of San Luigi Hospital from January 2007 to March 2013, collecting 13 lung cancer-diagnosed pts (10 completely sequenced; in 3 cases the analysis is ongoing), aged between 15-39 years. Genomic DNA was extracted by microdissected formalin-fixed and paraffin embedded (FFPE) tumor samples of all pts and by lymphocytes of three healthy controls (ctrl). Amplicons NGS libraries for 46 oncogenes included in the Ion Torrent Cancer Panel were generated, following manufacture guidelines, and sequenced in Personal Genome Machine (PGM) Ion Torrent instrument. Variant Caller included in Torrent Suite Software was used to identify mutations.

      Results
      Twenty-two non-synonymous, 3 frameshifts, 3 stop-gain and 55 synonymous somatic sequence variations were found in 10 young adult patients (allelic frequency ≥ 10%). Excluding synonymous mutations, the most frequently altered genes in patients were TP53 (7 mutations; 25%), followed by EGFR and KDR (5 mutations; 18%), PI3K (3 mutations; 11%), KIT (7 mutations; 14%), FGFR3-ABL1-MET-ATM-RB1-SMO (1 mutation; 3.6%). Furthermore, 14 of these mutations are annotated in SIFT or in PolyPhen databases as “mutations that could damage affected protein”. Overall, we identified 28 mutations annotated in COSMIC database, among which the most frequent were COSM149673, COSM28026 and COSM6223-COSM22413 with 5,4 and 2 counts, respectively. We also found 93 SNPs in our cohort, including the most frequent rs7688609, rs1873778 and rs1050171 with 13 counts (10 pts; 3 ctrl) followed by rs1800861 (9 pts; 3ctrl); rs41115 (8 pts; 2ctrl); rs1870377 (4 pts; 1ctrl); rs3822214 (2 pts; 2ctrl); rs3729687 (2 pts; 1ctrl); rs2228230 (2 pts) and rs3730358-rs3135898 (1 pt; 1ctrl).

      Conclusion
      The development of new biological techniques, such as the next-generation sequencing, could allow to collect a wide number of mutations. From these preliminary results, some interesting data have been discovered concerning SNPs or mutations. This pivotal retrospective analysis is the basis for the ongoing prospective collection. A better definition of molecular-genetic pattern in this selected young population of patients could increase the knowledge about the lung cancer etiology and suggest age-related new trials design.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-041 - Treatment with crizotinib in patients with IV stage non-small cell lung cancer (NSCLC) with ALK translocation: a single institution experience. (ID 2961)

      09:30 - 09:30  |  Author(s): S. Carnio

      • Abstract

      Background
      Crizotinibis is a MET inhibitor, having also an activity on ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) pathways. The ALK translocation is described in 4% of NSCLC and these patients (pts) benefit from crizotinib therapy with a response rate (RR) ranging from 51 to 61%.The drug is already approved by FDA and EMA; in Italy crizotinib is available in first line within controlled clinical trials and, until April 2013, within expanded access program (EAP).

      Methods
      From June 2010 to February 2013, 155 pts with advanced NSCLC were analyzed for Alk translocation using fluorescence in situ hybridization (FISH) at our institution. The selection criteria were: adenocarcinoma histology, never or ex smoker, EGFR status WT. Main pts characteristics were: 59% males, median age 57,5 years (range 26-76), 77 former smoker (76 pts for more than 15 years). Tissue samples were available from primary tumor and metastases in 78 and 22%, respectively, having 73% of cases with cytological material. In 23,2% of the specimens Alk rearrangement was not evaluable due to poor quality and/or quantity issues.

      Results
      Among the 155 pts, 22 (14%) are ALK translocated: 19 were treated within PROFILE clinical trials and 3 patients in the EAP. 20 pts are currently evaluable for response and toxicity: 6 of them received crizotinib as first-line treatment, the others in subsequent lines. The response rate was equal to 70%. The total number of administered cycles is 235.The reduction of the dose (7% of cycles) was necessary in two pts: in 1 case due to bradicardia and fatigue G3 (in first line treatment) and in the other one due to neutropenia G3 (in second line).The observed toxicities were mostly grade 1-2 (fatigue 47%, bradycardia 5,8%, visual disorder 5,8%, anemia 29%, neutropenia 18% and nausea 12%); grade 3-4 was less common. The temporary cessation of treatment was required in 3 pts (range 4-15 days) for grade 3-4 toxicity (mostly neutropenia plus fatigue). No drug interruption for unacceptable toxicity was reported. The most common progression sites were brain (37%) and bone (27%).

      Conclusion
      The introduction of a selection criteria (such as negative EGFR status) leads on an increase of our cases of Alk traslocated pts compared to literature data; this selection is moreover recommended in diagnostic algorithm recently proposed by the Italian Expert Panel (Marchetti A et al, JTO 2013). Efficacy and tolerability profile are consistent with published data.

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    P3.24 - Poster Session 3 - Supportive Care (ID 160)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P3.24-010 - The efficacy of a Mindfulness Based Intervention Body and Affective Intervention(MB-BAI) with cancer patients and their relatives (ID 1065)

      09:30 - 09:30  |  Author(s): S. Carnio

      • Abstract

      Background
      Cancer has a great impact on psychological functioning of patients and relatives and can be associated with various psychological disorders and symptoms. Mindfulness Based Intervention (MBI) is a relatively brief and cost-effective program that has been studied in patients with several diseases. Recent analyses have shown the efficacy of MBI in improving psychological symptoms related with physical illnesses like cancer, chronic fatigue syndrome, fibromyalgia, chronic pain, arthritis, diabetes, heart disease, stroke, and traumatic brain injury. MBI is based on the assumption that a non-judgmental awareness and acceptance of one’s moment-to-moment experience have an effect on the distressing tendencies to escape from or to over-engage with one’s disturbing feelings, emotions and thoughts. MBI can positively impact on coping strategies and on the adaptation to the disease, by encouraging patients to relate differently to their physical and psychological symptoms, resulting in a reduction of the psychological burden and improving patients’ Quality of Life (QoL). MB-BAI integrates MBI basic practices with increased attention to somatic resources and application of mindfulness in relationships.

      Methods
      We aim to evaluate whether a group-based Mindfulness Based Body and Affective Intervention can reduce psychological symptoms like anxiety, depression, perceived stress and improve the QoL of patients with cancer. Furthermore, our study involve patients’ caregivers/relatives in order to decrease the load of stress and difficulties related to the management of a disabling diseases like cancer. This project is designed as an observational study. The subjects currently involved in all are 36, including patients with advanced malignant disease (mostly lung cancer), their caregivers/relatives and the control group. Participants were enrolled at the Oncology Unit of San Luigi University Hospital of Orbassano, Italy, in collaboration with WALCE (Women Against Lung Cancer in Europe). The experimental group underwent a 8 weekly sessions of 3 hours each (plus an all day session) with a group based MB-BAI. The control group hasn’t receive any psychological intervention. The psychological assessment was performed at pre-intervention and after treatment for both groups. The evaluation encompasses the administration of the self-reportquestionnaires: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Five Facet Mindfulness Questionnaire (FFMQ), Posttraumatic Growth Inventory (PTGI) and WHOQoL-Brief, patients qualitative reports.

      Results
      not applicable

      Conclusion
      The study is currently ongoing. As far as we know this is the first MBI applicationinadvanced lung cancer. Specific attention to somatic resources and relationships may increase its effectiveness. Preliminary results from patients’ reports suggest that the MB-BAI both reduces symptoms of anxiety and depression and improves resources. Results will be presented after the complete achievement of the after-treatment assessment; we hope they will confirm that MBI favor positively impact on the adaptation to the disease, resulting in a reduction of the psychological burden and improving patients’ Quality of Life (QoL).