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P. Ulivi



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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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      P1.01-053 - Italian Nivolumab Expanded Access Programme (EAP): Data from Patients with Advanced Non-Squamous NSCLC and Brain Metastases (ID 10056)

      09:30 - 09:30  |  Author(s): P. Ulivi

      • Abstract

      Background:
      Among patients (pts) affected by non-squamous non-small cell lung cancer (non-Sq-NSCLC), those with secondary brain metastases are very common and are characterized by a poor prognosis. As they are usually excluded from clinical trials, the EAP offered an opportunity to evaluate nivolumab efficacy and safety in these patients outside of a controlled clinical trial in Italy.

      Method:
      Nivolumab was available upon physician request for pts aged ≥18 years with a diagnosis of non-Sq-NSCLC who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events using Common Terminology Criteria for Adverse Events. Pts with brain metastasis were eligible if asymptomatic, neurologically stable and either off corticosteroids or on a stable dose or decreasing dose of ≤ 10 mg daily prednisone.

      Result:
      Out of 1588 patients with non-Sq-NSCLC participating in the EAP in Italy, 409 (26%) had asymptomatic and controlled secondary brain metastases. Pts received a median number of 7 doses (1-45) and had a median follow-up of 6.1 months (0.1-21.9). The disease control rate was 40%, including 3 pts with a complete response, 65 pts with a partial response and 96 with stable disease. Among these pts, 118 were receiving steroid therapy at baseline and 74 received concomitant radiotherapy. As of March 2017, median overall survival of this subpopulation was 8.1 months (6.2-10.1). Overall, among pts with brain metastasis, 337 discontinued treatment for any reason, with only 23 (7%) pts who discontinued treatment due to adverse events, in line with what observed in the general population and in previous studies.

      Conclusion:
      These data confirmed the activity of nivolumab in patients with non-Sq-NSCLC and brain metastases, supporting the use of nivolumab in this population with poor prognosis. Moreover, as already observed in other tumor types, safety results were consistent to what already reported and confirmed the favorable safety profile.

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    P3.02 - Biology/Pathology (ID 620)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Biology/Pathology
    • Presentations: 1
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      P3.02-007 - Circulating miRNAs as Prognostic Biomarkers in Resected Early-Stages Non-Small-Cell Lung Cancer  (ID 8965)

      09:30 - 09:30  |  Author(s): P. Ulivi

      • Abstract

      Background:
      Non small cell lung cancer (NSCLC) is the primary cause of cancer-related death, and 5-years survival rate remains below 16% mainly because of disseminated disease, also in fully resected early stages. Biomarkers identifying patients with a higher risk of relapse could be very useful. Circulating microRNAs (miRNAs), represent promising markers in this setting.

      Method:
      A case series of 182 resected early stage (IA-IIIA) NSCLC, of which 99 adenocarcinoma (ADC) and 83 squamous cell carcinoma (SCC), was analyzed. Peripheral blood samples were collected from each patient before surgical resection and serum was obtained after centrifugation and stored at -80°C until miRNA extraction. A panel of 84 circulating miRNAs was analyzed by Real Time PCR. Data were normalized by means of an external spike in, cel-miR-39, and the mean of two most stable endogenous housekeeping chosen separately for ADC and SCC samples. miRNA expression was analyzed in relation to disease-free survival (DFS) through Cox regression model. Results are reported as hazard ratios (HRs) and 95% confidence intervals (CIs).

      Result:
      Of the 99 ADC, 45 (45.5%) had a relapse during the follow-up whereas among the 83 SCC patients, 50 relapses (60.2%) were observed. The minimum follow-up time was three years for both groups of patients. In the group of ADC patients, stage was significantly associated with DFS (HR stage II-IIIA vs stage I = 4.94 , 95% CI [2.71 - 9.02]). Multiple statistical analysis methods were used to analyze miRNA expression data. At univariate analysis, two miRNAs (miR-222-3p and miR-22-3p) were significantly associated with time to relapse (p = 0.033 and p = 0.041, respectively). The significance was not maintained after adjustment for multiple testing. In the group of SCC patients, stage of disease was significantly associated with DFS (HR stage II-IIIA vs stage I = 3.31, 95% CI [1.74 - 6.33]). Five miRNAs (let-7a-5p, miR-126-3p, miR-26a-5p, miR-130b-3p, miR-21-5p) were found significantly associated with DFS even after adjustment for multiple testing false discovery rate q-value <0.001.

      Conclusion:
      Pre-surgery circulating levels of let-7a-5p, miR-126-3p, miR-26a-5p, miR-130b-3p and miR-21-5p seem to be significantly correlated with prognosis in resected early stage SCC patients.