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A. Misino



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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
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      P1.06-017 - Observational Study on Prolonged Disease Stabilization in Advanced NSCLC EGFR WT/Unknown Patients Treated with Erlotinib in Second Line (ID 4998)

      14:30 - 15:45  |  Author(s): A. Misino

      • Abstract
      • Slides

      Background:
      In advanced NSCLC, erlotinib treatment was shown to improve survival independently of EGFR status and induce high rates of prolonged stable disease (SD). It has previously been reported that, after second-/third-line erlotinib, PFS and OS are long-lasting and similar between patients with SD ≥8 months and those attaining partial/complete response (PR/CR). The present study investigated the clinical value of SD in a real-world setting of advanced NSCLC.

      Methods:
      This Italian multicenter observational study enrolled patients with stage IIIB-IV NSCLC on second-line erlotinib and wild-type/unknown EGFR mutational status, with SD, CR or PR per RECIST v1.1 lasting for ≥4 weeks. Patients were observed from the beginning of erlotinib for approximately 8 months or until death. Primary end-points were the rate and duration of SD (i.e. time interval from erlotinib start to the last evidence of SD by RECIST) or CR+PR. Secondary end-points were OS and PFS (i.e. time interval from the erlotininb start to the first evidence of progression), estimated by the Kaplan-Meier method and calculated by response duration or disease stabilization. Adverse events occurring during the observation period were also recorded.

      Results:
      At the cut-off date of 30/04/16, 144/172 (83.7%) enrolled patients were evaluable for response (mean age 69.1 years, 61.8% males). At the start of erlotinib treatment, 85.4% were non-smokers, 89.6% had an ECOG-PS of 0-1, and 84.7% had stage IV NSCLC (83.3% adenocarcinoma and 11.8% squamous cell carcinoma). Following second-line erlotinib, 82.6% (119/144) of patients achieved SD and 17.4% (25/144) PR. Notably, SD was maintained for ≥8 months in 27% (39/144) of cases. At the end of the observation period, 12 (8.3%) patients had deceased, none with SD ≥8 months. Median OS had not been reached by the entire population. According to SD duration, median OS was 4.3 months if <2 months, 6.8 if between 2 and 5 months, and not reached if ≥5 months or if PR. Median PFS was 9.0 months in the entire population, 8.7 among patients with SD and 10.8 with PR. According to SD duration, PFS was 1.4 if <2 months, 4.4 months if between 2 and 5 months, 7.5 if between 5 and 8 months and 10.5 if ≥8 months. No unexpected toxicities were observed.

      Conclusion:
      In advanced NSCLC, second-line erlotinib yielded a high rate of SD, lasting ≥8 months in 27% of cases, with PFS similar to PR patients and low mortality rate.

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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
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      P3.02c-085 - Neutrophil/Lymphocyte  Ratio in Advanced Non-Small Cell Lung Cancer: Correlation with Prognosis and  Response to Anti-PD1 Therapy (ID 5772)

      14:30 - 15:45  |  Author(s): A. Misino

      • Abstract

      Background:
      The Neutrophil/Lymphocyte ratio (NLR), calculated from peripheral blood tests, represents an independent and easily available prognostic biomarker in numerous cancers, including lung cancer. This study aimed to investigate the prognostic role and the correlation with the therapeutical response of baseline NLR in patients with advanced Non-small cell lung cancer (a-NSCLC) submitted to anti-PD1 therapy.

      Methods:
      Nivolumab (3 mg/kg intravenously by rapid injection every 14 days) was administered to 47 patients (6 women , 41 men) with a-NSCLC. The mean age of patients was 47 years (range 40-83, SD 9.07), while the histotype was: 28 adenocarcinoma, 18 squamous, 1 adenosquamous. 68% of patients were current/former smokers. 25/47 patients (53%) received more than 2 previous lines of therapy. The baseline absolute neutrophil and lymphocytes count and the Neutrophil /Lymphocytes ratio were recorded. Time to progression (TTP) was statistically evaluated by Kaplan-Meyer method; univariate analysis was conducted by Cox regression method .

      Results:
      A median of 7.8 (range 1-20) cycles of therapy was administered . A better TTP (3 months vs 1,5 months; Cox regression rate (Hazard Ratio ) 1.000118, p= 0.003 (CI 1.000041-1.000195) was observed in patients with a lower absolute baseline Neutrophil count (Less than 7500); conversely, a higher absolute Lymphocyte baseline count was linked with a longer TTP (3.7 months vs 1.8; Cox regression rate (HR) 0.9994947, p= 0.055 (CI 0.9989785-1.000011). NLR was correlated with Time to Progression (TTP), that was longer in patients with NLR less than 4 (3.71 months vs 1.87 ; Cox regression rate (HR) 1.144335, p= 0.001 (CI 1.068327-1.22575) (Figure) Figure 1



      Conclusion:
      These preliminary findings highlight the correlation between the NLR and clinical outcome of a-NSCLC patients treated with anti-PD1. Further investigation in this setting is warranted, both to confirm the prognostic role and to investigate if NLR and the microenviromental inflammatory alterations could predict the response to immune-checkpoint inhibitors.

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    P3.05 - Poster Session with Presenters Present (ID 475)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Palliative Care/Ethics
    • Presentations: 1
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      P3.05-004 - Psycho-Social Function and Caregiver's Burden in Patients with Advanced Lung Cancer (ID 4469)

      14:30 - 15:45  |  Author(s): A. Misino

      • Abstract
      • Slides

      Background:
      Patients with advanced lung cancer (a-LC) are often characterized by high tumor burden and comorbidities also correlated to anxiety and depression. The Authors report the preliminary results of a pilot experience on early simultaneous interdisciplinary palliative approach in a-LC patients, referring to the Thoracic Oncology outpatient department of a Clinical Cancer Center. The first aim of the study was to evaluate the quality of life and health status of these patients. Secondly, the caregiver’s burden of care has been investigated.

      Methods:
      32 patients with a-LC (mean age 65 years; Standard Deviation (SD)= 8,3) were enrolled. Psychological distress and health status were assessed by Hospital Anxiety and Depression Scale (HADS), and Short Form 36 Health Survey (SF-36). 23 caregivers (mean age 57 years; SD= 14) compiled the Caregiver Burden Inventory (CBI) to evaluate their burden of care.

      Results:
      55% of patients showed higher score in the total scale of anxiety and depression. 35% of caregivers reported higher level of burden. Among caregivers, women reported higher levels of feelings of fatigue (Physical Burden) as compared to men (F= 4,45, p = 0.05) that reported higher levels of Emotional Burden (F= 7,55, p <0.05); the patient’s sons reported higher scores of Emotional Burden with respect to partners (F= 4,75, p <0.05). Finally, younger caregivers showed higher scores about the Social (F= 10,73, p <0.01) and Emotional Burden (F= 26,6, p <0.01). The correlations among the questionnaires are shown in table 1.

      Conclusion:
      In our sample of a-LC patients, psychological distress was correlated with general quality of life. The highest burden reported by caregivers was linked to the time dedicated to the assistance and to the feeling of fatigue. Our findings suggest to provide psychological support to caregivers, in particular for women to achieve a private and personal space, and for sons to the emotional management.Figure 1



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