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Norma Pilnik



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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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      P1.01-058 - Real World Data with Nivolumab: Experience in Argentina (ID 8800)

      09:30 - 16:00  |  Author(s): Norma Pilnik

      • Abstract
      • Slides

      Background:
      Nivolumab has improved overall survival (OS) in metastatic non-small cell lung cancer (NSCLC) patients. Analysis of the use of these drugs in real world provides more evidence about efficacy and toxicity. We describe here the experience of the use of nivolumab in NSCLC in Argentina.

      Method:
      NSCLC patients (pts) who received nivolumab between 6/2015 - 12/2016. Patients consented their respective physicians to be treated on a drug expanded access program. Data was collected retrospectively by the physician. Images and follow up were done according to physician´s discretion. Adverse events were classified according to CTC3.1. Responses were evaluated according to RECIST 1.1 criteria. DFS and OS was assessed. All pts who received at least one dose of Nivolumab were evaluated for toxicity.

      Result:
      N 109. Fup 8.83 m (IQR 3.4-12.67). 57.8% men, 29.4% current smoker, 78.0% non-squamous, 8.3% EGFR mutated. Chemotherapy lines before nivolumab 2 md (r 1-4), and 59.6% received radiotherapy. 89% received previously platinum based chemotherapy. Sites of relapse or progression before nivolumab were: lung (75.2%), lymph nodes (47.7%), bone (19.3%), liver (11.9%), central nervous system (11.0%), and adrenal gland (13.8%). PS 0 26.6%, 1 56.0%, 2 13.8% and 3 1.8%. Cycles of nivolumab 10 Md (IQR 3-18). Drug related toxicity 78.9%. Grade 2-3 28.4%. Corticoid use 33.9%. Responses were evaluated in 104 pts who had as best response CR 2/104 (2%), PR 28/104 (27. %), SD 33/104 (32%) and PD 41/104 (39.%). Time to the best response was 4.0 m (IQR 2.3-5.9). DFS 6.1 m (IQR 2.4-13.1) and OS 12.3 m (IQR 4.1-NR). Univariate analysis revealed that absence of corticoids use (p=0.034), toxicity grade 1-3 (p=0.0025), PS≤1 (p=0.049), age<=50 (p= 0.0011) were associated with longer DFS; PS≤1 (p<0.001) and toxicity grade 1-3 (p=0.001) were associated with longer OS. In multivariate cox regression analysis, toxicity grade 1-3 (HR 0.44 CI95% 0.24-0.81, p=0.008) and age<=50 (HR 0.28 CI95% 0.13-0.61, p=0.001) were associated with longer DFS while corticoids use was associated with shorter DFS (HR 2.06 CI95% 1.22-3.48, p=0.007); toxicity grade 1-3 (HR 0.28 CI95% 0.14-0.54, p<0.0001) and PS≤1 (HR 0.16 CI95% 0.08-0.31, p<0.0001) were associated with longer OS.

      Conclusion:
      The use of Nivolumab in a real world setting, in heavily pre-treated NSCLC patients was well tolerated and showed promising clinical efficacy. PS, the use of corticoids and immune-mediated toxicity seem to be conditions which could affect clinical outcomes.

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    P2.02 - Biology/Pathology (ID 616)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Biology/Pathology
    • Presentations: 1
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      P2.02-073b - Genetic Profile in NSCLC Biopsy Samples. A  Muticenter Local Study (ID 10356)

      09:30 - 16:00  |  Presenting Author(s): Norma Pilnik

      • Abstract

      Background:
      Substantial advances have been made in the understanding of the biology of NSCLC in relation to the characterization of molecular abnormalities such as activations of oncogenes by mutations, translocations and amplifications, which are being used as molecular targets and predictive biomarkers. Molecular analysis of NSCLC, adeno carcinoma (AC) is now the standard of care for therapy selection.

      Method:
      We determined the frequency of molecular alterations in EGFR and gene fusion ALK in our Caucasian and Hispanic populations to decide the adequate treatment . 123 small biopsies and resection specimens of patients with NSCLC (AC) in different institutions of Cordoba were studied during a period (2014 2017). In addition to histopathology type, we analyzed immunohistochemistry (IHC) characteristics and molecular profiles and several clinical variables were studied as well. Different tests were used to detect alterations of EGFR and fusion gene EML4-ALK expression, with the aim to identify our own profile and decide the adequate therapeutical option. EGFR mutation was studied by therascreen kit, PCR, in order to detect genetic alterations in exons 18, 19, 20 and 21. ALK translocations were analyzed by FISH (Vysis- Break Apart, Abbott) and IHC (clon D5F3, ventana, Roche). We correlated the molecular profile with different clinical variables (age, gender, and tobacco habits). The statistical method used was the multiple regression logistic model.

      Result:
      78 men and 45 women out of 123 samples were tested for EGFR expression. Eleven men and sixteen women expressed EGFR positive. Activating kinase-domain mutations in EGFR were identified in 27 pts (21, 95 %): exon 19 deletion = 17, L858R = 6, exon 20 insertion = 2, other = 2. EGFR alterations were associated with gender (p=0.044), women showed more alterations of the genes. Age and smoking habit of patients did not show significant association (p=0.757 and p=0.547, respectively). We used the multiple regression logistic model to correlate EGFR expression to age, gender, tobacco habits. We identified 4 pts (5%) with fusion gene EML4-ALK. ALK alterations were not related to gender (p=0.449), age (p=0.837) and smoking habit (p=0.452).

      Conclusion:
      Our results showed a comparable frequency in EGFR mutations and gene fusion ALK in western population, in relation to the data published. These results allow a proper diagnosis to provide pts with the most adequate therapy.