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Airam Padilla



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    P2.03 - Biology (ID 162)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Biology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.03-33 - ctDNA Levels Significantly Predicts Survival in NSCLC Patients with an EGFR Activating Mutation (ID 2016)

      10:15 - 18:15  |  Author(s): Airam Padilla

      • Abstract

      Background

      Circulating tumor DNA (ctDNA) have been shown to be useful for non-invasive biomarker testing in non-small cell lung cancer (NSCLC). In addition, there is growing evidence supporting that ctDNA levels can be useful for tumor response to treatment monitoring. Nevertheless, data from large prospective clinical longitudinal studies still limited.

      Method

      300 plasma samples from 100 advanced NSCLC patients, with tumors harboring an EGFR activating mutation and treated with a first line tyrosine Kinase inhibitor were analyzed. Samples were collected before the start of treatment, at first follow up evaluation, at 7 month and at disease progression. ctDNA was analyzed by dPCR.

      Result

      Median follow up was 11.3 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, afatinib or gefitinib). Patients harboring a deletion in exon 19 or a mutation in exon 21 exhibited better survival than those with an insertion in exon 20 (P<0.001). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. ctDNA levels before the start of the treatment did not significantly predict survival, although a tendency was observed, with patients with high levels of ctDNA showing poorer outcome. On the contrary, patients in which the EGFR sensitizing mutation was undetectable at first follow up had a markedly better PFS and OS (HR=2.7; 95IC= 1.4-5.5 and HR= 5.5 95IC: 1.8-17 respectively). In the same way, patients in which the EGFR sensitizing mutation remained negative at 7months had a significantly increased PFS (HR: 2.8; 95IC: 1.2-6.6). None of the patients with undetectable levels at 7 months has deceased.

      Conclusion

      ctDNA levels is of prognostic significance in EGFR positive NSCLC patients with advance disease and can be useful to monitor treatment outcome

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    P2.05 - Interventional Diagnostic/Pulmonology (ID 168)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Interventional Diagnostics/Pulmonology
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.05-10 - Liquid Biopsy: Association Between the Burden of Disease in Patients with EGFR-Mutated NSCLC and the Frequency of Its Detection in Blood (ID 2384)

      10:15 - 18:15  |  Author(s): Airam Padilla

      • Abstract
      • Slides

      Background

      In the management of patient’s whit non small cell lung cancer (NSCLC) with EGFR mutations after progression to first and second generation tyrosine kinasa inhibitors (TKI), the mechanism of resistance is very important. Our objective is to analyse the appearance kinetics of the T790M by means of digital PCR techniques in liquid biopsy.

      Method

      We conducted a multicenter study with 100 patients with EGFR-mutated NSCLC, treated with first-line TKI therapy. We analyze the ctDNA by dPCR before the start of treatment, at first follow up evaluation, at 6 months and at disease progression.

      Result

      We included a total of 100 patients from July 2016 to December of 2017. Seven patients with Exon 20 insertion in EGFR were excluded (final sample 93). The median of follow-up was 12 months. There were not significant differences in progression free survival (PFS) or overall survival (OS) according to treatment (erlotinib, gefitinib or afatinib). dPCR detected EGFR sensitizing mutation in 77% of the pre-treatment samples. Of these cases, EGFR sensitizing mutation was detected in 75% of the patients with stage IVA and 85% in stage IVB respectively, p=0,075. The resistance mutation p.T790M was detected in 52% of the samples collected at disease progression. The probability to detect the resistance mutation p.T790M by liquid biopsy, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation (11% vs 62%) p 0,009. In cases with progression of the disease the percent of detection of p.T790M was 52% and 54% in patients with Exon 19 deletion and L858R mutation respectively. The OS in patients with progression of the disease and p.T790M negative was 85% at 12 months (95%CI: 60%-94%) and 75% with p.T790M positive (95%CI: 49%-88%), p=0,01.

      Conclusion

      The burden of disease in patients with NSCLC mutated with EGFR is related to the appearance of sensitivity and resistance mutations in liquid biopsy. The probability to detect the resistance mutation p.T790M in blood, is greater if the pre-treatment sample was positive for EGFR sensitizing mutation.

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      P2.05-12 - Analysis of Biomarkers in Lung Cancer in Spain (ID 854)

      10:15 - 18:15  |  Author(s): Airam Padilla

      • Abstract

      Background

      The analysis of biomarkers in lung cancer (LC) is currently one of the most important care needs, given the importance of their presence in the selection of specific treatments. Our objective was to know the implementation degree of these tests in a large cohort of patients in Spain using the Thoracic Tumor Registry (TTR) of the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group).

      Method

      The TTR is an observational cohort multicenter study of the LC in Spain. Information on patients (p) enrolled from August 2016 to December 2018. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating institute. The registry was approved by the Spanish Drug Agency as a non-post-authorization, non-interventional study.

      Result

      A total of 7,872 patients from 58 Spanish sites were enrolled. Analysis of molecular markers considering all the LC stages: A molecular test, the most frequent being the EGFR test, was performed in 4,456 patients (67.5%). The proportion of biomarker evaluation has varied over time, ranging from 57.9% prior to 2012 up to 73.7% in 2017.

      Molecular markers in patients with stage IV. Three thousand four hundred forty-six (3,446) patients (52.2%) had a stage IV on diagnosis. The molecular assessment of some biomarkers reached 81.4% of all the patients, there being differences between Regional Communities in regard to the molecular tests made.

      There was performed some biomarker test in 92% of the 2570 patients with stage IV and adenocarcinoma histology. The analysis of ALK was tested in 79% of the patients, this being in 40% only 2 years ago. ROS was studied in 20% of the cases and EGFR in 92%.

      Conclusion

      Although no national plan exists for molecular biomarker analysis in LC in Spain, the implementation of the biomarkers analysis in all the hospitals that contribute to the TTR is high, as close to the maximum as possible. The increase in the ALK analysis in the last period is relevant. As regional differences exist, it would be of interest to go in depth to study its cause

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    P2.10 - Prevention and Tobacco Control (ID 176)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Prevention and Tobacco Control
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.10-02 - Smoking Habit in Lung Cancer in Spain   (ID 732)

      10:15 - 18:15  |  Author(s): Airam Padilla

      • Abstract
      • Slides

      Background

      Tobacco is the leading cause of lung cancer. The fight against the smoking habit is essential and should be continuous, to detect the national situation that makes it possible to design health care policies against this consumption. To do so, the Grupo Español de Cáncer de Pulmón (Spanish Lung Cancer Group) made this analysis within the context of the Thoracic Tumor Registry (TTR).

      Method

      The TTR is an observational cohort multicenter study in Spain. The study is conducted according to the Declaration of Helsinki and approved by the institutional review board of each participating site. The registry was approved by the Spanish Drug Agency, as a non-post-authorization, non-interventional study.

      Result

      We collected data from 6,600 patients diagnosed of lung cancer from 58 different Spanish hospital sites.

      A total of 3,039 patients were former smokers (46%), 2,611 were active smokers (39%) and only 866 (12%) patients stated to be non-smokers; the status in 2% is unknown. If we make a comparison by gender regarding the presence of this habit, large differences (p-valor < 0.001) are observed, with a greater number of non-smokers in women (37 % vs. 4.5% in males), while the percentage of former smokers is much higher in the males (53.4% vs. 27.9% in women) and a minor difference in active smokers (42.1% vs. 34.4% in women).

      Significant differences were observed in the study on the distribution of the smoking habit by gender and year of diagnosis. An increase is also observed in the last two years regarding the percentage of patients who were active smoked, both for the total population as well as for each one of the two genders separately. The increase is greater among the women and, also, the number of women who are active smokers is greater in recent years.

      Mean age of onset of the smoking habit is 18.2 years. Significant differences are observed between both genders (p-valor < 0.001), with a mean age of initiation of 17.9 years in the men (95%CI 17.6-18.2 years) and 19.2 years in the women (95%CI 18.5-19.8 years). Significant differences between Regional Communities were also found in the mean age at onset of the habit, with much lower levels in the Valencian Community (16.6 years) or Navarra (16.9 years) regarding other communities, such as the Region of Murcia (22.9 years) or the Balearic Islands (21.6 years)

      Conclusion

      Lung cancer in Spain is associated to tobacco consumption in 85% of the cases diagnosed. Consumption has shown an increase in both genders in recent years and is especially rapid and worrisome in women. Anti-smoking campaigns should be reactivated and the causes of the regional differences analyzed in depth

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