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M. Trigo



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    MA 15 - Lung Cancer Biology II (ID 670)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Biology/Pathology
    • Presentations: 1
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      MA 15.01 - LungBEAM: A Prospective Multicenter Trial to Monitor EGFR Mutations Using BEAMing Technology in Stage IV NSCLC Patients (ID 10145)

      15:45 - 17:30  |  Author(s): M. Trigo

      • Abstract
      • Presentation
      • Slides

      Background:
      Liquid biopsy is a promising approach to improve the management of NSCLC patients, offering a minimally-invasive alternative to tumor tissue testing and enabling timely monitoring of patients on-therapy. The goal of the present study was to evaluate the performance of the OncoBEAM EGFR plasma vs EGFR tissue testing across 19 Spanish hospitals and to examine the timing of T790M mutation emergence in patients during first-line EGFR TKI therapy with respect to radiological progression.

      Method:
      Blood samples from 112 therapy-naïve advanced NSCLC patients were collected at baseline and throughout EGFR TKI therapy. Results from OncoBEAM EGFR mutation were performed by Sysmex in Hamburg, Germany and then compared to those obtained by the initial EGFR tissue testing obtained at the referring hospital. In addition, the time at which T790M was first detected was compared to the date of progression determined by radiological imaging.

      Result:
      112 stage IV NSCLC patients (p) were enrolled between Nov 2016 and May 2017. Clinical characteristics: median age 65 y. , 81 female. Smoking pattern: never 70 p (62,5%), former 33 p (29.4%) and active 9 (8%). M1a 28 p (25%), M1b only brain 10 p (8.9%), only bone 17 p (15%). Baseline tissue samples: Exon 19 deletion 74 p (66%) , L858R 38 p (34%). Initial positive percent agreement (PPA) in 69 out of 112 p was 52/69 or 75.4%. Interestingly, the agreement between plasma and tissue EGFR mutation results for patients diagnosed at M0 was 56%, versus 81% with patients diagnosed at M1. In addition, the average number of days between tissue biopsy and blood collection for concordant cases was 128 days, versus 358 days for discordant cases. Currently, the tissue EGFR mutation status of all discordant cases is being re-examined using BEAMing. Preliminary results from serial T790M plasma analyses revealed cases where detection by OncoBEAM was observed several weeks prior to documented progression by imaging. More mature results will be available at the time of the meeting

      Conclusion:
      Overall, these initial results show high PPA of plasma and tissue EGFR mutation status at baseline. Moreover, early detection of T790M in blood may assist in anticipating resistance to first-line EGFR TKI therapy.

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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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      P1.01-040 - Clinical Utility of Plasma-Based NGS for Advanced-Stage NSCLC Patients with Insufficient or Unavailable Tumor Tissue (ID 10215)

      09:30 - 16:00  |  Author(s): M. Trigo

      • Abstract
      • Slides

      Background:
      The failure rate of tissue-based NGS in newly diagnosed NSCLCs is approximately 20-25 %, reaching 40 % in the case of tumor biopsy samples collected at disease progression. In this study, we are analyzing the clinical utility of plasma-based NGS using cell-free circulating tumor DNA (ctDNA) for advanced-stage lung adenocarcinoma patients, as a complement or alternative to tissue-based molecular profiling.

      Method:
      Eight Academic Spanish Institutions are participating in patient recruitment. We are stratifying patients in three cohorts: 1) Patients with advanced-stage lung adenocarcinomas with insufficient tumor tissue for EGFR, ALK or ROS1 analysis; 2) Patients with EGFR, ALK or ROS1 altered tumors with acquired TKI resistance; 3) Patients with EGFR T790M positive cancers progressing on third generation EGFR TKIs. Next-generation ctDNA sequencing is being performed using GUARDANT360 73-gene panel at a CLIA certified central laboratory facility (Redwood City, California). We are stratifying gene variant actionability into four levels according to the OncoKB website criteria.

      Result:
      We have currently included 97 patients (January-June 2017). Complete clinical and molecular data are available at present for the first 37 patients. Twelve, 19 and 6 patients have been enrolled in cohorts 1, 2 and 3 respectively. Never smoker patients were overrepresented (n = 21, 56 %), predominantly at cohorts 2 and 3. A total of 30 cases (81 %) had detectable ctDNA. We have detected potentially actionable genetic alterations involved in mitogenic pathways in 16 patients (43 %). Level 1 alterations (variants with matched approved drugs) were found in three patients’ tumors (25 %) from cohort 1 (two EGFR sensitizing mutations and one ROS1 rearrangement). Nine patients (36 %) from cohort 2 and 3 had tumors with potentially targetable acquired genetic alterations, including three cases with EGFR T790M mutations and one case with a ROS1 kinase domain mutation. Six patients (16 %) received matched targeted therapies, four (11 %) in genotype-driven clinical trials. Reasons for not receiving matched targeted therapies in patients with actionable tumors were clinical deterioration or death (n = 2), unavailability of matched clinical trials (n = 6), treatment with non-genotype-tailored therapies (n =1) or no disease progression to ongoing therapies (n =1). Final clinical and molecular data of the whole cohort will be provided at the meeting.

      Conclusion:
      On the basis of our preliminary data, next-generation ctDNA sequencing (GUARDANT 360) appears to detect actionable genetic alterations when tissue is unavailable, avoiding multiple biopsies and enabling rapid patient selection for genotype-tailored therapies.

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    P2.07 - Immunology and Immunotherapy (ID 708)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P2.07-016 - Inmunotherapy:  Which Is More Important,  Choosing Patients Who Will Respond or Identifying Those Who Will Die Early? (ID 8300)

      09:30 - 16:00  |  Author(s): M. Trigo

      • Abstract
      • Slides

      Background:
      Nivolumab has been approved in a second line, of non-small cell lung cancer (NSCLC) after the failure of the first line of platinum-based chemotherapy. The use of immunotherapy is assuming a new challenge in the clinical practice of the oncologist, who has to familiarize himself with a different toxicity profile than chemotherapy.The objective of this study is to describe the clinical characteristics of our patients, focusing on the toxicity profile found and trying to find something that will help us to identify patients who are going to have poor early evolution.

      Method:
      We have reviewed 49 patients treated with nivolumab, from their use in expanded access, until April 2017. Retrospective information was collected on the clinical, pathological, hematological and treatment characteristics of these patients. Statistical analysis was performed using the SPSS software version 21.0.

      Result:
      The characteristics of the patients are summarized in Table 1. More than half of the patients presented toxicity, in any of their grades, being approximately 56,5 % grades 1-2, and 8% grade 3. Only one patient was presented grade 4 toxicity. The different toxicities are described in Table 1. Attention is drawn to a large number of patients (23) who receive 4 or fewer cycles, who died quickly, most often in the context of rapid progression, and at other times unable to reevaluate the disease. Regardless of these patients, the time of progression was 7.6 months, and the overall survival was 12.6 months, data that can be superimposed on those seen in EECC. Figure 1



      Conclusion:
      Immunotherapy in NSCLC has become a basic pillar of treatment, presenting a different toxicity profile to that of chemotherapy, which we are learning to manage. We thought that it would be important, something that discard those patients who were presumed to have a rapid bad evolution.

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