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Nuria Vinolas



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    MA03 - Lung Cancer Screening - Next Step (ID 896)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Screening and Early Detection
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 206 AC
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      MA03.11 - Trained Dogs Can Identify Malignant Pulmonary Nodules in Exhaled Gas (ID 13056)

      11:35 - 11:40  |  Author(s): Nuria Vinolas

      • Abstract
      • Presentation
      • Slides

      Background

      After our recent report that trained dogs can identify the presence of lung cancer (LC) in exhaled air samples of patients with and without large LC(1), we designed a prospective controlled study to investigate if such trained dog can also discriminate between the exhaled gas samples of individuals with and without malignant pulmonary nodules.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We collected samples of exhaled air from 30 patients with indeterminate pulmonary nodules before the diagnostic and therapeutic surgery, and from 77 individuals without LC and without pulmonary nodules. Exclusion criteria were other neoplasm, and chemotherapy treatment. Participants refrained to eat, drink and smoke 30 minutes before they exhaled inside a crystal tube filled with hidrophilic and hidrophovic wool and closed with silicon taps, as we used in our previous report. Likewise, the training method of the dog was also based on a progressive prize-dependent learning method. Tubes containing the samples were introduced in wood boxes with an open side to enable the smelling of the sample. The dog was confronted to samples with and without pulmonary nodules in a proportion of 1/4 in order to discriminate malignant ones.

      4c3880bb027f159e801041b1021e88e8 Result

      The dog was confronted with 90 samples with indeterminate pulmonary nodules (3 per patient) and 372 samples without pulmonary nodules and without LC. The dog was confronted 10 times to each sample of pulmonary nodules with different combinations of “no LC” exhaled gas samples, which represents a total of 900 attempts. The dog must mark the samples he identifies as malignant ones. He achieved successful results with a sensitivity of 0,97, a specificity of 0,99, a PPV of 0,97 and a PNV of 0,99. Out of 30 patients with indeterminate pulmonary nodules the dog recognized 27 of them as positive for LC and 3 as negative for LC. Those results matched with the anatomical pathology surgery report.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Trained dogs can discriminate the presence of malignant pulmonary nodules from exhaled gas samples with an extraordinarily high degree of reliability.

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    OA01 - Improving Outcomes in Locoregional NSCLC I (ID 892)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 107
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      OA01.05 - Phase II Study of Neo-Adjuvant Chemo/Immunotherapy for Resectable Stages IIIA Non-Small Cell Lung Cancer- Nadim Study-SLCG (ID 12907)

      11:15 - 11:25  |  Author(s): Nuria Vinolas

      • Abstract
      • Presentation
      • Slides

      Background

      The combination of chemotherapy and immunotherapy (CT-IO) has a high response rate and longer survival in unselected patients (pts) with metastatic non-small cell lung cancer (NSCLC). There are no data about this combination in the neoadjuvant setting.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A Phase II, single-arm, open-label multicenter study of local-advanced resectable stage IIIA N2-NSCLC adult patients with CT plus IO (nivolumab (NV)) followed by adjuvant treatment for 1 year. Neoadjuvant treatment: Three cycles of NV 360mg IV Q3W + paclitaxel 200mg/m2 + carboplatin AUC 6 IV Q3W. After completing neoadjuvant therapy, tumor assessment is performed in patients prior to surgery. Surgery is performed in the 3rd or 4th week after day 21 of the third cycle of neoadjuvant treatment. Adjuvant treatment: NV 240mg IV Q2W for 4 months and NV 480mg IV Q4W for 8 months (total one year) after surgical resection. The study aims to recruit 46 pts. The primary endpoint is Progression-Free Survival (PFS) at 24 months. Efficacy is explored using objective pathologic response criteria. We present preliminary data on patients that completed 3 cycles and underwent surgical resection.

      4c3880bb027f159e801041b1021e88e8 Result

      At the time of submission, 46 pts had been included and 20 underwent surgery. CT-IO was well-tolerated and surgery was not delayed in any patient. None of the pts was withdrawn from the study preoperatively due to progression or toxicity.

      Twenty surgeries had been performed and all tumors were deemed resectable. The overall clinical response rate was 5% complete (CR) and 65% PR. The pathological response evaluated after surgery: 13 cases (65.0%) achieved CR (CPR) (95% CI 40.8-84.6%), and 3 (15.0%) had a major pathologic response (MPR), defined as <10% viable tumor cells in the resection specimen. Considering both CPR and MPR, the overall response rate was 80.0% (95% CI 56.3-94.3%) and 60% of complete responses were unsuspected

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is the first multicentric study testing CT-IO in the neoadjuvant setting with promising antitumor activity in locally advanced, potentially resectable NSCLC yields an unprecedented complete pathologic response rate. The data will be updated at the time of the congress. EudraCT Number: 2016-003732-20

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.04 - Immunooncology (Not CME Accredited Session) (ID 970)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.04-13 - PD-L1-Gene Expression by nCounter Correlates with PD-L1 Protein Expression in Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 13944)

      12:00 - 13:30  |  Author(s): Nuria Vinolas

      • Abstract
      • Slides

      Background

      PD-L1 immunohistochemistry (IHC) staining is a Food and Drug Administration­-approved marker to identify patients for immunotherapy treatment in advanced non-small cell lung cancer (NSCLC). However, several antibodies and cut-off criteria have been used and pathological evaluation involves a certain degree of subjectivity. Multiplexed technologies can be of help in this setting and provide an objective measurement of PD-L1 levels.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A 7-gene ‘immune signature’ comprising CD4, CD8, PD-1, PD-L1, IFNG, GZMM and FOXP3 was incorporated into our routine clinical practice as part of a customized nCounter panel (NanoString Technologies), which simultaneously screens for gene fusions (ALK, ROS1, RET and NTRK1), MET overexpression and MET exon 14-skipping mutations. Formalin-fixed paraffin embedded (FFPE) samples from advanced NSCLC patients were analyzed with the panel and compared with PD-L1 IHC evaluation on tumor cells, using 22C3 clone antibody.

      4c3880bb027f159e801041b1021e88e8 Result

      Since 2017, a total of 296 FFPE samples have been analyzed with the nCounter panel. PDL-1 IHC has been performed in 113 FFPE samples, as requested by the oncologist. All samples were evaluable for nCounter and IHC (100%). By IHC, 48/113samples (42.5%) were scored as negative for PD-L1 protein expression, whereas 65/113 (57.5%) were evaluated as positive. Of those, 39 presented moderate (≥1-49%) and 26 (23%) high PD-L1 staining (≥50%). Using an appropriate cut-off value, the levels of PD-L1 mRNA, as determined by the nCounter panel, closely correlated the PD-L1 IHC evaluation, with a 78% of concordance and a 0.554 Cohen’s kappa (confidence interval 95% 0.400- 0.709).

      8eea62084ca7e541d918e823422bd82e Conclusion

      PD-L1 mRNA expression closely correlates with PD-L1 protein expression. Clinical validation is warranted to determine if nCounter can be an alternative to IHC for PD-L1 evaluation.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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