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Marioara Simon

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    OA01 - Advanced Diagnostic Approaches for Intrathoracic Lymph Nodes and Peripheral Lung Tumors (ID 117)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Interventional Diagnostics/Pulmonology
    • Presentations: 8
    • Now Available
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      OA01.01 - Predictive Value of EBUS Strain Elastography in Mediastinal Lymph Node Staging; The E-Predict Multicenter Study Results (Now Available) (ID 1620)

      10:30 - 12:00  |  Presenting Author(s): Roel L.J. Verhoeven  |  Author(s): Rocco Trisolini, Fausto Leoncini, Michela Bezzi, Piero Candoli, Alessandro Messi, Mark Krasnik, Jouke Annema, Chris de Korte, Erik H.F.M. Van Der Heijden

      • Abstract
      • Presentation
      • Slides

      Background

      Systematic assessment of lymph nodal involvement by EBUS-TBNA is indicated for suspected and proven lung cancers. Nodal size and PET characteristics help guide which lymph nodes to sample. Especially smaller lymph nodes remain challenging, since PET is of limited value due to low resolution. Additional ultrasound B-mode features such as lymph node size, margin or node heterogeneity have shown variable predictive outcomes. Ultrasound strain elastography (EBUS-SE) is a promising technique. By monitoring tissue deformation over time using ultrasound imaging, a relative tissue strain can be computed. Lower tissue strain is shown to correlate to malignancy. Using a standardized measurement procedure (RespirationDOI: 10.1159/000494143), we aimed to assess the value of strain elastography for predicting lymph node malignancy in addition to size information.

      Method

      This multicenter prospective international trial [NCT02488928] included patient with suspected or proven lung cancer in five hospitals. Measurements were obtained following to a standardized operating procedure using Pentax-Hitachi EBUS systems. Nodal cytopathology combined with follow up imaging (>6 months) or surgery were used as reference standard. If uncertainty in outcome remained, nodes were excluded in final analysis.

      Result

      EBUS-SE was performed in 416 patients and 525 lymph nodes (June 2016 – July 2018). Final diagnoses showed 272 benign and 253 malignant nodes. Mean lymph node size was 12.3 mm. B-mode size and mean strain correlated to risk of malignancy with AUC of 78% and 76.8% (95% CI 0.73-0.81). Using a clinical work-up setting with 10mm and 8mm size cut-offs for aspiration, short axis size higher than 8 or 10mm resulted in respective sensitivity of 85% and 72%, specificity of 52% and 71%, PPV of 62% and 70% and NPV of 79% and 73%. Addition of strain elastography (mean<90) to EBUS-short-axis size (<10mm) increased overall sensitivity from 72% to 90% and NPV from 73% to 81%. More nodes were found false positive, specificity decreased from 71% to 42% and PPV went from 70% to 59%. Addition of strain (mean<78) to EBUS-size (<8mm) increased sensitivity from 85% to 94% and NPV from 79% to 85%. Specificity decreased from 52% to 32% and PPV from 63% to 55%.

      Conclusion

      EBUS strain elastography is of added value in guiding nodal sampling. Strain and size combined can help identify more malignant nodes, although it will ultimately also lead to more false positive sampling. Strain information may especially be of potential value in nodes of small size, where PET resolution is limited.

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      OA01.02 - Endobronchial Ultrasound Staging of Operable NSCLC: Triple Negative Lymph Nodes May Not Require Routine Biopsy (Now Available) (ID 2621)

      10:30 - 12:00  |  Presenting Author(s): Danielle Hylton  |  Author(s): Kaesavan Selvakumaran, Biniam Kidane, Jonathan D. Spicer, Simon R Turner, Daniel French, Chuck Wen, James Masters, Yogita S. Patel, Jenelle Taylor, Christian Finley, Yaron Shargall, Forough Farrokhyar, John Agzarian, Andrew Seely, Kazuhiro Yasufuku, Wael C. Hanna

      • Abstract
      • Presentation
      • Slides

      Background

      Current staging guidelines with endobronchial ultrasound (EBUS) still recommend systematic biopsy of at least 3 mediastinal stations prior to surgical resection. Recently, a 4-point ultrasonographic score (Canada Lymph Node Score- CLNS) was developed to determine the probability of nodal metastasis in any given lymph node. A LN with CLNS<2 is considered very low probability for malignancy. We hypothesized that, during EBUS assessment of patients with cN0 non-small cell lung cancer, individual nodal stations that have CLNS<2 do not require routine biopsy because they are likely to represent true pN0 disease.

      iaslc 2019 - clns lymph node figure.png

      Method

      The CLNS is a prospectively validated score that uses four ultrasonographic features to accurately predict LN malignancy. LNs were evaluated for ultrasonographic features at the time of EBUS and the CLNS was applied. “Triple Negative” LNs were defined as cN0 on CT (LN≤1cm), PET (no hypermetabolic activity) and EBUS (CLNS<2). Specificity, NPV, and false-negative rates were calculated against the gold-standard pathological diagnosis from surgically excised specimens.

      Result

      In total, 122 LNs in 58 cN0 patients were assessed. Triple Negative LNs were associated with the following T-stage distribution (T1a=12.07%, T1b=24.14%, T2a=34.38%, T2b=10.34%, T3=17.24%, T4=1.72%). Triple Negative LNs had a specificity, NPV, and false-negative rate of 86.10% (95%CI: 78.40-91.80%), 93.40% (95%CI: 86.90-97.30%), and 6.60%, respectively when using <2 as the CLNS malignancy cut-off. In total, only 5.74%(n=7) Triple Negative nodes were actually proven to be malignant, 6/7 (85.71%) on EBUS-TBNA, and 1/7 (14.29%) only after surgical resection.

      Conclusion

      Triple Negative LNs have a high NPV for malignancy. At the time of EBUS in cN0 patients, it may be possible that Triple Negative LNs do not require tissue sampling, thereby saving procedural time, cost, and discomfort. Findings also suggest that Triple Negative LNs with inconclusive biopsy results may not require repeat sampling. A prospective comparative trial is required to confirm these findings.

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      OA01.03 - Probability Model for Malignancy in Hilar and Mediastinal Lymph Nodes in Lung Cancer Based on PET-CT and EBUS (Now Available) (ID 133)

      10:30 - 12:00  |  Presenting Author(s): Jaume Bordas-Martinez  |  Author(s): Jose Luis Vercher Conejero, Guillermo Rodríguez Gonzalez, Paula Notta, Cristian Tebé Cordomi, Cristina Martín Cabeza, Noelia Cubero De Frutos, María Rosa López-Lisbona, Marta Díez-Ferrer, Nuria Baixeras Gonzalez, Cristina Gamez Cenzano, Jordi Dorca Sargatal, Antoni Rosell

      • Abstract
      • Presentation
      • Slides

      Background

      The mediastinal lymph nodes (LN) staging is routinely performed by PET-CT and EBUS- TBNA. Nevertheless, there are no studies that explore the diagnostic capacity of both techniques together. This study aims is to find an algorithm based on combined PET-CT and EBUS image variables together with clinical criteria that provides the most accurate probability of malignancy for each LN explored.

      Method

      Retrospective study of mediastinal staging of non-small cell lung cancer, based on PET-CT and EBUS-TBNA. The LN were identified by level (N1, N2 and N3) and by anatomical region (AR) (subcarinal, not subcarinal, and hilar). Standardized Uptake Value (SUV) was determined for each sampled LN (maximum, medium and peak) as well as for pulmonary mass, liver, and blood pool. The ultrasound features collected were: diameter in the short axis (DSA), morphology, border, ecogeneicity and presence of the vascular hilium. For the construction of the predictive algorithm a mixed model of logistic regression of Firth was used.

      Result

      116 consecutive patients were included and a total of 358 LN were evaluated. The set of variables that presented the best discrimination were: age, DSA, SUVmax and AR. The model determines the probability for malignancy for each LN, using the following formula = (-9.26) constant + (-0.21) Age + (4.29) SUVmax + (0.52) DSA + AR. The discrimination power of the model measured by the Area Under the Roc curve was = 0.95.

      distribution density of diameter (mm) and suvmax of positive and negative lymph nodes  .png

      Conclusion

      The model including age, DSA, SUVmax and AR provide the probability of malignancy for each LN with the highest accuracy. All other variables can be discarded when combining PET-CT and EBUS image features.

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      OA01.04 - Discussant - OA01.01, OA01.02, OA01.03 (Now Available) (ID 3721)

      10:30 - 12:00  |  Presenting Author(s): Rocco Trisolini

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      OA01.05 - Cryobiopsy Compared with Forceps Biopsy in Pathological Diagnosis and Biomarker Research in Lung Cancer: A Prospective, Single-Arm Study (Now Available) (ID 1564)

      10:30 - 12:00  |  Presenting Author(s): Tomoyuki Naito  |  Author(s): Hibiki Udagawa, Keisuke Kirita, Takaya Ikeda, Yoshitaka Zenke, Shingo Matsumoto, Kiyotaka Yoh, Seiji Niho, Genichiro Ishii, Koichi Goto

      • Abstract
      • Presentation
      • Slides

      Background

      Cryobiopsy is a novel transbronchial biopsy tool that enables the collection of larger samples than forceps biopsy. We evaluated the usefulness of cryobiopsy compared with forceps biopsy in pathological diagnosis and biomarker research in lung cancer.

      Method

      In this prospective single-arm study, 121 patients with or suspected of having lung cancer underwent concurrent transbronchial biopsy using a cryoprobe (ERBECRYO2) and forceps from the same lesion. Sample size and morphological classification were determined for patients whose cryobiopsy and forceps biopsy samples both contained tumor cells (n = 81). Patients diagnosed with non-small-cell lung carcinoma (NSCLC) with adequate samples from the two procedures (n = 65) were analyzed for programmed death ligand 1 (PD-L1) expression score (22C3). Genomic DNA and RNA were extracted from cryobiopsy and forceps biopsy formalin-fixed paraffin-embedded samples (20 NSCLC patients, 20 sections, 10 µm thick each) for whole-exome sequencing and RNA sequencing.

      Result

      Cryobiopsy samples were significantly larger than forceps biopsy samples (median 11.1 mm2[range: 3.3–135.0] vs. 2.0 mm2[0.7–6.6], p < 0.01). The confirmation rate of morphological classification of cryobiopsy samples was significantly higher than that of forceps biopsy samples (86% vs. 79%, p < 0.01, adenocarcinoma/squamous-cell carcinoma/small-cell carcinoma/other = 35/19/12/4 and 30/15/11/4, respectively). The success rate for evaluating PD-L1 score using cryobiopsy and forceps biopsy samples was 94% and 95%, respectively. A greater proportion of cryobiopsy samples tended to have PD-L1 > 1% than forceps biopsy samples (51% vs. 42%, p = 0.06). Significantly larger amounts of DNA (median 1.60μg vs. 0.58μg, p = 0.02) and RNA (median 0.62μg vs. 0.17μg, p < 0.01) were extracted from cryobiopsy samples than forceps biopsy samples. The success rate for whole-exome sequencing (90% vs. 15%, p < 0.01) and RNA sequencing (75% vs. 10%, p < 0.01) was higher for cryobiopsy samples than forceps biopsy samples. The median tumor-mutation burden in cryobiopsy samples was 84 (range 3–2396).

      Conclusion

      Cryobiopsy provided larger sample sizes compared with forceps biopsy, and were more useful for morphological classification, PD-L1 evaluation and genetic analysis.

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      OA01.06 - Cone Beam CT Imaging for Transbronchial Navigation in Small Peripheral Pulmonary Lesions (Now Available) (ID 1659)

      10:30 - 12:00  |  Presenting Author(s): Erik H.F.M. Van Der Heijden  |  Author(s): Roel L.J. Verhoeven, Jurgen Fütterer, Wouter Hoefsloot

      • Abstract
      • Presentation
      • Slides

      Background

      Small peripheral lung lesions have historically been identified and followed according to risk of malignancy. Ideally an accurate minimally invasive diagnostic procedure would become the more common first approach. The bronchoscopic approach herein remains of limited widespread use, and reported pooled diagnostic yields remain at approximately 70% even with the help of additional advanced guiding technology. We evaluated if inter-procedural cone beam CT (CBCT) improves yield in two prospective trials: CBCT assisted navigation bronchoscopy with electromagnetic navigation (EMN) guidance (CONTROL-E, NCT03355586) and without EMN using augmented CBCT fluoroscopy alone (CONTROL-A, NCT03274609).

      Method

      All patients with an indication for a minimal invasive diagnostic procedure of their peripheral pulmonary lesion as found by our multi-disciplinary tumor board between Dec 2017 and Jan 2019 were included. A total of 84 patients (100 nodules) were included and had a navigation bronchoscopy in the hybrid operating room under general anesthesia. Procedural workflow was as follows: CONTROL-A started off with a CBCT scan. The lesion and pathway were then segmented on a separate workstation. Afterwards, both pathway and nodule were projected 2D on live fluoroscopy for navigation and biopsy guidance. CONTROL-E workflow started with electromagnetic navigation (EMN). Upon reaching the planned target or concluding upon unsuccessful navigation, CBCT imaging was performed for verification (or if applicable; consecutive repositioning guidance). In both workflows, r-EBUS mini probe imaging and ROSE were available for additional guidance and verification.

      Result

      The mean lesion size in CONTROL-A (46 patients) was 16.7mm (range 5-43 mm), and 11.5mm (range 4-33 mm) in CONTROL-E (38 patients). A bronchus sign was seen in 62% and 71% of cases, respectively. The CONTROL-E study showed that EMN with r-EBUS had an approximate navigation success rate of 58%. Addition of live 3D-CBCT guidance was performed in all cases, increasing navigation success to 88%. The CONTROL-A study had navigation success of 80% by utilizing only r-EBUS and augmented CBCT-fluoroscopy. However, additional EMN (cross-over) was needed in several cases for navigation guidance, increasing navigation success to 88%. In follow up, both studies showed a diagnostic yield lower than the navigation success: in CONTROL-E 71% and in CONTROL-A, 72% had a biopsy outcome correlating to golden standard follow up.

      Conclusion

      Cone beam CT is of significant added value for transbronchial navigation to small peripheral lung lesions, with or without trans-parenchymal access. Diagnostic yield however remains approximately 71%. Additional refining of navigation and biopsy tools is necessary to further increase intuitiveness and accuracy.

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      OA01.07 - Ultrathin Bronchoscopy Combined with VBN and EBUS for the Diagnosis of PPLs With or Without Fluoroscopy: A Randomized Trial (Now Available) (ID 2242)

      10:30 - 12:00  |  Presenting Author(s): Jiayuan Sun  |  Author(s): Xiaoxuan Zheng, Fangfang Xie

      • Abstract
      • Presentation
      • Slides

      Background

      Since the utility of low‑dose computed tomography screening for lung cancer, the detection rate of ground‑glass nodules (GGNs) has increased.Transbronchial biopsy for peripheral pulmonary lesions is generally performed using ultrathin bronchoscopy combined with virtual bronchoscopic navigation (VBN) and endobronchial ultrasound (EBUS). The use of fluoroscopy with this method has not yet been explored. The study was designed as a randomized trial to determine the role of fluoroscopy in this method.

      Method

      Patients with peripheral pulmonary lesions suspicious for malignant were enrolled in the study and randomized to two groups, fluoroscopy group and non-fluoroscopy group. Fluoroscopy group was performed with a 3.0 mm external diameter and 1.7 mm internal diameter ultrathin bronchoscope, EBUS, VBN guidance and fluoroscopy. Non-fluoroscopy group was performed with the same ultrathin bronchoscopy combined with EBUS and VBN guidance, but without fluoroscopy. Biopsies Cytological and histological examinations were performed in both groups.

      Result

      A total of 126 patients were enrolled and randomized, of whom 120 patients (60, non-fluoroscopy group; 60, fluoroscopy group) were analyzed. The diagnostic yield was 75% (14 benign and 46 malignant lesions) in the non-fluoroscopy group and 83.3% (6 benign and 54 malignant lesions) in the fluoroscopy group (P=0.37). There were no obvious complications including pneumothorax, bleeding, chest pain and pneumonia in both groups.

      Conclusion

      There was no difference in the diagnostic yield of the non-fluoroscopy group method compared to the FG method using ultrathin bronchoscopy, navigational technology and EBUS for transbronchial biopsy to diagnose peripheral pulmonary lesions.

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      OA01.08 - Discussant - OA01.05, OA01.06, OA01.07 (Now Available) (ID 3722)

      10:30 - 12:00  |  Presenting Author(s): Mehrnaz Asadi

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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