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Genichiro Ishii



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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: 1
    • Now Available
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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  |  Author(s): Genichiro Ishii

      • 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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    P1.09 - Pathology (ID 173)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Pathology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.09-15 - Hybrid Organoid Reveals That Podoplanin-Positive Cancer-Associated Fibroblasts Enhance Proliferation of Lung Cancer Cell (ID 1027)

      09:45 - 18:00  |  Author(s): Genichiro Ishii

      • Abstract
      • Slides

      Background

      Podoplanin-positive cancer-associated fibroblasts (CAFs) play an important role in tumor progression. The aim of this study was to evaluate the effect of podoplanin (+) CAFs on the proliferation of cancer cells using a three-dimensional (3D) organoid model.

      Method

      We examined the success rate of organoid culture containing PC-9 cancer cells and CAFs. Thereafter, we compared the proliferating index (MIB-1 index) of PC-9 cells co-cultured with podoplanin-overexpressing CAFs and control CAFs using organoid specimens. Furthermore, we compared the MIB-1 labeling index of cancer cells in podoplanin (+) CAFs cases (n = 13) and podoplanin (-) CAFs cases (n = 14) using surgically resected adenocarcinoma specimens.

      Result

      Without CAFs, PC-9 cells did not form any organoid (success rate: 0%). When PC-9 cells were mixed with CAFs (1:10), the mixed cells generated round and steric aggregates (hybrid cancer organoids, success rate: 100%). In three independent experiments, the MIB-1 index of PC-9 cells in hybrid cancer organoids containing podoplanin-overexpressing CAFs was significantly higher than that of PC-9 cells in organoids containing control CAFs (Exp. 1: 40.4% vs. 24.4%; Exp. 2: 40.0% vs. 24.5%; Exp. 3: 40.3% vs. 25.2%; p < 0.001). Surgically resected human tumors revealed that the MIB-1 index of adenocarcinoma cells was significantly higher in the case of podoplanin (+) CAFs than in the case of podoplanin (-) CAFs (34.8% vs. 16.2%; p < 0.01).

      Conclusion

      Our data suggested that the hybrid cancer organoid model might reflect the growth-promoting effect of podoplanin (+) CAFs in cancer cells, and this new system can be a useful tool for evaluating the tumor microenvironment.

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    P1.13 - Staging (ID 181)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Staging
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.13-04 - Impact of the Presence and Proportion of GGO on Survival and Pathological Characteristics in Clinical Stage I Lung Adenocarcinoma (Now Available) (ID 1676)

      09:45 - 18:00  |  Author(s): Genichiro Ishii

      • Abstract
      • Slides

      Background

      The aim of this study was to investigate a prognostic and clinicopathological impact of ground-glass opacity (GGO) on existing clinical T classification.

      Method

      We analyzed 1228 patients with lung adenocarcinoma classified as clinical stage I who underwent complete resection by lobectomy or pneumonectomy from 2003 to 2013. We divided patients into four groups based on the presence and proportion of GGO by using consolidation-to-tumor ratio (CTR), calculated with the maximum solid component diameter divided by the maximum tumor diameter including GGO area on thin-slice computed tomography; A, CTR ≤0.5; B, 0.5< CTR ≤0.75; C, 0.75< CTR ≤1.0 including GGO; D, GGO negative (pure solid). We compared them on overall survival, pathological findings and histological subtypes in each clinical stage of IA1 to IB.

      Result

      In all clinical stage, we found no significant differences among group A-C on prognosis and pathological findings. The prognosis of each group of A-C was significantly more favorable than that of group D in clinical stage IA2 and IA3. With respect to the pathological findings, group D had significantly larger positive number of N/ly/v in stage IA2 and that of N/pl/v/STAS in stage IA3 than each group of A-C. Group D had significantly less proportion of lepidic component and consisted with more percentile of solid component than each group of A-C in clinical stage IA2-IB.

      Conclusion

      Not proportion but presence of GGO had great impact on prognosis and pathological characteristics. The presence of GGO might as well be included in the next T classification.

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    P1.18 - Treatment of Locoregional Disease - NSCLC (ID 190)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.18-04 - Neoadjuvant Ceritinib for Locally Advanced Non-Small Cell Lung Cancer with ALK Rearrangement: SAKULA Trial (ID 876)

      09:45 - 18:00  |  Author(s): Genichiro Ishii

      • Abstract
      • Slides

      Background

      Ceritinib is a highly selective ALK inhibitor that has been shown potent antitumor activity against ALK-positive non-small cell lung cancer (NSCLC). We conducted a multicenter single-arm phase II study to assess the efficacy and safety of neoadjuvant therapy with ceritinib followed by surgery in patients with ALK-positive resectable locally advanced (LA) NSCLC.

      Method

      Three cycles of ceritinib were administered as induction therapy. The drug was administered orally at the dose 750 mg once daily for 28 days per cycle. The primary endpoint was the major pathological response rate (mpRR). This study required 19 patients, with mpRR of 15% considered non-promising and 45% promising (one-side alpha = 0.025; beta = 0.2). Biomarker analyses using pre- and post-ceritinib through next-generation sequencing (NGS) of plasma and tissue is also planned. (Trial Identifier, UMIN000017906).

      Result

      A total of 395 patients with LA-NSCLC were screened from March 2015 to March 2018 and 15 patients (4%) were identified as ALK-positive. Only 7 patients were enrolled because of slow accrual. The median age of the patients was 50 years and 71% (n=5) were male. All patients had stage IIIA disease and adenocarcinoma. 6 out of 7 patients completed three cycles of neoadjuvant therapy with ceritinib as planned, 71% (n=5) of patients required dose adjustment. One patient was withdrawn from the study because of hepatitis. The objective clinical response rate was 100%. Surgical resection was performed in 6 patients, and complete (R0) resection was achieved in 5 patients. Among the 7 evaluable patients, the mpRR was 57% (95% CI, 18 to 90); 4 patients achieved mpR and 2 patients achieved pathologic complete response. With a median follow-up of 10 (range 8-33) months, 1 patient died of disease progression and 6 patients remain alive, including 4 patients who are recurrence-free. The most common toxicities were gastrointestinal toxicities.

      Conclusion

      Our results showed that neoadjuvant ceritinib is safe and effective, with a high rate of pathologic response, in patients with ALK-positive resectable LA-NSCLC, although the limitation of the data interpretation due to small sample size.

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