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Takashi Kasai



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    P2.09 - Pathology (Not CME Accredited Session) (ID 958)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.09-14 - The Detection of EGFR Gene Mutation from Washing Solution of Devices used for the Bronchoscopic Examination (ID 12836)

      16:45 - 18:00  |  Author(s): Takashi Kasai

      • Abstract

      Background

      The detection of epidermal growth factor receptor (EGFR) gene mutation is necessary for selection of lung cancer treatment. Recently, biopsy specimens are used in many genomic and immunohistochemical examination methods to select the treatment policy, so it is important not to waste valuable cancer cell samples. For detection of EGFR gene mutation we examine the washing solution of devices used for the bronchoscopic examination in order to solve the issue. In this report, we investigate the detection ratio of EGFR mutation using this cytological sample.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A total of 336 washing solution samples from lung cancer patients were examined for EGFR gene mutation testing in the period between November 2010 and October 2017. 328 cases of 336 excepting 8, which were carried out as re-biopsy, were surveyed in this examination. After the regular biopsy or scraping method, all devices were washed with 10ml saline liquid. Half volume of washing solution was used for regular cell examination to detect cancer cells. Only if a sufficient amount of non-small cancer cells were observed from it, the other volume was submitted for EGFR mutation examination. Final diagnosis was decided by histological specimen. Presence or absence of EGFR mutation and their types were observed from 328 samples retrospectively.

      4c3880bb027f159e801041b1021e88e8 Result

      Histological diagnosis of all 328 biopsy specimens are as follows; 200 Adenocarcinoma (AD), 100 Squamous cell carcinoma (SQ), 13 non-small cell lung carcinoma(NSCLC), 3 adenosquamous cell carcinoma(ADSQ), 7 high grade neuroendocrine carcinoma (HGNEC), and 5 others. The detection number of EGFR mutation from AD, SQ, ADSQ and NSCLC are 65, 4, 2, and 3 respectively. There is no EGFR mutation from remaining histology cases. In all of 74 EGFR mutation positive cases, Exon 19 deletion was detected in 33 cases (45%) and Exon 21 L858R was detected in 33 cases (45%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      The detection rate of EGFR gene mutation from washing solution of devices is 33% (65/200) in AD and 4% (4/100) in SQ. These results are approximate to previous reports. Consequently, it is acceptable to use this method to investigate EGFR gene mutation of non-small lung cancer patients. Furthermore, it is an advantage that we can carry out an EGFR mutation test using this method with a cytology sample earlier than a method with a histology sample.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 3
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-111 - Efficacy and Safety of Cytotoxic Drug Chemotherapy After First-Line EGFR-TKI in Elderly Patients with NSCLC Harboring Sensitive EGFR Mutations (ID 11126)

      12:00 - 13:30  |  Author(s): Takashi Kasai

      • Abstract
      • Slides

      Background

      Subsequent therapies confound the ability to discern the effect of first‑line chemotherapy on overall survival (OS). Therefore, the objective of our study was to determine the relationships between progression-free survival (PFS) or post-progression survival (PPS) and OS after first-line EGFR-TKI treatment in , using individual level data.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Between April 2008 and December 2015, we analyzed 68 cases of elderly patients with NSCLC harboring sensitive EGFR mutations treated with first-line EGFR-TKI. The relationships between PFS and PPS with OS were analyzed at an individual level.

      4c3880bb027f159e801041b1021e88e8 Result

      PPS was more closely associated with OS (R2 = 0.54) compared to PFS (R2 = 0.48), based on linear regression. Best response at first-line treatment, PS at the end of first-line treatment and administration of EGFR-TKI rechallenge were significantly linked to the PPS.

      8eea62084ca7e541d918e823422bd82e Conclusion

      PPS has a stronger impact on OS than PFS in elderly patients with NSCLC harboring sensitive EGFR mutations treated with first-line EGFR-TKI. fluenced by treatments subsequent to first-line chemotherapy; however, this remains to be verified with prospective studies.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P3.01-37 - Phase II Study of Amrubicin Plus Erlotinib in Previously Treated, Advanced Non-Small Cell Lung Cancer Patients with Wild-Type EGFR: TORG 1320 (ID 12559)

      12:00 - 13:30  |  Author(s): Takashi Kasai

      • Abstract
      • Slides

      Background

      The combination of amrubicin (AMR) and erlotinib (ERL) was reported to have synergistic effect on non-small cell lung cancer (NSCLC) cell line with wild-type EGFR in vitro. We accomplished a phase I study of AMR plus ERL in previously treated advanced NSCLC patients, and determined the maximum tolerated dose (MTD). Furthermore, we observed a high response rate of 33% (Am J Clin Oncol 2015).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC with wild-type EGFR. Patients were treated at 3weeks intervals with AMR (35mg/m2 on days 1-3) plus ERL (100mg/day on days 1-21). The patients without disease progression after 4 cycles continued ERL until disease progression or unacceptable toxicity. The primary endpoint is progression free survival (PFS). Secondary endpoints are response rate (RR), disease control rate (DCR), time to treatment failure (TTF), overall survival (OS), and toxicity. The concentration of trough ERL was measured after first cycle of treatment and in maintenance phase as an exploratory research to analyze relation between effectivity/safety and pharmacokinetics.

      4c3880bb027f159e801041b1021e88e8 Result

      From June 2013 to July 2016, 25 patients were enrolled. With a median follow-up of 14.3 months (95%CI: 10.9 – 17.6), median PFS was 3.6 months (95%CI: 2.1 - 5.1). The RR and the DCR were 24.0% and 64.0%, respectively. Median OS was 15.4 months (95%CI: 13.4 – 17.4). We observed grade 3 or 4 toxicities such as leukopenia (68%), neutropenia (72%), anemia (8%), febrile neutropenia (12%), anorexia (12%), oral mucositis (12%) and rash (8%). We had no treatment related death. In pharmacokinetic analysis, the mean (±SD) trough concentrations (C trough) of ERL in induction and maintenance phase were 1.070±0.463µg/mL and 0.879±0.427µg/mL, respectively. The C trough of ERL in induction phase was higher than that in maintenance phase (p=0.0371). There was no relation between C trough of ERL and any toxicity/response.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Although the primary endpoint was not met in this trial, the PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy which was previously reported. In this study, pharmacokinetic analysis showed that C trough of ERL were elevated in combination therapy. This combination therapy might be an optional treatment as cytotoxic chemotherapy for NSCLC patients after platinum-doublet failure. Clinical trial information: UMIN 000010582.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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      P3.01-43 - Predictive Value of Computed Tomography Characteristics for Nivolumab Response in Pretreated Non-Small Cell Lung Cancer (ID 13054)

      12:00 - 13:30  |  Author(s): Takashi Kasai

      • Abstract
      • Slides

      Background

      The efficacy and safety of nivolumab for the treatment of pretreated non-small cell lung cancer (NSCLC) have been established. We conducted a retrospective multicenter trial to determine the significance of computed tomography (CT) morphologic characteristics as a predictor of nivolumab efficacy for advanced NSCLC patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      From April 2013 to March 2017, 78 pretreated NSCLC patients were enrolled. Our radiologist assessed the following tumor characteristics on CT before nivolumab treatment; interstitial septal thickening, peritumoral ground-glass opacity, spiculated margin, air bronchogram, cavity or necrosis, adjacent organ invasion, bulky lymph node (≥ 2.5 cm), and accumulation of small lymph nodes. After nivolumab treatment, objective response rate (ORR), disease control rate (DCR) and progression free survival (PFS) were analyzed with logistic regression and Cox proportional hazards regression models. Patient and CT morphologic characteristics were retrospectively analyzed. Significant parameters identified by univariate analysis were included in a multiple analysis.

      4c3880bb027f159e801041b1021e88e8 Result

      Of the 78 patients, 60 (77%) were male, and 72 (92%) patients were of performance status 0 to 1. Heavy smoking was related to higher ORR than light or never smoking (28% vs 0%, p=0.01).No morphologic characteristics were related to ORR or DCR. Interstitial septal thickening was significantly associated with shorter PFS (p=0.015, 77 vs 126 days). Adjacent organ invasion was also significantly associated with shorter PFS (p=0.047, 72 vs 118 days). However, they were not found to be significant on multivariate analysis.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Interstitial septal thickening and adjacent organ invasion may be negative prognostic factors of nivolumab treatment for NSCLC.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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