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Tatsuya Yoshida



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-51 - Efficacy Impact of Serum VEGF for Elderly or Poor PS Patients Receiving Anti-PD-1 Antibody with Advanced Non-Small Cell Lung Cancer (ID 1691)

      08:00 - 18:00  |  Author(s): Tatsuya Yoshida

      • Abstract
      • Slides

      Background

      Anti-programmed cell death (PD)-1 antibody therapies have shown durable clinical efficacy and manageable toxicity profiles, and have become a standard therapy in advanced non-small cell lung cancer (NSCLC). Because of manageable toxicity profiles, extensive interest in the potential benefits of anti-PD-1 antibody has expanded to high-risk patients such as the elderly or poor performance status (PS) patients. Here, we aimed to investigate predictive markers for the efficacy of anti-PD-1 antibody in elderly patients and poor PS patients.

      Method

      The medical records of 75≥ years old or PS2 NSCLC patients treated with anti-PD-1 antibody (e.g., nivolumab and pembrolizumab) at the National Cancer Center Japan between December 1, 2015, and May 31, 2018, were reviewed retrospectively. We evaluated the association between efficacy for anti-PD-1 antibody and gender, smoking status, histology, PD-ligand 1(PD-L1) expression on tumor cells, white blood cell counts, lymphocyte counts, albumin, lactate dehydrogenase, c-reactive protein, and serum vascular endothelial growth factor (VEGF). We divided patients into two groups with the median values.

      Result

      A total of 235 patients with advanced NSCLC treated with anti-PD-1 antibody were reviewed. Of these patients, 31 patients were ≥ 75 years old, and 22 patients were PS2. The median PFS was 6.9 months in patients aged ≥ 75 years and 2.1 months in PS2 patients. Cox proportional hazard regression analysis showed that only the low-VEGF was significantly associated with longer PFS in patients aged ≥ 75 years (HR, 0.35; 95% CI, 0.13-0.88; P = 0.025) and in PS2 patients (HR, 0.31; 95% CI, 0.10-0.85; P = 0.023). The overall response rate of patients with low-VEGF was tend to be higher than that with high-VEGF among patients aged ≥ 75 years (43% vs. 20%; P = 0.18) and PS2 patients (20% vs. 0%; P = 0.084).

      Conclusion

      Low-VEGF in patients aged ≥ 75 years and PS2 patients was associated with longer PFS. Serum VEGF may thus be a biomarker for the efficacy of anti-PD-1 antibody therapy.

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    OA12 - Profiling the Multidisciplinary Management of Stage III NSCLC (ID 144)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Now Available
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      OA12.02 - Randomized Phase II Study of CDDP+S-1 vs CDDP+PEM Combined with Thoracic RT for Locally Advanced Non-Sq NSCLC: SPECTRA Study (Now Available) (ID 428)

      15:45 - 17:15  |  Author(s): Tatsuya Yoshida

      • Abstract
      • Presentation
      • Slides

      Background

      SPECTRA, a multicenter, randomized phase II study of CDDP+S-1 versus CDDP+pemetrexed (PEM) combined with thoracic radiotherapy (TRT) for locally advanced non-squamous non-small cell lung cancer (NSCLC), previously reported that toxicities were tolerable and manageable in both arms; however, febrile neutropenia was more frequently observed in the CDDP+S-1 arm (9.6%/2%). Completion rate of TRT (60Gy) and chemotherapy (4 cycles) was 92%/98% and 73%/86%, respectively. Response rate was 60%/64% (WCLC 2017, MA17.06). Here, we present primary analysis of 2-year survival data.

      Method

      Patients were randomly assigned to receive CDDP+S-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDP+PEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. The sample size was set at 100 patients.

      Result

      Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDP+S-1 and 50 to CDDP+PEM. Baseline characteristics were similar (CDDP+S-1/CDDP+PEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n=17 (33%)/n=17 (34%); stage IIIB, n=21 (40%)/n=20 (40%); ECOG PS of 1, n=14 (27%)/n=14 (28%); never smoker, n=12 (23%)/n=12 (24%); and adenocarcinoma, n=47(90%)/n=45(90%); activating EGFR mutation, n=9 (17%)/n=4 (8%); ALK fusion, n=2 (4%)/n=3 (6%). A total of 72 PFS events were observed at the data cut-off (28 November 2018). After a median follow-up of 32.1 months, median PFS was 12.7/13.8 months (HR=1.16, 95% CI, 0.73-1.84, p=0.538), and 2-year PFS rate was 36.5% (95% CI, 23.5-49.6)/32.1% (95%CI, 18.9-45.4). Disease progression was observed in 33 and 36 patients. Distant metastases were the first site of failure in 24 and 31 patients. Local relapse as the first site of failure was observed in 14 and 13 patients. After a median follow-up of 34.6 months, 44 OS events were observed. Median OS was 48.3/59.1 months (HR=1.05, 95%CI, 0.58-1.90, p=0.883), and 2-year OS rate was 69.2% (95%CI, 56.7-81.8)/66.4% (95%CI, 53.0-79.9). 27 patients in each arm received post-study chemotherapy including EGFR-TKIs (n=7/n=5), ALK-TKIs (n=0/n=3), and immune checkpoint inhibitors (n=6/n=10).

      Conclusion

      2-year PFS rate in the CDDP+S-1 arm was better than that in the CDDP+PEM arm. We will select the CDDP+S-1 arm as the investigational arm in a future phase III study. UMIN000009914 (release date: 31/Jan/2013)

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-102 - Actionable Gene Aberration and the Response of Matched Therapy Among Patients with Non-Small-Cell Lung Carcinoma (Now Available) (ID 1177)

      09:45 - 18:00  |  Author(s): Tatsuya Yoshida

      • Abstract
      • Slides

      Background

      Tumor genotyping using multiplex gene panel is now standard for precision medicine in non-small-cell lung carcinoma (NSCLC). We sought to assess the prevalence of actionable genomic alterations among NSCLC patients using our next-generation sequencing panel (NCC Oncopanel) and the response of matched therapy.

      Method

      This is a post-hoc analysis of prospective study in which patients with advanced solid cancer were prospectively enrolled to undergo the comprehensive genomic profiling panel (NCC Oncopanel) conducted between July 2013 and March 2018 in National Cancer Center Hospital. The NCC Oncopanel assay, a multiplexed next-generation sequencing (NGS) assay of 114 cancer-associated genes, was performed in a CLIA-compliant laboratory in National Cancer Center. Subjects were primarily patients without any known actionable alteration such as EGFR or ALK. Patients with NSCLC were extracted into this analysis. Clinical data and treatment outcomes were retrospectively collected.

      Result

      In total, 100 patients were extracted. Sufficient tumor tissue for NGS analysis were available in 91 patients; median age was 57 (range 30‒77); 74 (81.3%) adenocarcinoma; 44 (48.4%) female; 42 (46.2%) never smoker. According to the OncoKB and CIViC database, and the Clinical Practice Guidelines for NGS in Cancer Diagnosis and Treatment issued by three major Japanese cancer-related societies, 85 patients (93.4%) had at least one potential pathogenic alteration. Actionable gene aberrations were identified in 49 (53.9%). Evidence levels were ranked as follows: 24 (26%) harbored level 1 aberrations (ALK, EGFR, ROS1, BRAF); 15 (16%) harbored level 2 (RET, DDR2, MET, ATM, BRCA2, CDK4, CTNNB1, EZH2, JAK2, NRAS, TSC1); 10 (11%) harbored level 3A (CDKN2A, ERBB2, HRAS, PTEN, SMARCA4, STK11). Matched therapy was administered into 29 (31.9%) leading to the objective response rate of 58.6% and the disease control rate of 79.3% with the median progression-free survival of 10.5 months (95%CI; 5.1‒15.8).

      Conclusion

      Multiplex gene panel is feasible and useful in screening candidates for matched therapy among NSCLC patients. NSCLC patients without any known actionable mutations should be considered to undergo comprehensive genomic profiling.

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    P2.14 - Targeted Therapy (ID 183)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.14-11 - Retreatment with EGFR-TKI for 541 NSCLC Patients with EGFR Mutation (ID 2633)

      10:15 - 18:15  |  Author(s): Tatsuya Yoshida

      • Abstract

      Background

      Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) is remarkably effective against non-small cell lung cancer (NSCLC) harboring EGFR activating mutation. However, tumors almost inevitably develop resistance approximately after one year of EGFR-TKI treatment. In addition, some patients can not tolerate an EGFR-TKI treatment because of adverse events and result in discontinuation of the treatment. In such cases, the same or other EGFR-TKI may be re-administered. However, its efficacy is not fully evaluated.

      Method

      We retrospectively investigated patients who received EGFR-TKI between January 2008 and August 2017. Among these patients, the response rate and time to treatment failure (TTF) for each re-administered TKI were assessed. We assessed each TTF for patients who discontinued the prior EGFR-TKI because of progressive disease (PD group) and patients who discontinued TKI because of adverse events (AE group). We also evaluated the overall survival (OS) for the patients who received the retreatment with EGFR-TKI and who did not.

      Result

      A total of 1400 patients from 11 institutions were enrolled in this study. Among them, 570 patients received retreatment with EGFR-TKI, and 541 were eligible. Among the 395 patients who discontinued prior EGFR-TKI because of disease progression, the response rate and the median TTF of subsequent Gefitinib/Erlotinib/Afatinib were 8%/8%/18%, and 4.9/3.2/4.3 months, respectively. The median TTF for the AE group was significantly longer than that for the PD group (10.8 months vs 3.8 months, p<0.0001). In the AE group, The OS for patients receiving retreatment with EGFR-TKI was significantly better than the OS for patients without retreatment (Hazard Ratio = 0.256, p < 0.0001). Similarly, in the PD group, the OS for patients receiving retreatment with EGFR-TKI was significantly better than the OS for patients without retreatment (Hazard Ratio = 0.456, p < 0.0001).

      Conclusion

      Retreatment with EGFR-TKI was shown to be effective for both patients who discontinued prior EGFR-TKI because of disease progression as well as adverse events.