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Satoru Miura



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    EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.16-27 - Observational Study to Investigate the Implementation Rate of Re-Biopsy in EGFR-TKI-Resistant Patients (NLCTG1602) (Now Available) (ID 1051)

      08:00 - 18:00  |  Author(s): Satoru Miura

      • Abstract
      • Slides

      Background

      In EGFR-TKI treatment, cannot perform re-biopsy in all cases for recurrent style and involvement.
      In the case that only cytodiagnosis can gather, we cannot perform an examination for T790M by the Cobas method even if we can obtain a specimen.The examination of plasma is useful, but the case which cannot but provide the next treatment as we cannot confirm a resistant mechanism may often occur by the true clinic because we cannot detect all resistance.

      Method

      Examine the rate of use of re-biopsy in the EGFR-TKI-resistant case of the EGFR mutation in the gene-positive progress non-small cell lung cancer and histological diagnosis and rate of agreement of the T790M mutation detection by the Cobas method of the cytodiagnosis prospectively.
      <subjects>Treated by EGFR-TKI, and do the case that an effect was able to continue with primary registration, and do it with the second registration when treatment was resistant, and do the laboratory procedure and results with registration when there are a recurrence point, PS, use or nonuse of re-biosy.
      We added up the liquid as re-biosy after July, 2017.

      Result

      Start registration of this study in February, 2017, and 197 primary registration, second registration completion become 127 cases as of January, 2019.We conducted the interim analysis in 80 second registration in October, 2018.
      The Re-biopsy rate of use was 74/80 = 92.5%.The re-biopsy success rate was the whole, and 79.7%, the T790M positive rate were 41.9%.By the specimen distinction, the histological diagnosis, the cytodiagnosis, the re-biopsy success rate and the T790M positive rate by the examination of plasma were 92.3% /56.4%, 83.3%/8.3%, 56.5%/34 .8%, respectively.
      It is during data cleaning work and is going to report end results now at the general meeting.

      Conclusion

      Section not applicable

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    MA13 - Going Back to the Roots! (ID 139)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA13.06 - Ph3 Study of Maintenance Therapy with S-1 vs BSC After Induction Therapy with Carboplatin + S-1 for Advanced Squamous Cell Lung Cancer (WJOG7512L) (Now Available) (ID 563)

      14:00 - 15:30  |  Author(s): Satoru Miura

      • Abstract
      • Presentation
      • Slides

      Background

      Our previous phase 3 study established carboplatin plus the oral fluorinated pyrimidine formulation S-1 as a standard option for first-line treatment of advanced non–small cell lung cancer (NSCLC) (J Clin Oncol 2010; 28:5240). The importance of maintenance therapy for patients with advanced squamous NSCLC has been unknown, however.

      Method

      WJOG7512L was designed as a randomized phase 3 study to evaluate whether maintenance therapy with S-1 improves clinical outcome after induction therapy with carboplatin plus S-1 in such patients. Before randomization, patients received carboplatin (AUC of 5 on day 1 every 3 weeks) plus S-1 (40 mg/m2 twice per day on days 1 to 14 every 3 weeks) as induction therapy. Those who did not progress after four cycles of induction therapy were randomized to receive either S-1 plus best supportive care (BSC) or BSC alone. The primary objective was to confirm the superiority of S-1 plus BSC with regard to progression-free survival.

      Result

      Of the 365 patients enrolled, 347 participated in the induction phase and 131 of these individuals were randomized to receive S-1 plus BSC (n = 67) or BSC alone (n = 64). Baseline demographics and clinical characteristics of the subjects, including the response to induction therapy, were well balanced. Patients receiving S-1 plus BSC showed a significantly reduced risk of disease progression compared with those receiving BSC alone (hazard ratio [HR], 0.548; 95% confidence interval [CI], 0.374–0.802; P = 0.0019). Median overall survival from randomization did not differ significantly between the two arms: 17.8 months for BSC alone and 16.7 months for S-1 plus BSC (HR, 0.890; 95% CI, 0.583–1.357). Time to deterioration in quality of life also showed no significant difference (P = 0.8754 for FACT-TOI, P = 0.9016 for FACT-LCS). The incidence of adverse events during maintenance therapy was low, with neutropenia, anemia, and thrombocytopenia of grade 3 or 4 each occurring in ~1% to 4% of patients.

      Conclusion

      Maintenance with S-1 plus BSC is an effective and well-tolerated treatment option for patients with advanced squamous NSCLC.

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    MA21 - Non EGFR/MET Targeted Therapies (ID 153)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      MA21.05 - Phase II Trial of the Combination of Alectinib with Bevacizumab in ALK-Positive Nonsquamous Non-Small Cell Lung Cancer (Now Available) (ID 1306)

      14:30 - 16:00  |  Author(s): Satoru Miura

      • Abstract
      • Presentation
      • Slides

      Background

      Alectinib is a 2nd generation highly selective anaplastic lymphoma kinase (ALK) inhibitor. Although alectinib has improved progression-free survival (PFS) in patients with ALK-positive Non-Small Cell Lung Cancer (NSCLC), there are limited treatment options after progression of alectinib. Recent evidences have described promising results of the combination of bevacizumab with EGFR-TKIs, cytotoxic chemotherapies and immune-checkpoint inhibitors. We report the results from a phase II study of the combination of alectinib with bevacizumab in ALK-positive Nonsquamous NSCLC patients who were treated with alectinib and showed disease progression (UMIN 000017828).

      Method

      Patients with ALK+ Nonsquamous NSCLC who had progressed after alectinib treatment were enrolled. Primary objective of this study was PFS and safety. Secondary endpoints included overall survival, objective response rate and disease control rate.

      Result

      Twelve patients received alectinib (600 mg/day) with bevacizumab (15 mg/kg, Q3W). Nine patients were treated with crizotinib and alectinib, and 2 patients were treated with crizotinib, alectinib and ceritinib before enrollment to this study. The median PFS was 3.1 months (95% CI 1.2-16.1) and the median survival time was 32 months (95% CI 8.3-NE). The median treatment cycle was 5 (range, 1-37) and 3 patients received alectinib with bevacizumab more than 20 cycles. The objective response rate and disease control rate were 8% and 67%, respectively. The most common treatment related adverse events were decreased appetite (42%), proteinuria (42%), hypertension (33%), anemia (33%) and fatigue (33%). Treatment related adverse events of grade > 3 were anemia (8%), proteinuria (8%), diarrhea (8%) and hypokalemia (8%). No severe adverse events were observed.

      Conclusion

      This is the first study to investigate the combination of alectinib and bevacizumab. This combination had clinical efficacy and was well tolerated.

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