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Shun-ichi Isa



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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
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-14 - The Scour Using Pretreatment NLR, Liver Metastasis, PD-L1 Status and PS as a Marker of Outcomes in Nivolumab-Treated Patients with Advanced NSCLC (Now Available) (ID 884)

      08:00 - 18:00  |  Author(s): Shun-ichi Isa

      • Abstract
      • Slides

      Background

      Although nivolumab showed the significantly longer overall survival (OS) compared with docetaxel for non-small cell lung cancer (NSCLC) based on two phase III randomized controlled trials, programed death ligand 1 (PD-L1) expression alone is not yet an adequate biomarker in treating nivolumab for NSCLC patients. Furthermore, some prior analyses indicated the liver metastasis, performance status (PS) and pretreatment neutrophil-to-lymphocyte ratio (NLR) is one of the candidates of effect predictors. This retrospective study aimed to analyze the score combining pretreatment patients’ status as a predictive marker in NSCLC patients treated with nivolumab.

      Method

      ne hundred and twenty-eight patients treated with Nivolumab who could examine the PD-L1 status from December 2015 to July 2016 were retrospectively reviewed. This study was multicenter study conducted by the three respiratory medical centers in Japan. We collected clinical data including age, sex, smoking history, histological types, PS, NLR, existence of Liver metastasis and PD-L1 status. We made the predictive score (PS2-4: 3 points, >NLR 4: 1 point, Liver metastasis +: 1 point, PD-L1 0%: 1 point and over 50%: -1 point) from pretreatment patients’ characteristics and evaluate the score (over 4 points is high risk group, 2-3 points is mediate risk group, and under 1 point is low risk group) as a marker of outcomes. The data cut off was on 31th October 2017.

      Result

      Median age was 67 years old, 86 patients were male, 101 patients had smoking history, 99 patients were PS 0-1 and 29 patients were PS 2-4, 26 patients were squamous carcinoma, >NLR 4 were 48 patients, and 16 patients had liver metastasis, respectively. Furthermore, PD-L1 expression 0% were 62 patients, 1-49% were 42 patients, and over 50% were 24 patients.

      Progression disease rate, median progression free survival (PFS) and median OS was 61.1%, 1.1 months, 2.4 months in high risk group; 60.6%, 1.4 months, 10.9 months in mediate risk group; and 36.4%, 4.6 months, 16.3 months in low risk group, respectively.

      Conclusion

      We could classify the three group which could predict an patients’ outcome according to the patients’ characteristics.

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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
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-77 - Impact of Oral Drugs on the Prognosis of Non-Small-Cell Lung Cancer Patients Treated with Nivolumab (ID 895)

      09:45 - 18:00  |  Author(s): Shun-ichi Isa

      • Abstract
      • Slides

      Background

      Nivolumab (Nivo) has shown promising effects in patients with non-small-cell lung cancer (NSCLC) as a second- or later-line treatment. However, some drugs are reported to influence the efficacy of immune checkpoint inhibitors (ICIs). For example, steroids are related with worth prognosis treated with ICIs. On the other hands, opioids have direct and indirect effects on anti-tumor immunity. The aim of this study is to disclose the impact of oral drugs in patients harboring NSCLC treated with Nivo.

      Method

      In this study, data for 201 patients treated with Nivo during 17 December 2015 to 31 July 2016 at three respiratory medical centers in Japan were retrospectively reviewed. We collected clinical data including age, sex, smoking history, performance status (PS) score, body mass index (BMI), histological types, tumor proportion score (TPS) of program death-ligand1 (PD-L1), epidermal growth factor receptor (EGFR) mutation status, number of previous treatments, steroid use, opioid use, statin use, biguanide use and fibrates use at the time of Nivo treatment commencement. We investigated relationship between progression free survival (PFS), overall survival (OS) and drug use at the time of Nivo treatment. Patients were followed-up for disease status until October 2017.

      Result

      The median age at the time of administration Nivo was 68 years, 135 patients were male, 157 patients had smoking history, 152 patients had a PS score of 0–1, median BMI was 21.4kg/m2, 42 patients had squamous cell carcinoma, 24 patients had PD-L1 TPS 50 or over, 37 patients had positive EGFR mutation, 78 patients received 3 or more treatments before Nivo treatment, 23 patients received steroids, 33 patients received opioids, 12 patients received statin, 6 patients received biguanide and 2 patients received fibrates. In the multivariate analysis including above factors, steroid use was significantly associated with poor PFS (hazard ratio [HR]: 2.17; 95% confidence interval (CI): 1.31–3.43; p = 0.003) and OS (HR: 2.10; 95% CI: 1.18–3.58; p = 0.014). Moreover, opioid use was significantly associated with poor OS (HR: 1.87; 95% CI: 1.11–3.08; p = 0.020).

      Conclusion

      Steroid use at baseline was significantly associated with worse PFS and OS. Furthermore, opioid use at baseline was significantly associated with worse OS.

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    P1.04 - Immuno-oncology (ID 164)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.04-62 - Nomogram Based on Multivariable Regression Model Estimates the Overall Survival of Nivolumab for Previously Treated Advanced NSCLC (ID 2231)

      09:45 - 18:00  |  Author(s): Shun-ichi Isa

      • Abstract

      Background

      Nivolumab (Nivo) has demonstrated with its efficacy against metastatic non-small cell lung cancer (NSCLC). However, it has been also reported that Nivo does not show beneficial effects in approximately 80% of patients. The predictive ability of biomarkers still is yet unclear; thus identifying biomarkers which better predict overall survival (OS) of such patients treated with Nivo is crucial. In this study, we conducted multivariable cox regression analysis including biomarkers and clinical factors measured at the time of initiating treatment with Nivo to assess predictive ability of OS of patients. Results of the multivariable analysis were elucidated with a nomogram which estimates the OS of Nivo in previously treated patients with advanced NSCLC.

      Method

      In this study, data for 201 patients treated with nivolumab during 17 December 2015 to 31 July 2016 at three respiratory medical centers in Japan were retrospectively reviewed. We collected clinical data at the time of nivolumab treatment commencement, and we evaluated two programmed cell death ligand 1 (PD-L1) immunohistochemistry (IHC) assay systems (22C3 and 28-8).

      Result

      The median age at the time of administration nivolumab was 68 years, 135 patients were male, 157 patients had a smoking history, and 152 patients had a performance status (PS) score of 0–1. 39 patients had EGFR (37) or ALK (2) mutation positive. For 22C3 and 28-8, 36.3% and 36.8% of patients were negative, 17.4% and 14.4% had PD-L1 status of 1-49%, and 11.9% and 14.9% had PD-L1 status of ≥50%, 34.3% and 33.8% had PD-L1 status of missing, respectively. Kendall’s rank correlation coefficient between 22C3 and 28-8 was 0.8414. The median OS of all patients was 333 (95% confidence interval (CI): 116-520) days. In the multivariate analysis, PS score ≥2 (hazard ratio (HR): 2.23; 95%CI: 1.36-3.66 p<0.001), high LDH level at baseline (HR: 1.13 95%CI: 1.03-1.24; p=0.008, and progression disease (PD) of pre-treatment response (HR: 3.64 95%CI: 2.29-5.79 p<0.001) were significantly associated with poor OS. There was not significant distance between PD-L1 status and OS of Nivo. Based on these analyses, we created the nomogram to estimate the OS of Nivo in previously treated patients with advanced NSCLC.

      Conclusion

      PS score ≥2, high LDH levels at baseline, and PD of pre-treatment response were predictive of poor OS of Nivo, moreover the nomogram might be useful to estimate the OS of Nivo in previously treated patients with advanced NSCLC. (UMIN-ID: UMIN000025908)