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K. Tomii



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    P1.07 - Immunology and Immunotherapy (ID 693)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P1.07-004 - Predictive Biomarkers of Response to Nivolumab in Non–Small Cell Lung Cancer: A Multicenter Retrospective Cohort Study (ID 7441)

      09:30 - 09:30  |  Author(s): K. Tomii

      • Abstract

      Background:
      It is important to seek predictive factors for the efficient use of immune check point inhibitors in non-small-cell lung cancer (NSCLC), because of the lack of a definitive predictive biomarker.

      Method:
      Study design for the analysis: A multicenter retrospective cohort study. Patient eligibility criteria: Consecutive patients treated with nivolumab between January 2016 and October 2016 after the second line systemic chemotherapy outside of a clinical trial. Definition of exposures: Variables were retrieved from the medical records before the administration of nivolumab. All variables were dichotomized based on previous study or median. Definition of study endpoint: Progression free survival (PFS) defined by response evaluation criteria in solid tumours (RECIST) 1.1. Two researchers evaluated the endpoint independently. Any disagreements were resolved by discussion. Statistical methods: Cox proportional hazards models were used to assess the impact of pretreatment markers on PFS. Missing values were imputed by multiple imputation.

      Result:
      A total of 189 patients were included in the study. Median follow-up time was 5.5 months. Fourty six (24%) patients were censored. Median age was 69 (range, 38–88); 26% were female. 64% had received ≧2 prior systemic therapies. In multivariate analyses, worse performance status, higher lactate dehydrogenase, and higher carcinoembryonic antigen,were independently associated with inferior PFS (Table 1). Figure 1



      Conclusion:
      Our study indicated that patients with NSCLC treated with nivolumab in routine practice, pretreatment performance status ≧2, carcinoembryonic antigen ≦13.8, and Lactate Dehydrogenase ≧217 were associated with inferior PFS. Another study is warranted to determine the precise utility of each marker take account of the programmed death-ligand 1.

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    P2.07 - Immunology and Immunotherapy (ID 708)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P2.07-024 - Real-World Data of Nivolumab for Previously Treated Non-Small Cell Lung Cancer Patients in Japan: A Multicenter Retrospective Cohort Study (ID 8699)

      09:30 - 09:30  |  Author(s): K. Tomii

      • Abstract

      Background:
      Real-world data in non-small cell lung cancer (NSCLC) patients treated with nivolumab are currently lacking. This study aimed to obtain a detailed understanding of the characteristics and outcomes of these patients.

      Method:
      We retrospectively analyzed data for stage IIIB-IV (7th edition) NSCLC patients treated with nivolumab between January 2016 and January 2017.

      Result:
      A total of 394 patients were included in the study. Most patients had a PS of 0 or 1 (76%) and non-squamous histology (80%). Epidermal growth factor receptor (EGFR) gene mutations were detected in 16% of all patients. Two hundred and seventy-two patients (69%) had received ≥ 2 prior systemic therapies. Response rate was 20.8 %, and median progression-free survival (PFS) was 2.2 months. Estimated PFS and overall survival (OS) at 1-year were 17 % and 55 %, respectively. Multivariate analysis using Cox proportional hazards models identified poor performance status (PS 2-4) and EGFR mutation as independent predictors of PFS (hazard ratio [HR] 2.17; 95% confidence interval [CI], 1.68 to 2.80, P<0.001; HR 1.44; 95% CI, 1.02 to 2.02, P=0.04, respectively). In 255 patients without these negative predictive factors for PFS, response rate was 27.3 %. In these patients, estimated PFS and OS at 1 year were 23 % and 64 %. Severe immune related adverse events (≥Grade 3) were identified in 11.2 % of all patients, and 8.3 % of the patients developed pneumonitis (any grade). Overall incidence of pseudoprogression was approximately 2 %.

      Conclusion:
      Nivolumab has demonstrated a favorable efficacy and safety profile in real-world patients. Poor PS and EGFR mutation positivity were independent negative predictive factors for PFS. Importantly, pseudoprogression was rare in real-world patients.