Author of

• 20171

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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
  • Moderators:
  • Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 23399

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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): M. Fukui
    • 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.