Analysis of Early Death in Japanese Patients With Advanced Non–small-cell Lung Cancer Treated With Nivolumab

Abstract Background The increased risk for early death due to an anti PD-1 inhibitors is a one of major disadvantage which requires special management. We evaluated the frequency, causes, and risk factors of early death during nivolumab treatment for non-small cell lung cancer (NSCLC) in Japanese clinical setting. Patients and Methods The medical records of NSCLC patients who started receiving nivolumab between December 17, 2015 and July 31, 2016 in 3 Japanese institutes were collected. Early death was defined as any death within 3 months from the start of nivolumab treatment irrespective of its cause. Treatment response was evaluated using the RECIST criteria version 1.1. Results A total of 201 NSCLC patients were enrolled, and 38 (18.9%) died within the first 3 months. Thirty-one patients (81.6%) who experienced early death developed progressive disease, whereas 14 patients (36.8%) who experienced early death demonstrated nivolumab-induced immune-related adverse events, which required corticosteroid intervention, including interstitial lung disease in 7 patients (18.4%). Multivariate logistic regression demonstrated that an Eastern Cooperative Oncology Group performance status (ECOG PS) score ≥2 (odds ratio [OR] 5.66; 95% confidence interval [CI] 2.01-15.61; p 0.3 (OR 10.56; 95% CI 3.61-30.86; p Conclusion Disease progression and immune-related adverse events are two major causes of early death with nivolumab in patients with NSCLC. A PS score ≥2, pretreatment CAR >0.3, and poor response to prior treatment were associated with early death.