The therapeutic effect and immune-related adverse event of nivolmab in Anjo Kosei Hospital

Abstract

Abstract Background Nivolmab is approved as a novel immunocheckpoint inhibitor and peculiar immune-related adverse events (irAE) including interstitial lung disease (ILD), endocrinological disorder, and immunological colitis are reported. The rapid diagnosis and treatment are indispensable for the irAE of nivolmab. Cases and Methods We examined the therapeutic effect and irAE of the 116 cases administrated nivolmab from February 2016 to January 2019 in Anjo Kosei Hospital. Result The cases included 52 cases of non-squamous cell lung carcinoma (NSCLC), 20 cases of squamous cell lung carcinoma (SCLC), 12 cases of renal cell carcinoma (RCC) and adenocarcinoma of stomach, 5 cases of squamous carcinoma of head and neck region, and 3 cases of malignant melanoma and hodgkin lymphoma. The median observation period was 9.53 months in total. The median overall survival period was 26.8 months in the cases of NSCLC, 27.2 months in SCLC, 14.2 months in RCC, 11.0 months in adenocarcinoma of stomach, respectively. The 12 cases of hyper and hypothyroidism, 7 cases of colitis, 5 cases of ILD and endocrinological disorder, and other 15 cases of irAE were diagnosed. No case of novel diabetes mellitus was developed. The cumulative incidence rate of irAE reached 69.3% through all over the cases. The Brinkman Index over 700 was recognized as clinical factor for development of total irAE with significant p-value 0.039. No clinical factor for specific irAE including ILD, thyroid disorder, endocrinological disorder, colitis and diabetes mellitus respectively. Conclusion We examined 116 cases administrated nivolmab and recognized equivalent effect with clinical trial and significant relation of Brinkman Index to development of irAE.