Abstract
BACKGROUND: This all-case post-marketing surveillance (PMS) evaluated the real-world safety and effectiveness of nivolumab monotherapy in Japanese patients with un-resectable or metastatic renal cell carcinoma (RCC). METHODS: This multicenter, open-label, non-interventional, observational PMS study (registered from August 2016 to January 2017) was conducted in patients who were newly initiated on nivolumab monotherapy. Assessments included treatment-related adverse events (TRAEs) of special interest, patient characteristics affecting safety, and effectiveness over 12 months. RESULTS: Overall, 580 patients were enrolled; 555 and 554 patients comprised the safety and effectiveness analysis sets, respectively. The median (range) age of the population was 66 (14-90) years. Nivolumab was initiated as 1st-, 2nd-, and ≥ 3rd-line treatment in 0.2%, 42.0%, and 57.8% of patients, respectively. TRAEs were reported in 275 (49.5%) patients. The most common TRAEs of special interest included thyroid dysfunction (9.5%), hepatic dysfunction (8.6%), and interstitial lung disease (6.7%). The incidence of TRAEs was significantly higher in elderly patients (≥ 65 vs < 65 years; ≥ 75 vs < 75 years); patients with lower C-reactive protein levels (< 5 vs ≥ 5 mg/dL); and patients with vs without a past medical history, including hepatic, thyroid, and autoimmune diseases. The 6- and 12-month survival rates were 71.8% and 57.9%, respectively. CONCLUSION: The safety profile of nivolumab monotherapy in Japanese patients with advanced RCC was similar to that in the phase 3 CheckMate 025 trial. No new safety signals were observed in this study.