Safety and efficacy of nivolumab as a second line therapy in metastatic renal cell carcinoma: a retrospective chart review

AIM: To assess diseases outcomes and tolerability of real-life second-line nivolumab in a series of metastatic renal cell carcinoma (mRCC) patients. METHODS: This retrospective chart review involved prospectively monitored patients (named patient program) treated with second-line nivolumab for mRCC at the University Hospital Centre Zagreb from February 2016 to March 2018. RESULTS: The study enrolled 30 patients, 5 of whom (16.7%) had a complete response. The mean ± standard deviation therapeutic response time to nivolumab treatment was 14.07 ± 8.92 months, with a minimum treatment duration of 2 months and a maximum of 24 months. The median duration of therapy was 17 months (mean: 15.8 months; range: 3-24 months), and 50% (n = 15/30) of patients remained alive at the end of follow up. The most common adverse events associated with nivolumab were fatigue (26.67%; n = 8/30), anemia (10.0%; n = 3/30), adrenal insufficiency (6.67%; n = 2/30: G1 = 1, G2 = 1), grade 2 pneumonitis (6.67%; n = 2/30), grade 2 neuropathy (6.67%; n = 2/30), rash (6.67%; n = 2/30: G1 = 1, G2 = 1), and hepatitis (3.33%; n = 1/30). CONCLUSION: The present study indicates acceptable patient responses and tolerability of nivolumab in mRCC.