Efficacy and Safety Data in Elderly Patients (pts) with Metastatic Renal Cell Carcinoma (mrcc) Included in the Nivolumab Expanded Access Program (EAP) in Italy

Background: The risk of developing renal cell carcinoma (RCC) increases with age, and given the constant gain in life expectancy of the general population, RCC is frequently observed in the elderly. More than 80% of cancer pts aged ≥ 70 years have at least one comorbidity requiring treatment, leaving them exposed to drug interactions. Due to high frequency of comorbidities, these pts are often under-represented in clinical trials. The purpose of this analysis is to evaluate the feasibility of treatment with nivolumab in the elderly (≥ 70 years) and very elderly (≥ 75 years) in the EAP in Italy, given a more realistic picture of real world setting. Methods: Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after at least one prior systemic treatment in the advanced or metastatic setting. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events. Results: Of 389 Italian pts with mRCC enrolled in the EAP in Italy 125 pts (32%) had ≥70 years and 70 (18%) had ≥75 years. With a median follow-up of 9.8 months (0.1-16.2) in the elderly population (≥70 years), the disease control rate (DCR) was 58% including 1 patient in complete response (CR), 32 pts in partial response (PR) and 40 patients in stable disease (SD). Regarding the very elderly population (≥75 years), with a median follow-up of 9.8 months (0.1 -14.9), the DCR was 60% including 1 patient with CR, 19 pts with PR and 22 with SD. As of May 2017, 6 and 12 months overall survival (OS) rate were 87.2% and 77.8% respectively in the elderly population. Regarding the very elderly, the 6 and 12 months OS rate was 83.6% and 77.7%, respectively. The safety profile was consistent to what already observed in the general population. Conclusions: These results suggest that elderly population can benefit from nivolumab treatment with safety results consistent to what previously reported, supporting the use of nivolumab in this subpopulation. Clinical trial identification: CA209-99M Legal entity responsible for the study: Sergio Bracarda coordinator Italian RCC EAP Group Funding: None Disclosure: All authors have declared no conflicts of interest.