Real-world data of second-line immunotherapy in metastatic clear cell renal cell carcinoma: A retrospective study

Abstract

Background: Targeted therapies have prolonged the survival of patients with metastatic renal cell carcinomas (RCC). However, the majority of patients with metastatic RCC develop treatment resistance and disease progression. The programmed cell death protein 1 inhibitors offer a new ray of hope for such patients. Objectives: The primary objective of this study was to evaluate the overall survival (OS) of patients with relapsed metastatic RCC treated with immunotherapy in the second-line setting. The secondary objectives were to assess the safety profile and objective response rate (ORR) for nivolumab. Materials and Methods: This retrospective study was conducted in the Department of Medical Oncology at the Max Institute of Cancer Care, a tertiary care center in Delhi, India. Patients with histologically proven stage IV RCC who had progressed on first-line tyrosine kinase inhibitors (TKIs) and treated with at least four cycles of nivolumab at our center between December 2015 and January 2019 were enrolled in the study. The OS, progression-free survival (PFS), immune-mediated adverse events (irAEs), and ORR were determined. Results: Out of 50 patients with metastatic RCC who progressed on first-line TKIs, 19 received immunotherapy with nivolumab. The median age of the patients was 62 years (range, 31–71 years); the male-to-female ratio was 2:1. The median follow-up time and duration of treatment were 11 months (range, 2–23) and 4.5 months (95% confidence interval [CI], 3.52–5.96), respectively, and 8 (42.1%) patients were alive at the time of analysis. The median OS was 13 months (95% CI, 10.4–15.5) from the start of nivolumab therapy, and the median PFS was 8 months (95% CI, not evaluable). The best response was progressive disease in 47.3%; the ORR was 26.3%. Grade 1/2 and grade 3/4 adverse events were observed in 68.4% and 10.5% of the patients, respectively. Adverse events of any grade were reported in 13 (68.6%) patients. Fatigue and hypothyroidism were the most frequently observed irAEs associated with nivolumab and occurred in 4 (21%) and 11 (57.8%) patients, respectively. Four (15.7%) patients developed grade 1 pruritus. No fatal toxicities were recorded. Conclusion: Nivolumab is efficacious and safe as a second-line treatment option for metastatic RCC in Indian patients.