Abstract: SA-PO1258
Serious Adverse Events in Patients with Metastatic Renal Cell Carcinoma and ESKD Receiving Systemic Anticancer Therapy: A Real-World Study
Session Information
- Onconephrology: Epidemiological Trends, Risk Stratification, and Clinical Outcomes
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Onconephrology
- 1600 Onconephrology
Authors
- Milanez, Tomaz, Univerzitetni klinicni center Ljubljana, Ljubljana, Slovenia
- Srinivasan, Vinay, Rowan University Cooper Medical School, Camden, New Jersey, United States
- Seruga, Bostjan, Onkoloski Institut Ljubljana, Ljubljana, Slovenia
- Arnol, Miha, Univerzitetni klinicni center Ljubljana, Ljubljana, Slovenia
- Ocvirk, Janja, Onkoloski Institut Ljubljana, Ljubljana, Slovenia
- Jaimes, Edgar A., Weill Cornell Medicine, New York, New York, United States
Background
Real-world data (RWD) suggests prolonged survival with sequential systemic anticancer therapy (SACT) in patients with metastatic renal cell carcinoma (mRCC) who are at increased risk of End Stage Kidney Disease (ESKD). Hemodialysis (HD) and SACT with vascular endothelial growth factor receptor inhibitors (VEGFR-TKIs), immune checkpoint inhibitors (ICIs), or combinations may increase bleeding, infection, and immune-related serious adverse events (SAEs). However, data on the incidence and incidence rates (IRs) of SAEs in patients with mRCC and ESKD receiving SACT remain limited.
Methods
A retrospective analysis was conducted, including patients with mRCC and ESKD treated with VEGFR-TKIs, ICIs, mTOR inhibitors, or combinations at the Institute of Oncology Ljubljana, Slovenia (2009–2025). Medical records were reviewed for bleeding, infections, and immune-related SAEs. All patients were followed irrespective of SACT discontinuation. SAEs were defined per ICH E2A criteria.
Results
A total of 41 patients with mRCC and ESKD received SACT. The median age at SACT initiation was 70 years, with 80% male. 21 patients received ≥1 ICI cycle; 10 received ipilimumab+nivolumab or nivolumab as 1st-line SACT. The majority (63.4%) were already on HD, while those initiating SACT before HD had a median eGFR of 20 ml/min. AV fistula was the predominant dialysis access (71%). In total, 24 out of 41 patients (58.5%) experienced bleeding, infection, and/or immune-related SAEs. There were 17 bleeding SAEs, including hemorrhagic shock, in 13 patients (IR 0.162/person-year; 95% CI, 0.094–0.260). 16 infection SAEs occurred in 12 patients (IR 0.152/person-year; 95% CI, 0.083–0.248), including 6 bacteremias and 6 sepsis events (IR 0.057/person-year each; 95% CI, 0.021–0.124). 6 immune-related SAEs occurred in 6 patients (IR 0.057/person-year; 95% CI, 0.021–0.124). The total follow-up length was 105.3 patient-years.
Conclusion
Bleeding, infection, and immune-related SAEs are expected in patients with mRCC and ESKD receiving SACT. Given the complexity of management, care should be guided by specialized onco-nephrology services. As SAEs are not routinely captured in RWD, this may limit the evaluation of clinically meaningful outcomes in practice. Observational studies reporting SAEs are warranted to optimize treatment strategies and safety in this cohort.
Funding
- Other NIH Support