Abstract 312P
Background
Clear cell renal cell carcinoma (ccRCC) represents the most prevalent histological subtype of renal cell carcinoma, characterized by high malignancy and often asymptomatic in early stages. Recent years have seen numerous clinical studies exploring neoadjuvant therapy combining immune-oncology (IO) and tyrosine kinase inhibitor (TKI) treatments for ccRCC. Neoadjuvant regimens aim to achieve tumor shrinkage and immune activation, facilitating surgical resection and nephron-sparing surgery, while mitigating recurrence and enhancing long-term patient survival.
Methods
This study included patients with pathologically confirmed renal clear cell carcinoma at clinical stage ≥ cT2 who received a combination of tislelizumab and axitinib at Nanjing Drum Tower Hospital from September 2021 to June 2024. The primary endpoint was the objective response rate (ORR) assessed before surgery, with secondary endpoints including disease-free survival (DFS), overall survival (OS), and safety outcomes.
Results
By June 2024, 20 eligible patients were enrolled, all completing neoadjuvant therapy, with a median age of 65 years. 17 patients underwent planned surgery. Clinical stage ≥ cT3 was observed in 85% (17/20) of cases, with a median baseline tumor diameter of 8.3 cm (range: 5.1-14.2 cm), and 50% (10/20) presenting with tumor thrombus. Following 4 cycles of neoadjuvant therapy, the median primary tumor shrinkage was 21%. The objective response rate (ORR) was 45% (9/20), and the disease control rate (DCR) was 90% (18/20), including one patient achieving complete response (CR) of the primary tumor post-surgery. Over a median follow-up of 18 months, recurrent disease was noted in two patients, three of whom did not undergo surgery. Common adverse reactions included hematologic toxicity, hypothyroidism, nausea, vomiting, decreased appetite, asthenia, diarrhea, and elevated ALT/AST levels. No Grade 4/5 treatment-related adverse events occurred.
Conclusions
Neoadjuvant therapy with tislelizumab combined with axitinib shows significant clinical efficacy and controllable safety in patients with locally advanced ccRCC.
Clinical trial identification
NCT05172440.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
National Natural Science Foundation (82172777).
Disclosure
All authors have declared no conflicts of interest.