Abstract 325P
Background
To evaluate the efficacy and safety of extended immunotherapy in first-line immune checkpoint inhibitors (ICIs) - tyrosine kinase inhibitors (TKIs) combination treatment for advanced renal cell carcinoma (RCC).
Methods
We retrospectively analyzed data from patients with advanced RCC who received first-line ICIs-TKIs combination treatment at West China Hospital of Sichuan University between October 2018 and March 2024. Patients who are assessed as having a disease control status after 2 years of continuous treatment will continue to receive immune checkpoint inhibitors until the inhibitors are discontinued due to disease progression or death.
Results
A total of 86 patients were screened and 14 patients diagnosed with clear cell RCC (ccRCC) were enrolled. After 65 months of follow-up, three-year progression-free survival (PFS) rate was 71.4% and 4-year PFS rate was 59.5%. The 5-year overall survival (OS) rate was 58.3%. During extended treatment,one patients(7.1%) experienced a transition from stable disease (SD) to partial response (PR) and two patients(14.3%) experienced a transition from PR to complete response(CR). The best tumor shrinkage ratespresenting after 24 months had longer PFS and OS compared to those presenting within 24 months (median PFS: not reached vs. 36 months; Hazard Ratio(HR)=0.10, 95%CI 0.01-0.80, P=0.03; median OS: not reached vs. 43 months; HR=0.18, 95%CI 0.02-2.13, P=0.18).Compared with patients whose disease status was SD assessed at 24 months of immunotherapy, patients assessed with PR had longer PFS on extended therapy. For safety, extended immunotherapy did not increased treatment-related toxicities compared to safety profile before 24 months (14.3% vs. 42.9%; P = 0.21).
Conclusions
Our analysis of real-world data indicates that patients with extended immunotherapy after 24 months had sustained survival benefits and manageable toxicity. Large-scale, prospective studies are still needed to further verify the conclusion.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.