Efficacy of second-line ICIs combined with TKIs among patients with metastatic renal cell carcinoma: a real-world study.

Abstract

Aim: To evaluate the efficacy of immune checkpoint inhibitors (ICIs) plus tyrosine kinase inhibitors (TKIs) as second-line treatment in patients withmetastatic renal cell carcinoma (mRCC). Patients & methods: Baseline and follow-up data from patients withmRCCtreatedwith second-line ICIs plus TKIs or TKIs alone from a single institution were retrospectively gathered. Results: A total of 110 patients were included. The objective response rate was higher among patients treatedwith ICIs plus TKIs than those treatedwith TKIs alone (36.5vs 12.1%;p=0.002). Treatment withICIs plus TKIs was associated with longer progression-free survival(15.0 vs 9.0months;p=0.009) and overall survival (not reachedvs 16.0months;p=0.018) than TKI monotherapy. The survival rates at 2 (83.0vs 74.4%;p=0.426) and 3years (58.1vs 47.5%;p=0.214) between the two groups were not statistically different. Notably, patients with certain clinicopathological features tended to gain more survival benefits with combined therapy. Conclusion: ICIs plus TKIsshowed superior progression-free survival time and tumor response rate over TKIs alone as second-line treatment in patients with mRCC. Future randomized prospective trials are necessary to validate these preliminary findings.