First-line sunitinib for metastatic renal cell carcinoma, a 15-year single institution real-world evidence study.

Background: With the introduction of immuno-oncology (IO) tyrosine kinase inhibitor (TKI) combination therapy, sunitinib has become a rarely used drug because of its inferiority demonstrated in a number of randomized clinical trials (RCTs). However, limited studies has investigated the long-term outcomes of first-line sunitinib for mRCC. This study represents the first retrospective Danish real-world evidence (RWE) study evaluating the effect of sunitinib in first line in mRCC patients, PATIENTS AND METHODS: This study included a total of 268 patients over a 15 year period. Clinical data from patients treated with sunitinib for mRCC from 01-01-2010 to 30-05-2024 were extracted from a mRCC registry at the Department of Clinical Oncology, Aarhus University Hospital, Denmark. Patient data was collected through medical record review. The data was managed in RedCap. Median overall survival (mOS) and progression-free survival (mPFS) were estimated using the Kaplan-Meier (KM) method. A multivariate Cox proportional hazards regression analysis was conducted for the entire cohort. All statistical analyses were conducted in R version 4.3.3.

Results: For all patients, mPFS was 8.43 months (95% CI: 6.47-11.23) and mOS was 18.60 months (95% CI: 14.73-22.80). In the favorable risk group (IMDC = 0), mPFS reached 26.26 months (95% CI: 16.52-43.67) and mOS 57.73 months (95% CI: 38.62-75.31).

Conclusions: When compared to other RWEs, our PFS and OS for all patients fell within the spectrum of previously published results. IMDC risk group was identified as the most significant factor for PFS and OS. PFS and OS for IMDC favorable-risk patients were among the highest reported in existing RWE studies. Importantly, we found sunitinib monotherapy to be an effective treatment in IMDC favorable-risk patients, comparable to published IO-TKI results, supporting its use, especially seen in relation to price.