Introduction: Adjuvant pembrolizumab versus placebo significantly improved disease-free survival (DFS) in renal cell carcinoma (RCC) patients at high risk (HR) of recurrence following nephrectomy in KEYNOTE-564 trial (NCT03142334). The objective of this study was to evaluate efficacy and safety of adjuvant pembrolizumab in a real-world setting.
Methods: In this multicenter retrospective study, RCC patients receiving adjuvant pembrolizumab between 01/22 and 10/23 at seven tertiary referral centers were included. DFS and treatment safety were assessed.
Results: Fifty-two patients with RCC were included. 24 (46%), 5 (9.6%), 22 (42%), and 1 (1.9%) patients were classified as intermediate to high risk (IR to HR), HR, M1 with no evidence of disease (M1NED), and unknown. At a median follow-up of 6 months, DFS rates at 6 months were 64.2% in the overall cohort. In subgroup analyses, M1NED patients demonstrated significantly lower DFS compared to non-metastatic (combined: IR to HR/HR) patients (log-rank: p = 0.025). Regarding toxicity, grade 3 or higher adverse events occurred in 26% of patients. Treatment discontinuations were reported in 20% of the patients.
Conclusion: Recurrence rates in the M1NED group remained high and occurred earlier in our real-world compared to KEYNOTE-564. Long-term toxicities were comparable to clinical trials data.
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