Prognostic Impact of Adjuvant Immunotherapy in Patients with High-Risk Upper Tract Urothelial Cancer: Results from the ROBUUST 2.0 Collaborative Group

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Background/Objective: The impact of adjuvant immunotherapy (IO) on the prognosis of patients with upper tract urothelial carcinoma (UTUC) remains unclear. This study examines the association of adjuvant IO with oncologic outcomes in patients with high-risk UTUC. Methods: This retrospective study reviewed patients with high-risk UTUC treated with adjuvant IO using the ROBotic surgery for Upper tract Urothelial cancer STudy (ROBUUST) database. Propensity-score-matched analysis (nearest-neighbor algorithm, caliper 0.1) was conducted to compare patients receiving adjuvant IO versus those who did not, with matching based on pathologic T and N category and receipt of neoadjuvant chemotherapy. Associations between adjuvant IO and urothelial recurrence-free survival (URFS), non-urothelial recurrence-free survival (NRFS), and overall survival (OS) were estimated using a Cox proportional hazards model. Results: Seventy-five patients received adjuvant IO following nephroureterectomy (median four cycles, including eleven (14.7%) nivolumab, thirty-one (41.3%) pembrolizumab, four (5.3%) atezolizumab, and twenty-nine (38.6%) other agents. These patients were matched to 68 patients without adjuvant therapy. Median follow-up times were 17 (IQR, 10–29) months and 20 (9–44) months for IO and no adjuvant therapy, respectively. Multivariable analysis revealed that adjuvant IO was not associated with URFS, NRFS, or OS. Pathologic nodal involvement (HR 7.52, p < 0.001) was the only independent predictor of worse OS. Conclusions: In this real-world retrospective data set, adjuvant IO does not have an impact on oncologic outcomes of UTUC patients following extirpative surgery.

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