Efficacy of adjuvant nivolumab versus adjuvant gemcitabine plus cisplatin/carboplatin after radical nephroureterectomy for upper tract urothelial carcinoma: a real-world analysis using a Japanese large-scale claims database.

Abstract

Background: Upper tract urothelial carcinoma (UTUC) is a relatively rare malignancy with a poor prognosis. Although adjuvant platinum-based chemotherapy is a standard treatment after radical nephroureterectomy (RNU), the efficacy of adjuvant nivolumab in UTUC remains unclear, especially in real clinical practice. We examined this using a large Japanese real-world database.

Methods: Using the Medical Data Vision database, we identified UTUC patients who underwent RNU and received adjuvant therapy. The adjuvant GC/GCarbo group and the adjuvant nivolumab group were defined by distinct treatment eras to reduce treatment selection bias. Event-free survival (EFS) was compared using Kaplan-Meier curves and the log-rank test, with a sensitivity analysis truncating follow-up at 300 days.

Results: A total of 1,058 patients were analyzed (240 nivolumab, 818 GC/GCarbo). In the whole cohort, EFS was significantly longer in the nivolumab group (HR = 0.6365, P = 0.0076). This benefit was consistent in patients with neoadjuvant chemotherapy (HR = 0.4053, P = 0.001) and in those without it (HR = 0.6765, P = 0.0462).

Conclusion: In Japanese UTUC patients, adjuvant nivolumab may be at least not inferior to GC/GCarbo, suggesting the usefulness of an immunotherapy-after-chemotherapy sequence.