Real-world evaluation of nivolumab utilization in adjuvant treatment of localized muscle-invasive urothelial carcinoma

Introduction: In 2022, nivolumab was granted marketing authorization for adjuvant treatment in patients at high-risk of recurrence following surgery for localized invasive muscle urothelial carcinoma, who express PD-L1 on the operative specimen. We aimed to investigate its real-world utilization.

Materials and methods: Our bicentric real-world study, conducted at Foch Hospital and Georges-Pompidou European Hospital between July 2022 and January 2024, included patients who underwent surgery for urothelial carcinoma or were referred for adjuvant nivolumab treatment at these centers.

Results: A total of 200 patients underwent surgery during the study period, of whom 70 met the high-risk criteria, with 46% of these patients not receiving adjuvant treatment due to ineligibility. Our survival outcomes among patients treated by nivolumab are consistent with the results of the CheckMate 274 study (Bajorin et al. N Engl J Med. 2021). Our study population was older and frailer than that of the study cohort, with a mean age of 69years. Significant PD-L1 expression was observed in 66% of the tested patients. The median disease-free survival was 11.34months in patients who received neoadjuvant chemotherapy followed by surgery and adjuvant nivolumab. Nivolumab was generally well-tolerated, but 25% of patients discontinued it due to toxicity. Our initial data on treatments for recurrence after adjuvant nivolumab highlighted the effectiveness of conventional chemotherapy (cisplatin or carboplatin combined with gemcitabine) and targeted chemotherapy (enfortumab vedotin).

Conclusion: Our real-world data align with existing literature regarding adjuvant nivolumab in localized invasive muscle urothelial carcinoma.