Department of Urology, Foch Hospital, Suresnes, France.
Department of Urology, Foch Hospital, Suresnes, France.
Fr J Urol. 2024 Dec;34(13):102744. doi: 10.1016/j.fjurol.2024.102744. Epub 2024 Sep 17.
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.
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.
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).
Our real-world data align with existing literature regarding adjuvant nivolumab in localized invasive muscle urothelial carcinoma.
2022 年，纳武利尤单抗获批准用于手术治疗局部浸润性肌肉尿路上皮癌患者的辅助治疗，这些患者术后标本表达 PD-L1，且有高复发风险。我们旨在研究其真实世界的应用情况。
我们的这项两中心真实世界研究于 2022 年 7 月至 2024 年 1 月在 Foch 医院和 Georges-Pompidou 欧洲医院进行，纳入在这些中心接受手术治疗或转至这些中心接受辅助纳武利尤单抗治疗的尿路上皮癌患者。
研究期间共 200 例患者接受了手术，其中 70 例符合高危标准，但由于不适用，其中 46%的患者未接受辅助治疗。我们接受纳武利尤单抗治疗的患者的生存结果与 CheckMate 274 研究（Bajorin 等人，N Engl J Med. 2021）的结果一致。我们的研究人群比研究队列年龄更大且身体更脆弱，平均年龄为 69 岁。在接受检测的患者中，66%存在显著的 PD-L1 表达。接受新辅助化疗后手术及辅助纳武利尤单抗治疗的患者无疾病进展生存期中位数为 11.34 个月。纳武利尤单抗总体耐受性良好，但 25%的患者因毒性而停药。我们对辅助纳武利尤单抗治疗后复发的初始治疗数据突出了常规化疗（顺铂或卡铂联合吉西他滨）和靶向化疗（恩福妥单抗 Vedotin）的有效性。
我们的真实世界数据与局部浸润性肌肉尿路上皮癌中纳武利尤单抗的现有文献一致。
