尽管纳武单抗可延长经治疗的转移性肾细胞癌 (mRCC) 患者的总生存期 (OS)，但长期缓解的临床和生物学特征仍有待确定。本研究旨在调查在nivolumab治疗期间获得长期缓解的mRCC患者的临床和病理特征。对2016年5月至2019年1月期间在34个意大利肿瘤中心接受nivolumab作为第二或进一步治疗线的mRCC患者进行回顾性分析。通过结果评估和逻辑回归来评估影响长期缓解的因素。分析中总共纳入了 571 名中位年龄为 61 岁（范围 17-85）的患者。中位随访时间为 22.1 (1.0-89.0) 个月，23.1% 的患者接受纳武单抗治疗 2 年无进展，因此他们被归类为长期缓解者。长期和短期反应者的基线特征（包括年龄、性别和组织学）相似。卡诺夫斯基体能状态 ≥ 80%与长期缓解显着相关(p = 0.02)，而骨转移(p = 0.03)、国际mRCC数据库联盟中低风险(p < 0.01)和中性粒细胞与淋巴细胞比率 ≥ 3.2 (p = 0.02) 与短期反应相关。长期缓解者的中位无进展生存期为 55.0 个月，而短期缓解者为 4.0 个月。长期应答者的中位 OS 尚未达到，而短期应答者的中位 OS 为 17.0 个月。这项回顾性分析揭示了与 mRCC 纳武单抗长期应答相关的因素。了解这些临床特征对于选择最能从免疫治疗中受益的患者至关重要。© 2024。作者。

Although nivolumab prolongs overall survival (OS) in pretreated patients with metastatic renal cell carcinoma (mRCC), underlining clinical and biological features of long-term responses are still to be determined. This study aims to investigate clinical and pathological characteristics of mRCC patients who achieved long-term responses during nivolumab treatment.A retrospective analysis was performed on mRCC patients receiving nivolumab as second or further therapy line between May 2016 and January 2019 in 34 Italian Oncology Centres. Outcome assessments and logistic regression were performed to evaluate factors influencing long-term responses.A total of 571 patients with a median age of 61 years (range 17-85) were included in the analysis. With a median follow-up of 22.1 (1.0-89.0) months, 23.1% of patients were 2-year progression-free on treatment with nivolumab, hence they were categorized as long-term responders. Baseline characteristics, including age, gender, and histology, were similar between long- and short-term responders. Karnofsky Performance Status ≥ 80% was significantly associated with long-term response (p = 0.02), while bone metastases (p = 0.03), International mRCC Database Consortium intermediate-poor risk (p < 0.01) and Neutrophil-to-Lymphocyte Ratio ≥ 3.2 (p = 0.02) were associate with short-term responses. Long-term responders exhibited a median progression-free survival of 55.0 months versus 4.0 months of the short-term responders. The median OS was not reached in long-term responders while it was 17.0 months for short*term responders.This retrospective analysis sheds light on factors associated with long-term response to nivolumab in mRCC. Understanding these clinical features will be essential for selecting patients who may mostly benefit from immunotherapy.© 2024. The Author(s).