BACKGROUND The aim of this study was to compare the efficacy and safety of nivolumab as second-line and later-line (third-line or thereafter) therapy in metastatic renal cell carcinoma (mRCC). METHODS Sixty-seven patients who received nivolumab after the failure of at least one molecular-targeted therapy were evaluated. The patients were divided into two groups based on the line of nivolumab: second-line and later-line groups. Efficacy was assessed using progression-free survival and overall survival (OS) after nivolumab initiation, and objective response rate. Safety was assessed using the incidence of immune-related adverse events. These outcomes were compared between the second-line and later-line groups. RESULTS Forty-two patients (62.7%) received nivolumab as second-line therapy. There was no significant difference in the progression-free survival (median: 5.06 vs. 6.28 months, p = 0.691) or objective response rate (35.7% vs. 32.0%, p = 0.757) between the second-line and later-line groups. The OS tended to be longer in the second-line group (not reached vs. 26.0 months, p = 0.118), and the rate of patients who received subsequent therapy after nivolumab failure was significantly higher in the second-line group (90.9% vs. 55.0%, p = 0.0025). There was no difference in the incidences of immune-related adverse events between the second-line and later-line groups (any grade: 54.8% vs. 48.0%, p = 0.592; grade ≥ 3: 19.1% vs. 20.0%, p = 0.924). CONCLUSIONS The efficacy of nivolumab did not deteriorate and the tolerability was also maintained even in later-line therapy. However, a tendency of longer OS and a higher chance of subsequent therapy after nivolumab failure were observed with nivolumab as second-line therapy.

中文翻译：

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转移性肾细胞癌的二线和后线nivolumab治疗的疗效和安全性相当。

背景技术这项研究的目的是比较纳武单抗作为转移性肾细胞癌（mRCC）的二线和后线（三线或以后）治疗的有效性和安全性。方法评估了67例在至少一种分子靶向治疗失败后接受了nivolumab的患者。根据nivolumab线将患者分为两组：二线和后线组。使用nivolumab启动后的无进展生存期和总生存期（OS）以及客观缓解率评估疗效。使用免疫相关不良事件的发生率评估安全性。这些结果在二线和后线组之间进行了比较。结果42例患者（62.7％）接受了尼古鲁单抗作为二线治疗。二线和后线组的无进展生存期（中位数：5.06 vs. 6.28个月，p = 0.691）或客观缓解率（35.7％vs. 32.0％，p = 0.757）没有显着差异。 。二线组的OS倾向于更长（未达到vs. 26.0个月，p = 0.118），二线组在nivolumab失败后接受后续治疗的患者比率显着更高（90.9％vs 55.0％，p = 0.0025）。二线和后线组之间免疫相关不良事件的发生率没有差异（任何等级：54.8％vs. 48.0％，p = 0.592；等级≥3：19.1％vs. 20.0％，p = 0.924）。结论尼伏鲁单抗的疗效没有降低，甚至在以后的治疗中也保持了耐受性。然而，