Background/Objectives: The efficacy and safety of nivolumab plus ipilimumab (NIVO + IPI) for elderly patients with metastatic renal cell carcinoma have not been reported with sufficient evidence. Our study therefore aimed to compare the efficacy and safety of NIVO + IPI between patients ≥75 years and patients <75 years with metastatic renal cell carcinoma. Methods: We retrospectively analyzed a multi-center cohort of the 156 patients that received NIVO + IPI treatment at eight institutions. Among them, 33 patients were ≥75 years old, and the remainder were <75 years old. Results: Patient demographics and tumor characteristics were not significantly different between the two groups except for age. The objective response rate, disease control rate, progression-free survival, or cancer-specific survival were not significantly different between the groups. However, overall survival in the patients ≥75 years was significantly shorter than that in the patients <75 years (median: 18 months vs. 46 months,p =0.01). In addition, an age ≥75 years was shown in multivariable analysis to be a significant independent predictor of poor overall survival. Toxicity did not show any significant variation between the groups. Conclusions: Although the clinical efficacy and safety of NIVO + IPI was demonstrated in patients ≥75 years old, it is suggested that the indication for NIVO + IPI in this age group should be carefully considered, taking into account patients’ expected life expectancy.
背景/目的:纳武利尤单抗联合伊匹木单抗(NIVO + IPI)在老年转移性肾细胞癌患者中的疗效与安全性尚未获得充分证据支持。本研究旨在比较≥75岁与<75岁转移性肾细胞癌患者接受NIVO + IPI治疗的疗效与安全性差异。方法:我们回顾性分析了来自八家医疗中心的156例接受NIVO + IPI治疗的患者队列,其中33例患者年龄≥75岁,其余患者年龄<75岁。结果:除年龄外,两组患者的人口学特征与肿瘤特征无显著差异。客观缓解率、疾病控制率、无进展生存期及癌症特异性生存期在两组间均未呈现显著差异。然而,≥75岁患者的总生存期显著短于<75岁患者(中位生存期:18个月 vs. 46个月,p=0.01)。多变量分析进一步显示,年龄≥75岁是总生存期不良的显著独立预测因素。两组间的治疗毒性反应未见显著差异。结论:尽管NIVO + IPI在≥75岁患者中显示出临床疗效与安全性,但建议在该年龄组应用此治疗方案时需审慎评估,并综合考虑患者的预期生存期。