Yamashita Shimpei, Hamamoto Shuzo, Furukawa Junya, Fujita Kazutoshi, Takahashi Masayuki, Miyake Makito, Ito Noriyuki, Iwamoto Hideto, Kohjimoto Yasuo, Hara Isao
Department of Urology, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-0012, Japan.
Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.
Cancers (Basel). 2025 Jan 31;17(3):474. doi: 10.3390/cancers17030474.
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.
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.
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, 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.
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）用于老年转移性肾细胞癌患者的疗效和安全性尚未有充分证据报道。因此，我们的研究旨在比较年龄≥75岁和年龄<75岁的转移性肾细胞癌患者使用NIVO + IPI的疗效和安全性。
我们回顾性分析了在8家机构接受NIVO + IPI治疗的156例患者的多中心队列。其中，33例患者年龄≥75岁，其余患者年龄<75岁。
除年龄外，两组患者的人口统计学和肿瘤特征无显著差异。两组之间的客观缓解率、疾病控制率、无进展生存期或癌症特异性生存期无显著差异。然而，年龄≥75岁患者的总生存期显著短于年龄<75岁的患者（中位数：18个月对46个月，P = 0.01）。此外，多变量分析显示年龄≥75岁是总生存期差的显著独立预测因素。两组之间的毒性无显著差异。
尽管NIVO + IPI在≥75岁患者中显示出临床疗效和安全性，但建议在考虑该年龄组患者的预期寿命后，仔细考虑NIVO + IPI在该年龄组的适应证。
