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Abstract：
BACKGROUND: Immune checkpoint inhibitors (ICI) applied in patients with melanoma in an adjuvant setting have proven safety and efficacy in several studies, but data on elderly patients aged 75 years or more is scarce. Aim of this study was to investigate efficacy and safety of adjuvant ICI in patients aged ≥ 75 years compared to patients < 75 years in a real-world setting.
METHODS: We retrospectively analyzed clinical data, including occurrence of immune-related adverse events (irAE) and outcome of 456 patients that had been treated with adjuvant ICI between January 1st, 2018 and December 20th, 2022. We then compared patients aged ≥ 75 years (n = 117) to patients < 75 years (n = 339) in terms of safety and disease-free survival (DFS).
CONCLUSIONS: ICI were well tolerated in both groups, with no significant difference observed in the overall occurrence of irAE. However, within the elderly subgroup, there was a significantly higher proportion of skin or nephrological toxicity and colitis/diarrhea compared to the other group. In terms of efficacy, a significantly shorter DFS in patients aged ≥ 75 years was observed. Adjuvant ICI in patients ≥ 75 years was less effective and furthermore associated with an increased risk for skin, renal or bowel toxicity. Therefore, in elderly patients, adjuvant ICI should be used with precaution.
METHODS: We retrospectively analyzed clinical data, including occurrence of immune-related adverse events (irAE) and outcome of 456 patients that had been treated with adjuvant ICI between January 1st, 2018 and December 20th, 2022. We then compared patients aged ≥ 75 years (n = 117) to patients < 75 years (n = 339) in terms of safety and disease-free survival (DFS).
CONCLUSIONS: ICI were well tolerated in both groups, with no significant difference observed in the overall occurrence of irAE. However, within the elderly subgroup, there was a significantly higher proportion of skin or nephrological toxicity and colitis/diarrhea compared to the other group. In terms of efficacy, a significantly shorter DFS in patients aged ≥ 75 years was observed. Adjuvant ICI in patients ≥ 75 years was less effective and furthermore associated with an increased risk for skin, renal or bowel toxicity. Therefore, in elderly patients, adjuvant ICI should be used with precaution.
摘要：
背景：在一些研究中证明了在辅助环境中应用于黑色素瘤患者的免疫检查点抑制剂（ICI）的安全性和有效性，但是关于75岁或以上的老年患者的数据很少。这项研究的目的是研究与真实世界中<75岁的患者相比，年龄≥75岁的患者使用辅助ICI的疗效和安全性。
方法：我们回顾性分析临床资料，包括1月1日之间接受辅助ICI治疗的456名患者的免疫相关不良事件（irAE）的发生和结果，2018年12月20日,2022年。然后，我们在安全性和无病生存期（DFS）方面比较了年龄≥75岁（n=117）和<75岁（n=339）的患者。
结论：ICI在两组中均有良好的耐受性，在IRAE的总体发生率中没有观察到显着差异。然而,在老年人亚组中，与其他组相比,皮肤或肾病毒性和结肠炎/腹泻的比例明显更高.就功效而言,观察到≥75岁患者的DFS显著较短.≥75岁患者的辅助ICI效果较差，而且与皮肤风险增加有关。肾或肠毒性。因此,在老年患者中，佐剂ICI应谨慎使用。
方法：我们回顾性分析临床资料，包括1月1日之间接受辅助ICI治疗的456名患者的免疫相关不良事件（irAE）的发生和结果，2018年12月20日,2022年。然后，我们在安全性和无病生存期（DFS）方面比较了年龄≥75岁（n=117）和<75岁（n=339）的患者。
结论：ICI在两组中均有良好的耐受性，在IRAE的总体发生率中没有观察到显着差异。然而,在老年人亚组中，与其他组相比,皮肤或肾病毒性和结肠炎/腹泻的比例明显更高.就功效而言,观察到≥75岁患者的DFS显著较短.≥75岁患者的辅助ICI效果较差，而且与皮肤风险增加有关。肾或肠毒性。因此,在老年患者中，佐剂ICI应谨慎使用。
