Department of Medicine II, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany; Mannheim Cancer Center, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany.
Cermed Contract Research GmbH, Friedrichstr. 94, 10117 Berlin, Germany.
J Geriatr Oncol. 2024 Sep;15(7):101838. doi: 10.1016/j.jgo.2024.101838. Epub 2024 Aug 3.
The phase 2 RAMONA study demonstrated that second-line nivolumab ± ipilimumab immunotherapy was feasible and effective in older patients with advanced esophageal squamous cell cancer (ESCC). Here, we presented results from functional status (FS) and quality-of-life (QoL) analyses.
Patients aged ≥65 years with advanced ESCC and disease progression following first-line therapy were enrolled for study treatment with nivolumab ± ipilimumab. Geriatric assessments (GA) consisting of G8 and GoGo/SlowGo evaluation, and quality of life (QoL) assessments with EORTC QLQ-C30 questionnaires were conducted at baseline and during the treatment. A post hoc analysis was performed to compare therapy efficacy, toxicity, and QoL between age groups (≥70 years vs. <70 years) and functionality groups (G8 > 14 vs. ≤14 and GoGo vs. SlowGo).
In 66 treated patients with a median age of 70.5 years, older patients had non-inferior overall survival and tumor response compared to younger patients, with no increased treatment-related adverse events. Fitter patients (G8 > 14, GoGo) had a clinically, yet not statistically significant, survival advantage than less fit patients (G8 ≤ 14, SlowGo) patients. Moreover, FS by G8 and GoGo/SlowGo significantly correlated with QoL. Overall, QoL was impaired at baseline but remained stable in all scales over the course of immunotherapy.
The administration of nivolumab ± ipilimumab second-line immunotherapy in older patients with ESCC did not show age-dependent effects and maintained QoL. GA could identify functional deficits and limitations of QoL and should be implemented in the context of immunotherapy.
gov: NCT03416244.
RAMONA 二期研究表明，二线纳武利尤单抗±伊匹单抗免疫治疗在老年晚期食管鳞癌（ESCC）患者中是可行且有效的。在此，我们报告了功能状态（FS）和生活质量（QoL）分析的结果。
纳入年龄≥65 岁、接受一线治疗后疾病进展的晚期 ESCC 患者，接受纳武利尤单抗±伊匹单抗治疗。在基线和治疗期间进行了包括 G8 和 GoGo/SlowGo 评估的老年综合评估（GA）和 EORTC QLQ-C30 问卷的生活质量（QoL）评估。进行了一项事后分析，以比较年龄组（≥70 岁与<70 岁）和功能组（G8>14 与≤14 及 GoGo 与 SlowGo）之间的治疗效果、毒性和 QoL。
在 66 例接受治疗的中位年龄为 70.5 岁的患者中，与年轻患者相比，老年患者的总生存期和肿瘤反应非劣效，且无增加的治疗相关不良事件。功能状态较好的患者（G8>14，GoGo）比功能状态较差的患者（G8≤14，SlowGo）有临床意义但无统计学意义的生存优势。此外，G8 和 GoGo/SlowGo 的 FS 与 QoL 显著相关。总体而言，QoL 在基线时受损，但在免疫治疗过程中所有量表均保持稳定。
二线纳武利尤单抗±伊匹单抗免疫治疗在老年 ESCC 患者中并未显示出年龄依赖性影响，且保持 QoL。GA 可以识别功能缺陷和 QoL 的限制，应在免疫治疗中实施。
gov：NCT03416244。
