免疫检查点抑制剂在真实世界中治疗老年非小细胞肺癌患者的应用。
Immune Checkpoint Inhibitors in Real-World Treatment of Older Adults with Non-Small Cell Lung Cancer.
机构信息
James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.
Mackenzie Health, Richmond Hill, Ontario, Canada.
出版信息
J Am Geriatr Soc. 2019 May;67(5):905-912. doi: 10.1111/jgs.15750. Epub 2019 Jan 30.
OBJECTIVE
To evaluate the efficacy and toxicity of immune checkpoint inhibitors (ICIs) in older patients with advanced non-small cell lung cancer (NSCLC) seen in routine clinical practice.
DESIGN
Retrospective study.
SETTING
Single academic institution and its affiliated centers.
PARTICIPANTS
Patients 70 years or older with advanced-stage NSCLC seen between April 1, 2015, and April 1, 2017, and treated with ICIs.
MEASUREMENTS
Efficacy data included overall survival (OS) and time to treatment failure (TTF), stratified by age, comorbidities (Charlson Comorbidity Index [CCI]), and Eastern Cooperative Oncology Group Performance Status (ECOG PS), and estimated using the Kaplan-Meier method and log-rank test. Toxicity data included immune-related adverse events (irAEs), need for glucocorticoids, and hospitalization. The associations of toxicity with age, CCI, and ECOG PS were evaluated using the exact χ test or Fisher exact test.
RESULTS
We included 75 patients (median age: 74 y; range, 70-92 y); 53% had a CCI of 3 or higher; 49% had ECOG PS of 2 or higher. Median OS for the whole cohort was 8.2 months (ECOG PS 0-1 vs ≥2: 13.7 vs 3.8 mo; p < .01). Median TTF was 4.2 months (ECOG PS 0-1 vs ≥2: 5.6 vs 2.0 mo; p = .02). Overall, 37% of patients experienced irAE of any grade (a total of 37 events); 8% were grade 3 or higher (no ICI-related deaths). Of those who discontinued ICIs (N = 64), 15% were due to irAEs. Of those who experienced irAEs, 64% required glucocorticoids. Hospitalizations during ICI treatment occurred in 72%. Toxicity generally did not differ by age, CCI, or ECOG PS.
CONCLUSIONS
Outcomes in our cohort were driven by ECOG PS rather than chronological age or comorbidities. The relatively high rates of ICI discontinuation, use of glucocorticoids, and hospitalization during ICI treatment in our study highlight the vulnerability of older adults with advanced NSCLC even in the immunotherapy era. J Am Geriatr Soc 67:905-912, 2019.
目的
评估免疫检查点抑制剂（ICI）在常规临床实践中治疗老年晚期非小细胞肺癌（NSCLC）患者的疗效和毒性。
设计
回顾性研究。
地点
单所学术机构及其附属中心。
参与者
2015 年 4 月 1 日至 2017 年 4 月 1 日期间接受 ICI 治疗的年龄在 70 岁或以上的晚期 NSCLC 患者。
测量
疗效数据包括总生存（OS）和治疗失败时间（TTF），按年龄、合并症（Charlson 合并症指数[CCI]）和东部合作肿瘤学组表现状态（ECOG PS）分层，并使用 Kaplan-Meier 方法和对数秩检验进行估计。毒性数据包括免疫相关不良事件（irAE）、糖皮质激素的需要和住院情况。使用确切的 χ 检验或 Fisher 确切检验评估毒性与年龄、CCI 和 ECOG PS 的关系。
结果
我们纳入了 75 名患者（中位年龄：74 岁；范围，70-92 岁）；53%的患者 CCI 为 3 或更高；49%的患者 ECOG PS 为 2 或更高。整个队列的中位 OS 为 8.2 个月（ECOG PS 0-1 与≥2：13.7 与 3.8 mo；p<.01）。中位 TTF 为 4.2 个月（ECOG PS 0-1 与≥2：5.6 与 2.0 mo；p=.02）。总体而言，37%的患者出现任何等级的 irAE（共 37 例事件）；8%为 3 级或更高（无 ICI 相关死亡）。在停止 ICI 治疗的患者中（N=64），15%因 irAE 而停药。在发生 irAE 的患者中，64%需要使用糖皮质激素。ICI 治疗期间有 72%的患者住院。毒性通常与年龄、CCI 或 ECOG PS 无关。
结论
在我们的队列中，ECOG PS 而不是实际年龄或合并症是决定预后的因素。在我们的研究中，ICI 治疗期间较高的 ICI 停药率、糖皮质激素使用率和住院率突显了即使在免疫治疗时代，老年晚期 NSCLC 患者也很脆弱。J Am Geriatr Soc 67:905-912, 2019。
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