免疫疗法在老年晚期非小细胞肺癌一线治疗中的应用：意大利胸肿瘤学会（AIOT）国际专家小组会议的结果。
Immunotherapy in the first-line treatment of elderly patients with advanced non-small-cell lung cancer: results of an International Experts Panel Meeting by the Italian Association of Thoracic Oncology (AIOT).
机构信息
Division of Medical Oncology, "S.G. Moscati" Hospital, Avellino, Italy.
Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
出版信息
ESMO Open. 2023 Apr;8(2):101192. doi: 10.1016/j.esmoop.2023.101192. Epub 2023 Mar 23.
BACKGROUND
The use of immune checkpoint inhibitors (ICIs) in the front-line treatment of advanced non-small-cell lung cancer (NSCLC) is currently the standard of care. However, as clinical trials include a very limited number of elderly patients, evidence on the safety and efficacy of using ICI-based regimens is still limited.
METHODS
A virtual International Expert Panel took place in July 2022 to review the available evidence on the use of ICI-based regimens in the first-line setting in elderly patients with NSCLC and provide a position paper on the field both in clinical practice and in a research setting.
RESULTS
All panelists agreed that age per se is not a limitation for ICI treatments, as the elderly should be considered only as a surrogate for other clinical factors of frailty. Overall, ICI efficacy in the elderly population is supported by reviewed data. In addition, the panelists were confident that available data support the safety of single-agent immunotherapy in elderly patients with NSCLC. Conversely, concerns were expressed on the safety of chemo + ICI-based combination, which were considered mainly related to the toxicities of chemotherapy components. Therefore, suggestions were proposed to tailor combined approaches in the elderly patients with NSCLC. The panelists defined high, medium, and low priorities in clinical research. High priority was attributed to implementing the real-world assessment of elderly patients treated with ICIs, who are mostly underrepresented in pivotal clinical trials.
CONCLUSIONS
Based on the current evidence, the panelists outlined the significant limitations affecting the clinical practice in elderly patients affected by NSCLC, and reached common considerations on the feasibility, safety, and effectiveness of ICI monotherapy and ICI combinations in the first-line setting.
背景
免疫检查点抑制剂（ICI）在晚期非小细胞肺癌（NSCLC）的一线治疗中的应用目前是标准治疗方法。然而，由于临床试验纳入的老年患者数量非常有限，因此关于使用基于 ICI 的方案的安全性和疗效的证据仍然有限。
方法
一个虚拟的国际专家小组于 2022 年 7 月举行会议，审查了在 NSCLC 老年患者中使用基于 ICI 的方案作为一线治疗的现有证据，并就临床实践和研究环境中的该领域提供了一份立场文件。
结果
所有小组成员都认为，年龄本身并不是 ICI 治疗的限制因素，因为老年人仅应被视为其他脆弱性临床因素的替代指标。总体而言，审查数据支持 ICI 在老年人群中的疗效。此外，小组成员对单药免疫治疗在 NSCLC 老年患者中的安全性充满信心。相反，对化疗+ICI 联合方案的安全性表示担忧，这主要与化疗成分的毒性有关。因此，提出了在 NSCLC 老年患者中调整联合治疗方法的建议。小组成员对临床研究确定了高、中、低优先级。高度优先考虑对接受 ICI 治疗的老年患者进行真实世界的评估，这些患者在关键性临床试验中代表性不足。
结论
基于现有证据，小组成员概述了影响 NSCLC 老年患者临床实践的重大局限性，并就 ICI 单药治疗和一线治疗中 ICI 联合治疗的可行性、安全性和有效性达成了共识。
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