ECOG 体能状况 2 分的晚期非小细胞肺癌患者的一线免疫治疗：意大利胸部肿瘤学会国际专家小组会议的结果。
First-line immunotherapy in advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an International Expert Panel Meeting by the Italian Association of Thoracic Oncology.
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. 2022 Feb;7(1):100355. doi: 10.1016/j.esmoop.2021.100355. Epub 2021 Dec 16.
BACKGROUND
Immunotherapy represents the standard of care in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), either as monotherapy in high programmed death-ligand 1 (PD-L1)-positive tumors (≥50%) or in combination with platinum-based chemotherapy regardless of PD-L1 status. However, most pivotal clinical trials of immune checkpoint inhibitors (ICIs) did not include patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2. Hence, a consensus is lacking on the safety and efficacy of ICIs in this specific subgroup of patients.
MATERIALS AND METHODS
A virtual International Expert Panel took place in July 2021 with the aim of reviewing the available evidence on the use of ICIs in NSCLC patients with ECOG PS 2, both in clinical practice and in a research setting.
RESULTS
All panelists expressed concern about the applicability of currently available PS scales to evaluate patients for ICI treatment. The panelists agreed that, though limited, the available data support the safety of single-agent immunotherapy in PS 2 NSCLC patients, whereas concern was raised on the safety of ICI combinations, mainly related to chemotherapy and/or anti-cytotoxic T-lymphocyte-associated antigen 4 toxicity. On the basis of reviewed data, ICI efficacy may be speculated in PS 2 NSCLC patients; however, PS 2 remains a negative prognostic category as compared to PS 0-1 in patients treated with ICI, as it is for chemotherapy. The panelists defined high, medium and low priorities in clinical research. High priority was attributed to the inclusion of PS 2 patients in prospective clinical trials and the specific evaluation of combined ICI treatments with attenuated chemotherapy doses.
CONCLUSIONS
Based on the current evidence, the panelists outlined the major limitations affecting PS 2 patients with NSCLC and reached common considerations on the feasibility, safety and effectiveness of ICI monotherapy and ICI combinations in the first-line setting.
背景
免疫疗法代表了晚期非小细胞肺癌（NSCLC）一线治疗的标准治疗方法，无论是在高程序性死亡配体 1（PD-L1）阳性肿瘤（≥50%）中作为单药治疗，还是在不考虑 PD-L1 状态的情况下与铂类化疗联合使用。然而，大多数免疫检查点抑制剂（ICI）的关键临床试验并未纳入东部合作肿瘤学组（ECOG）表现状态（PS）为 2 的患者。因此，对于这一特定亚组患者，ICI 的安全性和疗效缺乏共识。
材料和方法
2021 年 7 月举行了一次虚拟的国际专家小组会议，目的是审查在临床实践和研究环境中，ECOG PS 2 的 NSCLC 患者使用 ICI 的现有证据。
结果
所有小组成员都对目前可用的 PS 量表评估 ICI 治疗患者的适用性表示关注。小组成员一致认为，尽管数据有限，但现有的数据支持单药免疫疗法在 PS 2 NSCLC 患者中的安全性，而对 ICI 联合治疗的安全性提出了担忧，主要与化疗和/或抗细胞毒性 T 淋巴细胞相关抗原 4 毒性有关。基于回顾的数据，可以推测 PS 2 NSCLC 患者的 ICI 疗效；然而，与 PS 0-1 患者相比，PS 2 仍然是一个负面的预后类别，无论是接受 ICI 治疗还是化疗。小组成员在临床研究中确定了高、中、低优先级。高优先级归因于将 PS 2 患者纳入前瞻性临床试验，以及对具有减轻化疗剂量的联合 ICI 治疗进行具体评估。
结论
基于目前的证据，小组成员概述了影响 NSCLC PS 2 患者的主要限制，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同考虑。
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