间质性肺疾病（ILD）是最常见的致命性免疫相关不良事件（irAE）之一。 ILD 的发展会对抗癌药物治疗的持续产生不利影响，包括免疫检查点抑制剂 (ICI) 治疗和预后。目前尚无既定有用的临床指标可用于早期检测 ILD。此外，导致主治医生怀疑 ICI 诱发 ILD (ICI-ILD) 的因素仍不清楚。本研究旨在探讨接受抗PD-1/PD-L1抗体治疗的患者基于主观症状的ICI-ILD检测及其与疾病严重程度的关系。这是一项回顾性观察研究。我们招募了 2014 年 9 月至 2021 年 4 月期间在京都大学医院接受抗 PD-1/PD-L1 抗体的患者。根据引发怀疑 ILD 发展的因素，将发生 ICI-ILD 的患者分为两个不同的组。 “主观症状”组被定义为根据主观症状检测出ILD的患者。相反，“常规检查”组被定义为根据预定的常规检查怀疑患有 ILD 的患者。评估各组ILD的严重程度，并检查其与呼吸道症状变化的关系。 在接受抗PD-1/PD-L1抗体的926名患者中，51名患者（5.5%）发展为ICI-ILD。肺癌患者ICI-ILD的发生率显着高于其他癌症患者（P<0.001）。在ICI-ILD患者中，27名患者（52.9%）被归入“主观症状”组。 “主观症状”组3-5级ICI-ILD病例比例显着高于“常规检查”组（76.2% vs. 23.8%，P = 0.010）。末次就诊时，在疑似ILD发病前，27例患者中有21例（77.8%）无症状或呼吸道症状无变化。主观症状引发怀疑3-5级ICI-ILD。加强监测和患者教育对于早期发现 ICI-ILD 至关重要，因为 ILD 可能发展迅速。我们的研究结果可能有助于在临床实践中管理 ICI-ILD。© 2024。作者。

Interstitial lung disease (ILD) is one of the most common fatal immune-related adverse events (irAEs). ILD development adversely affects the continuation of anticancer drug therapy, including immune checkpoint inhibitor (ICI) therapy and prognosis. There are no established useful clinical indicators for the early detection of ILD. Furthermore, the factors that lead the attending physician to suspect ICI-induced ILD (ICI-ILD) remain unclear. This study aimed to investigate the ICI-ILD detection based on subjective symptoms and their relationship with disease severity in patients receiving anti-PD-1/PD-L1 antibody.This was a retrospective observational study. We enrolled the patients who received anti-PD-1/PD-L1 antibody at Kyoto University Hospital between September 2014 and April 2021. Patients who developed ICI-ILD were stratified into two distinct groups based on factors that triggered the suspicion of ILD development. The "Subjective symptoms" group was defined as patients in whom ILD was detected based on subjective symptoms. Conversely, the "Routine examinations" group was defined as patients in whom ILD was suspected based on scheduled routine examinations. The severity of ILD in each group was assessed and its association with changes in the respiratory symptoms was examined.Of 926 patients who received anti-PD-1/PD-L1 antibody, 51 patients (5.5%) developed ICI-ILD. The incidence of ICI-ILD in patients with lung cancer was significantly higher than that in patients with other cancers (P < 0.001). Among the patients with ICI-ILD, 27 patients (52.9%) were classified into the "Subjective symptoms" group. The "Subjective symptoms" group exhibited a significantly higher proportion of Grade 3-5 ICI-ILD cases than the "Routine examinations" group (76.2% vs. 23.8%, P = 0.010). At the last visit, before the suspected onset of ILD, 21 of the 27 patients (77.8%) had no symptoms or no change in the respiratory symptoms.Subjective symptoms triggered the suspicion of Grade 3-5 ICI-ILD. Enhanced monitoring and patient education could be essential for the early detection of ICI-ILD because ILD may develop rapidly. Our findings might help to manage ICI-ILD in clinical practice.© 2024. The Author(s).