Department of Chemotherapy, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.
BMC Pulm Med. 2024 Oct 8;24(1):495. doi: 10.1186/s12890-024-03284-3.
Immune-related pneumonitis (irP) is one of the most important immune-related adverse events caused by immune checkpoint inhibitors (ICIs). After corticosteroid therapy irP frequently relapses, which can interfere with cancer therapy. However, risk factors for irP relapse are unknown.
This study was a follow-up analysis of a phase II study that evaluated 56 patients with grade ≥ 2 irP treated with oral prednisolone, 1 mg/kg/day, tapered over 6 weeks. Clinical factors including patient characteristics, blood test findings, and response to prednisolone therapy were assessed to identify risk factors for irP relapse using the Fine-Gray test.
Among 56 patients with irP, 22 (39.3%) experienced irP relapse after 6 weeks of prednisolone therapy during the follow-up observation period. Radiographic organising pneumonia (OP) pattern and duration to irP onset ≥ 100 days from ICI initiation were determined to be significant risk factors for irP relapse in a multivariate Fine-Gray test (hazard ratio [HR] = 3.17, 95% CI 1.37-7.32, p = 0.007, and HR = 2.61, 95% CI 1.01-6.74, p = 0.048, respectively). Other patient characteristics, blood test findings, irP severity, and response to prednisolone therapy were not associated with irP relapse.
In irP patients treated with 6-week prednisolone tapering therapy, OP pattern and duration to irP onset ≥ 100 days were associated with relapse risk. Assessment of the risk factors for irP relapse will be helpful for irP management.
免疫相关性肺炎（irP）是免疫检查点抑制剂（ICI）引起的最重要的免疫相关不良事件之一。皮质类固醇治疗后，irP 常复发，这会干扰癌症治疗。然而，irP 复发的危险因素尚不清楚。
本研究是对一项评估 56 例 2 级及以上 irP 患者的 II 期研究的随访分析，这些患者接受了为期 6 周的口服泼尼松龙治疗，剂量为 1mg/kg/天。采用 Fine-Gray 检验评估临床因素，包括患者特征、血液检查结果和对泼尼松龙治疗的反应，以确定 irP 复发的危险因素。
在 56 例 irP 患者中，有 22 例（39.3%）在泼尼松龙治疗后 6 周的随访观察期间发生 irP 复发。多变量 Fine-Gray 检验显示，影像学表现为机化性肺炎（OP）模式和从 ICI 开始到 irP 发病的时间≥100 天是 irP 复发的显著危险因素（风险比[HR]分别为 3.17，95%CI 1.37-7.32，p=0.007 和 2.61，95%CI 1.01-6.74，p=0.048）。其他患者特征、血液检查结果、irP 严重程度和对泼尼松龙治疗的反应与 irP 复发无关。
在接受 6 周泼尼松龙逐渐减量治疗的 irP 患者中，OP 模式和 irP 发病时间≥100 天与复发风险相关。评估 irP 复发的危险因素将有助于 irP 的管理。
