参加早期临床试验的患者的间质性肺疾病:ILDE 研究。
Interstitial lung disease in patients enrolled in early-phase clinical trials: the ILDE study.
发表日期:2024 Aug 02
作者:
D Trapani, R Scalia, E Giordano, G Castellano, G Doi, A Gaeta, G Pellizzari, A Carnevale Schianca, J Katrini, S D'Ambrosio, C Santoro, L Guidi, C Valenza, C Belli, S Gandini, A Russo, G Curigliano
来源:
ESMO Open
摘要:
间质性肺疾病 (ILD) 包含一组具有共同病理生理炎症机制的异质性疾病,可导致实质扭曲。新抗癌药物引起 ILD 的患病率报告不足:识别潜在决定因素是首要任务。ILDE 是一项回顾性研究,旨在描述接受实验治疗的患者 ILD 的临床病程和潜在决定因素。我们确定了 226 名符合条件的患者,其中 5.3 % (n = 12) 患有 ILD。 5 名患者的诊断是放射学诊断,7 名患者最初出现咳嗽、呼吸困难、疲劳或发烧。 ILD 在 4 名患者中被评定为 1 级 (G1),在 5 名患者中被评定为 G2,在 3 名患者中被评定为 G3。 50% 的患者首次出现 ILD 后完全消退 (n = 6/12)。没有患者患有致命的 ILD。 8 名患者 (66.7%) 在首次 ILD 发作后恢复治疗,而 4 名患者 (33.3%) 不得不停止治疗。六名患者中的五名已经解决了第一次 ILD 发作,然后恢复治疗,经历了第二次 ILD 发作(n = 5/6;83.3%)。第二个 ILD 事件为 3 名患者的 G1 和 2 名患者的 G2,导致 3 名患者最终停止治疗(n = 3/5;60%)。相关分析显示,老年患者 (P = 0.051)、既往接受过胸部放射治疗的患者 (P = 0.047) 或接受抗体药物偶联物的患者 (P = 0.006) 发生 ILD 的风险较高。在针对永生时间偏差进行调整的生存分析中,ILD 并不是独立的预后因素(风险比 0.50,95% 置信区间 0.23-1.09,P = 0.082)。在 ILDE 中,经历 ILD 的患者通常有良好的结果,许多人可能会复发癌症治疗。实施最佳实践来促进 ILD 的诊断和管理对于治疗新药潜在的严重不良反应,同时不影响患者的治疗结果至关重要。有必要开展研究工作来确定风险因素,实施基于风险的监测计划并制定临时策略来提高 ILD 的治愈率。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。
Interstitial lung disease (ILD) encompasses a heterogeneous group of disorders sharing pathophysiological inflammatory mechanisms, leading to parenchymal distortions. The prevalence of ILD with new cancer drugs is underreported: the identification of potential determinants is priority.ILDE is a retrospective study aimed at describing the clinical course and potential determinants of ILD in patients receiving experimental treatments.We identified 226 eligible patients, of whom 5.3% (n = 12) had ILD. In five patients, the diagnosis was radiological, while seven patients had initial cough, dyspnea, fatigue or fever. ILD was graded as grade 1 (G1) in four, G2 in five and G3 in three patients. The first occurrence of ILD resolved completely in 50% of patients (n = 6/12). No patient had fatal ILD. Eight patients (66.7%) resumed the treatment after the first episode of ILD, while four patients (33.3%) had to discontinue the therapy. Five out of six patients had resolved the first ILD episode and then resumed treatment, experiencing a second ILD episode (n = 5/6; 83.3%). The second ILD event was G1 in three patients and G2 in two patients, resulting in three patients who eventually discontinued the treatment (n = 3/5; 60%). Correlation analysis showed a higher risk of ILD in older patients (P = 0.051), those who had received previous chest radiation therapy (P = 0.047) or those receiving antibody-drug conjugates (P = 0.006). In a survival analysis adjusted for immortal time bias, ILD was not independently prognostic (hazard ratio 0.50, 95% confidence interval 0.23-1.09, P = 0.082).In ILDE, patients experiencing ILD had generally good outcomes, and many could resume the cancer treatments. Implementing best practices to prompt diagnosis and management of ILD is critical to treat a potentially severe adverse effect of new drugs, while not affecting patients' outcomes. Research efforts to identify risk factors is warranted, to implement risk-based monitoring schedules and develop ad hoc strategies to improve the cure rates of ILD.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.