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曲妥珠单抗-德鲁替康治疗的癌症患者的间质性肺病的临床和影像学特征。

Clinical and imaging features of interstitial lung disease in cancer patients treated with trastuzumab deruxtecan.

机构信息

Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomiokahigashi, Kanazawa-ku, Yokohama-shi, Kanagawa, 236-0051, Japan.

Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

出版信息

Int J Clin Oncol. 2023 Dec;28(12):1585-1596. doi: 10.1007/s10147-023-02414-x. Epub 2023 Oct 3.

Abstract

BACKGROUND

Interstitial lung disease/pneumonitis (ILD/pneumonitis) has been identified as a drug-related adverse event of special interest of trastuzumab deruxtecan (T-DXd), but there were a few reports of T-DXd-related ILD/pneumonitis in clinical practice.

METHODS

Between May 25, 2020 (the launch of T-DXd in Japan) and February 24, 2022, there were 287 physician-reported potential ILD/pneumonitis cases from the Japanese post-marketing all-case surveillance. By February 27, 2022, an independent adjudication committee assessed 138 cases and adjudicated 130 cases as T-DXd-related ILD/pneumonitis. The clinical features and imaging characteristics of these cases were evaluated.

RESULTS

The majority of adjudicated T-DXd-related ILD/pneumonitis cases were grade 1 or 2 (100/130, 76.9%). The most common radiological pattern types observed were organizing pneumonia patterns (63.1%), hypersensitivity pneumonitis patterns (16.9%), and diffuse alveolar damage (DAD) patterns (14.6%). Eleven cases (8.5%) from 130 resulted in death; the majority of these (8/11, 72.7%) had DAD patterns. The overall proportion of recovery (including the outcomes of recovered, recovered with sequelae, and recovering) was 76.9%, and the median time to recovery was 83.5 days (interquartile range: 42.25-143.75 days). Most cases (59/71, 83.1%) that were treated with corticosteroids were considered responsive to treatment.

CONCLUSIONS

This is the first report to evaluate T-DXd-related ILD/pneumonitis cases in clinical practice. Our findings are consistent with previous reports and suggest that patients with DAD patterns have poor outcomes. Evaluation of a larger real-world dataset may further identify predictors of clinical outcome.

摘要

背景

间质性肺疾病/肺炎(ILD/肺炎)已被确定为曲妥珠单抗德曲妥珠单抗(T-DXd)的一种特别关注的药物相关不良事件,但在临床实践中也有少数 T-DXd 相关 ILD/肺炎的报告。

方法

在 2020 年 5 月 25 日(T-DXd 在日本上市)至 2022 年 2 月 24 日期间,来自日本上市后全病例监测的 287 例由医生报告的潜在 ILD/肺炎病例。截至 2022 年 2 月 27 日,一个独立的裁决委员会评估了 138 例病例,并裁决 130 例为 T-DXd 相关的 ILD/肺炎。评估了这些病例的临床特征和影像学特征。

结果

裁决的 T-DXd 相关 ILD/肺炎病例多数为 1 级或 2 级(100/130,76.9%)。最常见的影像学模式类型为机化性肺炎模式(63.1%)、过敏性肺炎模式(16.9%)和弥漫性肺泡损伤(DAD)模式(14.6%)。130 例中有 11 例(8.5%)导致死亡;其中大多数(8/11,72.7%)为 DAD 模式。总体恢复比例(包括恢复、恢复后留有后遗症和正在恢复)为 76.9%,恢复中位数时间为 83.5 天(四分位距:42.25-143.75 天)。大多数接受皮质类固醇治疗的病例(59/71,83.1%)被认为对治疗有反应。

结论

这是首次报告评估 T-DXd 相关 ILD/肺炎病例在临床实践中的情况。我们的发现与之前的报告一致,表明 DAD 模式的患者预后较差。对更大的真实世界数据集的评估可能进一步确定临床结局的预测因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7d4/10687185/c3a70d91d431/10147_2023_2414_Fig1_HTML.jpg

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