Real-world characteristics of trastuzumab deruxtecan-related interstitial lung disease in Japanese patients with breast cancer and gastric cancer.

IF 4.7 2区医学 Q1 ONCOLOGY

Oncologist Pub Date : 2026-09-09 DOI:10.1093/oncolo/oyag340

Yutaka Fujiwara, Katsunori Oikado, Tomohisa Baba, Masahiko Kusumoto, Shinichi Sasaki, Masahiro Endo, Terufumi Kato, Yasuyuki Kurihara, Yoshinobu Saito, Kunihiro Yagihashi, Masafumi Sata, Yoshinao Sato, Hirotsugu Kenmotsu, Taiki Fukuda, Teppei Yamaguchi, Saiko Isshiki, Hiroshi Wakui, Haruki Kobayashi, Satoshi Ikeda, Motoyasu Kato, Ou Yamaguchi, Toshimi Takano, Ken Kato, Yoshiharu Hiruma, Koji Hirata, Wataru Hashimoto, Kazuyoshi Kuwano

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引用次数: 0

Abstract

Background: Interstitial lung disease (ILD)/pneumonitis is an important adverse drug reaction associated with trastuzumab deruxtecan (T-DXd). This report comprehensively characterized clinical and imaging features of T-DXd-related ILD, systematically evaluated by an independent ILD Adjudication Committee (AC), in Japanese patients with breast/gastric cancer from all-patient post-marketing surveillance studies.

Patients and methods: This post hoc analysis evaluated independent ILD AC-adjudicated T-DXd-related ILD cases. Demographics, clinical/radiological features, time to onset, treatment interventions, and outcomes (followed up to 12 months from onset) were analyzed.

Results: Among 2801 T-DXd-treated patients (breast cancer: 1731; gastric cancer: 1070), 421 potential cases were reviewed: 381 were adjudicated as T-DXd-related ILD (breast cancer: 278; gastric cancer: 103). Median age was 65.0 years, 75.1% were female, and 28.3% had a smoking history. ILD occurred throughout observation (including fatal cases ≥12 months post-initiation) with no specific onset window. Time to onset did not differ across CTCAE grades. Organizing pneumonia was the predominant imaging pattern (67.7%), followed by hypersensitivity pneumonitis (14.2%) and diffuse alveolar damage (DAD, 12.6%). Most cases (78.2%) were worst CTCAE Grade 1-2. Grade 5 ILD occurred in 30 patients (7.9%), with DAD the most common pattern (26 patients). Overall recovery was 83.5%. Corticosteroids were used in 54.6% of cases, with 79.3% responding. High-dose corticosteroids and additional immunosuppressants were ineffective in seven DAD cases.

Conclusions: Most T-DXd-related ILD cases were mild/moderate and corticosteroid-responsive; DAD pattern was associated with higher mortality. These findings underscore the importance of vigilant monitoring, early recognition, and prompt corticosteroid treatment to mitigate fatal T-DXd-related ILD.

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日本乳腺癌和胃癌患者曲妥珠单抗相关间质性肺病的真实世界特征

背景：间质性肺疾病(ILD)/肺炎是与曲妥珠单抗（T-DXd）相关的重要药物不良反应。本报告全面描述了t- dxd相关ILD的临床和影像学特征，由独立的ILD裁决委员会（AC）系统评估了日本乳腺癌/胃癌患者上市后所有患者的监测研究。患者和方法：这项事后分析评估了独立的ILD ac判定的t - dxd相关ILD病例。分析了人口统计学、临床/放射学特征、发病时间、治疗干预措施和结果（发病后随访至12个月）。结果：在2801例接受t - dxd治疗的患者中（乳腺癌：1731例；胃癌：1070例），回顾了421例潜在病例，其中381例被判定为t - dxd相关ILD（乳腺癌：278例；胃癌：103例）。中位年龄65.0岁，女性占75.1%，28.3%有吸烟史。ILD发生在整个观察过程中（包括开始治疗后≥12个月的死亡病例），没有特定的发病窗口。不同CTCAE等级的发病时间无差异。组织性肺炎是主要的影像学表现（67.7%），其次是过敏性肺炎（14.2%）和弥漫性肺泡损伤（DAD, 12.6%）。大多数病例（78.2%）为最差CTCAE 1-2级。5级ILD发生在30例（7.9%）中，DAD最常见（26例）。总体回收率为83.5%。54.6%的病例使用了皮质类固醇，79.3%的病例有反应。在7例DAD病例中，大剂量皮质类固醇和额外的免疫抑制剂无效。结论：大多数与t - dxd相关的ILD病例为轻/中度且皮质类固醇反应性；DAD模式与较高的死亡率相关。这些发现强调了警惕监测、早期识别和及时皮质类固醇治疗对减轻致命的t - dxd相关ILD的重要性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncologist 医学-肿瘤学

CiteScore

10.40

自引率

3.40%

发文量

309

审稿时长

3-8 weeks

期刊介绍： The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.