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Pooled analysis of drug-related interstitial lung disease and/or pneumonitis in nine trastuzumab deruxtecan monotherapy studies

Open access
Powell, C.A., Modi, S., Iwata, H., Takahashi, S., Smit, E.F., Siena, S., Chang, D.-Y., Macpherson, E., Qin, A., Singh, J., Taitt, C., Shire, N., Camidge, D. Ross·2022·ESMO Open
DOI 10.1016/j.esmoop.2022.100554
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Abstract

INTRODUCTION: This pooled analysis of nine phase I and II trastuzumab deruxtecan (T-DXd) monotherapy studies described drug-related interstitial lung disease (ILD)/pneumonitis in patients treated with T-DXd. METHODS: Patients who received T-DXd across nine studies were included. Investigator-assessed ILD/pneumonitis events were retrospectively reviewed by an independent adjudication committee; events adjudicated as drug-related ILD/pneumonitis are summarized. RESULTS: The analysis included 1150 patients (breast cancer, 44.3%; gastric cancer, 25.6%; lung cancer, 17.7%; colorectal cancer, 9.3%; other cancer, 3.0%). Median treatment duration was 5.8 (range, 0.7-56.3) months, with a median of 4 (range, 1-27) prior lines of therapy. The overall incidence of adjudicated drug-related ILD/pneumonitis was 15.4% (grade 5, 2.2%). Most patients with ILD/pneumonitis experienced low-grade events (grade 1 or 2, 77.4%); 87.0% had their first event within 12 months [median, 5.4 (range, <0.1-46.8) months] of their first dose of T-DXd. Based on data review, adjudicated ILD/pneumonitis onset occurred earlier than identified by investigators for 53.2% of events [median difference in onset date, 43 (range, 1-499) days]. Stepwise Cox regression identified several baseline factors potentially associated with increased risk of adjudicated drug-related ILD/pneumonitis: age <65 years, enrollment in Japan, T-DXd dose >6.4 mg/kg, oxygen saturation <95%, moderate/severe renal impairment, presence of lung comorbidities, and time since initial diagnosis >4 years. CONCLUSIONS: In this pooled analysis of heavily treated patients, the incidence of ILD/pneumonitis was 15.4%, with most being low grade and occurring in the first 12 months of treatment. The benefit-risk of T-DXd treatment is positive; however, some patients may be at increased risk of developing ILD/pneumonitis, and further investigation is needed to confirm ILD/pneumonitis risk factors. Close monitoring and proactive management of ILD/pneumonitis are warranted for all.

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Authors
Powell, C. A., Modi, S., Iwata, H., Takahashi, S., Smit, E. F., Siena, S., Chang, D.-Y., Macpherson, E., Qin, A., Singh, J., Taitt, C., Shire, N., & Camidge, D. R.
Venue
ESMO Open
Publisher
Elsevier BV
Published
2022-08
Volume
7
Issue
4
Pages
100554
ISSN
2059-7029 (ISSN-L)
DOI
10.1016/j.esmoop.2022.100554
OpenAlex
W4291396228
Cited by
270
References
29
FWCI
17.04
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Pooled analysis of drug-related interstitial lung disease and/or pneumonitis in nine trastuzumab deruxtecan monotherapy studies. https://app.cochat.ai/papers/10.1016/j.esmoop.2022.100554
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Powell, C. A., Modi, S., Iwata, H., Takahashi, S., Smit, E. F., Siena, S., Chang, D.-Y., Macpherson, E., Qin, A., Singh, J., Taitt, C., Shire, N., & Camidge, D. R. (2022). Pooled analysis of drug-related interstitial lung disease and/or pneumonitis in nine trastuzumab deruxtecan monotherapy studies. ESMO Open. https://doi.org/10.1016/j.esmoop.2022.100554

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.