ArticlePharmacoepidemiology and drug safety2025
Effectiveness of Additional Risk Minimization Measures Related to Interstitial Lung Disease/Pneumonitis With Trastuzumab Deruxtecan Treatment of Breast Cancer in European Countries: Results and Learnings From a Post-Authorization Safety Survey Among Physicians.
Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
- Effectiveness of Additional Risk Minimization Measures Related to Interstitial Lung Disease/Pneumonitis With Trastuzumab Deruxtecan Treatment of Breast Cancer in European Countries: Results and Learnings From a Post-Authorization Safety Survey Among Physicians.Pharmacoepidemiology and drug safety · 2025Article
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5 authors.
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Abstract
backgroundInterstitial lung disease (ILD)/pneumonitis is an important safety risk of trastuzumab deruxtecan (T-DXd) treatment. This study assessed the effectiveness of additional risk minimization measures (aRMMs) outlined in the educational material (EM) for the product regarding physicians' awareness, knowledge, and implementation related to the risk, early detection, and management of ILD/pneumonitis.
methodsA web-based survey was conducted among prescribers of T-DXd from seven European countries (Austria, Denmark, France, Germany, Sweden, Spain, and the UK) between 03/2021 and 11/2022. The overall effectiveness of the aRMMs was determined as the percentage of physicians correctly responding to questions in the awareness, knowledge, and implementation domains, with cut-off thresholds of ≥ 80%, ≥ 60%, and ≥ 75%, respectively.
resultsOverall, 172 prescribing physicians from seven countries completed the survey questionnaire (response rate: 3.1%). The majority (73.8%) of the physicians acknowledged receiving EMs. In all, 91.6%, 46.7%, and 76.7% of the physicians correctly responded to questions in the awareness, knowledge, and implementation domains, respectively. The low score observed in the knowledge domain was primarily because the respondents did not acknowledge fever as a typical symptom of ILD/pneumonitis. When a post hoc sensitivity analysis was performed where "fever" was not classified as a mandatory answer to the question about typical symptoms for ILD/pneumonitis, the proportion of physicians achieving the threshold increased to 68.6%.
conclusionThe aRMMs effectively imparted awareness and supported the management of T-DXd-induced ILD/pneumonitis.
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