Dermatologic adverse events associated with Sacituzumab Govitecan: an international retrospective study from the EADV Task Force "Dermatology for Cancer Patients" and pharmacovigilance analysis.

Authors

Ioannis-Alexios Koumprentziotis, Alexander Cawley, Elliot Ewig, Alexandre O Gérard, Maëlys Labat, Grażyna Kamińska-Winciorek, Marcin Kubeczko, Luca Rapparini, Michela Starace, Katerina Grafanaki, Maria Kamaratou, Dimitrios Mavroudis, Alexander Katoulis, Vasiliki Nikolaou, Kara Heelan, Dimitra Koumaki

Published in

Breast cancer research and treatment. Volume 219. Issue 3. Sep 28, 2026. Epub Sep 28, 2026.

Abstract

Sacituzumab govitecan (SG) is an antibody-drug conjugate approved across multiple metastatic breast cancer settings. Although hematologic and gastrointestinal toxicities dominate its safety profile, dermatologic adverse events (dAEs) remain poorly characterized, despite the physiological expression of Trop-2 in epidermal keratinocytes. We aimed to comprehensively characterize the spectrum, severity, time to onset, and oncologic impact of SG-associated dAEs across real-world and pharmacovigilance data sources.
An international retrospective cohort study was conducted within the EADV Task Force "Dermatology for Cancer Patients" (n = 56 breast cancer patients). Findings were triangulated with disproportionality analyses of the WHO Global Pharmacovigilance database (VigiBase^®; n = 696 cases) and the French Pharmacovigilance Database (FPVD; n = 46 cases), alongside a literature review of SG clinical trials reporting dAEs.
Across all data sources, alopecia was the most frequently reported dAE (EADV cohort: 41.1%; FPVD: 52.2%; VigiBase^®: 67.6%), followed by stomatitis/mucositis, pruritus, xerosis, and maculopapular rash. In the EADV cohort, 13 distinct dAE types were identified; median time to first dAE was 56 days, and 96.4% of events were grade 1-2. Treatment discontinuation attributable to dAEs occurred in only 3.6% of patients. VigiBase^® disproportionality analysis identified significant reporting signals for alopecia (IC 3.3 [3.09; 3.53]), infusion-related reactions (IC 1.9 [1.07; 2.55]), and stomatitis (IC 1.6 [0.86; 2.30]). Preliminary signals of cutaneous infections were observed but did not consistently meet the threshold for statistical significance.
SG-associated dAEs are predominantly low-grade and infrequently precipitate treatment discontinuation. Pharmacovigilance data raises a potential signal for cutaneous infections that warrants further investigation. As SG increasingly enters combination regimens, structured dermatologic monitoring and prospective characterization of dAEs are essential to guide oncodermatologic management and protect oncological outcomes.
Not applicable.

PMID:
42804021
Bibliographic data and abstract were imported from PubMed on 29 Sep 2026.

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