ORIGINAL RESEARCH article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
This article is part of the Research TopicCommunity Series in Reducing Adverse Effects of Cancer Immunotherapy: Volume IIIView all 17 articles
Unveiling the hidden cardiovascular risk of sipuleucel-T: A pharmacovigilance analysis using the FDA Adverse Event Reporting System, 2010–2025
Provisionally accepted
- 1Department of Pharmacy, Shanghai Cancer Center, Fudan University, Shanghai, China
- 2Clinical Research Center, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- 3Department of Pharmacy, Fudan University Shanghai Cancer Center Xiamen Hospital, Xiamen, China
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Background: Sipuleucel-T, the first therapeutic cancer vaccine approved by the U.S. Food and Drug Administration (FDA), represents a crucial treatment option for patients with metastatic castration-resistant prostate cancer (mCRPC). However, the characteristics of cardiovascular adverse events (CVAEs) associated with sipuleucel-T remain poorly understood. Methods: This retrospective, pharmacovigilance analysis used case safety reports from the FDA Adverse Event Reporting System (FAERS) spanning April 2010 to March 2025. Reporting odds ratio (ROR) and information component (IC) were applied to identify and evaluate potential CVAEs associated with sipuleucel-T. Kaplan–Meier method and Weibull distribution were used to analyze reported time-to-onset patterns of sipuleucel-T-related CVAEs. Multivariate logistic regression was employed to explore risk factors for CVAEs following sipuleucel-T treatment. Results: Among 4,797 sipuleucel-T-related reports, 743 (15.49%) documented CVAEs, of which 427 (57.5%) were classified as serious. Positive CVAE signals associated with sipuleucel-T included hypertension, venous thromboembolic events, arterial thromboembolic events, cardiac failure, cardiac arrhythmias, and myocardial infarction. The median time to onset of sipuleucel-T-related CVAEs was 14 days, with 80.11% occurring within 1 month. Moreover, the median time to onset of fatal CVAEs was significantly later than that of non-fatal CVAEs (22 days vs. 14 days; p = 0.0076). Additionally, age ≥ 75 years, body weight ≥ 75 kg, and concomitant use of ≥5 medications were identified as independent risk factors for sipuleucel-T-related CVAEs (p < 0.001). Conclusions: This study characterizes the clinical spectrum, time-to-onset patterns, and risk factors of sipuleucel-T-associated CVAEs, providing essential pharmacovigilance data for managing patients with mCRPC.
Keywords: Castration-resistant, Disproportionality analysis, FAERS, Pharmacovigilance, prostate cancer, provenge, Sipuleucel-T
Received: 30 Sep 2025; Accepted: 15 Dec 2025.
Copyright: © 2025 Liu, Song, Wang, Liu and Du. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Wensheng Liu
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