PMID- 38027003
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231201
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 14
DP  - 2023
TI  - Post-marketing safety surveillance of sacituzumab govitecan: an observational, 
      pharmacovigilance study leveraging FAERS database.
PG  - 1283247
LID - 10.3389/fphar.2023.1283247 [doi]
LID - 1283247
AB  - Background and objective: Sacituzumab govitecan (SG), the first antibody-drug 
      conjugate targeting human trophoblast cell-surface antigen 2 (Trop-2), has been 
      approved by the Food and Drug Administration (FDA) for the treatment of advanced 
      or metastatic breast cancer and urothelial cancer. However, there is currently a 
      dearth of information regarding the safety profiles of SG in a large sample 
      cohort. The objective of the present study is to investigate SG-related adverse 
      events (AEs) in real-world settings leveraging the FDA Adverse Event Reporting 
      System (FAERS) database to guide the safety management of clinical medication. 
      Methods: The FAERS database was retrospectively queried to extract reports 
      associated with SG from April 2020 to March 2023. To identify and evaluate 
      potential AEs in patients receiving SG, various disproportionality analyses such 
      as reporting odds ratio (ROR), the proportional reporting ratio (PRR), the 
      Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma 
      Poisson shrinker (MGPS) were employed. Results: Overall, 2069 reports of SG as 
      the "primary suspect" were identified. Noteworthy, SG was significantly 
      associated with an increased risk of blood lymphatic system disorders (ROR, 7.18; 
      95% CI, 6.58-7.84) and hepatobiliary disorders (ROR, 2.68; 95% CI, 2.17-3.30) at 
      the System Organ Class (SOC) level. Meanwhile, 61 significant disproportionality 
      preferred terms (PTs) simultaneously complied with all four algorithms were 
      adopted. Therein, anemia, thrombocytopenia, neutropenia, leukopenia, diarrhea, 
      asthenia, alopecia, and electrolyte imbalance were consistent with the common AEs 
      described in the clinical trials and specification of SG. Furthermore, unexpected 
      significant AEs include colitis (ROR, 12.09; 95% CI, 9.1-16.08), heart rate 
      increased (ROR, 5.11; 95% CI, 3.84-6.79), sepsis (ROR, 4.77; 95% CI, 3.59-6.34), 
      cholestasis (ROR, 6.28; 95% CI, 3.48-11.36), blood bilirubin increased (ROR, 
      4.65; 95% CI, 2.42-8.94) and meningitis (ROR, 7.23; 95% CI, 2.71-19.29) were also 
      be detected. The median time to onset of SG-related AEs was 14 [interquartile 
      range (IQR), 7-52] days, with the majority occurring within the initial month of 
      SG treatment. Conclusion: Our study validates the commonly known AEs and also 
      found some potentially emerging safety issues related to SG in real-world 
      clinical practice, which could provide valuable vigilance evidence for clinicians 
      and pharmacists to manage the safety issues of SG.
CI  - Copyright (c) 2023 Liu, Du, Guo, Ye and Liu.
FAU - Liu, Wensheng
AU  - Liu W
AD  - Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
FAU - Du, Qiong
AU  - Du Q
AD  - Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
FAU - Guo, Zihan
AU  - Guo Z
AD  - Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
FAU - Ye, Xuan
AU  - Ye X
AD  - Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
FAU - Liu, Jiyong
AU  - Liu J
AD  - Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
LA  - eng
PT  - Journal Article
DEP - 20231110
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10667432
OTO - NOTNLM
OT  - FAERS
OT  - Trop-2
OT  - adverse event
OT  - antibody-drug conjugate
OT  - pharmacovigilance
OT  - sacituzumab govitecan
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/11/29 18:42
MHDA- 2023/11/29 18:43
PMCR- 2023/11/10
CRDT- 2023/11/29 17:00
PHST- 2023/08/25 00:00 [received]
PHST- 2023/10/30 00:00 [accepted]
PHST- 2023/11/29 18:43 [medline]
PHST- 2023/11/29 18:42 [pubmed]
PHST- 2023/11/29 17:00 [entrez]
PHST- 2023/11/10 00:00 [pmc-release]
AID - 1283247 [pii]
AID - 10.3389/fphar.2023.1283247 [doi]
PST - epublish
SO  - Front Pharmacol. 2023 Nov 10;14:1283247. doi: 10.3389/fphar.2023.1283247. 
      eCollection 2023.