PMID- 37994531
OWN - NLM
STAT- MEDLINE
DCOM- 20240123
LR  - 20240411
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Linking)
VI  - 115
IP  - 2
DP  - 2024 Feb
TI  - Postmarketing Safety of Sacituzumab Govitecan: A Pharmacovigilance Study Based on 
      the FDA Adverse Event Reporting System.
PG  - 256-268
LID - 10.1002/cpt.3098 [doi]
AB  - Sacituzumab govitecan is widely used for the treatment of breast cancer and 
      urothelial carcinoma, but available information regarding adverse events (AEs) is 
      limited. We aim to explore the AE induced by sacituzumab govitecan by mining the 
      FDA Adverse Event Reporting System (FAERS) database. The association between 
      sacituzumab govitecan and AEs was evaluated using the information component. A 
      multivariate logistic regression analysis was conducted for all identified 
      signals to explore the risk factors associated with AEs leading to 
      hospitalization. In total, 1,884 reports related to sacituzumab govitecan were 
      retrieved, and 114 AE signals involving 20 systems were identified. The median 
      time for onset of AEs was ~ 6-7 days after initiating treatment with sacituzumab 
      govitecan, with over 80% of AEs occurring within 30 days. Subgroup analysis 
      revealed that 14 signals were reported in men and 110 in women. There were 58 
      signals reported in patients under 65 following the use of sacituzumab govitecan, 
      59 signals in patients over 65, and 31 signals were present in both groups. 
      Multivariable analysis showed that being male and the occurrence of colitis, 
      pneumonitis, febrile neutropenia, pyrexia, sepsis, dehydration, and diarrhea were 
      risk factors leading to hospitalization with an area under the curve (AUC) of 
      0.89. Additionally, sensitivity analysis revealed that this study had good 
      robustness. This is the first retrospective analysis based on FAERS to review the 
      safety of sacituzumab govitecan. The results highlight the need to closely 
      monitor adverse reactions such as neutropenia, diarrhea, colitis, and sepsis when 
      using sacituzumab govitecan.
CI  - (c) 2023 The Authors. Clinical Pharmacology & Therapeutics (c) 2023 American Society 
      for Clinical Pharmacology and Therapeutics.
FAU - Li, Xingxing
AU  - Li X
AUID- ORCID: 0000-0003-4398-4508
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
FAU - Zhang, Lin
AU  - Zhang L
AUID- ORCID: 0000-0001-5684-2555
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
FAU - Hu, Sang
AU  - Hu S
AUID- ORCID: 0009-0005-6528-3800
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
FAU - Liu, Dan
AU  - Liu D
AUID- ORCID: 0009-0009-6442-9539
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
FAU - Hu, Bin
AU  - Hu B
AUID- ORCID: 0009-0002-9871-4871
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
FAU - Ran, Jie
AU  - Ran J
AUID- ORCID: 0009-0002-2882-0003
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
FAU - Lin, Xiaofang
AU  - Lin X
AUID- ORCID: 0009-0005-0120-6291
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
FAU - Mao, Wei
AU  - Mao W
AUID- ORCID: 0000-0002-4083-1242
AD  - Department of Pharmacy, Nan'an People's Hospital of Chongqing, Chongqing, China.
FAU - Hu, Jing
AU  - Hu J
AUID- ORCID: 0009-0007-8446-0862
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University 
      (Third Military Medical University), Chongqing, China.
LA  - eng
PT  - Journal Article
DEP - 20231214
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - M9BYU8XDQ6 (sacituzumab govitecan)
RN  - XT3Z54Z28A (Camptothecin)
RN  - 0 (Immunoconjugates)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - Male
MH  - Female
MH  - *Carcinoma, Transitional Cell
MH  - Pharmacovigilance
MH  - Retrospective Studies
MH  - *Urinary Bladder Neoplasms
MH  - Diarrhea
MH  - *Colitis
MH  - *Sepsis
MH  - Camptothecin/*analogs & derivatives
MH  - *Immunoconjugates
MH  - *Antibodies, Monoclonal, Humanized
EDAT- 2023/11/23 06:42
MHDA- 2024/01/23 06:42
CRDT- 2023/11/23 04:33
PHST- 2023/08/17 00:00 [received]
PHST- 2023/10/30 00:00 [accepted]
PHST- 2024/01/23 06:42 [medline]
PHST- 2023/11/23 06:42 [pubmed]
PHST- 2023/11/23 04:33 [entrez]
AID - 10.1002/cpt.3098 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2024 Feb;115(2):256-268. doi: 10.1002/cpt.3098. Epub 2023 
      Dec 14.