PMID- 37068935
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231102
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 22
IP  - 8
DP  - 2023 Jul-Dec
TI  - High risks adverse events associated with trastuzumab emtansine and trastuzumab 
      deruxtecan for the treatment of HER2-positive/mutated malignancies: a 
      pharmacovigilance study based on the FAERS database.
PG  - 685-696
LID - 10.1080/14740338.2023.2204228 [doi]
AB  - BACKGROUND: T-DM1 and T-DXd are two promising antibody-drug conjugates for 
      treating advanced HER2-positive breast cancer and HER2-mutated lung cancer. 
      Understanding the differences in the adverse events (AEs) profile of both drugs 
      may help clinicians make an appropriate treatment decision. RESEARCH DESIGN AND 
      METHODS: All data obtained from the FDA Adverse Event Reporting System (FAERS) 
      database from Q1 2004 to Q3 2022 underwent disproportionality analysis and 
      Bayesian analysis to detect and assess the AE signals of T-DM1 and T-DXd for 
      comparison. RESULTS: A total of 2,113 and 1,269 AE reports associated with T-DM1 
      and T-Dxd, respectively, were retrieved from FAERS database, in which, 
      respondents were mostly elderly women. Their statistical differences (p < 0.001), 
      poses high incidence of thrombocytopenia, including cardiotoxicity (p < 0.05) for 
      T-DM1, while myelosuppression, interstitial lung disease (ILD), and pneumonitis 
      for T-DXd. Splenomegaly, nodular regenerative hyperplasia, hepatic cirrhosis, 
      portal hypertension, neuropathy peripheral, and spider nevus, are particular to 
      T-DM1. Similarly, febrile neutropenia, pneumocystis jirovecii pneumonia, 
      neutrophil count decreased, and KL-6 increased, are unique to T-DXd. CONCLUSIONS: 
      T-DXd is more likely to induce ILD/pneumonia and myelosuppression than T-DM1, 
      whereas T-DM1 has higher risk of hepatotoxicity, cardiotoxicity, and 
      thrombocytopenia than T-DXd. T-DM1-related hepatotoxicity may need redefinition. 
      Clinicians may need to balance the benefits and risks of antibody-drug conjugates 
      treatment for certain patients.
FAU - Ma, Pan
AU  - Ma P
AUID- ORCID: 0000-0002-0121-0769
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University, 
      Chongqing, China.
AD  - State Key Laboratory of Ultrasound in Medicine and Engineering, College of 
      Biomedical Engineering, Chongqing Medical University, Chongqing, China.
FAU - Tian, Hao
AU  - Tian H
AUID- ORCID: 0000-0002-8606-6806
AD  - Department of Breast and Thyroid Surgery, Southwest Hospital, The First 
      Affiliated Hospital of Army Medical University, Chongqing, China.
FAU - Shi, Qiuling
AU  - Shi Q
AUID- ORCID: 0000-0003-0660-3809
AD  - State Key Laboratory of Ultrasound in Medicine and Engineering, College of 
      Biomedical Engineering, Chongqing Medical University, Chongqing, China.
FAU - Liu, Ruixiang
AU  - Liu R
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University, 
      Chongqing, China.
FAU - Zhang, Yi
AU  - Zhang Y
AD  - Department of Breast and Thyroid Surgery, Southwest Hospital, The First 
      Affiliated Hospital of Army Medical University, Chongqing, China.
FAU - Qi, Xiaowei
AU  - Qi X
AUID- ORCID: 0000-0002-5876-4957
AD  - Department of Breast and Thyroid Surgery, Southwest Hospital, The First 
      Affiliated Hospital of Army Medical University, Chongqing, China.
FAU - Chen, Yongchuan
AU  - Chen Y
AUID- ORCID: 0000-0003-0274-5797
AD  - Department of Pharmacy, The First Affiliated Hospital of Army Medical University, 
      Chongqing, China.
LA  - eng
PT  - Journal Article
DEP - 20230420
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 5384HK7574 (trastuzumab deruxtecan)
RN  - SE2KH7T06F (Ado-Trastuzumab Emtansine)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 14083FR882 (Maytansine)
RN  - P188ANX8CK (Trastuzumab)
RN  - 0 (Immunoconjugates)
SB  - IM
MH  - Humans
MH  - Female
MH  - Aged
MH  - Ado-Trastuzumab Emtansine/adverse effects
MH  - Bayes Theorem
MH  - Cardiotoxicity/etiology
MH  - Pharmacovigilance
MH  - Receptor, ErbB-2
MH  - Antibodies, Monoclonal, Humanized/adverse effects
MH  - *Maytansine/adverse effects
MH  - Trastuzumab/adverse effects
MH  - *Immunoconjugates/pharmacology
MH  - *Neoplasms/drug therapy/chemically induced
MH  - *Lung Diseases, Interstitial/chemically induced
MH  - *Thrombocytopenia/chemically induced
MH  - *Chemical and Drug Induced Liver Injury/epidemiology/etiology/drug therapy
MH  - *Breast Neoplasms/drug therapy/genetics
OTO - NOTNLM
OT  - Antibody-drug conjugates
OT  - adverse events
OT  - hepatotoxicity
OT  - interstitial lung disease
OT  - pharmacovigilance analysis
OT  - safety signals
EDAT- 2023/04/18 06:00
MHDA- 2023/04/18 06:01
CRDT- 2023/04/17 21:41
PHST- 2023/04/18 06:01 [medline]
PHST- 2023/04/18 06:00 [pubmed]
PHST- 2023/04/17 21:41 [entrez]
AID - 10.1080/14740338.2023.2204228 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2023 Jul-Dec;22(8):685-696. doi: 
      10.1080/14740338.2023.2204228. Epub 2023 Apr 20.