PMID- 36062413
OWN - NLM
STAT- MEDLINE
DCOM- 20221116
LR  - 20221116
IS  - 1751-2441 (Electronic)
IS  - 1751-2433 (Linking)
VI  - 15
IP  - 11
DP  - 2022 Nov
TI  - Incidence and risk of severe adverse events associated with trastuzumab emtansine 
      (T-DM1) in the treatment of breast cancer: an up-to-date systematic review and 
      meta-analysis of randomized controlled clinical trials.
PG  - 1343-1350
LID - 10.1080/17512433.2022.2121704 [doi]
AB  - OBJECTIVES: We performed an up-to-date meta-analysis to quantify the overall 
      incidence and risk of severe adverse events (AEs) associated with T-DM1 in 
      patients with breast cancer. METHODS: Pubmed, Embase, and oncology conference 
      proceedings were searched for relevant studies. Data were extracted to calculate 
      the summary incidence rate and relative risk (RR) of grade >/=3 AEs. RESULTS: A 
      total of 5,045 patients from 7 RCTs were included in the meta-analysis. The use 
      of T-DM1 was associated with an increased risk of severe thrombocytopenia (RR 
      10.66, 95% CI 3.23-35.18, P < 0.001), anemia (RR 1.68, 95% CI 1.15-2.44, P 
      = 0.007), elevated ALT (RR 2.67, 95% CI 1.60-4.47, P < 0.001), and AST (RR 3.76, 
      95% CI 1.45-9.78, P = 0.007). In addition, the use of T-DM1 can increase the risk 
      of severe hypertension (RR 1.59, 95% CI 1.03-2.45, P = 0.037) and peripheral 
      sensory neuropathy (RR 8.13, 95% CI 1.89-35.03, P = 0.005). CONCLUSIONS: 
      Treatment with T-DM1 increases the risk of severe hematologic toxicities, 
      hepatotoxicity, hypertension, and peripheral sensory neuropathy in patients with 
      breast cancer, while the overall incidence of these AEs is low.
FAU - Liu, Kuan
AU  - Liu K
AD  - Department of Radiotherapy, Affiliated Hospital of Hebei University, Baoding, 
      China.
FAU - Li, Yan-Hong
AU  - Li YH
AD  - Department of Radiotherapy, Affiliated Hospital of Hebei University, Baoding, 
      China.
FAU - Zhang, Xi
AU  - Zhang X
AUID- ORCID: 0000-0002-3869-3856
AD  - Department of Radiotherapy, Affiliated Hospital of Hebei University, Baoding, 
      China.
FAU - Su, Lei
AU  - Su L
AD  - Department of Radiotherapy, Affiliated Hospital of Hebei University, Baoding, 
      China.
FAU - Li, Jing-Hua
AU  - Li JH
AD  - Department of Hepatobiliary Surgery, Affiliated Hospital of Hebei University, 
      Baoding, People's Republic of China.
FAU - Shi, Hong-Yun
AU  - Shi HY
AD  - Department of Radiotherapy, Affiliated Hospital of Hebei University, Baoding, 
      China.
FAU - Zhang, Jun-Hua
AU  - Zhang JH
AD  - Department of Breast Surgery, Affiliated Hospital of Hebei University, Baoding, 
      China.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20220914
PL  - England
TA  - Expert Rev Clin Pharmacol
JT  - Expert review of clinical pharmacology
JID - 101278296
RN  - SE2KH7T06F (Ado-Trastuzumab Emtansine)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Female
MH  - Humans
MH  - *Ado-Trastuzumab Emtansine/adverse effects
MH  - *Breast Neoplasms/drug therapy
MH  - Hypertension/chemically induced/epidemiology
MH  - Incidence
MH  - Receptor, ErbB-2
MH  - Chemical and Drug Induced Liver Injury/epidemiology
OTO - NOTNLM
OT  - T-DM1
OT  - adverse event
OT  - breast cancer
OT  - high grade
OT  - safety
EDAT- 2022/09/06 06:00
MHDA- 2022/11/15 06:00
CRDT- 2022/09/05 04:42
PHST- 2022/09/06 06:00 [pubmed]
PHST- 2022/11/15 06:00 [medline]
PHST- 2022/09/05 04:42 [entrez]
AID - 10.1080/17512433.2022.2121704 [doi]
PST - ppublish
SO  - Expert Rev Clin Pharmacol. 2022 Nov;15(11):1343-1350. doi: 
      10.1080/17512433.2022.2121704. Epub 2022 Sep 14.