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author:

Ke, Chengjie (Ke, Chengjie.) [1] | Chen, Maohua (Chen, Maohua.) [2] | Lin, Li (Lin, Li.) [3] | Huang, Yaping (Huang, Yaping.) [4]

Indexed by:

Scopus SCIE

Abstract:

Tamoxifen (TAM), a selective estrogen receptor (ER) modulator, has received approval for use in patients with breast cancer (BC) exhibiting positive ER expression. Given the widespread clinical use of TAM, a comprehensive real-world study of its adverse events (AEs) is warranted. The database for analysis, sourced from the Food and Drug Administration Adverse Event Reporting System (FAERS), covers the period from the first quarter of 2014 to the third quarter of 2023. A disproportionality analysis was conducted to quantify the correlation between TAM and AEs. Subgroup analyses were performed to identify differences between BC AEs in males and females receiving TAM, aiming to assess the risk factors of male BC AEs. Total 4890 reports indicated BC, with 91 and 4190 specifically linked to AEs in male and female patients with BC, respectively. Male-specific AE was libido decreased (reporting odds ratio [ROR]: 43.33), and female-specific AE was uterine disease, including sarcoma uterus (ROR: 519.51), endometrial cancer (ROR: 131.26), uterine polyp (ROR: 40.83), endometriosis (ROR: 11.39), among others. A notably higher risk of AEs in male patients with BC was observed in individuals aged >65 years (chi(2) = 20.83, p < .001). Male patients with BC had a relatively higher risk of hospitalization (chi(2) = 4.83, p = .03) and a lower risk of deaths (chi(2) = 5.32, p = .02). Theses finding may assist healthcare professionals in recognizing the TAM-associated AEs and understanding gender differences, potentially improving safety in clinical applications.

Keyword:

breast cancer FAERS pharmacovigilance study tamoxifen

Community:

  • [ 1 ] [Ke, Chengjie]Fujian Med Univ, Affiliated Hosp 1, Dept Pharm, Fuzhou, Peoples R China
  • [ 2 ] [Ke, Chengjie]Fujian Med Univ, Affiliated Hosp 1, Natl Reg Med Ctr, Dept Pharm, Binhai Campus, Fuzhou, Peoples R China
  • [ 3 ] [Chen, Maohua]Pingtan Comprehens Expt Area Hosp, Dept Pharm, Pingtan Comprehens Expt Area, Fuzhou, Peoples R China
  • [ 4 ] [Lin, Li]Fuzhou Univ, Fujian Med Univ, Affiliated Prov Hosp, Shengli Clin Med Coll,Fujian Prov Hosp,Dept Med On, 134 Dongjie St, Fuzhou 350001, Fujian, Peoples R China
  • [ 5 ] [Huang, Yaping]Fuzhou Univ, Fujian Med Univ, Affiliated Prov Hosp, Shengli Clin Med Coll ,Fujian Prov Hosp,Dept Pharm, 134 Dongjie St, Fuzhou 350001, Fujian, Peoples R China

Reprint 's Address:

  • [Lin, Li]Fuzhou Univ, Fujian Med Univ, Affiliated Prov Hosp, Shengli Clin Med Coll,Fujian Prov Hosp,Dept Med On, 134 Dongjie St, Fuzhou 350001, Fujian, Peoples R China;;[Huang, Yaping]Fuzhou Univ, Fujian Med Univ, Affiliated Prov Hosp, Shengli Clin Med Coll ,Fujian Prov Hosp,Dept Pharm, 134 Dongjie St, Fuzhou 350001, Fujian, Peoples R China;;

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Source :

INTERNATIONAL JOURNAL OF CANCER

ISSN: 0020-7136

Year: 2024

Issue: 4

Volume: 156

Page: 734-743

5 . 7 0 0

JCR@2023

CAS Journal Grade:2

Cited Count:

WoS CC Cited Count:

SCOPUS Cited Count: 1

ESI Highly Cited Papers on the List: 0 Unfold All

WanFang Cited Count:

Chinese Cited Count:

30 Days PV: 2

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