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Chinese Journal of Breast Disease(Electronic Edition) ›› 2024, Vol. 18 ›› Issue (05): 281-286. doi: 10.3877/cma.j.issn.1674-0807.2024.05.005

• Original Articles • Previous Articles     Next Articles

Safety of abemaciclib in hormone receptor-positive/HER-2 negative breast cancer patients

Sihan Ji1, Xinyu Tang1, Bangjie Wang1, Wenyang Di1, Jiaming Wang1, Xiaoming Zha1, Hui Xie1, Wenbin Zhou1, Hong Pan1, Shui Wang1,()   

  1. 1.Department of Breast Surgery, First Affiliated Hospital of Nanjing Medical University,Nanjing 210029, China
  • Received:2024-02-02 Online:2024-10-01 Published:2024-11-14
  • Contact: Shui Wang

Abstract:

Objective To report a preliminary safety profile of abemaciclib in China.

Methods

Totally 102 patients with non-metastatic hormone receptor-positive/HER-2 negative (HR+/HER-2-)breast cancer who received treatment regimens containing abemaciclib in the First Affiliated Hospital of Nanjing Medical University from January 2021 to April 2023 were continuously enrolled for a retrospective,uncontrolled, single-center study. The adverse event(AE)-related data were acquired via the follow-up.Categorical variables were expressed as frequency and percentage, and compared between groups using χ2 test or Fisher exact test. Continuous variables were expressed as ±s and compared between groups using Student t test. Univariate and multivariate logistic regression analysis were used to analyze the factors associated with abemaciclib-related AE ≥ grade 2 and the factors associated with dose reduction/treatment suspension/discontinuation.

Results

The overall incidence of AE(≥grade 2) related to abemaciclib was 28.4%(29/102), including 14.7%(15/102) of hematological toxicity,10.8%(11/102) of diarrhea and 4.9%(5/102) of hepatic function damage. Univariate analysis showed that abemaciclib-related AE(≥grade 2) were not related to age, BMI, T stage, histological type, histological grade and endocrine treatment regimens(all P<0.050).Among all cases, 28.4%(29/102) of the patients had to reduce the dose of abemaciclib, 12.7%(13/1 02)had treatment suspension, 12.7%(13/102) had discontinuation, 39.2%(40/102) had drug intervention(such as hepatic function protectors, antidiarrheal drugs), and 6.9%(7/102) required other symptomatic treatment.Univariate analysis showed that diarrhea(≥grade 2) was a risk factor for dose reduction/treatment suspension/discontinuation(OR=5.18, 95%CI:1.24-21.60, P =0.024).

Conclusions

Abemaciclib exhibits acceptable safety and tolerability in HR+/HER-2- breast cancer patients in China. Clinical trials with larger cohorts are warranted for a more reliable conclusion.

Key words: Breast neoplasms, Adverse drug reaction, Cyclin-dependent kinase, Abemaciclib

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