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中华乳腺病杂志(电子版) ›› 2024, Vol. 18 ›› Issue (05) : 281 -286. doi: 10.3877/cma.j.issn.1674-0807.2024.05.005

论 著

阿贝西利在激素受体阳性、HER-2 阴性乳腺癌患者中的安全性研究
季思涵1, 唐新宇1, 王邦杰1, 狄汶洋1, 王佳鸣1, 查小明1, 谢晖1, 周文斌1, 潘红1, 王水1,()   
  1. 1.210029 南京医科大学第一附属医院乳腺外科
  • 收稿日期:2024-02-02 出版日期:2024-10-01
  • 通信作者: 王水
  • 基金资助:
    国家自然科学基金资助项目(81771953、82172683)江苏省自然科学基金资助项目(BK20180108)北京科创医学发展基金(KC2021-ZZ-0010-3)

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 Published:2024-10-01
  • Corresponding author: Shui Wang
引用本文:

季思涵, 唐新宇, 王邦杰, 狄汶洋, 王佳鸣, 查小明, 谢晖, 周文斌, 潘红, 王水. 阿贝西利在激素受体阳性、HER-2 阴性乳腺癌患者中的安全性研究[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(05): 281-286.

Sihan Ji, Xinyu Tang, Bangjie Wang, Wenyang Di, Jiaming Wang, Xiaoming Zha, Hui Xie, Wenbin Zhou, Hong Pan, Shui Wang. Safety of abemaciclib in hormone receptor-positive/HER-2 negative breast cancer patients[J/OL]. Chinese Journal of Breast Disease(Electronic Edition), 2024, 18(05): 281-286.

目的

报告阿贝西利在中国乳腺癌患者中的安全性。

方法

本研究是一项回顾性、非对照、单中心研究,连续纳入从2021 年1 月至2023 年4 月在南京医科大学第一附属医院接受含有阿贝西利的治疗方案且无远处转移的激素受体阳性、HER-2 阴性(HR+/HER-2-)乳腺癌患者102 例。 通过随访获取不良事件(AE)相关数据。 分类变量以频数和百分比表示,组间比较使用χ2检验或Fisher 确切概率法。 连续变量以±s 表示,用Student t 检验进行组间比较。 应用单因素和多因素Logistic 回归分析阿贝西利相关≥2 级AE 的相关因素及与阿贝西利剂量减少或治疗暂停/中止的相关因素。

结果

阿贝西利相关≥2 级不良事件总发生率为28.4%(29/102),其中≥2 级血液学毒性、腹泻和肝功能损伤的发生率分别为14.7%(15/102)、10.8%(11/102)和4.9%(5/102)。 单因素分析显示,阿贝西利相关≥2 级AE与年龄、BMI、T 分期、组织学类型、组织学分级及内分泌治疗方案无关(P 均<0.050)。 在所有病例中,28.4%(29/102)患者在治疗过程中需降低阿贝西利剂量,12.7%(13/1 02)需暂停治疗,12.7%(13/102)需中止治疗,39.2%(40/102)需药物干预(如肝功能保护剂、止泻药等),6.9%(7/102)需其他对症治疗。单因素分析显示发生≥2 级腹泻是需要阿贝西利减量或暂停/中止治疗的危险因素(OR =5.18,95%CI:1.24~21.60,P=0.024)。

结论

阿贝西利在中国HR+/HER-2-乳腺癌患者中的耐受性和安全性总体较好,但仍需更大规模临床试验进一步证实。

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.

表1 102 例阿贝西利治疗的乳腺癌患者的临床病理特征
表2 102 例阿贝西利治疗的乳腺癌患者的不良事件
表3 102 例乳腺癌患者发生阿贝西利相关≥2 级不良事件的单因素分析
表4 102 例接受阿贝西利治疗的乳腺癌患者的不良事件管理
表5 97 例乳腺癌患者阿贝西利减量或暂停/中止治疗的单因素分析
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