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中华临床医师杂志(电子版) ›› 2022, Vol. 16 ›› Issue (11) : 1075 -1080. doi: 10.3877/cma.j.issn.1674-0785.2022.11.008

所属专题: 乳腺疾病

乳腺癌·临床研究

HER2阳性乳腺癌TCHP方案新辅助治疗的不良反应分析
云涌洋1, 张晓丹1, 程元甲1, 孙名帅1, 辛灵1, 刘倩1, 刘荫华1, 段学宁1, 张卓2, 刘倩欣2, 崔一民2, 向倩1,(), 徐玲1,()   
  1. 1. 100035 北京,北京大学第一医院乳腺疾病中心
    2. 100035 北京,北京大学第一医院药学部
  • 收稿日期:2022-06-09 出版日期:2022-11-15
  • 通信作者: 向倩, 徐玲

Adverse events of TCHP neoadjuvant therapy in patients with human epidermal growth factor receptor 2 positive breast cancer

Yongyang Yun1, Xiaodan Zhang1, Yuanjia Cheng1, Mingshuai Sun1, Ling Xin1, Qian Liu1, Yinhua Liu1, Xuening Duan1, Zhuo Zhang2, Qianxin Liu2, Yimin Cui2, Qian Xiang1,(), Ling Xu1,()   

  1. 1. Breast Disease Center, Peking University First Hospital, Beijing 100035, China
    2. Department of Pharmacy, Peking University First Hospital, Beijing 100035, China
  • Received:2022-06-09 Published:2022-11-15
  • Corresponding author: Qian Xiang, Ling Xu
引用本文:

云涌洋, 张晓丹, 程元甲, 孙名帅, 辛灵, 刘倩, 刘荫华, 段学宁, 张卓, 刘倩欣, 崔一民, 向倩, 徐玲. HER2阳性乳腺癌TCHP方案新辅助治疗的不良反应分析[J/OL]. 中华临床医师杂志(电子版), 2022, 16(11): 1075-1080.

Yongyang Yun, Xiaodan Zhang, Yuanjia Cheng, Mingshuai Sun, Ling Xin, Qian Liu, Yinhua Liu, Xuening Duan, Zhuo Zhang, Qianxin Liu, Yimin Cui, Qian Xiang, Ling Xu. Adverse events of TCHP neoadjuvant therapy in patients with human epidermal growth factor receptor 2 positive breast cancer[J/OL]. Chinese Journal of Clinicians(Electronic Edition), 2022, 16(11): 1075-1080.

目的

探讨人表皮生长因子受体2(HER2)阳性乳腺癌患者采用曲妥珠单抗(H)+帕妥珠单抗(P)联合紫杉类(T)+卡铂(C),即TCHP方案新辅助治疗的不良反应发生情况。

方法

收集2019年5月至2020年5月北京大学第一医院乳腺疾病中心接受TCHP方案新辅助治疗并完成手术的HER2阳性乳腺癌患者的临床资料。TCHP方案每21天重复,预防性使用粒细胞集落刺激因子(G-CSF)。研究就治疗期间不良事件发生情况进行回顾性分析。采用美国国立癌症研究院通用不良事件术语标准5.0 版进行不良事件评价。由专职临床药师负责随访每周期患者的不良反应,进行评价并记录。

结果

纳入分析的患者共56例,全为女性,平均年龄48岁(24~68岁),平均治疗周期数为3.7个周期。总体来说化疗相关的不良反应发生率为98.2%(55/56),常见≥3级以上不良反应发生率35.7%(20/56)。不良反应发生率较高者:腹泻(49例,87.5%)、疲劳(47例,83.9%)、恶心(44例,78.5%)、厌食(37例,66.0%)、便秘(34例,60.7%)。常见≥3级以上不良反应包括:厌食(7例,1.5%)、恶心(6例,10.7%)、腹泻(3例,5.3%)、中性粒细胞减少(2例,3.5%)、白细胞减少(1例,1.7%)、呕吐(1例,1.7%)。在药师和医生联合监测随访下,患者每周期预防性使用G-CSF,白细胞与中性粒细胞减少的不良反应发生率较低。

结论

接受TCHP方案治疗的HER2阳性乳腺癌患者总不良反应发生率较高,该方案常见不良反应为腹泻、疲劳、恶心、厌食、便秘等,常见≥3级以上不良反应包括:厌食、恶心、腹泻、中性粒细胞减少等。

Objective

To investigate the adverse events of trastuzumab (H) + pertuzumab (P) combined with taxanes (T) + carboplatin (C) (TCHP) neoadjuvant therapy in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer.

Methods

The clinical data of patients with HER2 positive breast cancer who received neoadjuvant therapy with the TCHP regimen and underwent surgery at the Breast Disease Center of Peking University First Hospital from March 2019 to October 20120 were analyzed retrospectively. The TCHP regimen was repeated every 21 days and granulocyte colony stimulating factor (G-CSF) was used prophylactically. A retrospective analysis of the adverse events was conducted during the treatment period. Adverse events were evaluated with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Full-time clinical pharmacists were responsible for following, recording, and evaluating the adverse reactions in each cycle.

Results

A total of 56 patients were included in the analysis; all of them were female. The average age was 48 years (range, 24-68 years), and the average number of treatment cycles were 3.7. Among the patients included, only one had no adverse events related to the TCHP regimen, and the patient was followed for only one cycle. Overall, the incidence of treatment-related adverse events was 98.2% (55/56), and the incidence of grade adverse events of grade 3 or above was 35.7% (20/56). Adverse events with a high incidence are listed as follows: diarrhea (49/56, 87.5%), fatigue (47/56, 83.9%), nausea (44/56, 78.5%), anorexia (37/56, 66.0%), and constipation (34/56, 60.7%). Under the monitoring and follow-up by pharmacists and doctors, the patients were treated with G-CSF every cycle, and the incidence of leukopenia and neutropenia was low.

Conclusion

The incidence of adverse events in breast cancer patients who receive the TCHP regimen is high. The common adverse events associated with this regimen are diarrhea, fatigue, nausea, anorexia, and constipation. Treatment-related adverse events of grade 3 or above include anorexia, nausea, diarrhea, and neutropenia.

表1 接受TCHP化疗方案的乳腺癌患者中药物不良反应的分级情况[例(%)]
表2 接受TCHP方案治疗的HER2阳性乳腺癌患者周围神经异常危险因素的单因素分析
表3 接受TCHP方案治疗的HER2阳性乳腺癌患者中性粒细胞减少危险因素的单因素分析
表4 接受TCHP方案治疗的HER2阳性乳腺癌患者白细胞减少危险因素的单因素分析
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