吡咯替尼对携带HER-2突变的HER-2阴性晚期乳腺癌患者的疗效观察

王津京; 马飞; 田朋飞; 孙晓莹; 李晓爽

doi:10.12354/j.issn.1000-8179.2023.20221354

吡咯替尼对携带HER-2突变的HER-2阴性晚期乳腺癌患者的疗效观察

doi: 10.12354/j.issn.1000-8179.2023.20221354

1.
北京市朝阳区桓兴肿瘤医院肿瘤内科（北京市100021）
2.
国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院肿瘤内科

基金项目: 本文课题受北京市朝阳区科技计划项目（编号：CYSF2047）资助

详细信息

作者简介:
王津京：专业方向为乳腺癌的化疗、分子靶向治疗、内分泌治疗及肿瘤的内科治疗

通讯作者:
马飞　drmafei@126.com

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出版历程
- 收稿日期: 2022-09-22
- 录用日期: 2022-12-07
- 修回日期: 2022-11-13

Evaluation of efficacy of pyrotinib in patients with HER-2 negative advanced breast cancer and HER-2 mutation

1.
Department of Oncology, Huan Xing Cancer Hospital, Beijing 100021, China
2.
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Funds: This work was supported by the Science and Technology Program of Chaoyang District, Beijing (No. CYSF2047)

More Information

Corresponding author: Fei Ma; E-mail: drmafei@126.com

摘要

摘要: 目的评估吡咯替尼对携带HER-2突变的HER-2阴性晚期乳腺癌患者的治疗疗效和安全性。方法回顾性分析2018年1月至2019年6月于北京市朝阳区桓兴肿瘤医院收治的13例携带HER-2突变的HER-2阴性晚期乳腺癌患者的临床资料，均使用吡咯替尼单药行抗HER-2治疗，对患者的治疗疗效和不良反应进行综合评估。结果 13例患者中3例因不良反应难以耐受出组，未行疗效评价，其余10例患者中获得完全缓解（complete response，CR）1例、部分缓解（partial response，PR）3例、疾病稳定（stable disease，SD）3例、疾病进展（progressive disease，PD）3例。客观缓解（CR+PR）率为40%（4/10），临床获益（CR+PR+SD≥6.0个月）率为60%（6/10），疾病控制（CR+PR+SD）率为70%（7/10）。无进展生存时间最长者达15.5个月，中位无进展生存期（progression-free survival，PFS）为4.9个月（95% CI：3.8～6.0）。吡咯替尼最常见的不良反应为腹泻、占84.6%（11/13），3级及以上的不良反应包括腹泻为15.4%（2/13）、恶心为7.7%（1/13）、呕吐为7.7%（1/13）。结论携带HER-2突变的HER-2阴性晚期乳腺癌患者，可能从吡咯替尼的抗HER-2治疗中获益。
- HER-2突变 /
- HER-2阴性 /
- 吡咯替尼 /
- 晚期乳腺癌
Abstract: Objective To evaluate the efficacy and safety of pyrotinib in managing patients with HER-2 negative advanced breast cancer, with HER-2 mutation. Methods A retrospective analysis was performed using the clinical data of 13 patients with HER-2 negative advanced breast cancer, with HER-2 mutation, admitted to the Huan Xing Cancer Hospital, Chaoyang District, Beijing, from January 2018 to June 2019. All patients were managed with pyrotinib monotherapy against HER-2. The therapeutic efficacy and adverse events of the patients were comprehensively evaluated. Results Among the 13 patients, three were excluded from the study because of intolerant adverse events before the first tumor response evaluation. Among the ten remaining patients, one patient achieved a complete response (CR), three patients achieved partial response (PR), three patients achieved a best response of stable disease (SD), and three patients experienced progressive disease (PD). The objective response (CR+PR) rate was 40.0% (4/10), the clinical benefit (CR+PR+SD≥6.0 months) rate was 60% (6/10), and the disease control (CR+PR+SD) rate was 70% (7/10). The longest progression-free survival (PFS) time was 15.5 months, and the median PFS was 4.9 months (95% CI: 3.8-6.0). The main toxicity related to pyrotinib was diarrhea, accounting for 84.6% (11/13). Adverse events above grade 3 experienced by the patients included diarrhea (2/13, 15.4%), nausea (1/13, 7.7%), and vomiting (1/13, 7.7%). Conclusions Patients with HER-2 negative advanced breast cancer, with HER-2 mutation, may benefit from anti-HER-2 treatment with pyrotinib.
- HER-2 mutation /
- HER-2 negative /
- pyrotinib /
- advanced breast cancer

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图 1 携带HER-2突变的HER-2阴性晚期乳腺癌患者吡咯替尼治疗后PFS曲线

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表 1 13例晚期乳腺癌患者的基因突变位点

患者序号	HER-2突变位点	合并PIK3CA 突变	最佳疗效
1	p.L755_T759del	否	未评价
2	p.G776V	是	未评价
3	p.S310Y、p.L403V、p.E1021K、p.V659L	否	未评价
4	p.S310F	是	CR
5	p.L755S	是	PR
6	p.Y772_A775dup	否	PR
7	p.D769Y、p.T862A	否	PR
8	p.S310Y、p.L403V	是	SD
9	p.D769Y、p.V777L	否	SD
10	p.S310F、p.D769Y	是	SD
11	p.A1076T	否	PD
12	p.Y772_A775dup	否	PD
13	p.L767M	否	PD

下载: 导出CSV

表 2 13例晚期乳腺癌患者吡咯替尼治疗后出现的不良反应情况

不良反应	总计		不良反应≥3级
不良反应	例数	百分比（%）	例数	百分比（%）
腹泻	11	84.6	2	15.4
呕吐	2	15.4	1	7.7
AST升高	2	15.4	0	0
食欲下降	2	15.4	0	0
口腔溃疡	1	7.7	0	0
恶心	1	7.7	1	7.7
肌酐升高	1	7.7	0	0
ALT升高	1	7.7	0	0
乏力	1	7.7	0	0
ALT：丙氨酸氨基转移酶；AST：天门冬氨酸氨基转移酶

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