Pyrotinib Plus Taxanes or Vinorelbine for the Treatment of Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: Prospective Evaluation of Efficacy and Safety.

IF 2.9 3区 医学 Q2 ONCOLOGY Clinical breast cancer Pub Date : 2024-12-05 DOI:10.1016/j.clbc.2024.12.006
Weili Xiong, Jiukang Sun, Quan Gu, Ting Xu, Lili Zhang, Yuan Yuan
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Abstract

Purpose: The clinical benefits of pyrotinib plus taxanes or vinorelbine have not been studied systemically. Consequently, we conducted a prospective evaluation to assess the efficacy and safety of pyrotinib plus taxanes or vinorelbine in patients with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer (MBC).

Methods: Patients with HER2-positive MBC were included to receive pyrotinib combined with taxanes or vinorelbine in Jiangsu Cancer Hospital. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), and adverse effects (AEs).

Results: Between December 22, 2020 and January 11, 2023, a total of 101 patients were assigned to pyrotinib plus taxanes (n = 83) and pyrotinib plus vinorelbine (n = 18) groups. As of May 24, 2023, the median PFS for all patients was 11.5 months (95% confidence interval [CI], 8.8-15.7). The median PFS was significantly longer in pyrotinib plus taxanes group than in pyrotinib plus vinorelbine group (median PFS, 12.2 months [95% CI, 9.2-18.6] vs. 8.4 months [95% CI, 5.5-13.7]; P = .005). All the treatment-related side effects were tolerated. The most frequent grade 3 or 4 side effects included diarrhea (22.8%), leukopenia (19.5%), and neutropenia (18.2%).

Conclusion: Pyrotinib plus taxanes could be an alternative or even the preferred treatment strategy for patients with HER2-positive MBC after trastuzumab and small-molecule tyrosine kinase inhibitors (TKIs). We also suggest that pyrotinib combined with vinorelbine has a therapeutic potential.

Registration: This trial was registered in Chinese Clinical Trial Registry. URL: https://www.chictr.org.cn/showproj.html?proj=65697 (ChiCTR2000041217).

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吡罗替尼联合紫杉烷或长春瑞滨治疗人表皮生长因子受体2阳性转移性乳腺癌:疗效和安全性的前瞻性评价
目的:吡罗替尼联合紫杉烷或长春瑞滨的临床疗效尚未系统研究。因此,我们进行了一项前瞻性评估,以评估pyrotinib联合紫杉烷或长春瑞滨在人表皮生长因子2 (HER2)阳性转移性乳腺癌(MBC)患者中的疗效和安全性。方法:选取江苏省肿瘤医院her2阳性MBC患者,采用吡罗替尼联合紫杉烷或长春瑞滨治疗。主要终点为无进展生存期(PFS),次要终点为客观缓解率(ORR)、疾病控制率(DCR)、临床获益率(CBR)和不良反应(ae)。结果:在2020年12月22日至2023年1月11日期间,共有101例患者被分配到吡罗替尼加紫杉烷组(n = 83)和吡罗替尼加长春瑞滨组(n = 18)。截至2023年5月24日,所有患者的中位PFS为11.5个月(95%可信区间[CI], 8.8-15.7)。吡罗替尼加紫杉烷组的中位PFS明显长于吡罗替尼加长春瑞滨组(中位PFS为12.2个月[95% CI, 9.2-18.6] vs. 8.4个月[95% CI, 5.5-13.7];P = .005)。所有与治疗相关的副作用均可耐受。最常见的3级或4级副作用包括腹泻(22.8%)、白细胞减少(19.5%)和中性粒细胞减少(18.2%)。结论:吡罗替尼联合紫杉烷可作为her2阳性MBC患者在曲妥珠单抗和小分子酪氨酸激酶抑制剂(TKIs)治疗后的替代甚至首选治疗策略。我们也认为吡罗替尼联合长春瑞滨具有治疗潜力。注册:本试验已在中国临床试验注册中心注册。网址:https://www.chictr.org.cn/showproj.html?proj=65697 (ChiCTR2000041217)。
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来源期刊
Clinical breast cancer
Clinical breast cancer 医学-肿瘤学
CiteScore
5.40
自引率
3.20%
发文量
174
审稿时长
48 days
期刊介绍: Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Specific areas of interest include clinical research reports from various therapeutic modalities, cancer genetics, drug sensitivity and resistance, novel imaging, tumor genomics, biomarkers, and chemoprevention strategies.
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