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拉帕替尼与卡培他滨全口服联合方案用于HER2阳性乳腺癌脑转移患者——一项II期研究

All-oral combination of lapatinib and capecitabine in patients with brain metastases from HER2-positive breast cancer--a phase II study.

作者信息

Shawky Hanan, Tawfik Hesham

机构信息

Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital, Egypt.

Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital, Egypt.

出版信息

J Egypt Natl Canc Inst. 2014 Dec;26(4):187-94. doi: 10.1016/j.jnci.2014.08.001. Epub 2014 Oct 5.

DOI:10.1016/j.jnci.2014.08.001
PMID:25294797
Abstract

PURPOSE

Approximately one-third of patients with advanced, HER2+ve breast cancer (BC) develop brain metastases (BMs). The aim of this study is to investigate efficacy and tolerability of the combination of lapatinib and capecitabine (LC) in HER2+ve BC patients with brain metastases (BCBM).

PATIENTS AND METHODS

Between January 2011 and January 2013, 21 patients with HER2+ve BCBM were included. Sixteen patients (76.19%) progressed after whole brain radiotherapy (WBRT) and 5 patients (23.81%) were treatment-naïve for BM. Patients received lapatinib (1250 mg/day continuously) and capecitabine (2000 mg/m2 on days 1-14 of a 21-day cycle). All patients were treated with trastuzumab either in the adjuvant or metastatic setting. No patients had received prior lapatinib and/or capecitabine. End-points were response rate (RR), progression free survival (PFS), overall survival (OS) and toxicity.

RESULTS

The overall response rate (ORR) was 33.3% (7/21) and all were partial response. For patients receiving prior WBRT and patients receiving LC as first line treatment for BCBM the ORR was 31.2% (5/16) and 40.0% (2/5) respectively. Median PFS was 5.5 months. Median OS was 11 months. Treatment-related adverse events were manageable. Grade 3-4 toxicities were hand-foot syndrome (14.3%), diarrhea (14.3%), nausea/vomiting (9.5%), mucositis (4.8%), and skin rash (4.8%).

CONCLUSION

The combination of LC is active and well-tolerated treatment in patients with HER2+ve BCBM.

摘要

目的

约三分之一的晚期HER2阳性乳腺癌(BC)患者会发生脑转移(BMs)。本研究旨在探讨拉帕替尼与卡培他滨联合用药(LC)对HER2阳性脑转移乳腺癌(BCBM)患者的疗效和耐受性。

患者与方法

2011年1月至2013年1月期间,纳入21例HER2阳性BCBM患者。16例患者(76.19%)在全脑放疗(WBRT)后病情进展,5例患者(23.81%)未接受过BM治疗。患者接受拉帕替尼(持续每日1250 mg)和卡培他滨(21天周期的第1 - 14天,2000 mg/m²)治疗。所有患者在辅助或转移情况下均接受曲妥珠单抗治疗。所有患者均未接受过拉帕替尼和/或卡培他滨治疗。观察终点为缓解率(RR)、无进展生存期(PFS)、总生存期(OS)和毒性。

结果

总缓解率(ORR)为33.3%(7/21),均为部分缓解。对于接受过WBRT的患者和接受LC作为BCBM一线治疗的患者,ORR分别为31.2%(5/16)和40.0%(2/5)。中位PFS为5.5个月。中位OS为11个月。与治疗相关的不良事件可控。3 - 4级毒性反应为手足综合征(14.3%)、腹泻(14.3%)、恶心/呕吐(9.5%)、黏膜炎(4.8%)和皮疹(4.8%)。

结论

LC联合用药对HER2阳性BCBM患者有效且耐受性良好。

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