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Breast Cancer, Version 4.2017, NCCN Clinical Practice Guidelines in Oncology.《乳腺癌临床实践指南(NCCN 指南)》第 4 版 2017 年版
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Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study.皮下注射曲妥珠单抗与静脉注射曲妥珠单抗作为HER2阳性早期乳腺癌辅助治疗一部分的疗效和安全性:随机双队列PrefHer研究的最终分析
Eur J Cancer. 2017 Nov;86:82-90. doi: 10.1016/j.ejca.2017.08.019. Epub 2017 Sep 28.
3
Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study.HER2阳性转移性乳腺癌患者对曲妥珠单抗给药方式(皮下注射与静脉注射)的偏好:随机MetaspHer研究结果
Eur J Cancer. 2017 Sep;82:230-236. doi: 10.1016/j.ejca.2017.05.009. Epub 2017 Jun 23.
4
Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients.皮下注射曲妥珠单抗辅助治疗人表皮生长因子受体2阳性早期乳腺癌的安全性和耐受性:SafeHer III期研究对2573例患者的初步分析。
Eur J Cancer. 2017 Sep;82:237-246. doi: 10.1016/j.ejca.2017.05.010. Epub 2017 Jun 16.
5
Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain.西班牙曲妥珠单抗静脉或皮下治疗人表皮生长因子受体 2 阳性乳腺癌的成本最小化分析。
Clin Transl Oncol. 2017 Dec;19(12):1454-1461. doi: 10.1007/s12094-017-1684-4. Epub 2017 Jun 2.
6
Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial.曲妥珠单抗静脉注射与皮下注射的转换:PrefHer试验的安全性结果。
Breast. 2017 Aug;34:89-95. doi: 10.1016/j.breast.2017.05.004. Epub 2017 May 23.
7
11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial.HER2阳性早期乳腺癌辅助化疗后曲妥珠单抗的11年随访:HERceptin辅助治疗(HERA)试验的最终分析
Lancet. 2017 Mar 25;389(10075):1195-1205. doi: 10.1016/S0140-6736(16)32616-2. Epub 2017 Feb 17.
8
HannaH phase III randomised study: Association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up.HannaH Ⅲ 期随机研究:在 2 年无治疗随访后接受新辅助-辅助曲妥珠单抗治疗的 HER2 阳性早期乳腺癌患者中,总病理完全缓解与无事件生存的相关性。
Eur J Cancer. 2016 Jul;62:62-75. doi: 10.1016/j.ejca.2016.03.087. Epub 2016 May 20.
9
A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer.HER2阳性早期乳腺癌患者皮下注射与静脉注射曲妥珠单抗的时间与动作研究。
Cancer Med. 2016 Mar;5(3):389-97. doi: 10.1002/cam4.573. Epub 2016 Jan 25.
10
Rituximab for subcutaneous delivery: Clinical management principles from a nursing perspective.皮下注射用利妥昔单抗:护理视角下的临床管理原则
Int J Nurs Pract. 2015 Dec;21 Suppl 3:1-13. doi: 10.1111/ijn.12413.

曲妥珠单抗皮下给药治疗 HER2 阳性乳腺癌的多学科视角。

A multidisciplinary perspective on the subcutaneous administration of trastuzumab in HER2-positive breast cancer.

机构信息

Duke Cancer Center, Durham, NC, U.S.A.

Canadian Breast Cancer Network, Montreal, QC.

出版信息

Curr Oncol. 2019 Feb;26(1):e70-e80. doi: 10.3747/co.26.4220. Epub 2019 Feb 1.

DOI:10.3747/co.26.4220
PMID:30853812
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6380645/
Abstract

Trastuzumab is the standard treatment in Canada for patients with breast cancer positive for her2 (human epidermal growth factor receptor 2), dramatically improving outcomes in that patient group. However, its current intravenous (IV) administration is associated with long infusion times that place a significant burden on health care resources and patient quality of life. In an effort to provide a faster and easier administration method, a subcutaneous (sc) formulation of trastuzumab has been developed. Data from comparative trials demonstrate that the two formulations are comparable with respect to pharmacokinetics and efficacy. They also have similar safety profiles, with the exception of mild local and administration reactions with the sc formulation. Furthermore, the sc formulation is preferred by patients and health care professionals, and greatly reduces administration and chair time. Additional advantages include easier preparation and dosing, reduced drug wastage, and reduced discomfort at the injection site. By using well-thought-out administration procedures, the sc formulation can be given safely and effectively, potentially reducing the burden on health care resources and improving quality of life for patients.

摘要

曲妥珠单抗是加拿大用于治疗人表皮生长因子受体 2(HER2)阳性乳腺癌患者的标准治疗药物,显著改善了该患者群体的治疗效果。然而,其目前的静脉注射(IV)给药方式与较长的输注时间相关,这给医疗资源和患者的生活质量带来了很大的负担。为了提供更快、更简便的给药方法,已经开发了曲妥珠单抗的皮下(SC)制剂。来自比较试验的数据表明,这两种制剂在药代动力学和疗效方面具有可比性。它们也具有相似的安全性特征,除了 SC 制剂的轻微局部和给药反应。此外,SC 制剂更受患者和医疗保健专业人员的青睐,并且大大减少了给药和椅子时间。其他优点包括更容易的准备和给药、减少药物浪费以及减少注射部位的不适。通过使用深思熟虑的给药程序,可以安全有效地使用 SC 制剂,可能会减轻医疗资源的负担并改善患者的生活质量。